Tag: vaccine safety systems

Are Vaccines Contaminated with Retroviruses?

Would you be concerned to know that the FDA is investigating how to make sure vaccines aren’t contaminated with retroviruses?

“Therefore, to ensure the safety of vaccines, our laboratory is investigating ways to activate latent viruses in cell lines and to detect the activated viruses, as well as other unknown viruses, using new technologies. We will then adapt our findings to detect viruses in the same types of cell substrates that are used to produce vaccines. We are also trying to identify specific biological processes that reflect virus activity.”

Investigating Viruses in Cells Used to Make Vaccines; and Evaluating the Potential Threat Posed by Transmission of Viruses to Humans

Or like most folks, would it reassure you that they are continuing to work to make sure that our vaccines are safe.

Are Vaccines Contaminated with Retroviruses?

Vaccines are not contaminated with infectious retroviruses.

“Vaccines effectively reduce and prevent death and disease from many viral infections. However, vaccine production occasionally has been complicated by inadvertent contamination with adventitious agents that may have originated from cell substrates used to propagate vaccine strains.”

Hussain et al on Lack of Evidence of Endogenous Avian Leukosis Virus and Endogenous Avian Retrovirus Transmission to Measles Mumps Rubella Vaccine Recipients

The issue first came up back in 1995 when it was discovered that MMR vaccines contained reverse transcriptase proteins. Researchers later found endogenous avian leukosis virus (ALV) and endogenous avian retrovirus (EAV) in those vaccines. Fortunately, they were not infectious and did not actually cause infections in any of the folks who got the vaccines.

Why were they there?

“Virtually all vertebrates studied, including humans, carry endogenous retroviral genomes as part of their natural genetic constitution.”

Adventitious Viral Genomes in Vaccines but Not in Vaccinees

The MMR vaccine is grown in chick embryo tissue culture. Partial or complete genomes of these viruses can be present in chicken DNA. In fact, all chickens contain endogenous avian retroviral genome (EAV), and although that means they can release viral particles, they are noninfectious, so can’t make you sick.

Why weren’t they detected when the vaccines were first developed and approved?

The technology wasn’t available at the time.

“The absence of an infectious retrovirus in the MVVE material used in this study and in the CEF supernatant used in the previous study (which contained levels of RT activity similar to those of MVVE, based upon comparison with the positive control AMV RT dilution series) provides confidence regarding the safety of the earlier MV vaccines used in humans. The results of this study further demonstrate the absence of a known public health safety concern related to the presence of RT activity in chick-cell-derived vaccines and support World Health Organization recommendations for the continued use of chick-cell-derived vaccines in humans.”

Shahabuddin et al on No Evidence of Infectious Retroviruses in Measles Virus Vaccines Produced in Chicken Embryo Cell Cultures

And once the technology was available, these retroviruses were thoroughly investigated and found to not be a safety hazard. That’s not surprising though, as no problems were previously detected by our vaccine safety systems.

So why are we still talking about retroviruses in vaccines?

Judy Mikovits is still finding retroviruses wherever she looks for them…
Judy Mikovits is still finding retroviruses wherever she looks for them…

Because anti-vaccine folks need something else to use to scare folks away from vaccinating and protecting their kids

More on Vaccines and Retroviruses

Do Vaccines Cause Bell’s Palsy?

We don’t usually know what causes Bell’s Palsy, so that makes it a perfect candidate for some people to think it’s a vaccine injury.

Mercola cites a study that looked at VAERS reports, so none of the cases were verified to see if they were actually caused by a vaccine. And he fails to mention all of the real studies that found no association between vaccines and Bell's Palsy!
Mercola cites a study that looked at VAERS reports, so none of the cases were verified to see if they were actually caused by a vaccine. And he fails to mention all of the real studies that found no association between vaccines and Bell’s Palsy!

And for anti-vaccine folks to use in their propaganda to scare you away from vaccinating and protecting your kids.

What Causes Bell’s Palsy?

Although we may not always know what causes it, Bell’s Palsy is fairly easy to diagnose.

“Bell’s palsy is a nerve problem that affects the muscles of your face. It causes weakness or partial paralysis of the muscles on one side of your face. With Bell’s palsy, your eyelid may not close properly and your smile may seem uneven.”

What Is Bell’s Palsy?

So what causes it?

“Bell’s palsy occurs when the nerve that controls the facial muscles is swollen, inflamed, or compressed, resulting in facial weakness or paralysis. Exactly what causes this damage, however, is unknown.”

Bell’s Palsy Fact Sheet

Most experts think that Bell’s Palsy is caused by a viral infection, which leads to swelling and inflammation of the facial nerve. That’s likely why steroids and antiviral medications, like acyclovir, are often helpful treatments.

“The prognosis for individuals with Bell’s palsy is generally very good. The extent of nerve damage determines the extent of recovery. Improvement is gradual and recovery times vary. With or without treatment, most individuals begin to get better within 2 weeks after the initial onset of symptoms and most recover completely, returning to normal function within 3 to 6 months.”

Bell’s Palsy Fact Sheet

Fortunately, most people with Bell’s Palsy, which mainly affects adults, get better.

Do Vaccines Cause Bell’s Palsy?

Bell’s Palsy was first described by Sir Charles Bell in 1821.

There are reported cases before that though, with the earliest by Cornelis Stalpart van der Wiel (1620-1702) from The Hague, The Netherlands in 1683.

And no, we didn’t have any vaccines in 1683.

That’s not to say that vaccines couldn’t cause Bell’s Palsy.

One vaccine, an inactivated intranasal influenza vaccine that was only used in Switzerland during the 2000-01 flu season, was associated with an increased risk of Bell’s Palsy.

Why? It was likely because of the enzymatically active Escherichia coli Heat Labile Toxin (LT) adjuvant that was used in the vaccine, which is not something you find in any of the vaccines we now use.

While you might find an occasional case report about a vaccine and Bell’s Palsy, remember that a case report published about one patient isn’t strong evidence that it wasn’t a coincidence.

It should be reassuring to everyone that plenty of studies have been done confirming that other vaccines we use do not cause Bell’s Palsy. And even in the case of that flu vaccine, the association was quickly discovered and the vaccine was discontinued.

In fact, since vaccines, especially the chicken pox vaccine and Tdap, can prevent infections that actually cause Bell’s Palsy, if you are worried about Bell’s Palsy, get vaccinated!

More on Bell’s Palsy?

Why Aren’t Vaccines Regulated like Drugs?

Have you ever heard the argument that vaccines aren’t held to the same standards as drugs, food, or other products?

“Vaccines are not held to the same double blind gold standard of clinical testing as other pharmaceutical drugs because they are considered biological products under the Public Health Federal Food, Drug and Cosmetic Act. They meet the same standards as cosmetics.”

20 VACCINE “FACTS” you need to know to make an informed decision

Placebos, liability, testing – these are all arguments that anti-vaccine folks try to use to scare parents into thinking that vaccine development isn’t well regulated and vaccines aren’t held to the same standard as drugs.

Why Aren’t Vaccines Regulated like Drugs?

Would you be surprised to learn that part of their argument is true?

Even after approval by the FDA, a vaccine still has to be reviewed by the ACIP before it is put on the immunization schedule.
Even after approval by the FDA, a vaccine still has to be reviewed by the ACIP before it is put on the immunization schedule.

No, not the part that vaccine development isn’t well regulated!

“Current authority for the regulation of vaccines resides primarily in Section 351 of the Public Health Service Act and specific sections of the Federal Food, Drug and Cosmetic Act.”

Vaccine Product Approval Process

Federal regulations and rules ensure that our vaccines are safe.

  • Public Health Service Act (42 USC 262-63) §351
  • Food, Drug, and Cosmetic Act (21 USC 301-392)
  • Title 21 Code of Federal Regulations (CFR) 600-680 – standards for biological products
  • Title 21 CFR 314 (21 CFR 601.25[d][2], specific to biologicals – ensures adequate and well-controlled clinical trials
  • Title 21 CFR 312 – investigational new drug application (IND)
  • Title 21 CFR 210-211 – good manufacturing practices
  • Title 21 CFR 58 – good laboratory practices
  • Title 21 CFR 56 – institutional review boards
  • Title 21 CFR 50 – protection of human subjects
  • Prescription Drug User Fee Act (PDUFA) of 1992, 2002, and 2007
  • Food and Drug Agency Modernization Act (FDAMA) of 1997
  • Food and Drug Agency Amendments Act (FDAAA) of 2007

I meant the part that vaccines aren’t regulated like drugs.

While both vaccines and prescription drugs are regulated by the FDA, that work occurs within two different centers of the FDA:

  • Center for Biologics Evaluation and Research (CBER) – vaccines
  • Center for Drug Evaluation and Research (CDER) – over-the-counter and prescription drugs

Both centers work to make sure we have safe and effective vaccines and drugs to keep us healthy, even if there are some differences in how they do it.

“Vaccine clinical development follows the same general pathway as for drugs and other biologics.”

Vaccine Product Approval Process

That’s right, vaccines and drugs go through the same types of clinical trials.

After completing the three phases though, vaccine developers must then apply for a Biologics License Application (BLA), which is reviewed by a multidisciplinary FDA reviewer team. This is also when their manufacturing facility gets inspected.

“Following FDA’s review of a license application for a new indication, the sponsor and the FDA may present their findings to FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC). This non-FDA expert committee (scientists, physicians, biostatisticians, and a consumer representative) provides advice to the Agency regarding the safety and efficacy of the vaccine for the proposed indication.”

Vaccine Product Approval Process

Once approved and licensed, the FDA and CDC continue to work to make sure the vaccine is safe, including having some vaccines undergo undergo Phase 4 studies and monitoring for side effects through VAERS and the Vaccine Safety Datalink.

And then, even after approval by the FDA, new vaccines aren’t put on the immunization schedule until a review and approval by the Advisory Committee on Immunization Practices (ACIP).

“Canada, like many other countries, exercises tight regulatory oversight over vaccines because they are usually given to very large numbers of healthy individuals. Vaccines in Canada are subject to the Food and Drugs Act and the Food and Drug Regulations. Vaccines are regulated under a specific set of regulations for a subset of drugs known as biologic drugs.”

The Regulation of Vaccines for Human Use in Canada

It is also important to keep in mind that this process doesn’t just happen in the United States.

Still wondering why vaccines aren’t regulated like drugs?

“Vaccine development differs from drug development in several important ways. First, because vaccines are preventive and are given to healthy individuals – often children – they require very large clinical trials, leading to increased research and development costs. Second, vaccines are biological products that can be very complex to manufacture and are subject to stringent quality control standards, resulting in much higher capital costs. Third, unlike drugs, vaccines have no secondary markets, making it unlikely that manufacturers will generate additional profits beyond the initial target markets. Finally, unlike generic drugs, which only need to demonstrate adherence to a pre-established development process, vaccines are biologicals that require full re-development to demonstrate their equivalence. (World Health Organization, 2014). Each manufacturer is required to invest in the full regulatory approval process for their vaccine products.

Myths and Facts about Vaccine Product Price and Procurement

It’s only because vaccines are more strictly regulated than drugs and other products.

Vaccines are safe and necessary.

More on Vaccine Regulation

The National Vaccine Injury Compensation Program Payouts Prove that Vaccines are Dangerous

Have you heard this argument?

Misinformation about the NVICP, like from this Focus for Health article, likely helps confuse and scare many parents.
Misinformation about the NVICP, like from this Focus for Health article, likely helps confuse and scare many parents.

Apparently, some folks think that because we have a National Vaccine Injury Compensation Program that compensates those who have serious problems after a vaccine, even deaths, then it must mean that vaccines are dangerous.

Do the National Vaccine Injury Compensation Program Payouts Prove that Vaccines are Dangerous?

To most other people, that argument doesn’t hold water.

Why?

Because we know that:

  • the National Vaccine Injury Compensation Program is a no-fault alternative to the traditional legal system for resolving vaccine injury petitions
  • of over 3.1 billion doses of vaccines that were distributed in the United States between 2006 and 2016, there were 3,749 compensated claims through the NVICP
  • almost 80% of all compensated awards by the NVICP come as a “result of a negotiated settlement between the parties in which HHS has not concluded, based upon review of the evidence, that the alleged vaccine(s) caused the alleged injury.”
  • the NVICP settlements are funded by an excise tax on vaccines
  • the NVICP cases are published by the U.S. Court of Federal Claims, so all information is disclosed to the public and no safety concerns are hidden

So what does the National Vaccine Injury Compensation Program (VICP) really prove?

It proves that true vaccine injuries are very rare – about 1 in a million rare.

It proves that while vaccines are not 100% safe, they are very safe.

Certainly safer than the complications of a vaccine-preventable disease.

And it proves that anti-vaccine arguments are very easy to refute

More on the NVICP and Vaccine Safety