School Vaccine Mandates
The Centers for Disease Control (CDC) recommends some 35 doses of 12 vaccines (including a COVID vaccine and yearly flu shots) for kids from birth to age six. No U.S. federal laws mandate vaccination, but all 50 states require certain vaccinations for children entering public schools. Most states offer medical and religious exemptions, and some states allow philosophical exemptions. [1][121]
Early History of Vaccines
The Chinese used inoculation techniques against smallpox as early as 1000 AD and similar techniques were also used in ancient Africa and Turkey. The first instance of vaccine promotion in the United States was in 1721 when Cotton Mather, a Puritan minister, encouraged smallpox vaccination in response to an outbreak. Vaccination as practiced today came into being when Edward Jenner, English physician and scientist, created the first smallpox vaccine using cowpox (a disease similar to smallpox that infects cows) and vaccinating an eight-year-old boy in 1796. Jenner’s innovation was used for 200 years, with updates, and eradicated smallpox. [2][3]
In 1801 Benjamin Waterhouse, physician and co-founder and president of Harvard Medical School, began using the “Cowpox Vaccine,” leading to Massachusetts becoming the first U.S. state to promote the use of vaccination. In 1809 the town of Milton, Massachusetts became the first U.S. town to offer free smallpox vaccinations, which was followed by a state law that same year requiring the smallpox vaccination. [3][4]
Later, on Feb. 27, 1813, U.S. President James Madison signed into law An Act to Encourage Vaccination, which created the National Vaccine Agency (now part of the U.S. Department of Health & Human Services). [5]
In 1855 Massachusetts passed the first U.S. state law mandating vaccinations for schoolchildren, followed by New York (1862), Connecticut (1872), Indiana (1881), Arkansas (1882), Illinois (1882), Virginia (1882), Wisconsin (1882), California (1888), Iowa (1889), and Pennsylvania (1895). By 1963, 20 states would require immunization to attend public schools; and 29 states by 1970. [4][5][6]
In response to immunization laws, in 1878, the National Anti-Compulsory Vaccination Reporter stated that “the dangerous illnesses following the vaccine process are … on the whole … a greater evil to humanity than small-pox itself!” The Anti-Vaccination Society of America was founded in 1879 in response to the states enacting vaccination mandates and with the belief that it “is undignified” to mandate vaccinations and that the “efficacy of vaccination as a disease preventative is a matter of individual opinion.” In 1882 the New England Anti-Compulsory Vaccination League was founded and in 1885 the Anti-Vaccination League of New York City was created. With their influence, the anti-vaccination groups began getting vaccine mandates repealed in California, Illinois, Indiana, Minnesota, Utah, West Virginia, and Wisconsin. [7][8]
The first laboratory-created vaccine was for avian cholera (which most commonly infects chickens), developed by Louis Pasteur, French chemist and microbiologist, in 1879. In 1885, Pasteur created the rabies vaccine, beginning an active period of vaccine development for human illnesses through the 1930s that saw vaccines developed for typhoid (1899), cholera (1911), diphtheria (1914), tuberculosis (1921), and tetanus (1924), among others. Vaccines for polio (1955), measles (1963), mumps (1967), and rubella (1969) followed in the mid-20th century. [2]
During the active period of vaccine development, in 1901 the first Nobel Prize in Physiology or Medicine was awarded to Emil von Behring, a German physiologist, for his work developing serum therapy in connection to a diphtheria vaccination. [10]
On July 1, 1902, Congress passed An Act to Regulate the Sale of Viruses, Serums, Toxins, and Analogous Products (also referred to as the Biologics Control Act), which was the first legislation to control the quality of drugs, specifically the quality of vaccines. [2]
Later, on Feb. 20, 1905, mandatory vaccination was upheld by the U.S. Supreme Court in Jacobson v. Massachusetts (7-2). In the aftermath of the ruling more states across the country began to implement mandatory child vaccination as a condition of public school attendance. [9]
On Nov. 13, 1922, the constitutionality of mandatory vaccination of school children was once again challenged and upheld in the Zucht v. King; the U.S. Supreme Court declined to hear the case, stating that it was “within the police power of a state to provide for compulsory vaccination.” [5][11]
In 1951, Jonas Salk and his team developed a method to cultivate the polio virus in monkey kidney tissue in order to be able to produce large amounts of the vaccine. On Apr. 12, 1955, the results of the Salk vaccine trials showed the vaccine was 80-90% effective and the U.S. government licensed the IPV polio vaccine the same day. The vaccination program was suspended on May 8, 1955 to investigate paralysis resulting from the vaccine injection; changes to the production method were made and vaccination resumed on May 27, 1955. The number of paralytic polio cases decreased from 28,985 in 1955 to 72 in 1965. The last case of the disease in the United States was reported in 1993, and polio was declared eliminated in the western hemisphere on Sep. 29, 1994 by the Pan American Health Organization. [12][13][27]
National Childhood Vaccine Injury Act and Vaccine Adverse Event Reporting System
In 1986 the National Childhood Vaccine Injury Act was passed in response to a large number of lawsuits filed claiming vaccines were causing adverse reactions including brain damage and death. The act shielded medical professionals and vaccine manufacturers from liability if an individual suffered injury from receiving vaccines. The act mandated that vaccine injury claims be filed with the U.S. Court of Federal Claims rather than filed directly against physicians or vaccine manufacturers in civil court. Unlike civil court, people filing injury claims are not required to prove negligence or failure to warn; they only need to prove that a vaccine caused injury. [14][15][16]
On Oct. 1, 1988, the National Vaccine Injury Compensation Program (VICP) was created under the National Childhood Vaccine Injury Act. The VICP was “established to ensure an adequate supply of vaccines, stabilize vaccine costs, and establish and maintain an accessible and efficient forum for individuals found to be injured by certain vaccines.” Between 1989 and July 1, 2014, 3,645 compensation awards have been made (amounting to over $2.7 billion in awards and $113.2 million to cover legal costs) and 9,786 claims have been dismissed (amounting to $62.8 million paid to 4,925 dismissed claimants to cover legal costs). [17]
Subsequently, in 1990 the CDC and FDA created the Vaccine Adverse Event Reporting System (VAERS). VAERS collects information about adverse events via reports filed by anyone, including medical professionals and family members. VAERS receives about 30,000 reports each year. 85-90% of VAERS reports are for “mild adverse events such as fever, local reactions [such as redness at the injection site], and episodes or crying or mild irritability.” The other 10-15% of VAERS reports is for “serious adverse events involving life-threatening conditions, hospitalization, permanent disability, or death, which may or may not have been caused by a vaccine.” [18]
In 1993 the U.S. Congress passed the Comprehensive Childhood Immunization Act of 1993 that created the Vaccines for Children (VFC) program to provide vaccinations free of charge to children in need in order to increase the number of vaccinated children. [19]
Andrew Wakefield and the Autism Controversy
In Feb. 1998 Lancet published an article by Andrew Wakefield titled “Ileal-Lymphoid-Nodular Hyperplasia, Non-Specific Colitis, and Pervasive Developmental Disorder in Children.” The article claimed “Rubella virus is associated with autism and the combined measles, mumps, and rubella [MMR] vaccine … has also been implicated.” Anti-vaccination groups and parents began using Wakefield’s article as rationale to opt-out of vaccinating their children. [20]
Between 2003 and 2012, Brian Deer, an investigative reporter, examined the story and published 36 articles that accused Wakefield of “falsifying medical histories of children and essentially concocting a picture, which was the picture he was contracted to find by lawyers hoping to sue vaccine manufacturers and to create a vaccine scare.” On March 3, 2004, ten of the twelve co-authors of Wakefield’s article released a “Retraction of an Interpretation” in Lancet, stating “We wish to make it clear that in this paper no causal link was established between MMR vaccine and autism as the data were insufficient.” Lancet retracted Wakefield’s article on Feb. 2, 2010, stating “it has become clear that several elements of the 1998 paper by Wakefield et al are incorrect.” On Jan. 5, 2011, the British Journal of Medicine published an article stating that Wakefield received over $674,000 from lawyers and that, of 12 children examined, five had developmental problems before being vaccinated and three never had autism. [21][22][23][24]
As a result, on May 24, 2011, Britain stripped Wakefield of his medical license, stating Wakefield had “abused his position of trust” and “brought the medical profession into disrepute.” Wakefield contends that the investigation of his work is part of a conspiracy to “discredit and silence his research” in order to “shield the government from exposure on the vaccine scandal.” [21][25]
Thimerosal and Autism
On July 9, 1999, in response to growing concern over a link between vaccination and autism, the American Academy of Pediatrics (AAP) and the U.S. Public Health Service (PHS) recommended that thimerosal be removed from vaccines “as soon as possible.” However, they also stated, “there are no data or evidence of any harm caused by the level of exposure that some children may have encountered in following the existing immunization schedule” and that “the large risks of not vaccinating children far outweigh the unknown and probably much smaller risk, if any, of cumulative exposure to thimerosal-containing vaccines over the first 6 months of life.” [26]
In May 2003, U.S. Representative Dan Burton (R-IN) released a report titled “Mercury in Medicine – Taking Unnecessary Risks” in which he requested that the FDA remove thimerosal from the flu vaccine and recommended independent research on the link between thimerosal in vaccines and autism. [27]
In 2005, Robert F. Kennedy, Jr. wrote an article co-published by Salon (June 16) and Rolling Stone (July 14) titled “Deadly Immunity,” arguing that the 2000 Simpsonwood CDC Conference was spent “discussing how to cover up the damaging data” that there were a “staggering number of earlier studies that indicate a link between thimerosal and speech delays, attention-deficit disorder, hyperactivity, and autism.” The article was corrected multiple times within days of publication and then retracted and deleted by Salon and Rolling Stone on Jan. 16, 2011. The controversy resulted in an 18-month investigation by the U.S. Senate Committee on Health, Education, Labor and Pensions, which concluded that Kennedy’s allegation was unsubstantiated and “thimerosal was [being] voluntarily removed from childhood vaccines distributed in the United States as a precaution,” prompted by a joint request by the American Academy of Pediatrics and the U.S. Public Health Service. As of 2007, vaccines for children 6 years old and younger contain no thimerosal or only trace amounts, except for inactivated flu vaccines, which are available in both thimerosal-containing and preservative-free versions. By Nov. 30, 2009, the mercury-based preservative thimerosal had been phased out of all vaccines in the United States with the exception of certain influenza, meningococcal, and tetanus vaccines. [28][29][30][112]
On Aug. 27, 2010, the U.S. Court of Appeals for the Federal Circuit ruled (3-0) that there is no link between vaccination and autism in the case of Cedillo v. Secretary of Health and Human Services. The decision upheld two earlier rulings: a 2007 ruling by the United States Court of Federal Claims Office of Special Masters and an affirmation of that ruling by the Court of Federal Claims. On Feb. 22, 2011, the U.S. Supreme Court ruled (6-2) in the case of Bruesewitz v. Wyeth that vaccine injury claims must continue to be filed with the U.S. Court of Federal Claims set up under the National Childhood Vaccine Injury Act of 1986, and cannot be filed directly against physicians or vaccine manufacturers in civil court. [31][32]
On Aug. 25, 2011, the Institute of Medicine (IOM) issued a report, “Adverse Effects of Vaccines: Evidence and Causality.” The report brief stated that “evidence favors rejection of a causal relationship” between the Measles-Mumps-Rubella (MMR) vaccine and autism. The Cochrane Collaboration, in a Feb. 15, 2012, independent investigation of studies on vaccines and autism concluded, “We could assess no significant association between MMR immunisation and the following conditions: autism, asthma, leukaemia, hay fever, type 1 diabetes, gait disturbance, Chrohn’s disease, demyelinating diseases, or bacterial or viral infections.” A study published in the Proceedings of the National Academy of Sciences of the United States of America (PNAS) on Oct. 6, 2015, found that infant rhesus macaques, whose physiology closely resembles human infants, injected with human childhood vaccines from the early 1990s (that contained thimerosal) and from 2008 (after thimerosal was phased out of childhood vaccines) exhibited no behavioral or neuropathological changes that could be linked to autism. A March 5, 2019, study published in the Annals of Internal Medicine, studied 657,461 children over ten years in Denmark, and concluded, “The study strongly supports that MMR vaccination does not increase the risk for autism, does not trigger autism in susceptible children, and is not associated with clustering of autism cases after vaccination.” [33][34][35][114][115][122]
COVID-19 Vaccine
On Oct. 20, 2022, the CDC voted to add the coronavirus vaccine to the schedule of recommended vaccines for children and adults. However, only California (effective July 1, 2023) and D.C. (effective for the 2022-2023 school year) have announced the intent to require the COVID-19 vaccine and both will require only fully FDA approved coronavirus vaccines for the recommended age groups, which are the Pfizer-BioNTech COVID-19 vaccine (brand name Comirnaty) for children 12 and up, and the Moderna COVID-19 vaccine (brand name Spikevax) for those 18 and up (which could include some high school students) as of Oct. 24, 2022. [134][135][136][137][138]
Potential Consequences for Unvaccinated Children and Their Parents
State laws in North Carolina, Ohio, and New York allow the public school system to suspend children who are not vaccinated. Approximately 2,000 seventh- to twelfth-grade children not vaccinated against pertussis (whooping cough) were barred from attending classes in San Francisco in 2011. On June 22, 2014, federal Judge William Kuntz upheld New York state law barring unvaccinated children from public school when other children have chickenpox. Many pediatricians will not treat children who have not been vaccinated. Some legal experts believe that parents who do not vaccinate their children should be subject to criminal prosecution (including criminally negligent homicide and monetary damages) if their unvaccinated children infect and harm other children who are too young or immunocompromised to receive vaccines. [36][37][38][39][40][41][42]
Despite potential consequences, an Aug. 7, 2024, Gallup poll found that “fewer Americans today consider childhood vaccines important, with 40% saying it is extremely important for parents to have their children vaccinated, down from 58% in 2019 and 64% in 2001. There has been a similar decline in the combined ‘extremely’ and ‘very important’ percentage, which was 94% in 2001 but sits at 69% today.” [147]
Eradication and Elimination of Disease
Elimination means that the disease is not present in a region, while eradication means that the disease does not exist anywhere globally. Polio was declared eliminated in the United States in 1979 and in the Western Hemisphere in 1994. Rubella was declared eliminated in the Americas on Apr. 29, 2015, and measles on Sept. 27, 2016. Smallpox was declared globally eradicated in 1980, the first and only disease to be eradicated thus far. The World Health Organization states that eradication and elimination is the product of vaccination programs that promote high rates of inoculation, while those opposed to vaccination state that better sanitation and clean water led to the elimination of the diseases. [16][117][118][119][120]
So, should states be allowed to mandate vaccines for school attendance? Explore the debate below.
Pros and Cons at a Glance
| PROS | CONS |
|---|---|
| Pro 1: Vaccine-preventable diseases have not disappeared, so mandated vaccination is still necessary. Read More. | Con 1: Vaccine mandates infringe upon constitutionally protected religious freedoms. Read More. |
| Pro 2: Vaccine mandates ensure the “herd” is protected. Read More. | Con 2: Mandates are not the most effective way to ensure vaccine-hesitant parents vaccinate their children. Read More. |
| Pro 3: Vaccine mandates save children, parents, and society time and money. Read More. | Con 3: The government should not intervene in personal medical choices. Read More. |
Pro Arguments
(Go to Con Arguments)Pro 1: Vaccine-preventable diseases have not disappeared, so mandated vaccination is still necessary.
Children are no longer vaccinated against smallpox because the disease no longer exists due to vaccination. The last case of smallpox in the United States was in 1948; the last case in the world was 1977 in Somalia. However, earlier in the 20th century, there were 29,004 deaths from smallpox yearly in the United States. [74][75]
According to the WHO, “Wild poliovirus cases have decreased by over 99% since 1988, from an estimated 350 000 cases in more than 125 endemic countries to 6 reported cases in 2021.” The disease now only exists in two countries: Pakistan and Afghanistan. [140]
Diphtheria killed 21,053 people yearly; measles killed 530,217 people yearly; mumps killed 162,344 people yearly; rubella killed 47,745 people yearly; and Hib (a bacterium that causes pneumonia and meningitis) killed 20,000 people yearly in the twentieth century United States; by 2012 each of these diseases were decreased by 99% because of vaccinations. [75]
However, the CDC notes that many vaccine-preventable diseases are still in the United States or “only a plane ride away.” Between Jan. 1, 2019, and May 17, 2019, there were 880 individual measles cases reported in 24 states (compared to 372 cases in all of 2018). Of those, 44 cases were directly imported from 12 other countries, including Philippines, Ukraine, Israel, and Thailand. According to the WHO, in Jan. 2019 alone, there were 1,802 cases of measles in Philippines, 13,760 in Ukraine, 290 in Israel, and 797 in Thailand. [76][130][131][132]
UNICEF reported that, globally, 453,000 children die from rotavirus, 476,000 die from pneumococcus (the bacterium that causes pneumonia, meningitis, and blood infections), 199,000 die from Hib, 195,000 die from pertussis (whooping cough), 118,000 die from the measles, and 60,000 die from tetanus each year, all vaccine-preventable diseases. [52]
Pro 2: Vaccine mandates ensure the “herd” is protected.
According to Brian K. Lee, Assistant Professor at the School of Public Health at Drexel University, herd immunity (or community immunity) is the “state in which a large proportion of a population is able to repel an infectious disease, thereby limiting the extent to which the disease can spread from person to person.” Herd immunity is able to “occur when the population density of persons who are susceptible to infection is sufficiently low so as to minimize the likelihood of an infected individual coming in contact with a susceptible individual. Herd immunity can prevent sustained disease spread in populations, thereby protecting susceptible individuals from infection.” [146]
Children and adults who cannot be vaccinated due to age, poor health (who are immune-compromised or undergoing chemotherapy, for example), or other reasons rely on herd immunity to prevent contraction of vaccine-preventable diseases. [62]
An Apr. 2019 measles outbreak resulted in the quarantine of over 200 people who had been exposed to the measles on the campuses of the University of California at Los Angeles and California State University. Because they could not verify their vaccinations, quarantining them raised the campus’ herd immunity and blocked the spread of the disease. In 2011, 49 US states did not meet the 92-94% herd immunity threshold for pertussis (whooping cough), resulting in a 2012 outbreak that sickened 48,277 people and was the biggest outbreak since 1955. [64][123][124]
However, in 2005, an 18-month-old Amish girl contracted polio and spread the disease to four other unvaccinated children, but because the community met the herd immunity threshold for the disease, there was no polio outbreak. Vaccine mandates ensure that herd immunity remains high enough to protect the vulnerable. [65][66]
Pro 3: Vaccine mandates save children, parents, and society time and money.
Vaccines cost less in time and money to obtain than infectious diseases cost in time off of work to care for a sick child, potential short- or long-term disability care, and medical costs. For example, children under five with the flu are contagious for about eight days, and, according to a 2012 CDC study, cost their parents an average of 11 to 73 hours of wages (about $222 to $1,456) and $300 to $4,000 in medical expenses. Children with rotavirus are contagious for up to 30 days, greatly increasing costs to parents. Children miss critical school days rich in education and social development, while being subjected to an illness. Furthermore, under the Patient Protection and Affordable Care Act (PPACA, or Obamacare) many vaccines are available to children and adults without copay. [67][68][69][70][71]
Taxpayers, even those without children or with vaccinated children, also pay for children who contract vaccine-preventable diseases. A 2018 study found that each case of measles in Arkansas cost the health department $47,962. Between Jan. 1 and May 20, 2019, there were 880 cases of measles in 24 states, costing taxpayers an estimated $42.2 million. [125][126]
The CDC estimates that vaccinated children born between 1994 and 2018 have yielded net savings of $406 billion in direct costs and $1.9 trillion in societal costs, which includes money saved by preventing lost productivity due to disability and early death. The United States saves about $27 per $1 invested in DTaP vaccination, and $13 per $1 spent on MMR vaccination. [80][128]
Globally, UNICEF estimates that $6.2 billion could be saved in treatment costs if vaccines were more prominent in the world’s poorest countries. According to the International Vaccines Access Center, $62.9 billion could be saved by providing Hib, pneumococcal, and rotavirus vaccinations to the 73 poorest countries: $1.4 billion in treatment costs, $300 million in lost caretaker wages, $6.2 billion in lifetime productivity loss due to disability, and $55 billion in lifetime productivity loss because of death. American taxpayers subsidize aid to these countries. [52][81]
Con Arguments
(Go to Pro Arguments)Con 1: Vaccine mandates infringe upon constitutionally protected religious freedoms.
The First Amendment of the U.S. Constitution states, “Congress shall make no law respecting an establishment of religion, or prohibiting the free exercise thereof.” [91]
In the unanimous 1939 ruling for Cantwell v. Connecticut, the US Supreme Court held that state and local governments’ infringement upon religious freedom is also unconstitutional. [92]
Several religions oppose vaccines and mandatory vaccinations. Some Christian Scientists consider vaccinations against their religion because founder Mary Baker Eddy stated that the “calm, Christian state of mind is a better preventative of contagion than a drug, or than any other possible sanative method… the ‘perfect Love’ that ‘casteth out fear’ is a sure defense.” [93]
Amish communities do not view all vaccinations as “necessary” and some believe that vaccinations weaken the immune system. [78][94]
The Church of Illumination states that “the teachings of the Church unequivocally affirm that injections of vaccines and inoculations are a violation of these biblical teachings… Immunizations and vaccinations are a form of blood pollution because they have devastating effects on the regeneration of the soul that each Church member seeks to attain.” [95]
The Universal Family Church believes that parents should decide whether their children should be vaccinated and that “God intends the health decisions of individuals should… be honored by all authorities.” [96]
Con 2: Mandates are not the most effective way to ensure vaccine-hesitant parents vaccinate their children.
Because a high percentage of kids will already be vaccinated, or their parents are agreeable to additional vaccines, state school policies are necessarily directed toward parents and caregivers who are vaccine hesitant or whose children are under- or unvaccinated.
A 2019 study found “Vaccine-hesitant parents who are on the fence far outnumber vaccine refusers; therefore, counseling this group might be more effective,” because mandates are not the best way to change peoples’ minds about vaccines. The study found that “Practical tips for addressing parental vaccine hesitancy in primary care include starting early, presenting vaccination as the default approach, building trust, being honest about side effects, providing reassurance on a robust vaccine safety system, focusing on protection of the child and community, telling stories, and addressing pain.” [139]
The study concluded family physicians are a front-line resource in battling vaccine hesitancy: “Reasons behind vaccine hesitancy are complex and encompass more than just a knowledge deficit. As a trusted source of information on vaccines, family physicians play a key role in driving vaccine acceptance.” [139]
People of color and LGBTQ+ people have high rates of healthcare distrust due to current and historical medical mistreatment and discrimination, which can translate into vaccine hesitancy. As the Commonwealth Fund explained, “The medical establishment has a long history of mistreating Black Americans — from gruesome experiments on enslaved people to the forced sterilizations of Black women and the infamous Tuskegee syphilis study that withheld treatment from hundreds of Black men for decades to let doctors track the course of the disease.” These concerns have continued into the modern medicine era and are applicable to other communities of color, including Latinos and Indigenous people. Offering education about vaccines would be a more effective and kind policy than mandates. [141][142][143][144][145]
Con 3: The government should not intervene in personal medical choices.
Medical decisions for children should be left to parents or caregivers. Barbara Loe Fisher, Co-founder of National Vaccine Information Center, stated, “If the State can tag, track down and force citizens against their will to be injected with biological products… there will be no limit on which individual freedoms the State can take away in the name of the greater good tomorrow.” [89]
Ron Paul, former US Representative (R-TX), stated, “intimately personal medical decisions should not be made by government…. Freedom over one’s physical person is the most basic freedom of all, and people in a free society should be sovereign over their own bodies. When we give government the power to make medical decisions for us, we in essence accept that the state owns our bodies.” [90]
Further, some vaccines contain ingredients some parents consider immoral or otherwise objectionable; mandates infringe on those sincerely held beliefs. For example, some DTaP/IPV/Hib combination, Hep A/Hep B combination, HepA, MMR, and chickenpox vaccines are cultivated in cells from two fetuses aborted in the 1960s (listed as MRC-5 and WI-38 on package inserts). The Catholic Church, in a report about using vaccines made using cells from aborted fetuses, indicated that “there is a grave responsibility to use alternative vaccines” to avoid the “evil” of actively or passively participating in anything that involves abortion. [97]
And some vaccines for DTaP, Hep A, RV, Hib, HPV, IPV, flu, MMR, and chickenpox are made using animal products like chicken eggs, bovine casein, insect cells, Cocker Spaniel cells, pig gelatin, and cells from African Green monkeys, making those vaccines conflict with some vegetarian and vegan philosophies. Others consider it problematic that some vaccines are produced using human albumin, a blood plasma protein.
Vaccinations Required for Public School Kindergarten
Each state and D.C. has its own vaccine requirements to attend public school. Below, find which vaccines are mandated for public school kindergarten entry as of Aug. 16, 2021. At the bottom of the page, find a link for each state’s requirements.
On Oct. 20, 2022, the CDC voted to add the coronavirus vaccine to the schedule of recommended vaccines for children and adults. However, only California (effective July 1, 2023) and D.C. (effective for the 2022-2023 school year) have announced the intent to require the COVID-19 vaccine for school attendance. Both require only fully FDA approved coronavirus vaccines for the recommended age groups, which are the Pfizer-BioNTech COVID-19 vaccine (brand name Comirnaty) for children 12 and up, and the Moderna COVID-19 vaccine (brand name Spikevax) for those 18 and up (which could include some high school students) as of Oct. 24, 2022, meaning no kindergartener will have to be vaccinated against COVID-19 for school entry. [134][135][136][137][138]
Though each state and D.C. has vaccine requirements, every state and D.C. also allows for vaccine exemptions. Note that this resource is for educational purposes only and may not reflect the most recent changes in any state requirements. Always check with your state’s Department of Health, Department of Education, or local school for current vaccination requirements. The CDC also provides vaccination schedules.
DTaP: Diphtheria, Tetanus, & Pertussis
All 50 states and D.C. require the DTap vaccine (or another vaccine combination for diphtheria, tetanus, and pertussis) for kindergarten entry.
IPV: Polio
All 50 states and D.C. require the IPV vaccine for kindergarten entry.
Varicella: Chickenpox
All 50 states and D.C. require the varicella vaccine for kindergarten entry, though some will accept proof of immunity (meaning the child had chickenpox) instead of vaccination. Some states list the MMRV (measles, mumps, rubella, and varicella) vaccine as appropriate.
MMR: Measles, Mumps, & Rubella
49 states and D.C. require the MMR vaccine for kindergarten entry. Some states list the MMRV (measles, mumps, rubella, and varicella) vaccine as appropriate.
Iowa, the only state to not require the MMR vaccine, requires a measles and a rubella vaccine, but not a mumps vaccine.
HepB: Hepatitis B
44 states and D.C. require the Hep B vaccine for kindergarten entry.
Alabama, Maine, Montana, Rhode Island, South Dakota, and Vermont do not require the HepB vaccine for kindergarten entry.
HepA: Hepatitis A
17 states require the Hep A vaccine for kindergarten entry: Alaska, Arkansas, Connecticut, Georgia, Hawaii, Idaho, Indiana, Kansas, Kentucky, Nevada, Oklahoma, Oregon, South Carolina, Tennessee, Texas, Utah, and Virginia.
Hib: Haemophilus Influenza Type b
Some states require this vaccine if the child is entering kindergarten before turning 5 years old. We have included only vaccine requirements for all kindergartners. Please consult your state requirements if the child will be 4 years old when entering kindergarten.
PCV: Pneumococcal
Some states require this vaccine if the child is entering kindergarten before turning 5 years old. We have included only vaccine requirements for all kindergartners. Please consult your state requirements if the child will be 4 years old when entering kindergarten.
State Vaccination Exemptions for Children Entering Public Schools
No U.S. federal vaccination laws exist, but all 50 states have laws requiring children attending public school to be vaccinated against diphtheria, tetanus, and pertussis (generally in a DTaP vaccine); polio (an IPV vaccine); measles and rubella (generally in an MMR vaccine); and varicella (chickenpox). All 50 states allow medical exemptions, 45 states allow religious exemptions, and 15 states allow philosophical (or personal belief) exemptions. D.C. allows medical and religious exemptions.
While reasonable effort has been made to ensure the accuracy of the information provided, do not rely on this information without first checking with your local school or government.
| Allows Medical Exemptions | Allows Religious Exemptions | Allows Philosophical Exemptions | |
|---|---|---|---|
| 50 states & D.C. | 45 states & D.C. | 15 states & D.C. | |
| Alabama | yes | yes | no |
| Alaska | yes | yes | no |
| Arizona | yes | yes | yes |
| Arkansas | yes | yes | yes |
| California | yes | no | no |
| Colorado | yes | yes | yes |
| Connecticut | yes | no | no |
| Delaware | yes | yes | no |
| DC | yes | yes | no |
| Florida | yes | yes | no |
| Georgia | yes | yes | no |
| Hawaii | yes | yes | no |
| Idaho | yes | yes | yes |
| Illinois | yes | yes | no |
| Indiana | yes | yes | no |
| Iowa | yes | yes | no |
| Kansas | yes | yes | no |
| Kentucky | yes | yes | no |
| Louisiana | yes | yes | yes |
| Maine | yes | no | no |
| Maryland | yes | yes | no |
| Massachusetts | yes | yes | no |
| Michigan | yes | yes | yes |
| Minnesota | yes | yes | yes |
| Mississippi | yes | yes | no |
| Missouri | yes | yes | no |
| Montana | yes | yes | no |
| Nebraska | yes | yes | no |
| Nevada | yes | yes | no |
| New Hampshire | yes | yes | no |
| New Jersey | yes | yes | no |
| New Mexico | yes | yes | no |
| New York | yes | no | no |
| North Carolina | yes | yes | no |
| North Dakota | yes | yes | yes |
| Ohio | yes | yes | yes |
| Oklahoma | yes | yes | yes |
| Oregon | yes | yes | yes |
| Pennsylvania | yes | yes | yes |
| Rhode Island | yes | yes | no |
| South Carolina | yes | yes | no |
| South Dakota | yes | yes | no |
| Tennessee | yes | yes | no |
| Texas | yes | yes | yes |
| Utah | yes | yes | yes |
| Vermont | yes | yes | no |
| Virginia | yes | yes | no |
| Washington | yes | yes | yes |
| West Virginia | yes | no | no |
| Wisconsin | yes | yes | yes |
| Wyoming | yes | yes | no |
Vaccine Ingredients and Manufacturer Information
Listed below are vaccine ingredients (substances that appear in the final vaccine product), process ingredients (substances used to create the vaccine that may or may not appear in the final vaccine product), and growth mediums (the substances vaccines are grown in) for vaccines licensed for use by the Food & Drug Administration (FDA).
Three vaccines licensed for use by the FDA (plague, poliovax, and rabies vaccine adsorbed) are listed on the FDA site, but do not have available package inserts or other information, and thus are not included below.
Controversial products used to make vaccines include but are not limited to: African Green Monkey (Vero) cells, aluminum, cow products, Cocker Spaniel cells, formaldehyde, human fetal lung tissue cells, insect products, and mouse brains. More information on some controversial products may be found in the glossary on this page.
Though not listed, each vaccine contains strains of the virus being vaccinated against. Each vaccine entry links to the manufacturer’s package insert that contains information about dosage, ingredient quantity, and how the vaccine is made. Some vaccines, like influenza (flu) vaccines, are modified frequently and you may wish to consult your doctor’s office or pharmacy for the most current information. [148][149][150][151][152][153][154][155][156][157][157]
Adenovirus Vaccine
Adenovirus Type 4 and Type 7 Vaccine, Live, Oral
- Manufacturer: Barr Labs Inc.
- Package Insert (Oct. 2019)
- Growth Mediums and Process Ingredients:human-diploid fibroblast cell cultures (WI-38), Dulbecco’s Modified Eagle’s Medium, fetal bovine serum, sodium bicarbonate
- Vaccine Ingredients: anhydrous lactose, microcrystalline cellulose, polacrilin potassium, magnesium stearate, live adenovirus [Type 4 or Type 7, dried substance includes monosodium glutamate, sucrose, D-mannose, D-fructose, dextrose, human serum albumin, potassium phosphate, and plasdone C], microcrystalline cellulose, magnesium stearate, and anhydrous lactose, cellulose acetate phthalate, alcohol, acetone, castor oil; Type 7 tablet also contains FD&C Yellow #6 aluminum lake dye.
Anthrax
Anthrax Vaccine Adsorbed
- Manufacturer: Emergent BioDefense Operations Lansing LLC
- Biothrax Package Insert (Nov. 2015)
- Growth Mediums and Process Ingredients:amino acids, vitamins, inorganic salts, sugars
- Vaccine Ingredients: proteins [including the 83kDa protective antigen (PA) protein], aluminum, benzethonium chloride, formaldehyde
BCG Vaccine
(tuberculosis)
BCG Vaccine
- Manufacturer: Organon Teknika Corp.
- Package Insert (undated)
- Growth Mediums and Process Ingredients:glycerin, asparagine, citric acid, potassium phosphate, magnesium sulfate, iron ammonium citrate
- Vaccine Ingredients: lactose, sterile water
BCG Live
- Manufacturer: Organon Teknika Corp.
- Tice BCG Package Insert (Feb. 2009)
- Growth Mediums and Process Ingredients:glycerin, asparagine, citric acid, potassium phosphate, magnesium sulfate, iron ammonium citrate
- Vaccine Ingredients: lactose, saline
Cholera Vaccine
Cholera Vaccine Live Oral
- Manufacturer: Emergent Travel Health, Inc.
- Vaxchora Package Insert (Dec. 2020)
- Growth Mediums and Process Ingredients:frozen: casamino acids, yeast extract, mineral salts, anti-foaming agent, ascorbic acid, Hy-Case SF, sodium chloride, sucrose, dried lactose; other: casamino acids, yeast extract, mineral salts, anti-foaming agent, ascorbic acid, Hy-Case SF, sucrose, anhydrous lactose
- Vaccine Ingredients: frozen: sodium bicarbonate, sodium carbonate, ascorbic acid, dried lactose, sucrose, sodium chloride, Hy-Case SF; other: sodium bicarbonate, sodium carbonate, ascorbic acid, anhydrous lactose, sucrose, Hy-Case SF, anhydrous lactose
COVID-19 Vaccine
COVID-19 Vaccine, mRNA
This vaccine is commonly known as the Pfizer coronavirus vaccine.
- Manufacturer: BioNTech Manufacturing GmbH
- Comirnaty Package Insert (Aug. 2021)
- Growth Mediums and Process Ingredients:n/a
- Vaccine Ingredients: sodium chloride, lipids ((4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate), 2-(polyethylene glycol 2000)-N,N-ditetradecylacetamide, 1,2-distearoyl-sn-glycero-3-phosphocholine, cholesterol), potassium chloride, monobasic potassium phosphate, dibasic sodium phosphate dihydrate, sucrose
Dengue Vaccine
Dengue Tetravalent Vaccine, Live
- Manufacturer: Sanofi Pasteur Inc.
- DENGVAXIA Package Insert (June 2019)
- Growth Mediums and Process Ingredients:Vero cells (African Green Monkey kidney), stabilizer solution
- Vaccine Ingredients: sodium chloride, essential amino acids (including L-phenylalanine), non-essential amino acids, L-arginine hydrochloride, sucrose, D-trehalose dihydrate, D-sorbitol, trometamol, urea
DT Vaccine
(diphtheria & tetanus)
Diphtheria and Tetanus Toxoids Adsorbed
- Manufacturer: Sanofi Pasteur Inc.
- Package Insert (June 2018)
- Growth Mediums and Process Ingredients:aluminum phosphate, isotonic sodium chloride solution, formalin, tryptic digest of casein, cystine, maltose, uracil, inorganic salts, vitamins
- Vaccine Ingredients: aluminum phosphate, formaldehyde
DTaP Vaccine
(diphtheria, tetanus, & pertussis)
Diphtheria & Tetanus Toxoids & Acellular Pertussis Vaccine Adsorbed
- Manufacturer: GlaxoSmithKline Biologicals
- Infanrix Package Insert (undated)
- Growth Mediums and Process Ingredients:Fenton medium (containing bovine extract), Latham medium, Stainer-Scholte liquid medium, glutaraldehyde, formaldehyde, aluminum hydroxide
- Vaccine Ingredients: filamentous hemagglutinin (FHA), pertactin (69 kiloDalton outer membrane protein), aluminum hydroxide, sodium chloride, formaldehyde, polysorbate 80 (Tween 80).
Diphtheria & Tetanus Toxoids & Acellular Pertussis Vaccine Adsorbed
- Manufacturer: GlaxoSmithKline Biologicals
- DAPTACEL Package Insert (undated)
- Growth Mediums and Process Ingredients:Stainer-Scholte medium, casamino acids, dimethyl-beta-cyclodextrin, glutaraldehyde, formaldehyde, aluminum phosphate, Mueller’s growth medium, ammonium sulfate, Mueller-Miller casamino acid medium (without beef heart infusion), 2-phenoxyethanol, water
- Vaccine Ingredients: filamentous hemagglutinin (FHA), pertactin (PRN), fimbriae types 2 and 3 (FIM), aluminum phosphate, formaldehyde, glutaraldehyde, 2-phenoxyethanol
DTap-HepB-IPV Vaccine
(diphtheria, tetanus, pertussis, hepatitis B, & polio)
Diphtheria & Tetanus Toxoids & Acellular Pertussis Vaccine Adsorbed, Hepatitis B (recombinant) and Inactivated Poliovirus Vaccine Combined
- Manufacturer: GlaxoSmithKline Biologicals
- Pediarix Package Insert (undated)
- Growth Mediums and Process Ingredients:Fenton medium containing a bovine extract, Latham medium derived from bovine casein, formaldehyde, Stainer-Scholte liquid medium, glutaraldehyde, genetically engineered Saccharomyces cerevisiae (S. cerevisiae) cells, VERO cells, calf serum, lactalbumin hydrolysate, aluminum hydroxide, aluminum phosphate
- Vaccine Ingredients: filamentous hemagglutinin (FHA), pertactin (69 kiloDalton outer membrane protein), HBsAg, aluminum salts, sodium chloride, formaldehyde, polysorbate 80 (Tween 80), neomycin sulfate, polymyxin B, yeast protein
DTaP-IPV Vaccine
(diphtheria, tetanus, pertussis, & polio)
Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine
- Manufacturer: GlaxoSmithKline Biologicals
- KINRIX Package Insert (undated)
- Growth Mediums and Process Ingredients:Fenton medium containing a bovine extract, Latham medium derived from bovine casein, formaldehyde, Stainer-Scholte liquid medium, glutaraldehyde, aluminum hydroxide, VERO cells, calf serum and lactalbumin hydrolysate
- Vaccine Ingredients: filamentous hemagglutinin (FHA), pertactin (69 kiloDalton outer membrane protein), aluminum hydroxide, sodium chloride, formaldehyde, polysorbate 80 (Tween 80), neomycin sulfate, polymyxin B
Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine
- Manufacturer: Sanofi Pasteur Limited
- Quadracel version 1 Package Insert (Feb, 2021)
- Quadracel version 2 Package Insert (Dec. 2019)
- Growth Mediums and Process Ingredients:version 1: Mueller’s growth medium, ammonium sulfate, formaldehyde, Mueller-Miller casamino acid medium without beef heart infusion, aluminum phosphate, Stainer-Scholte medium, casamino acids, dimethyl-betacyclodextrin, glutaraldehyde, aluminum phosphate, MRC-5 cells, CMRL (Connaught Medical Research Laboratories) 1969 medium supplemented with calf serum, Medium 199 without calf serum, 2-phenoxyethanol, water
- version 2: Mueller’s growth medium, ammonium sulfate, formaldehyde, Mueller-Miller casamino acid medium without beef heart infusion, aluminum phosphate, Stainer-Scholte medium, casamino acids, dimethyl-betacyclodextrin, glutaraldehyde, Vero cells, Iscove’s medium, calf serum, M199 medium without calf serum, 2-phenoxyethanol, water
- Vaccine Ingredients: version 1: filamentous hemagglutinin(FHA), pertactin (PRN), fimbriae types 2 and 3 (FIM), aluminum phosphate, 2-phenoxyethanol, water, polysorbate 80, formaldehyde, glutaraldehyde, bovine serum albumin, 2-phenoxyethanol, neomycin, polymyxin B sulfate
- version 2: filamentous hemagglutinin (FHA), pertactin (PRN), fimbriae types 2 and 3 (FIM), aluminum phosphate, polysorbate 80, 2-phenoxyethanol, formaldehyde, glutaraldehyde, bovine serum albumin, streptomycin sulphate, neomycin and polymyxin B sulphate
DTaP-IPV-Hib-HepB Vaccine
(diphtheria, tetanus, pertussis, polio, haemophilus influenzae type B, & hepatitis B)
Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus, Haemophilus b Conjugate [Meningococcal Protein Conjugate] and Hepatitis B [Recombinant] Vaccine
- Manufacturer: MSP Vaccine Company
- VAXELIS Package Insert (Oct. 2020)
- Growth Mediums and Process Ingredients:Mueller’s growth medium, ammonium sulfate, formaldehyde, Mueller-Miller casamino acid medium without beef heart infusion, aluminum phosphate, Stainer-Scholte medium, casamino acids, dimethyl-betacyclodextrin, glutaraldehyde, Vero cells, yeast Saccharomyces cerevisiae, yeast, soy peptone, dextrose, amino acids, mineral salts, phosphate buffer, alum (potassium aluminum sulfate), amorphous aluminum hydroxyphosphate sulfate, nicotinamide adenine dinucleotide, hemin chloride, soy peptone, dextrose, mineral salts, N. meningitidis serogroup B
- Vaccine Ingredients: filamentous hemagglutinin (FHA), pertactin (PRN), fimbriae types 2 and 3 (FIM), aluminum, polysorbate 80, formaldehyde, glutaraldehyde, bovine serum albumin, neomycin, streptomycin sulfate, polymyxin B sulfate, ammonium thiocyanate, yeast protein
DTaP-IPV-Hib Vaccine
(diphtheria, tetanus, pertussis, polio, & haemophilus influenzae type B)
Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate) Vaccine
- Manufacturer: Sanofi Pasteur Limited
- Pentacel version 1 Package Insert (Feb. 2021)
- Pentacel version 2 Package Insert (Dec. 2019)
- Growth Mediums and Process Ingredients:version 1: Mueller’s growth medium, ammonium sulfate, formaldehyde, Mueller-Miller casamino acid medium without beef heart infusion, aluminum phosphate, Stainer-Scholte medium, casamino acids, dimethyl-betacyclodextrin, glutaraldehyde, aluminum phosphate, MRC-5 cells, CMRL (Connaught Medical Research Laboratories) 1969 medium (supplemented with calf serum), Medium 199 (without calf serum), 2-phenoxyethanol, water, semi-synthetic medium
- version 2: Mueller’s growth medium, ammonium sulfate, formaldehyde, Mueller-Miller casamino acid medium without beef heart infusion, aluminum phosphate, Stainer-Scholte medium, casamino acids, dimethyl-beta310 cyclodextrin, glutaraldehyde, Vero cells, Iscove’s medium (supplemented with calf serum), M199 medium without calf serum, 2-phenoxyethanol, water
- Vaccine Ingredients: version 1: filamentous hemagglutinin (FHA), pertactin (PRN), fimbriae types 2 and 3 (FIM), aluminum phosphate, polysorbate 80, sucrose, formaldehyde, glutaraldehyde, bovine serum albumin, 2-phenoxyethanol, neomycin, polymyxin B sulfate
- version 2: filamentous hemagglutinin (FHA), pertactin (PRN), fimbriae types 2 and 3 (FIM), aluminum phosphate, polysorbate 80, 2-phenoxyethanol, sucrose, formaldehyde, glutaraldehyde, bovine serum albumin, streptomycin sulphate, neomycin, polymyxin B sulphate.
Ebola Vaccine
Ebola Zaire Vaccine, Live
- Manufacturer: Merck Sharp & Dohme Corp.
- ERVEBO Package Insert (2019)
- Growth Mediums and Process Ingredients:serum-free Vero cell cultures
- Vaccine Ingredients: Tromethamine (Tris), rice-derived recombinant human serum albumin, host cell DNA, benzonase, rice protein
Hib Vaccine
(haemophilus influenzae type B)
Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate)
- Manufacturer: Merck Sharp & Dohme Corp.
- PedvaxHIB Package Insert (1998)
- Growth Mediums and Process Ingredients:complex fermentation media
- Vaccine Ingredients: amorphous aluminum hydroxyphosphate sulfate (previously referred to as aluminum hydroxide), sodium chloride
Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate)
- Manufacturer: Sanofi Pasteur, SA
- ActHIB Package Insert (May 17, 2019)
- Growth Mediums and Process Ingredients:semi-synthetic medium, ammonium sulfate, Mueller and Miller medium, milk-derived raw materials (casein derivatives)
- Vaccine Ingredients: saline diluent, purified capsular polysaccharide
Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate)
- Manufacturer: GlaxoSmithKline Biologicals
- Hiberix Package Insert (Apr. 2018)
- Growth Mediums and Process Ingredients:synthetic medium, semi-synthetic medium, formaldehyde, lactose, sterile saline solution
- Vaccine Ingredients: purified capsular polysaccharide, lactose, formaldehyde
Hep A Vaccine
(hepatitis A)
Hepatitis A Vaccine, Inactivated
- Manufacturer: GlaxoSmithKline Biologicals
- Havrix Package Insert (undated)
- Growth Mediums and Process Ingredients:MRC-5 human diploid cells
- Vaccine Ingredients: aluminum hydroxide, amino acid supplement, phosphate-buffered saline solution, polysorbate 20, MRC-5 cellular proteins, formalin, neomycin sulfate
Hepatitis A Vaccine, Inactivated
- Manufacturer: Merck Sharp & Dohme Corp.
- VAQTA Package Insert (undated)
- Growth Mediums and Process Ingredients:MRC-5 diploid fibroblasts, amorphous aluminum hydroxyphosphate sulfate
- Vaccine Ingredients: nonviral protein, DNA, bovine albumin, formaldehyde, neomycin, amorphous aluminum hydroxyphosphate sulfate, sodium borate, sodium chloride
Hep A & Hep B Vaccine
(hepatitis A & hepatitis B)
Hepatitis A Inactivated and Hepatitis B (Recombinant) Vaccine
- Manufacturer: GlaxoSmithKline Biologicals
- Twinrix Package Insert (undated)
- Growth Mediums and Process Ingredients:MRC-5 human diploid cells, formalin, Saccharomyces cerevisiae yeast cells, aluminum salts
- Vaccine Ingredients: listaluminum phosphate, aluminum hydroxide, amino acids, sodium chloride, phosphate buffer, polysorbate 20, water, formalin, MRC-5 cellular proteins, neomycin sulfate, yeast protein
Hep B Vaccine
(hepatitis B)
Hepatitis B Vaccine (Recombinant)
- Manufacturer: Merck & Co, Inc
- Recombivax HB Package Insert (Dec. 2018)
- Growth Mediums and Process Ingredients:yeast cells, fermentation medium [extract of yeast, soy peptone, dextrose, amino acids, mineral salts], phosphate buffer, formaldehyde, potassium aluminum sulfate, amorphous aluminum hydroxyphosphate sulfate
- Vaccine Ingredients: yeast protein, amorphous aluminum hydroxyphosphate sulfate, formaldehyde
Hepatitis B Vaccine (Recombinant)
- Manufacturer: GlaxoSmithKline Biologicals
- Engerix-B Package Insert (undated)
- Growth Mediums and Process Ingredients:Saccharomyces cerevisiae cells, aluminum hydroxide
- Vaccine Ingredients: listyeast protein. aluminum hydroxide, sodium chloride, phosphate buffers [disodium phosphate dihydrate, sodium dihydrogen phosphate dihydrate]
Hepatitis B Vaccine (Recombinant), Adjuvanted
- Manufacturer: Dynavax Technologies Corporation
- HEPLISAV-B Package Insert (2019)
- Growth Mediums and Process Ingredients:Hansenula polymorpha yeast, fermentation media [vitamins, mineral salts], CpG 1018 adjuvant [22-mer phosphorothioate linked oligodeoxynucleotide, phosphate buffered saline (sodium chloride, sodium phosphate, dibasic dodecahydrate, monobasic dihydrate, polysorbate 80)]
- Vaccine Ingredients: yeast protein, yeast DNA, deoxycholate, CpG 1018
HPV Vaccine
(human papillomavirus)
Human Papillomavirus Quadrivalent (Types 6, 11, 16, 18) Vaccine, Recombinant
- Manufacturer: Merck & Co., Inc
- Gardasil Package Insert (Apr. 2015)
- Growth Mediums and Process Ingredients:Saccharomyces cerevisiae, fermentation media [vitamins, amino acids, mineral salts, carbohydrates], amorphous aluminum hydroxyphosphate sulfate
- Vaccine Ingredients: amorphous aluminum hydroxyphosphate sulfate adjuvant, sodium chloride, L-histidine, polysorbate 80, sodium borate, yeast protein, water
Human Papillomavirus 9-valent Vaccine, Recombinant
- Manufacturer: Merck Sharp & Dohme Corp.
- Gardasil 9 Package Insert (Aug. 2020)
- Growth Mediums and Process Ingredients:Saccharomyces cerevisiae, fermentation media [vitamins, amino acids, mineral salts, carbohydrates], amorphous aluminum hydroxyphosphate sulfate
- Vaccine Ingredients: amorphous aluminum hydroxyphosphate sulfate, sodium chloride, L-histidine, polysorbate 80, sodium borate, yeast protein, water
Human Papillomavirus Bivalent (Types 16, 18) Vaccine, Recombinant
- Manufacturer: GlaxoSmithKline Biologicals
- Cervarix Package Insert (undated)
- Growth Mediums and Process Ingredients:serum-free culture media [lipids, vitamins, amino acids, mineral salts], hydroxide salt, AS04 [3-O-desacyl-4’-monophosphoryl lipid A (MPL), hydroxide salt, sodium chloride, sodium dihydrogen phosphate dihydrate, water
- Vaccine Ingredients: 3-O-desacyl-4’-monophosphoryl lipid A (MPL), aluminum hydroxide, sodium chloride, sodium dihydrogen phosphate dihydrate, insect cell and viral protein, bacterial cell protein
Influenza A (H1N1) Vaccine
(swine flu)
Influenza A (H1N1) 2009 Monovalent Vaccine
- Manufacturer: CSL Limited
- Package Insert (Nov. 2009)
- Growth Mediums and Process Ingredients:allantoic fluid of embryonated chicken eggs, sucrose density gradient, betapropiolactone, sodium taurodeoxycholate, phosphate buffered isotonic solution
- Vaccine Ingredients: allantoic fluid of embryonated chicken eggs, sucrose density gradient, betapropiolactone, sodium taurodeoxycholate, phosphate buffered isotonic solution
Influenza A (H1N1) 2009 Monovalent Vaccine
- Manufacturer: ID Biomedical Corporation of Quebec
- Package Insert (Jan. 2010)
- Growth Mediums and Process Ingredients:allantoic cavity of embryonated hens’ eggs, formaldehyde, sodium deoxycholate
- Vaccine Ingredients: phosphate-buffered saline solution, thimerosal, egg proteins, formaldehyde, sodium deoxycholate
Influenza A (H1N1) 2009 Monovalent Vaccine
- Manufacturer: Merck Sharp & Dohme Corp.
- ERVEBO Package Insert (2019)
- Growth Mediums and Process Ingredients:serum-free Vero cell cultures
- Vaccine Ingredients: Tromethamine (Tris), rice-derived recombinant human serum albumin, host cell DNA, benzonase, rice protein
Influenza A (H1N1) 2009 Monovalent Vaccine
- Manufacturer: Novartis Vaccines and Diagnostics Limited
- Package Insert (Sep. 2009)
- Growth Mediums and Process Ingredients:allantoic cavity of embryonated hens’ eggs, neomycin, polymyxin, betapropiolactone, nonylphenol ethoxylate
- Vaccine Ingredients: phosphate buffered saline, thimerosal, egg proteins, polymyxin, neomycin, betapropiolactone, nonylphenol ethoxylate
Influenza A (H1N1) 2009 Monovalent Vaccine
- Manufacturer: Sanofi Pasteur, Inc.
- Package Insert (Sep. 2009)
- Growth Mediums and Process Ingredients:embryonated chicken eggs, formaldehyde, linear sucrose density gradient solution, non-ionic surfactant, polyethylene glycol p-isooctylphenyl ether (Triton® X-100), sodium phosphate-buffered isotonic sodium chloride solution
- Vaccine Ingredients: formaldehyde, polyethylene glycol p-isooctylphenyl ether, sucrose, thimerosal
Influenza A (H5N1) Vaccine
(bird flu)
Influenza Virus Vaccine, H5N1 (for National Stockpile)
- Manufacturer: Sanofi Pasteur Inc.
- Package Insert (Apr. 2007)
- Growth Mediums and Process Ingredients:embryonated chicken eggs, formaldehyde, linear sucrose density gradient solution, nonionic surfactant, polyethylene glycol p-isooctylphenyl ether (Triton® X-100), sodium phosphate-buffered isotonic sodium chloride solution
- Vaccine Ingredients: porcine gelatin, thimerosal, formaldehyde, polyethylene glycol pIsooctylphenyl ether, sucrose
Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted
- Manufacturer: ID Biomedical Corporation of Quebec
- Package Insert (undated)
- Growth Mediums and Process Ingredients:phosphate-buffered saline solution, allantoic cavity of embryonated hen’s eggs, formaldehyde, sodium deoxycholate, squalene, DL-α-tocopherol, polysorbate 80
- Vaccine Ingredients: AS03 adjuvant emulsion, thimerosal, DL-α-tocopherol, polysorbate 80, ovalbumin, formaldehyde, sodium deoxycholate
Influenza A (H5N1) Monovalent Vaccine, Adjuvanted
- Manufacturer: Seqirus, Inc.
- AUDENZ Package Insert (Sep. 2021)
- Growth Mediums and Process Ingredients:Madin Darby Canine Kidney (MDCK) cells, culture medium, ß-propiolactone, cetyltrimethylammonium bromide
- Vaccine Ingredients: MF59C.1 adjuvant (MF59) [squalene, polysorbate 80, sorbitan trioleate, sodium citrate dihydrate, citric acid monohydrate], protein other than HA, MDCK cell protein, MDCK cell DNA, polysorbate 80, cetyltrimethylammonium bromide, ß-propiolactone, thimerosal
Influenza A (H5N1) Vaccine
(bird flu)
Ebola Zaire Vaccine, Live
- Manufacturer: Merck Sharp & Dohme Corp.
- ERVEBO Package Insert (2019)
- Growth Mediums and Process Ingredients:serum-free Vero cell cultures
- Vaccine Ingredients: Tromethamine (Tris), rice-derived recombinant human serum albumin, host cell DNA, benzonase, rice protein
Japanese Encephalitis Vaccine
Japanese Encephalitis Virus Vaccine, Inactivated, Adsorbed
- Manufacturer: Valneva Austria GmbH
- Ixiaro
- Growth Mediums and Process Ingredients:Vero cells, protamine sulfate, sucrose density gradient, formaldehyde
- Vaccine Ingredients: aluminum hydroxide, formaldehyde, bovine serum albumin, host cell DNA, sodium metabisulphite, host cell protein, protamine sulfate
MMR Vaccine
Measles, Mumps, and Rubella Virus Vaccine, Live
- Manufacturer: Merck, Sharp & Dohme Corp.
- M-M-R II Package Insert (undated)
- Growth Mediums and Process Ingredients:chick embryo cell culture; WI-38 human diploid lung fibroblasts, recombinant human serum albumin, fetal bovine serum
- Vaccine Ingredients: sorbitol, sucrose, hydrolyzed gelatin, recombinant human albumin, fetal bovine serum, neomycin, other buffer and media ingredients
MMR & Varicella Vaccine
(measles, mumps, rubella, & chickenpox)
Measles, Mumps, Rubella, and Varicella Virus Vaccine Live
- Manufacturer: Merck Sharpe & Dohme Corp
- ProQuad Frozen Package Insert (Apr. 2021)
- ProQuad Refrigerated Package Insert (Oct. 2018)
- Growth Mediums and Process Ingredients:Refrigerator-Stable Formulation: chick embryo cell culture, WI-38 human diploid lung fibroblasts, MRC-5 cells
- Frozen Formulation – Recombinant Human Albumin (RHA): embryo cell culture; WI-38 human diploid lung fibroblasts, MRC-5 cells
- Frozen Formulation – Human SerumAlbumin (HSA): chick embryo cell culture, WI-38 human diploid lung fibroblasts, MRC-5 cells
- Frozen: chick embryo cell culture, WI-38 human diploid lung, MRC-5 cells
- Refrigerated: chick embryo cell culture, WI-38 human diploid lung fibroblasts, MRC-5 cells
- Vaccine Ingredients: Refrigerator-Stable Formulation: sucrose, hydrolyzed gelatin, urea, sodium chloride, sorbitol, monosodium L-glutamate, sodium phosphate, recombinant human albumin, sodium bicarbonate, potassium phosphate, potassium chloride, residual components of MRC-5 cells including DNA and protein, neomycin, bovine serum albumin, other buffer and media ingredients
- Frozen Formulation – Recombinant Human Albumin (RHA): sucrose, hydrolyzed gelatin, sodium chloride, sorbitol, monosodium L-glutamate, sodium phosphate dibasic, recombinant human albumin, sodium bicarbonate, potassium phosphate monobasic, potassium chloride; potassium phosphate dibasic, residual components of MRC-5 cells including DNA and protein, neomycin, bovine calf serum, other buffer and media ingredients
- Frozen Formulation – Human SerumAlbumin (HSA): sucrose, hydrolyzed gelatin, urea, sodium chloride, sorbitol, monosodium L-glutamate, sodium phosphate, recombinant human albumin, sodium bicarbonate, potassium phosphate, potassium chloride, residual components of MRC-5 cells including DNA and protein, neomycin, bovine serum albumin, other buffer and media ingredients
- Frozen: sucrose, hydrolyzed gelatin, sodium chloride, sorbitol, monosodium L-glutamate, sodium phosphate dibasic, recombinant human albumin, sodium bicarbonate, potassium phosphate monobasic, potassium chloride, potassium phosphate dibasic, residual components from the manufacturing process [MRC-5 cells including DNA and protein, neomycin, bovine calf serum, other buffer and media ingredients]
- Refrigerated: sucrose, sorbitol, hydrolyzed gelatin, urea, sodium chloride, sodium phosphate, monosodium L-glutamate, recombinant human albumin, sodium bicarbonate, potassium phosphate, potassium chloride, residual components from the manufacturing process [MRC-5 cells including DNA and protein, neomycin, bovine calf serum, other buffer and media ingredients]
Meningococcal Vaccine
Meningococcal (Groups A, C, Y, and W-135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine
- Manufacturer: GlaxoSmithKline Biologicals SA
- Menveo Package Insert (July 2020)
- Growth Mediums and Process Ingredients:Franz Complete medium, formaldehyde, CY medium [yeast extracts, amino acids]
- Vaccine Ingredients: formaldehyde
Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine
- Manufacturer: Manufacturer: Sanofi Pasteur Inc.
- Menactra Package Insert (Apr. 2018)
- Growth Mediums and Process Ingredients:sMueller Hinton agar, Watson Scherp media [casamino acid], modified culture medium [hydrolyzed casein], formaldehyde, ammonium sulfate
- Vaccine Ingredients: sodium phosphate buffered isotonic sodium chloride solution, formaldehyde
Meningococcal Group B Vaccine
- Manufacturer: Novartis Vaccines and Diagnostics, Inc
- BEXSERO Package Insert (undated)
- Growth Mediums and Process Ingredients:Escherichia coli, deoxycholate, aluminum hydroxide
- Vaccine Ingredients: Neisserial adhesin A (NadA), Neisserial Heparin Binding Antigen (NHBA), factor H binding protein (fHbp), outer membrane vesicles (OMV), aluminum hydroxide, sodium chloride, histidine, sucrose, kanamycin
Meningococcal Group B Vaccine
- Manufacturer: Wyeth Pharmaceuticals, Inc.
- TRUMENBA Package Insert (2018)
- Growth Mediums and Process Ingredients:E. coli, fermentation growth media, polysorbate 80 (PS80)
- Vaccine Ingredients: polysorbate 80, Al³+ as AlPO4, histidine buffered saline
Meningococcal Polysaccharide Vaccine, Groups A, C, Y and W-135 Combined
- Manufacturer: Sanofi Pasteur Inc.
- Menomune-A/C/Y/W-135 Package Insert (Mar. 14, 2016)
- Growth Mediums and Process Ingredients:Mueller Hinton casein agar, Watson Scherp casamino acid media
- Vaccine Ingredients: water, thimerosal, polysaccharide from each of serogroups A, C, Y, and W-135, lactose
Meningococcal (Groups A, C, Y, W) Conjugate Vaccine
- Manufacturer: Sanofi Pasteur, Inc.
- MenQuadfi Package Insert (Oct. 2021)
- Growth Mediums and Process Ingredients:Mueller Hinton agar medium, Watson Scherp medium, carbonyldiimidazole (CDI), adipic acid dihydrazide (ADH), periodate, ammonium sulfate, formaldehyde
- Vaccine Ingredients: sodium chloride, sodium acetate, formaldehyde
Pneumococcal Vaccine
(pneumonia)
Pneumococcal Vaccine, Polyvalent
- Manufacturer: Merck Sharp & Dohme Corp.
- Pneumovax 23 Package Insert (Apr. 2021)
- Growth Mediums and Process Ingredients:n/a
- Vaccine Ingredients: isotonic saline solution, phenol
Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM197 Protein)
- Manufacturer: Wyeth Pharmaceuticals, Inc.
- Prevnar 13 Package Insert (Aug. 2017)
- Growth Mediums and Process Ingredients:soy peptone broth, casamino acids and yeast extract-based medium, chemically-defined medium, ammonium sulfate
- Vaccine Ingredients: polysorbate 80, succinate buffer, aluminum phosphate
Pneumococcal 15-valent Conjugate Vaccine
- Manufacturer: Merck Sharp & Dohme Corp.
- VAXNEUVANCE Package Insert (undated)
- Growth Mediums and Process Ingredients:growth media [yeast extract, dextrose, salts, soy peptone], glycerol-based chemically-defined salt medium, aluminum phosphate, histidine, polysorbate 20, sodium chloride.
- Vaccine Ingredients: L-histidine, polysorbate 20, sodium chloride, aluminum phosphate
Pneumococcal 20-valent Conjugate Vaccine
- Manufacturer: Wyeth Pharmaceuticals, LLC
- Prevnar 20 Package Insert (June 2021)
- Growth Mediums and Process Ingredients:soy peptone broth, casamino acids and yeast extract-based medium, chemically defined medium
- Vaccine Ingredients: polysorbate 80, succinate buffer, sodium chloride, aluminum phosphate
Polio Vaccine
Poliovirus Vaccine Inactivated (Monkey Kidney Cell)
- Manufacturer: Sanofi Pasteur, SA
- IPOL Package Insert (undated)
- Growth Mediums and Process Ingredients:Vero cells, Eagle MEM modified medium, newborn calf bovine serum, M-199 [without calf bovine serum], formalin
- Vaccine Ingredients: M-199 medium, 2-phenoxyethanol, formaldehyde, neomycin, streptomycin, polymyxin B, calf bovine serum albumin
Rabies Vaccine
Rabies Vaccine
- Manufacturer: Sanofi Pasteur SA
- Imovax Package Insert (Oct. 2019)
- Growth Mediums and Process Ingredients:human diploid cells [MRC-5 strain], beta-propiolactone
- Vaccine Ingredients: human albumin, neomycin sulfate, phenol red indicator, beta-propiolactone
Rabies Vaccine
- Manufacturer: Novartis Vaccines and Diagnostics
- RabAvert Package Insert (undated)
- Growth Mediums and Process Ingredients:chicken fibroblasts, synthetic cell culture medium [with added human albumin, polygeline (processed bovine gelatin), antibiotics], β-propiolactone, sucrose density gradient, stabilizer solution [buffered polygeline, potassium glutamate]
- Vaccine Ingredients: polygeline (processed bovine gelatin), human serum albumin, potassium glutamate, sodium EDTA, bovine serum, chicken protein, ovalbumin, neomycin, chlortetracycline, amphotericin B
Rotavirus Vaccine
Rotavirus Vaccine, Live, Oral
- Manufacturer: GlaxoSmithKline Biologicals
- ROTARIX Package Insert (undated)
- Growth Mediums and Process Ingredients:Vero cells
- Vaccine Ingredients: amino acids, dextran, Dulbecco’s Modified Eagle Medium (DMEM) [sodium chloride, potassium chloride, magnesium sulfate, ferric (III) nitrate, sodium phosphate, sodium pyruvate, D-glucose, concentrated vitamin solution, L-cystine, L-tyrosine, amino acids solution, Lglutamine, calcium chloride, sodium hydrogenocarbonate, phenol red], sorbitol, sucrose, Porcine circovirus type 1 (PCV-1), liquid diluent [calcium carbonate, sterile water, xanthan, calcium carbonate]
Rotavirus Vaccine, Live, Oral, Pentavalent
- Manufacturer: Merck Sharp & Dohme Corp.
- RotaTeq Package Insert (undated)
- Growth Mediums and Process Ingredients:Vero cells, buffered stabilizer solution
- Vaccine Ingredients: sucrose, sodium citrate, sodium phosphate monobasic monohydrate, sodium hydroxide, polysorbate 80, cell culture media, fetal bovine serum
Smallpox & Mpox/Monkeypox Vaccine
Smallpox and Mpox/Monkeypox Vaccine, Live, Non-Replicating
- Manufacturer: Bavarian Nordic A/S
- JYNNEOS Package Insert (June 2021)
- Growth Mediums and Process Ingredients:chicken embryo fibroblast (CEF) cells, serum-free medium
- Vaccine Ingredients: Tris (tromethamine), sodium chloride, host-cell DNA, protein, benzonase, gentamicin, ciprofloxacin
Smallpox Vaccine
Smallpox (Vaccinia) Vaccine, Live
- Manufacturer: Emergent Product Development Gaithersburg, Inc.
- ACAM2000 Package Insert (Apr. 2018)
- Growth Mediums and Process Ingredients:African Green Monkey kidney (Vero) cells
- Vaccine Ingredients: HEPES, human serum albumin, sodium chloride, mannitol, neomycin, polymyxin B, diluent [glycerin, phenol, water]
TD Vaccine
(tetanus & diphtheria)
Tetanus & Diphtheria Toxoids, Adsorbed
- Manufacturer: MassBiologics
- TDVAX (NDC 14362-0111) Package Insert (Sep. 2018)
- TDVAX (NDC 13533-131) Package Insert (Sep. 2018)
- Growth Mediums and Process Ingredients:TDVAX (NDC 14362-0111): modified Mueller’s media, formaldehyde, ammonium sulfate, aluminum phosphate
- TDVAX (NDC 13533-131): modified Mueller’s media, formaldehyde, ammonium sulfate, aluminum phosphate
- Vaccine Ingredients: TDVAX (NDC 14362-0111): aluminum, formaldehyde, thimerosal
- TDVAX (NDC 13533-131): aluminum, formaldehyde, thimerosal
Tetanus & Diphtheria Toxoids Adsorbed for Adult Use
- Manufacturer: Sanofi Pasteur, Ltd.
- TENIVAC Package Insert (Nov. 2019)
- Growth Mediums and Process Ingredients:modified Mueller-Miller casamino acid medium without beef heart infusion, formaldehyde, ammonium sulfate, modified Mueller’s growth medium, aluminum phosphate
- Vaccine Ingredients: aluminum phosphate, formaldehyde, sodium chloride, water
Diphtheria & Tetanus Toxoid Adsorbed
- Manufacturer: Sanofi Pasteur, Inc
- Package Insert (June 2018)
- Growth Mediums and Process Ingredients:formalin, culture medium [casein, cystine, maltose, uracil, inorganic salts, vitamins]
- Vaccine Ingredients: aluminum phosphate, isotonic sodium chloride solution, free formaldehyde
Tdap Vaccine
(tetanus, diphtheria, & pertussis)
Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed
- Manufacturer: Sanofi Pasteur, Ltd.
- Adacel Package Insert (Dec. 2020)
- Growth Mediums and Process Ingredients:Stainer-Scholte medium, casamino acids, dimethylbeta-cyclodextrin, glutaraldehyde, formaldehyde, aluminum phosphate, Mueller-Miller casamino acid medium without beef heart infusion, ammonium sulfate, modified Mueller’s growth medium
- Vaccine Ingredients: aluminum phosphate, formaldehyde, glutaraldehyde, 2-phenoxyethanol, water
Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed
- Manufacturer: GlaxoSmithKline Biologicals
- Boostrix Package Insert (Sep. 2020)
- Growth Mediums and Process Ingredients:modified Latham medium derived from bovine casein, Fenton medium containing a bovine extract, formaldehyde, modified Stainer-Scholte liquid medium, glutaraldehyde, aluminum hydroxide
- Vaccine Ingredients: aluminum hydroxide, sodium chloride, formaldehyde, polysorbate 80 (Tween 80)
Tick-Borne Encephalitis Vaccine
Tick-Borne Encephalitis Vaccine
- Manufacturer: Pfizer Ireland Pharmaceuticals
- TICOVAC Package Insert (undated)
- Growth Mediums and Process Ingredients:schick embryo fibroblast (CEF) cells, formaldehyde, sucrose gradient, aluminum hydroxide
- Vaccine Ingredients: human serum albumin, aluminum hydroxide, sodium chloride, dibasic sodium phosphate, monobasic potassium phosphate, formaldehyde, sucrose, protamine sulfate, chick protein, DNA from CEF cells, neomycin, gentamicin
Typhoid Vaccine
Typhoid Vaccine Live Oral Ty21a
- Manufacturer: Berna Biotech, Ltd.
- Vivotif Package Insert (Sep. 2013)
- Growth Mediums and Process Ingredients:gelatin capsules, sucrose, ascorbic acid, amino acid mixture, lactose, magnesium stearate
- Vaccine Ingredients: gelatin capsules, sucrose, ascorbic acid, amino acid mixture, lactose, magnesium stearate
Typhoid Vaccine Live Oral TTyphoid Vi Polysaccharide Vacciney21a
- Manufacturer: Sanofi Pasteur SA
- TYPHIM Vi Package Insert (Mar. 2020)
- Growth Mediums and Process Ingredients:semisynthetic medium, casein derived raw materials, hexadecyltrimethylammonium bromide, formaldehyde
- Vaccine Ingredients: formaldehyde, phenol, polydimethylsiloxane, fatty-acid ester-based antifoam, isotonic phosphate buffered saline, sodium chloride, disodium phosphate, monosodium phosphate, water
Varicella Vaccine
(chickenpox)
Varicella Virus Vaccine Live
- Manufacturer: Merck Shark & Dohme Corp.
- Varivax Frozen Package Insert (undated)
- Varivax Refrigerator Package Insert (undated)
- Growth Mediums and Process Ingredients:Frozen: human embryonic lung cell cultures, embryonic guinea pig cell cultures, human diploid cell cultures (WI-38)
- Refrigerator: human embryonic lung cell cultures, embryonic guinea pig cell cultures, human diploid cell cultures (WI-38)
- Vaccine Ingredients: Frozen: sucrose, phosphate, glutamate, processed gelatin, sodium chloride, monosodium L-glutamate, sodium phosphate dibasic, potassium phosphate monobasic, potassium chloride. MRC-5 cells [DNA, protein], sodium phosphate monobasic, EDTA, neomycin, fetal bovine serum
- Refrigerator: sucrose, phosphate, glutamate, processed gelatin, urea, sucrose, hydrolyzed gelatin, sodium chloride, monosodium L-glutamate, sodium phosphate dibasic, potassium phosphate monobasic, potassium chloride, MRC-5 cells [DNA, protein], neomycin, bovine calf serum
Yellow Fever Vaccine
Yellow Fever Vaccine
- Manufacturer: Sanofi Pasteur, Inc.
- YF-Vax Package Insert (Feb. 2019)
- Growth Mediums and Process Ingredients:sliving avian leukosis virus-free (ALV-free) chicken embryos
- Vaccine Ingredients: sorbitol, gelatin, sterile diluent [sodium chloride injection]
Zoster Vaccine
(shingles)
Zoster Vaccine, Live, (Oka/Merck)
- Manufacturer: Merck & Co., Inc
- Zostavax Frozen Package Insert (Jan. 2019)
- Zostavax Refrigerator Stable Package Insert (Aug. 2018)
- Growth Mediums and Process Ingredients:Frozen: n/a
- Refrigerator Stable: n/a
- Vaccine Ingredients: Frozen: sucrose, hydrolyzed porcine gelatin, sodium chloride, monosodium L-glutamate, sodium phosphate dibasic, potassium phosphate monobasic, potassium chloride, MRC-5 cells [DNA, protein], neomycin, bovine calf serumsucrose, hydrolyzed porcine gelatin, sodium chloride, monosodium L-glutamate, sodium phosphate dibasic, potassium phosphate monobasic, potassium chloride, MRC-5 cells [DNA, protein], neomycin, bovine calf serum
- Refrigerator Stable: sucrose, hydrolyzed porcine gelatin, urea, sodium chloride, monosodium L-glutamate, sodium phosphate dibasic, potassium phosphate monobasic, potassium chloride, MRC-5 cells [DNA, protein], neomycin, bovine calf serum
Zoster Vaccine Recombinant, Adjuvanted
- Manufacturer: GlaxoSmithKline Biologicals
- SHINGRIX Package Insert (July 2021)
- Growth Mediums and Process Ingredients:genetically engineered Chinese hamster ovary cells, growth media [amino acids], AS01B [3-O-desacyl-4’-monophosphoryl lipid A (MPL) from Salmonella minnesota, QS-21 (saponin purified from plant extract Quillaja saponaria Molina), liposomal formulation (dioleoyl phosphatidylcholine (DOPC), cholesterol, phosphate-buffered saline solution (disodium phosphate anhydrous, potassium dihydrogen phosphate, sodium chloride, water for injection))]
- Vaccine Ingredients: sucrose, sodium chloride, DOPC, potassium dihydrogen phosphate, cholesterol, sodium dihydrogen phosphate dihydrate, disodium phosphate anhydrous, dipotassium phosphate, polysorbate 80, host cell proteins, host cell DNA
Glossary
| Product | Explanation of Product |
|---|---|
| 2-Phenoxyethanol | 2-Phenoxyethanol is a glycol ether used as a preservative in vaccines. |
| Aluminum | Aluminum is used in vaccines as an adjuvant, which helps the vaccine work more quickly and more powerfully. |
| Bovine casein | A casein is a family of phosphoproteins commonly found in mammalian milk. 80% of the proteins in cow’s milk are casein. |
| Bovine serum | "[T]he centrifuged fluid component of either clotted or defibrinated whole blood. Bovine serum comes from blood taken from domestic cattle. Serum from other animals is also collected and processed but bovine serum is processed in the greatest volume." |
| "Bovine serum is categorized according to the age of the animal from which the blood was collected as follows: ’Fetal bovine serum’ comes from fetuses; ’Newborn calf serum’ comes from calves less than three weeks old; ’Calf serum’ comes from calves aged between three weeks and 12 months; ’Adult bovine serum’ comes from cattle older than 12 months. Serum processed from donor blood is termed ’donor bovine serum’. Donor animals can be up to three years old." | |
| Chicken Eggs | Viruses can be grown in chicken eggs before being used in vaccinations. |
| CMRL-1969 | Common Ingredients: L-alanine, L-arginine (free base) b, L-aspartic acid, L-cysteine-HCL, L-cystine, L-glutamic acid-H20, L-glutamine, glycine, L-histidine (free base)b, L-hydroxyproline, L-isoleucine, L-leucine, L-lysine, L-methionine, L-phenylalanine, L-proline, L-serine, L-threonine, L-tryptophan, L-tyrosine, L-valine,p-aminobenzoic acid, ascorbic acid,d-biotin, calcium pantothenate, cholesterol, choline chloride, ethanol, folic acid, glutathione,i-inositol, menadione, nicotinamide, nicotinic acid, pyridoxal-HCL, pyridoxine-HCL, riboflavine, riboflavine-5-phosphate, sodium acetate-3H2O, thiamine-HCL, Tween 80, vitamin A acetate, vitamin D (calciferol), vitamin E (a-tocopherol phosphate), D-glucose, phenol red, sodium chloride, potassium chloride, calcium chloride, magnesium culphate heptahydrate, sodium phosphate dibasic, sodium dihydrogen phosphate, monopotassium phosphate, sodium bicarbonate, iron nitrate nonahydrate |
| Dulbecco’s Modified Eagle’s Serum | Common Ingredients: glucose, sodium bicarbonate, L-glutamine, pyridoxine HCl, pyridocal HCl, folic acid, phenol red, HEPES (2-[4-(2-hydroxyethyl)piperazin-1-yl]ethanesulfonic acid), L-methionine, L-cystine, sodium phosphate mono-basic, sodium pyruvate, vitamins |
| Earle’s Balanced Salt Medium | Common Ingredients: inorganic salts, D-glucose, phenol red, calcium, magnesium salts |
| Fenton Medium | bovine extract |
| Formaldehyde | Formaldehyde is used in vaccines to inactivate the virus so the person being inoculated does not contract the disease. |
| Human albumin | Human albumin is a blood plasma protein produced in the liver that, among other functions, transports hormones, fatty acids, and other compounds, and buffers pH. |
| Insect Cells | Cabbage moth and fall armyworm cells are used to grow viruses for vaccines. |
| Latham Medium | bovine casein |
| MDCK (Madin-Carby canine kidney cells) | Common Ingredients: Cells from normal female adult Cocker Spaniel (harvested in 1958 by SH Madin and NB Darby), EMEM(EBSS) (Eagle’s Minimum Essential Medium with Earle’s Balanced Salt Solution), glutamine, non essential amino acids, foetal bovine serum |
| Mouse Brains | Live mice brains are inoculated with the Japanese encephalitis virus to grow the virus used in the vaccine. |
| MRC-5 | Common Ingredients: Medical Research Council 5, human diploid cells (cells containing two sets of chromosomes) derived from the normal lung tissues of a 14-week-old male fetus aborted for "psychiatric reasons" in 1966 in the United Kingdom, Eagle’s Basal Medium in Earle’s balanced salt solution with bovine serum. |
| Mueller Hinton Agar | Common Ingredients: beef extract, acid hydrolysate of casein, starch, agar |
| Mueller-Miller Medium | Common Ingredients: glucose, sodium chloride, sodium phosphate dibasic, monopotassium, phosphate, magnesium sulfate hydrate, ferrous sulfate heptaphydrate, cystine hydrochloride, tyrosine hydrochloride, urasil hydrochloride, Ca-pantothenate in ethanol, thiamine in ethanol, pyridoxin-hydrochloride in ethanol, riboflavin in ethanol, biotin in ethanol, sodium hydroxide, beef heart infusion (de-fatted beef heart and distilled water), casein solution |
| Polysorbate 80 | Also called Tween 80, Alkest 80, or Canarcel 80 (brand names), Polysorbate 80 is used as an excipient (something to basically thicken a vaccine for proper dosing) and an emulsifier (something to bond the ingredients). |
| Porcine gelatin | Gelatin is used to protect viruses in vaccines from freeze-drying or heat and to stabilize vaccines so they stay stable. |
| Stainer-Scholte Liquid Medium | Common Ingredients: tris hydrochloride, tris base, glutamate (monosodium salt), proline, salt, monopotassium phosphate, potassium chloride, magnesium chloride, calcium chloride, ferrous sulfate, ascorbic acid, niacin, glutathione |
| Thimerosal | Thimerosal is an organomercury compound used as a preservative. |
| Vero Cells (African Green Monkey Cells) | Vero cells were derived from the kidney of a normal, adult African Green monkey in 1962 by Y. Yasumura and Y. Kawakita. |
| WI-38 human diploid cells | Winstar Institute 38 is the human diploid lung fibroblasts derived from the lung tissues of a female fetus aborted because the family felt they had too many children in 1964 in the United States. |
Vaccine Histories and Impact
DTaP: Diphtheria, Tetanus, and Pertussis
The CDC recommends that children receive the first dose of the DTaP vaccination at 2 months of age.
Diphtheria
Diphtheria, according to the CDC, is “a infection caused by Corynebacterium dipheriae” that “causes a thick covering in the back of the throat. It can lead to breathing problems, paralysis, heart failure, and even death.”
In 1826, Pierre Bretonneau, a French physician, called the disease diphtérite and distinguished diphtheria from scarlet fever. In 1883, Swiss-German pathologist, Edwin Klebs, identified the bacterium that causes diphtheria and in 1884, Friedrich Loeffler, first cultivated the bacterium, which resulted in its first name of Klebs-Loeffler bacterium (it is now called Corynebacterium diphtheria). In 1890 Kitasato Shibasaburo, a Japanese physician and bacteriologist, and Emil von Behring, a German physiologist who would win the Nobel Prize in Medicine in 1901 for his work on diphtheria, successfully immunized guinea pigs with a heat-treated diphtheria toxin.
On Oct. 16, 1894, two Cincinnati physicians successfully treated a two-year-old girl with a diphtheria antitoxin. On Dec. 4, 1894 the New York City Board of Health regulated the purity and potency of diphtheria antitoxin. In 1895 the Mulford Company of Philadelphia (later Merck) and the New York City Health Department started producing and testing diphtheria antitoxin using guinea pigs and horses.
In 1897 Paul Ehrlich, a German scientist, developed a method to measure the potency of diphtheria antitoxin. In 1907 Emil von Behring demonstrated that mixing the diphtheria antitoxin and toxin provided a safe immunity to diphtheria in humans. In 1914 William H. Park developed a toxin/antitoxin mixture diphtheria immunization. In 1923 Gaston Ramon, French veterinarian and biologist at the Pasteur Institute in France, developed diphtheria toxoid that could later be used for a toxoid vaccination at the same time as Alexander Thomas Glenny, a London physician at Wellcome Research Laboratories. Glenny would develop the adjuvant (the substance that enhances the body’s immune response to an antigen) for the toxoid vaccine in 1926.[160][161]
Tetanus (Lockjaw)
Tetanus, according to the CDC, is “a serious disease that causes painful tightening of the muscles, usually all over the body. It can lead to ‘locking’ of the jaw so the victim cannot open his mouth or swallow. Tetanus leads to death in about 1 in 10 cases.”
Records from the fifth century first describe tetanus. Giorgio Rattone and Antonio Carle, Italian scientists, first produced tetanus in animals by injecting them with pus from a human case in 1884, the same year Arthur Nicolaier, a German internist, produced tetanus in animals by injecting them with soil samples. In 1889, Kitasato Shibasaburo isolated the tetanus toxin from a human and proved that the toxin can be neutralized by antibodies. In 1897, Edmond Nocard, a French microbiologist and veterinarian, demonstrated passive immunization. Gaston Ramon inactivated the tetanus toxoid with formaldehyde in the early 1920s. In 1924, P. Descombey produced the tetanus toxoid that was used in the U.S. military during World War II. [162][163]
Pertussis (Whooping Cough)
Pertussis (whooping cough), according to the CDC, “is a highly contagious respiratory tract infection. Although it initially resembles an ordinary cold, whooping cough may eventually turn more serious, especially in infants.”
In 1900 Jules Bordet and Octave Gengou, Belgian scientists, first observed Bordetella pertussis and then isolated the pertussis bacterium in 1906, it was called Bordet-Gengou bacillus. In 1925 Thorvald Madsen, a Danish physician, tested the pertussis vaccine; the 1925 report suggested the vaccine was a success but a 1933 report stated that two children may have died from the vaccine. In 1939, the pertussis vaccine was shown to be effective by Pearl Kendrick and Grace Elderding American scientists.[164]
In 1948, the DTaP (diphtheria, tetanus, and pertussis) combination vaccine was developed. [165][166][167]
Hepatitis B
The CDC recommends that children receive the first dose of the hepatitis B vaccination at birth.
Hepatitis B (hep B), according to the CDC, is “a contagious virus that is transmitted through blood, blood products, and other body fluids (such as semen)… Symptoms include a sudden fever, tiredness, loss of appetite, nausea, vomiting, stomach pain, dark urine, joint pain, and yellowing of the skin and eyes (jaundice).”
In 1965, Baruch Blumberg, an American doctor who won the Nobel Prize in Medicine (1976) for his work on hepatitis B, matched a protein found in an Australian Aboriginal’s blood with an antibody found in an American hemophiliac. First called the “Australian antigen,” it was discovered to be the hepatitis B virus and provided a source for the vaccine created in 1969. Because the virus could not be recreated in a lab, the first vaccine was a heat-treated form of the virus.
In 1981, the FDA approved Heptavax-B, a vaccine created by Maurice Hilleman. Because Heptavax-B used human serum and the fear of HIV infection was high, a new recombinant DNA vaccine, Recombivax HB, was licensed on June 23, 1986 that did not use human serum. As of July 2014, two hepatitis B vaccines are used, Engerix-B and Recombivax, as well as Twinrix (a hepatitis A and hepatitis B combination vaccine). [165][166][167][168][169]
Hib
The CDC recommends that children receive the first dose of Hib vaccination at two months of age.
Haemophilus influenza (which includes Haemophilus influenza type B, or Hib), according to the CDC, is “a bacterium that can cause severe infection, occurring mostly in infants and children younger than five years of age. In spite of its name, Haemophilus influenza does not cause influenza (the ‘flu’). It can cause lifelong disability and be deadly.”
In 1892, Richard Pfeiffer, a German physicist, isolated a bacterium from the lungs of flu patients that would be called “Pfeiffer influenza bacillus” in 1896 by Karl Lehmann and Rudolf Neuman in Atlas and Principles of Bacteriology. The bacterium was assumed to cause influenza. In the 1930s, researchers established that influenza was caused by a virus and not a bacterium so “Pfeiffer influenza bacillus” was renamed Haemophilus influenzae type B (Hib) as a nod to the incorrect association with the flu. In 1931, Margaret Pittman, an American researcher, linked Hib to meningitis. Later it would be confirmed that Hib can cause other serious diseases including infections of the skin, blood, bones, and joints; pneumonia; and epiglottitis.
Work on an Hib vaccine began in 1968 by Porter W. Anderson, Jr. and David Smith, which lead to a 1975 trial that showed the vaccine worked in infants but not toddlers. Smith founded a company to produce the vaccine when it was licensed in 1985 because no existing pharmaceutical company wanted to manufacture it. This HbPV polysaccharide vaccine was used until 1988. As of July 24, 2014, there are six Hib vaccines on the market (three for Hib only; one Hib/Hep B combination; one DTaP-IPV/Hib combination; and one meningococcal vaccine).[165][166][167][170][171]
Measles, Mumps, and Rubella
The CDC recommends that children receive the first dose of the MMR vaccination between 12 and 15 months of age.
Measles
The measles, according to the CDC, is “a highly contagious respiratory disease caused by the measles virus… Measles causes fever, runny nose, cough, and a rash all over the body. About one out of 10 children with measles also gets an ear infection, and up to one out of 20 gets pneumonia.”
In 900 AD, Rhazes, a Persian physician, distinguished measles from smallpox. In 1676, Thomas Sydenham, an English physician, added more detail in the distinction between the viruses and also distinguished measles from scarlet fever. Francis Home, a Scottish physician, successfully infected healthy patients with blood from patients with measles in 1757. In 1916, Charles Nicolle and Ernest Conseil, French researchers, discovered that people with measles developed protective antibodies in their blood, making them immune to the disease; the researchers used a serum made of the antibodies to show that the antibodies could protect healthy people from the virus. On Feb. 8, 1954, Thomas Peebles isolated the measles virus from a blood sample of 13-year-old David Edmonston. On Oct. 15, 1958, Sam Katz, an infectious disease specialist who worked with Thomas Peebles, tested the first measles vaccine, which worked but caused measles symptoms.
On Feb. 8, 1960, researchers in Boston tested a measles vaccine on children with intellectual disabilities in New York; the vaccine was effective at preventing illness but caused many side effects. In 1961, Henry Rubin, a virologist, developed a method of growing vaccines in chicken eggs to prevent leukemia that proved useful for developing the measles vaccine. In 1962 a killed-virus measles vaccines failed. In 1963, John Enders, a biomedical scientist and the “Father of Modern Vaccines,” and his team proved their measles vaccine was safe and effective to the FDA; the vaccine was licensed the same year. In 1968, Maurice Hilleman, debuted an improved version of the vaccine created that eliminated the use of human blood proteins and is still used as of July 22, 2014. [165][166][167][172][176]
Mumps
Mumps, according to the CDC, is “a contagious disease that is caused by the mumps virus. Mumps typically starts with a few days of fever, headache, muscle aches, tiredness, and loss of appetite, and is followed by swelling of salivary glands.”
In 1945 the mumps virus was isolated. In 1948 an inactivated vaccine was developed but it provided only short-term immunity and its use was discontinued in the 1970s. On March 30, 1967, the FDA licensed Mumpsvax, a mumps vaccine developed by Maurice Hilleman that was created from the mumps virus that infected his five-year-old daughter, Jeryl Lynn. This Jeryl Lynn strain of live attenuated mumps virus vaccine is still used as of July 22, 2014. [165][166][167][173][174][176]
Rubella (German Measles)
Rubella, according to the CDC, is “a disease caused by a virus. The infection is usually mild with fever and rash. But, if a pregnant woman gets infected, the virus can cause serious birth defects.”
In 1740, Friedrich Hoffmann, German physician, gave the first clinical description of “German measles” (“Rötheln” in German) In 1841 the virus was referred to as “rubella” (meaning “little red”) in connection with an outbreak at a school in India. In 1866, Henry Veale, English surgeon, suggested renaming the virus “Rubella” to replace “Rötheln.”
In 1938, S. Tasaka and Y. Hiro, Japanese scientists, successfully transmitted rubella from sick children to healthy children but did not find the causative agent of the disease. In 1960 the rubella virus was isolated by Thomas Weller, a Harvard School of Public Health researcher, from his 10-year-old son who was infected with the virus. The first mumps vaccine was created by Maurice Hilleman, was first used in 1969.
In 1971, the combination MMR (measles, mumps, rubella) vaccine was licensed for use.
In 2005, a combination MMRV (measles, mumps, rubella, varicella) vaccine was licensed for use. [165][166][167][175][176]
Polio
The CDC recommends that children receive the first dose of the polio (IPV) vaccination at 2 months of age.
Polio, according to the CDC, is an incurable, “crippling and potentially deadly infectious disease caused by a virus that spreads from person to person invading the brain and spinal cord and causing paralysis.”
Polio was not discovered to be contagious until 1905 by Swedish physician Ivar Wickham. In 1908, Karl Lansdteiner and Erwin Popper identified and isolated the polio virus. The idea of a vaccine against polio was first introduced in 1910 as a result of research by Simon Flexner. In 1935 two teams tested a polio vaccine but neither were successful and both teams infected and killed some test subjects (the scientists, chimpanzees, human adults, and children). In 1951, Jonas Salk, and his team developed a method to cultivate polio virus in monkey kidney tissue in order to be able to produce large amounts of the vaccine. On Apr. 12, 1955, the results of the Salk vaccine trials showed the vaccine was 80-90% effective and the US government licensed the IPV (inactivated polio vaccine) vaccine the same day. The vaccination program was suspended on May 8, 1955 to investigate paralysis resulting from the vaccine injection; changes to the production method were made and vaccination resumed on May 27, 1955. On Aug. 24, 1960, a polio vaccine (OPV; oral polio vaccine) created by Albert Sabin, was licensed for use in the US and recommended by US Surgeon General Leroy E. Burney. In 1968 U.S. use of Salk’s IPV vaccine was phased out. Polio was declared eradicated in the Americas on Sept. 29, 1994 by the Pan American Health Organization. An improved version of Jonas Salk’s IPV vaccine was phased in again in 1997, because OPV had an increased risk of infecting children with the virus in the first dose. In 2000 the transition to all-IPV vaccine schedule was complete. [165][166][167][177][178][179]
Varicella (Chickenpox)
The CDC recommends that children receive the first dose of the varicella vaccination between 12 and 18 months of age.
Varicella, according to the CDC, is “a very contagious disease caused by the varicella-zoster virus (VZV). It causes a blister-like rash, itching, tiredness, and fever.”
In 1767, English doctor William Heberden first distinguished chickenpox (varicella) from smallpox (variola major and variola minor). In 1892, Hungarian pediatrics professor James Bokay wrote of the connection between chickenpox and later contraction of shingles; his theory was be proven correct in 1925 by K. Kundratitz. Thomas Weller first isolated the varicella virus in 1953. In 1974, Michiaki Takahashi attenutated (keeping the virus live but weakening it so that it is essentially harmless) the varicella virus, creating a vaccination. A version of that vaccine, Varivax, was licensed and used in the United States in 1995 and, as of June 25, 2014, remains the only varicella vaccination used in the United States. [165][166][167][180]
