Tag: development

Which Vaccines Do You Get When You Join the Military?

The oral adenovirus vaccine is approved to prevent adenovirus infections in military populations.

Believe it or not, many vaccines are available that we don’t routinely get.

Some we only get if we travel, like vaccines for yellow fever and typhoid. Others we only get in high risk situations, like if you get exposed to a bat with rabies.

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?

It depends…

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:

  • Adenovirus vaccine – given to enlisted soldiers during basic training
  • 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
Which vaccines you get in the military might be determined by where you are getting deployed to.
Which vaccines you get in the military will likely be determined by where you get deployed.

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
  • Tularemia 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.

More on Military Vaccines

 

Understanding the Recommendations to Get a Men B Vaccine

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:

  • MenB vaccines are routinely given during outbreaks on college campuses.
    MenB vaccines are routinely given during outbreaks on college campuses.

    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)
  • could be exposed in a serogroup B meningococcal disease outbreak

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.

So why did the Men B vaccines only get a permissive recommendation? After all, Bexsero is routinely given to all infants in the UK at 8 weeks, 16 weeks, and 1 year as part of their routine childhood immunization schedule.

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

Et Tu, Slate? Flaws with Their Questions About Gardasil

Questioning vaccines doesn’t make someone anti-vaccine.

Something is missing in this article about Gardasil testing in Slate...
Something is missing in this article about Gardasil testing in Slate…

Doing a poor job of it and making folks scared to get vaccinated and protected?

I’ll let you decide what to call them…

Slate Investigates the Gardasil Clinical Trials

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.”

This case of a subject with POTS was reported as being "well characterized" by the EMA, even though it likely wasn't caused by her Gardasil shots.
This case of a subject with POTS was reported as being “well characterized” by the EMA, even though it likely wasn’t caused by her Gardasil shots.

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.

The HPV vaccines are safe. They work and they are necessary. Don’t skip them.

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.

More on the Slate Gardasil Investigation

How Are Vaccines Really Made?

Do you know how vaccines are made?

A lab worker injects flu virus into an egg, one of many steps in making our flu vaccines.
A lab worker injects flu virus into an egg, one of many steps in making our flu vaccines. Photo courtesy of the FDA

When we say that chickens are used to make flu vaccine, do you think that means that live chickens are actually infected with the flu to make the vaccine?

They aren’t.

Just like live monkeys aren’t injected with the polio virus to make the polio vaccine.

Those are just myths you see in vaccine scare videos on anti-vaccine websites.

How Are Vaccines Really Made?

So how are vaccines really made?

It depends, after all, there are a lot of different types of vaccines.

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.

Do you picture a series of these large scale, stainless steel bioreactors when you think about how vaccines are made?
Do you picture a series of these large scale, stainless steel bioreactors when you think about how vaccines are made?

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.
  • combine all of the ingredientsstabilizers and preservatives might also be added in this step.
  • 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.

Vaccines are safe. Vaccines are made safely.

What to Know About How Vaccines Are Really Made

Vaccines are made using a very safe and scientific process that is heavily regulated that will neither scare nor shock you.

More on How Vaccines Are Really Made

Vaccines Are Made in China!

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
At least 34 manufacturers make vaccines for use in China, like this Hib vaccine.
At least 34 manufacturers make vaccines for use in China, like this Hib vaccine.

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. 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.

Vaccines are expensive

They are safe, but expensive. Necessary too.

What to Know About Vaccines Made in China

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:

Are Vaccines Evaluated for Mutagenicity, Carcinogenicity or Impairment of Fertility?

Spend much time on anti-vaccine websites or forums and you will soon be warned that vaccines are not evaluated for mutagenicity, carcinogenicity or impairment of fertility.

Actually, you can often read that simply by reading a vaccine’s package insert.

Mutagenicity, Carcinogenicity and Impairment of Fertility

What are these term exactly?

  • mutagenicity – being known or suspected of causing mutations in our DNA, which can lead to cancer
  • carcinogenicity – being known or suspected of being able to cause cancer
  • impairment of fertility

And why are they listed in Section 13 of a vaccine’s package insert?

The Section 13 Vaccine Conspiracy?

More importantly, why do some folks talk about Section 13.1 of a vaccine’s package insert like it is Area 51 or Agenda 21?

“13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, mutagenesis, impairment of fertility. This subsection must state whether long term studies in animals have been performed to evaluate carcinogenic potential and, if so, the species and results. If results from reproduction studies or other data in animals raise concern about mutagenesis or impairment of fertility in either males or females, this must be described. Any precautionary statement on these topics must include practical, relevant advice to the prescriber on the significance of these animal findings. Human data suggesting that the drug may be carcinogenic or mutagenic, or suggesting that it impairs fertility, as described in the “Warnings and Precautions” section, must not be included in this subsection of the labeling.”

CFR – Code of Federal Regulations Title 21

So no material for a vaccine conspiracy?

Just information on studies in animals?

“The goals of the nonclinical safety evaluation generally include a characterization of toxic effects with respect to target organs, dose dependence, relationship to exposure, and, when appropriate, potential reversibility. This information is used to estimate an initial safe starting dose and dose range for the human trials and to identify parameters for clinical monitoring for potential adverse effects. The nonclinical safety studies, although usually limited at the beginning of clinical development, should be adequate to characterize potential adverse effects that might occur under the conditions of the clinical trial to be supported.”

FDA on Guidance for Industry M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals 

It still sounds important though…

Are Vaccines Evaluated for Mutagenicity, Carcinogenicity or Impairment of Fertility?

As important as vaccines are, no one wants them to mutate our children, cause cancer, or keep them from having babies.

Fortunately, they don’t!

“To ensure the safety of new vaccines, preclinical toxicology studies are conducted prior to the initiation of, and concurrently with, clinical studies. There are five different types of preclinical toxicology study in the evaluation of vaccine safety: single and/or repeat dose, reproductive and developmental, mutagenicity, carcinogenicity, and safety pharmacology. If any adverse effects are observed in the course of these studies, they should be fully evaluated and a final safety decision made accordingly. ”

M.D. Green on the Preclinical Toxicology of Vaccines

And that’s because vaccines are safe and well tested.

Then why do anti-vaccine folks scare parents into thinking that vaccines are missing necessary testing when the package insert states that they are “not evaluated for mutagenicity, carcinogenicity or impairment of fertility?”

Cancer is caused by a host of factors. Vaccines have a role in preventing and potentially treating some types of cancer. Components of vaccines and their associated cell lines that viruses are grown in are safe and have not been shown to induce cancer in the vaccinated host.
“Cancer is caused by a host of factors. Vaccines have a role in preventing and potentially treating some types of cancer. Components of vaccines and their associated cell lines that viruses are grown in are safe and have not been shown to induce cancer in the vaccinated host.”

Probably because it sounds scarier than saying that vaccines have a low risk of inducing tumors and that there are very specific guidelines and rules for when a manufacturer needs to perform fertility studies.

That means that if  a package insert says that it has “not been evaluated,” it is simply because it was not necessary or appropriate. It is not because they just didn’t want to do it and left those tests out.

That doesn’t sound as scary though.

All necessary pre-clinical or nonclinical testing is done on vaccines and their components. You just don’t see long term testing that would be listed in the package insert unless the initial tests found a problem.

Also remember that vaccines are monitored through several passive and active safety systems that would detect issues with mutagenicity, carcinogenicity, and impairment of fertility.

And several vaccines actually prevent cancer!

What to Know About Vaccines and Mutagenicity, Carcinogenicity and Impairment of Fertility

Vaccines are appropriately evaluated for mutagenicity, carcinogenicity and impairment of fertility, when necessary, as a part of pre-clinical or nonclinical studies that occur even before the first phase one studies on people.

More About Vaccines and Mutagenicity, Carcinogenicity and Impairment of Fertility

 

Vaccine Testing and Development Timeline and Myths

New vaccines must go through a long journey before they are finally approved by the FDA and get added to the recommended immunization schedule.

vaccine-dev-testing

Vaccine Testing and Development Myths

There are many myths and much misinformation surrounding vaccine testing and development that is used to scare parents away from vaccinating their kids.

Have you heard that vaccines aren’t tested together?

Or that flu vaccines or Tdap were never tested on pregnant women?

Then there are the myths about fast-tracking, and that important steps are skipped when a vaccine is on fast track for FDA approval, or that the whole vaccine testing and development process happens very quickly.

Vaccine Testing and Development Timeline

The vaccine development process is anything but quick.

“Vaccine development is a long, complex process, often lasting 10-15 years and involving a combination of public and private involvement.”

The History of Vaccines on Vaccine Development, Testing, and Regulation

During this time of the exploratory and pre-clinical stage research and then phase 1,2, and 3 trails, vaccines are:

  • tested on animals
  • tested on small groups of people
  • tested on larger groups of people
  • tested alone
  • tested together with other vaccines
  • tested for safety
  • tested for efficacy (to make sure they work)

This often includes double-blind, placebo controlled vaccine trials.

Fast tracking does speed the process up, but not because any of the testing is skipped. The researchers just get more frequent meetings and communication with the FDA and “Eligibility for Accelerated Approval and Priority Review, if relevant criteria are met.”

“Vaccine development is a complex multidisciplinary activity, combining understanding of host-pathogen interactions at the molecular level, with clinical science, population-level epidemiology and the biomechanical requirements of production.”

Anthony L. Cunningham, et al on Vaccine development: From concept to early clinical testing

Testing doesn’t stop once a vaccine is approved by the FDA and is added to the immunization schedule either. We often continue to see testing for vaccine safety and efficacy using phase 4 trials and with our post-licensure vaccine safety system, including VAERS and the Vaccine Safety Datalink.

And of course testing continues long after we begin using vaccines to see how long their protection will last. For example, because of continued testing, we now know that Gardasil and Cervarix are providing protection that lasts at least 8 and 9 years.

What To Know About Vaccine Testing and Development

From pre-clinical studies and years of phase 1, 2, and 3 trials to continued monitoring after a vaccine is approved and added to the immunization schedule, the vaccine testing and development process helps make sure that vaccines are safe and that they work.

More About Vaccine Testing and Development