Believe it or not, vaccines aren’t a one-size-fits-all kind of a thing.
“There are several different types of vaccines. Each type is designed to teach your immune system how to fight off certain kinds of germs — and the serious diseases they cause.”
In addition to live vaccines, like MMR, there are inactivated vaccines, toxoid vaccines, and subunit, recombinant, polysaccharide, and conjugate vaccines.
Are You Ready for DNA Vaccines?
Vaccines made with current technology have helped save millions of lives.
It’s time for some new approaches though, especially as we are seeing the limitations of some of our current vaccines, especially the seasonal flu vaccine.
“DNA vaccines take immunization to a new technological level. These vaccines dispense with both the whole organism and its parts and get right down to the essentials: the microbe’s genetic material. In particular, DNA vaccines use the genes that code for those all-important antigens.”
NIH on Vaccine Types
While a DNA vaccine might sound like something out of the 23rd century, researchers have been studying them since the 1990s.
“Researchers have found that when the genes for a microbe’s antigens are introduced into the body, some cells will take up that DNA. The DNA then instructs those cells to make the antigen molecules. The cells secrete the antigens and display them on their surfaces. In other words, the body’s own cells become vaccine-making factories, creating the antigens necessary to stimulate the immune system.”
NIH on Vaccine Types
Does the idea of being injected with the genes for a microbe’s antigens scare you?
“The original concerns associated with the DNA platform were the potential for genomic integration and development of anti-DNA immune responses. Exhaustive research has found little evidence of integration, and the risk for integration appears to be significantly lower than that associated with naturally occurring mutations”
Ferraro et al on Clinical Applications of DNA Vaccines: Current Progress
What do you think happens when you get the flu?
The flu virus and it’s DNA is taken up by your cells, and those cells then start making more flu proteins.
“This approach offers a number of potential advantages over traditional approaches, including the stimulation of both B- and T-cell responses, improved vaccine stability, the absence of any infectious agent and the relative ease of large-scale manufacture.”
WHO on DNA Vaccines
So where are all of the DNA vaccines?
“However, the results of these early clinical trials were disappointing. The DNA vaccines were safe and well tolerated, but they proved to be poorly immunogenic. The induced antibody titers were very low or nonexistent, CD8+ T-cell responses were sporadic, and CD4+ T-cell responses were of low frequency. However, these studies provided proof of concept that DNA vaccines could safely induce immune responses (albeit low-level responses) in humans.”
Ferraro et al on Clinical Applications of DNA Vaccines: Current Progress
After getting disappointing results in the 1990s, researchers have since moved on to second-generation DNA vaccines, which are being tested for HIV treatment and prevention, Zika, Dengue fever, influenza (DNA vaccine prime), HPV, cancer treatment (metastatic breast, B cell lymphoma, melanoma, prostate, colorectal), chronic hepatitis B treatment, chronic hepatitis C treatment, herpes, and malaria.
While many of these DNA vaccines are now in phase I and II trials, unfortunately, that means we are still a long time away from having a DNA vaccine on the immunization schedule.
Like a few other vaccines, Gardasil underwent Fast Track approval by the FDA.
“This is the first vaccine licensed specifically to prevent cervical cancer. Its rapid approval underscores FDA’s commitment to help make safe and effective vaccines available as quickly as possible. Not only have vaccines dramatically reduced the toll of diseases in infants and children, like polio and measles, but they are playing an increasing role protecting and improving the lives of adolescents and adults.”
Jesse Goodman, MD, MPH, Director of FDA’s Center for Biologics Evaluation and Research
But that doesn’t mean that any corners were cut in getting it quickly approved or that the vaccine isn’t safe.
Vaccine Fast Tracking
The Fast Track process can help get new drugs and vaccines approved more quickly by the FDA because they have:
more frequent meetings with the FDA to discuss the drug’s development plan and to help ensure the collection of appropriate data needed to support drug approval
more frequent written communication from the FDA about such things as the design of the proposed clinical trials and the use of biomarkers
eligibility for Accelerated Approval and Priority Review, if relevant criteria are met
a Rolling Review, which means that a drug company can submit completed sections of its Biologic License Application (BLA) or New Drug Application (NDA) for review by FDA, rather than waiting until every section of the NDA is completed before the entire application can be reviewed. BLA or NDA review usually does not begin until the drug company has submitted the entire application to the FDA.
In very simple terms, it is kind of like having a VIP pass at an amusement park. It gets you a guide and helps you jump to the front of many of the lines, but you still don’t get to operate the rides yourself.
Others that have Fast Track designation include vaccines for anthrax (NuThrax anthrax vaccine adsorbed with CPG 7909 adjuvant), chikungunya, Clostridium difficile (Clostridium difficile toxoid vaccine), malaria, RSV, Zika, Ebola, Invasive Staphylococcus aureus infections in surgical populations, Shigella (Flexyn2a), and Lyme disease. None are approved yet though.
And that all of these vaccines have Fast Track designation is a good reminder that it isn’t a guarantee of approval.
“With Fast Track designation, early and frequent communication between the FDA and the biopharmaceutical company is encouraged throughout the entire drug development and review process to help to quickly resolve any questions or issues that arise, potentially leading to an earlier approval and access by patients.”
Encouraging Vaccine Innovation: Promoting the Development of Vaccines that Minimize the Burden of Infectious Diseases in the 21st Century
It just puts them on a Fast Track to get approved if they meet all of the FDA requirements for safety and efficacy.
The ability to develop and approve new vaccines quickly is also important as we continue to face new emerging disease threats. Faced with a deadly global pandemic, everyone will be glad that we have the ability to Fast Track vaccines and other drugs.
And one, the adenovirus vaccine, you can only get if you join the military.
Which Vaccines Do You Get When You Join the Military?
But don’t folks get a lot of vaccines when they join the military?
Whether you join the Army, Navy, Air Force, Marine Corps, or Coast Guard, health personnel will evaluate your immunity status by checking your titers to routine vaccine-preventable diseases. So no, if you were wondering, it doesn’t seem like they just check the vaccine records that you might bring from your pediatrician.
And then once they assess your immunization or immunity status, you will get vaccinated:
upon accession – adenovirus, influenza, meningococcal, MMR, Tdap, and chicken pox
during the first or second half of collective training – hep A, hep B, and polio (if needed) and other vaccines based on risk
So, in addition to getting caught up on all routine vaccines that they might be missing, there are other “military vaccines” that they might need, including:
Anthrax vaccine – only military personnel with extra risk, although some civilians can get this vaccine too
Smallpox vaccine – only military personnel who are high risk and smallpox epidemic response team members, although some civilians can get this vaccine too
Like the recommendations for civilians, other vaccines are mainly given to military personal if they have extra risk based on where they are being deployed.
Cholera – only military personnel with extra risk based on deployment or travel to endemic areas
Japanese encephalitis – only military personnel with extra risk based on deployment or travel to endemic area in Eastern Asia and certain western Pacific Islands
Rabies vaccine – pre-exposure vaccination is only for military personnel with animal control duties or with extra risk based on deployment, including special operations personnel
Typhoid vaccine – only military personnel with extra risk based on deployment or travel to typhoid-endemic areas and other areas with poor sanitation.
Yellow fever vaccine – only military personnel with extra risk based on deployment or travel to yellow-fever-endemic areas in sub-Saharan Africa and tropical South America.
These are the same vaccines that we would get if we traveled to high risk areas.
Military Vaccines in Development
It shouldn’t be a surprise that the military does research on infectious diseases and vaccines.
Members of the military are often put at great risk for known and emerging diseases, like Ebola, Zika, and malaria.
That’s why some vaccines might have been given as an investigational new drug in special situations, typically when “individuals who have a high occupational risk – laboratory workers, facilities inspectors, vaccine manufacturers and certain military response teams.”
These vaccines, which were initially developed at US Army labs, are no longer being produced, but have included:
Argentine hemorrhagic fever (Junin virus) vaccine
Chikungunya fever vaccine
Eastern equine encephalitis vaccine
Q fever vaccine
Rift Valley fever vaccine
Venezuelan equine encephalitis vaccine
Western equine encephalitis vaccine
Today, the Walter Reed Army Institute of Research (WRAIR) “is a leader in global efforts against the world’s most pervasive and high impact infectious diseases.”
WRAIR is working on vaccines for HIV, Ebola, MERS, and Zika.
What to Know About Military Vaccines
You will need some extra vaccines when you enlist in the military, but how many will depend on if you are up-to-date when you join and your area of responsibility. So there is no one-size-fits-all military immunization schedule.
A lot of folks, even some pediatricians, are still confused about the recommendations for the meningococcal B vaccines.
Remember, two vaccines, Bexsero and Trumenba, are approved to protect against serogroup B meningococcal disease.
The Men B Vaccine for High Risk Kids
There is no confusion about the recommendation that high risk kids should get vaccinated against meningococcal B disease.
“Certain persons aged ≥10 years who are at increased risk for meningococcal disease should receive MenB vaccine.”
ACIP on Use of Serogroup B Meningococcal Vaccines in Persons Aged ≥10 Years at Increased Risk for Serogroup B Meningococcal Disease: Recommendations of the Advisory Committee on Immunization Practices, 2015
Who’s high risk?
In addition to microbiologists who work with the Neisseria meningitidis bacteria, you are considered to be high risk if you are at least 10 years old and:
have a persistent complement component deficiency, including inherited or chronic deficiencies in C3, C5–C9, properdin, factor D, or factor H
have anatomic or functional asplenia, including sickle cell disease, children with congenital asplenia, and children who’s spleen was removed (splenectomy) to prevent complications of other conditions, such as ITP, hereditary spherocytosis, pyruvate kinase deficiency, Gaucher disease, and hypersplenism, etc.
are taking the medication eculizumab (Soliris), which is used to treat two rare blood disorders, atypical hemolytic uremic syndrome (aHUS) and paroxysmal nocturnal hemoglobinuria (PNH)
And, if high risk, you should either get a 3 dose series of Trumenba or a 2 dose series of Bexsero.
Keep in mind that traveling is not usually a risk factor for Men B, but can be for the other meningococcal vaccines.
The Men B Vaccine for Healthy Teens
But what if you aren’t at high risk?
While teens should routinely get vaccinated with other meningococcal vaccines, Menactra or Menveo, that provide protection against serogroups A, C, W, Y, the recommendation for Men B vaccination is more permissive.
“A MenB vaccine series may be administered to adolescents and young adults aged 16–23 years to provide short-term protection against most strains of serogroup B meningococcal disease. The preferred age for MenB vaccination is 16–18 years.”
ACIP on Use of Serogroup B Meningococcal Vaccines in Adolescents and Young Adults: Recommendations of the Advisory Committee on Immunization Practices, 2015
When given to healthy teens who are not at high risk for meningococcal disease, both Bexsero and Trumenba can be given as a two dose series.
A Permissive Recommendation for Men B Vaccines
This permissive recommendation for Men B is what has got folks confused…
“The recommendation is labeled as “Category B,” meaning that individual clinical decision-making is recommended. A Category A recommendation means a vaccine is recommended for everyone in an age-group or risk factor group.”
ACIP endorses individual choice on meningitis B vaccine
So there is a recommendation for older teens to get vaccinated with the Men B vaccines, it just isn’t the clear cut, get the vaccine, kind of recommendation that we are used to. The recommendation instead says that you can get the vaccine if you want to be vaccinated and protected against meningococcal B disease.
And that’s where the confusion comes from, as over 75% of doctors don’t even know what a category B recommendation really means! That’s not surprising though, as the Advisory Committee on Immunization Practices doesn’t often make category B recommendations for vaccines.
Things that factored into the decision for a permissive recommendation seemed to include that:
routine vaccination of all teens would prevent about 15 to 29 cases of Men B and two to five deaths each year, as there are about 50 to 60 cases and five to 10 deaths each year in children and young adults between the ages of 11 and 23 years, and giving it only to kids going to college would only prevent about nine cases and one death each year
there are some concerns about how effective the MenB vaccines might be, but only because vaccine effectiveness “was inferred based on an immunologic marker of protection,” as it is difficult to otherwise test how well the vaccine works because the disease has a low prevalence and there is no data yet about how long the protection will last, as they are new vaccines. Still, from 63 to 88% of people get protective levels of antibodies after getting the MenB vaccines and the protection should last for at least two to four years.
data on safety was limited, but there were no “no concerning patterns of serious adverse events”
the vaccine likely won’t reduce the nasopharyngeal colonization by MenB bacteria, so might not contribute to herd immunity
If you are still confused, you will hopefully be reassured that a combination, pentavalent MenABCW-135Y meningococcal vaccine is in the pipeline and once available, will almost certainly be recommended for all teens, replacing the need to get separate meningococcal vaccines for protection.
Making a Decision About the MenB Vaccines
So do you get your kids the Men B vaccine series?
“Pediatricians are encouraged to discuss the availability of the MenB vaccines with families.”
AAP on Recommendations for Serogroup B Meningococcal Vaccine for Persons 10 Years and Older
The one thing that is very clear is that you should make your decision after talking to your pediatrician about the risks and benefits of getting vaccinated.
Although many people think that there is no recommendation for healthy teens to get a Men B vaccine, that isn’t really true. There just isn’t a recommendation for routine vaccination of all teens.
It is true that the Men B vaccines aren’t required by most colleges, although some are starting to require them, just like they do Menactra or Menveo.
“The treating clinician should discuss the benefits, risks, and costs with patients and their families and then work with them to determine what is in their best interest.”
AAP on Recommendations for Serogroup B Meningococcal Vaccine for Persons 10 Years and Older
What are the benefits? Your child doesn’t get Men B disease, a disease that is often life-threatening.
What are the risks? In addition to extremely rare risks that you can see with any vaccine, like anaphylaxis, there are the risks that the vaccine doesn’t work, as no vaccine is 100% effective, pain from the shot, or that your child is never exposed, so didn’t actually need the shot, since Men B disease is pretty rare.
“The CDC has estimated the risk of anaphylaxis is 1.3 cases/1 million doses following administration of any vaccine. Thus, the vaccine benefit from prevention of death from MenB disease is approximately equal to the risk of anaphylaxis from MenB vaccine administration.”
H. Cody Meissner, MD on MenB vaccines: a remarkable technical accomplishment but uncertain clinical role
Although thinking about it this way, the risk of anaphylaxis vs the benefit of preventing Men B deaths seems to be equal, remember that anaphylaxis is often treatable.
What are the costs? Men B vaccines are expensive, but are covered by insurance and the Vaccines for Children Program. Still, someone is always paying for them.
What other factors come into play? Some teens are getting caught up on their HPV vaccines and are getting a booster dose of the other meningococcal vaccine at around this same time. While they can certainly all be given together, some pediatricians prioritize getting kids vaccinated and protected with Gardasil and Menactra or Menveo, and so don’t focus on the Men B vaccines.
Still, the vaccine is safe and it works, so the question really may come down to – is it necessary? Or is Men B so rare, that it is worth taking a chance and skipping this vaccine.
What to Know About the Recommendations to Get a Men B Vaccine
Talk to your pediatrician and see if your child should get the Men B vaccine series.
More on Understanding the Recommendations to Get a Men B Vaccine
So after an eight-month long investigation, a journalist for Slate thinks he has evidence that the clinical trials that helped get Gardasil approved by the European Medical Agency were flawed.
What was the problem?
The way that they recorded possible side effects after folks were vaccinated.
“To track the safety of its product, the drugmaker used a convoluted method that made objective evaluation and reporting of potential side effects impossible during all but a few weeks of its years long trials.”
What made the method convoluted?
“In an internal 2014 EMA report about Gardasil 9 obtained through a freedom-of-information request, senior experts called the company’s approach “unconventional and suboptimal” and said it left some “uncertainty” about the safety results.
Merck, which is known as Merck Sharp & Dohme outside the U.S. and Canada, did not address the EMA’s safety concerns.”
When you read the internal 2014 EMA report about Gardasil 9, it is clear that Merck has a thorough response to each and every question that the EMA asked.
And those other quotes?
The EMA does state that:
“At all other time points in the study medical events were reported as “new medical history”. This is an unconventional and suboptimal study procedure.”
“While it is considered that the required safety data eventually has been made available for assessment, this feature of the study protocol brings some degree of uncertainty into safety assessment.”
So the EMA got the required safety data they were looking for, which is likely why Gardasil was approved in Europe.
They also said that “As the AE reporting procedure as seen at the inspection sites was in line with the approved protocol, the inspectors did not comment on it in the inspection reports. It was discussed with assessors during the course of the inspections, as in the inspectors’ opinion it is not an optimal method of collecting safety data, especially not systemic side effects that could appear long after the vaccinations were given.”
But if it was suboptimal, how come they were able to record someone getting diagnosed with POTS 1,389 days after their third dose of vaccine?
I’m starting to understand why Dr. Yehuda Shoenfeld wasn’t quoted in the piece. He likely knew how it was going to be perceived…
“Imagining a link between HPV vaccination and CFS is not all that far-fetched, according to Dr. Jose Montoya, a professor of medicine at Stanford University and a CFS expert.”
Not far-fetched at all, which is why studies are done to see if there really is a link.
So even if part of the study design was suboptimal, the Slate piece shouldn’t have cherry picked those quotes and should have included these other big pieces of information:
A study in the UK using the MHRA’s Yellow Card passive surveillance scheme found no increase in reports of chronic fatigue syndromes following the introduction of Cervarix (another HPV vaccine)
In 2015, the EMA confirmed evidence that HPV vaccines do not cause complex regional pain syndrome (CRPS) and postural orthostatic tachycardia syndrome (POTS)
A large, nationwide register-based study from Norway found no indication of increased risk of chronic fatigue syndrome/myalgic encephalomyelitis following HPV vaccination
A large cohort study of over 2 million young girls in France found no risk for autoimmune diseases (including neurological, rheumatological, hematological, endocrine, and gastro-intestinal disorders)
A large cohort study of girls in Sweden with pre-existing autoimmune diseases found that HPV vaccination was not associated with increased incidence of new-onset autoimmune disease (49 types of autoimmune diseases)
A review of VAERS reports that “did not detect any unusual or unexpected reporting patterns that would suggest a safety problem” with HPV vaccination
The Slate piece does mention two of these studies, but just barely. One gets a single sentence and the other, half a sentence.
We see page after page of anecdotes of folks with supposed vaccine injuries, but the evidence that shows the vaccine is safe is almost buried and easy to miss. Many of the other studies seem to be left out.
And just because these patients have agonistic auto-antibodies, it doesn’t mean that they are from a vaccine.
“Five of the 14 POTS subjects and 2 of the 10 “healthy controls” recalled a respiratory infection in the 6 months prior to onset of their symptoms or inclusion in the study for the healthy controls.”
Li et al on Autoimmune Basis for Postural Tachycardia Syndrome
Lastly, what’s with calling cervical cancer uncommon???
“Cervical cancer is the 4th most common cause of cancer death in women worldwide, with tens of thousands of deaths in Europe each year despite the existence of screening programmes to identify the cancer early.”
European Medicines Agency
Downplaying the risks of vaccine-preventable diseases, while trying to scare folks about vaccines – that’s what gets you labeled as anti-vaccine.
What to Know About the Slate Gardasil Investigation
Although the study design for Gardasil used for licensing in Europe might have been suboptimal, that doesn’t really come across in this Slate piece, as it seems clear that it didn’t result in safety data being missed, and as post-licensure tests have confirmed, Gardasil is safe.
But instead of monkey cages and chicken coops in the labs of today’s vaccine manufacturers, you will find clean rooms with large scale, stainless steel bioreactors, master cell banks, seed fermenters, microcarriers, centrifuges, filtration and chromatography equipment, and filling and lyophilization equipment.
That doesn’t sound so scary or shocking, does it?
What’s shocking about the whole process of making a vaccine?
It takes a long time. Often one to three years! And that’s after all of the time that went into the research, testing, and licensing of the vaccine.
“Viruses are grown in cells, which can be either primary cells, such as chicken fbroblasts (e.g., yellow fever vaccine), or continuous cell lines, such as MRC-5 (e.g., hepatitis A vaccine). Bacterial pathogens are grown in bioreactors using medium developed to optimize the yield of the antigen while maintaining its integrity. Recombinant proteins can be manufactured in bacteria, yeast, or cell culture. ”
Plotkin’s Vaccines (Seventh Edition)
The only other shocking thing about making vaccines is how boring it all is, at least if you aren’t into biology, with most vaccines using the same basic steps:
decide on the type of antigen – vaccines can be made of attenuated live viruses, inactivated viruses or bacteria, or just part of the virus or bacteria (subunit and conjugate vaccines)
generate an antigen – this is the thing in the vaccine that will stimulate an immune response and protect your child. It used to be what anti-vaccine folks were concerned about until we explained that kids today are exposed to far fewer antigens, even though they get more vaccines and more protection.
release and isolate the antigen – the antigen was either growing in cells or other medium and in this step, as much of the antigen is collected as possible.
purify the antigen – multiple steps are involved in removing many of the vaccine ingredients or excipients that were used up to this step by precipitation, ultrafiltration, and column chromatography, etc. That’s why many are said to remain only in residual amounts, like formaldehyde.
strengthen the antigen – in this step, an adjuvant might be added.
last steps – finished vaccine is put in vials and syringes and then packaged
lot release and distribution – each lot is tested before it is released to make sure it meets FDA standards for potency, safety, and sterility.
None of that sounds as scary as injecting monkeys with smallpox, watching them die, and then harvesting their infected kidney cells though, does it? If you have watched any of the anti-vaccine scare videos, hopefully the first thing that came to mind is that the smallpox vaccine isn’t actually made with the smallpox virus! It is, of course, made with vaccinia virus and wouldn’t cause anyone, whether a monkey, cow, or person to actually get smallpox. And if you haven’t figured it out by now, monkeys aren’t used to make smallpox vaccines.
“Both vaccines are derived from the New York City Board of Health strain of vaccinia, but Dryvax was grown on the skin of calves and then essentially freeze-dried for storage. It was licensed by FDA in 1931 but is no longer manufactured. ACAM2000, a “second generation” smallpox vaccine, is derived from a clone of Dryvax, purified, and produced using modern cell culture technology.”
FDA on ACAM2000 (Smallpox Vaccine) Questions and Answers
In fact, most of today’s vaccines are made in bioreactors, not in cows or monkeys.
Flu vaccine is mostly still made using chicken eggs, specifically 11-day-old embryonated chicken eggs. The flu viruses are passed into the eggs, incubated for a time to allow them to grow, and then harvested, inactivated, and purified.
How purified do they get? So purified that even people with egg allergies can get a flu vaccine these days.
It shouldn’t be a secret that vaccines are made in China.
There are over 1.3 billion people in China, and no, they don’t import all of their vaccines from the United States.
Neither does India, for all of their 1.2 billion people.
For example, the Serum Institute of India Pvt. Ltd. makes many vaccines, including:
GeneVac-B – hepatitis B
Quadrovax – DTP-Hib combo
Pentavac – DTP-HepB-Hib combo
Tresivac – MMR
Poliovac – polio
Triple Antigen – DTP
MenAfriVac – meningococcal group A
And there are over 34 vaccine manufacturers in China, including:
Chengdu Institute of Biological Products Co., Ltd
Hualan Biolgical Bacterin Co., Ltd
Jilin Brother Biotech Co., Ltd
Wuhan Institute of Biological Products
Lanzhouz Institute of Biological Products
These vaccine manufacturers in China, a mix of state run, private, and international joint ventures, help produce the vaccines used in China’s immunization program.
Some US vaccine companies even have vaccine manufacturing plants in China and other countries, but they make vaccines that are used in nearby parts of the world.
For example, Merck recently opened a new vaccine plant in Hangzhou, China to make vaccines to be used in the Asia Pacific region.
Should We Be Concerned About Vaccines Made in China?
If you are getting vaccinated in China, then you likely want to know more about where and how your vaccines are made, especially as there have been some recent vaccine scandals in China. Everyone else should probably be wondering why anti-vaccine folks make such a fuss about this.
In addition to implying that vaccines are made under unsafe conditions, much of this anti-vaccine propaganda includes racist themes.
Parents who are concerned should understand that the United States doesn’t get any vaccines from China or India, or from Brazil, Cuba, Indonesia, or Russia for that matter.
The concern, of course, would be that it might be hard to test and verify these vaccines if they were.
“Following approval, FDA also carefully monitors the quality of vaccines—all manufactured lots must pass tests before they can be used. And as with all manufacturers of medical products, vaccine manufacturers must follow strict manufacturing standards. In addition, FDA conducts routine inspections of manufacturing sites.”
FDA on How does FDA assess the safety of vaccines?
Instead, vaccines that are used in the United States are made by:
Emergent Biosolutions – USA – Anthrax vaccine
ID Biomedical Corp – Canada – Fluvaval
GSK Vaccines – based in Belgium, but vaccines are made in Belgium (Boostrix, Cervarix, Energix-B, Havrix, Hiberix, Infanrix, MenHibrix, Kinrix, Pediarix, Rotarix), Germany (Boostrix, Fluarix, Infanrix, Kinrix, Pediarix, Rabavert), and Italy (Bexsero, Menveo)
MedImmune – USA – FluMist
Merck – USA – BCG, Gardasil9, MMRII, PedvaxHIB, PneumoVax23, ProQuad, RecombivaxHB, RotaTeq, Vaqta, Varivax, Zostavax are made at Merck’s vaccine manufacturing plants in West Point, Pennsylvania, Elkton, Virginia, and Durham, North Carolina
PaxVax – USA – their Vivotif typhoid vaccine is made in Thörishaus, Switzerland
Pfizer – USA – (Prevnar, Trumenba)
Protein Sciences Corporation – USA – Flublok
Sanofi Pasteur – Canada (Adacel, Daptacel, Pentacel), France (IPOL, Pentacel), USA (Menactra, YF-Vax, ),
Seqirus – USA – Afluria, Flucelvax, Fluvirin
Valneva (Intercell USA) -their Japanese encephalitis vaccine (IXIARO) is made in Livingston, Scotland, UK
Valneva Sweden AB – their Dukoral cholera vaccine is made in Solna, Sweden
A little competition in the vaccine industry wouldn’t be a horrible thing though.
Although plenty of vaccines are made in China, the vaccines that are used in the United States are not, although anti-vaccine folks use this as a talking point to scare parents away from vaccinating and protecting their kids.
For More Information on Vaccine Manufacturer Sites: