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

Do Vaccines Cause Tics or Tourette Syndrome?

One thing to understand when talking about tics and Tourette Syndrome is that tics are not Tourette Syndrome.

Instead, Tourette Syndrome is a type of tic disorder.

What Causes Tics and Tourette Syndrome?

You should also understand that tics are common.

In fact, about 20% of school age kids get tics, although few have them for more than a year. These motor or vocal tics (involuntary eye blinking, head jerking, shoulder shrugging, humming, sniffing, grunting, throat clearing, or yelling out a word or phrase) are most common when kids are between the ages of 10 to 12 years old, but may start as early as age 6 to 7 years.

Not only are these tics common, but they are thought to be normal and very often go away without treatment. About 97% of kids have complete resolution of their tics within a year or so.

The rest might go on to have a persistent motor or vocal tic disorder though.

And some kids with persistent motor and vocal tics might have Tourette Syndrome.

Why?

“While environmental factors and illness may influence ticcing, the weight of evidence argues that tic disorders and their comorbidities are inherited/genetic. The inheritance pattern can be subtle and unexpected. In clinic, we often see a parent, while either indicating that they experienced childhood tics that remitted or that no one in the immediate family ever had tics, demonstrating frequent subtle tics.”

Kids and Tics: What’s “Normal” and When to see a Specialist

That’s right. Genetics.

Tics and Tourette Syndrome often run in families.

Do Vaccines Cause Tics or Tourette Syndrome?

As you might suspect, vaccines do not cause tics or Tourette Syndrome.

Neither does thimerosal, which used to be a common preservative in vaccines.

That’s not surprising, as neither tics nor Tourette Syndrome are new conditions.

Why can you find studies that try to link thimerosal and vaccines to tics and Tourette Syndrome? Because they are poorly done studies by folks who routinely do studies that try to make it look like vaccines cause everything from autism and tics to ADHD.

Other studies have found no link between thimerosal and tics, including the study Neuropsychological Performance 10 Years After Immunization in Infancy With Thimerosal-Containing Vaccines.

Even the studies that found some association weren’t very convincing.

“With the possible exception of tics, there was no evidence that thimerosal exposure via DTP/DT vaccines causes neurodevelopmental disorders.”

Andrews et al on Thimerosal exposure in infants and developmental disorders: a retrospective cohort study in the United kingdom does not support a causal association.

One study, for example, did actually find some association between thimerosal and tics.

Maybe.

Infants who received one dose of DTP with thimerosal had a higher rate of tics than infants who didn’t. The strange thing about the study though is that infants who had two or three doses also had a higher rate than getting just one dose and a similar rate as kids who didn’t get any vaccines with thimerosal.

“We did find one statistically significant association between exposure to thimerosal-containing vaccines and the presence of tics among boys, however, this association was not replicated in girls. Previous associations between thimerosal containing vaccines and tics were found by Verstraeten et al. (2003) and Andrews et al. (2004) but the findings were not sex specific. Our tic finding was also consistent with the tic finding reported in the original study (Thompson et al., 2007).”

John Barile et al on Thimerosal Exposure in Early Life and Neuropsychological Outcomes 7–10 Years Later

None of this sounds like evidence that vaccines cause tics, does it?

No.

None of these studies found clinically significant evidence that vaccines cause tics or Tourette Syndrome.

What about other thimerosal-free vaccines? There have been no reports of increased rates of tics or Tourette Syndrome with any thimerosal-free vaccines either.

“There were 17 reports of Tourette’s disorder. Two patients developed movement disorders following 4vHPV with symptoms similar to Tourette’s, but did not have a definitive clinical diagnosis of Tourette’s disorder from a specialist (i.e., a neurologist or psychiatrist). In three additional reports, patients had a Tourette’s diagnosis or displayed symptoms of Tourette’s prior to vaccination. The remaining 12 reports were submitted by one physician who read on internet websites about possible Tourette disorder occurring after vaccines, but he had no firsthand information on any patient. None of these 12 reports could be verified.”

Arana et al on Post-licensure safety monitoring of quadrivalent human papillomavirus vaccine in the Vaccine Adverse Event Reporting System (VAERS), 2009-2015.

There is no evidence that vaccines cause tics or Tourette Syndrome.

In fact, at the December 2017 meeting of the Advisory Committee on Childhood Vaccines, there was a petition to add tics as a vaccine table injury. After reviewing all available evidence, including the work of William Thompson, the so-called CDC Whistleblower, the committee voted 5-1 for the option to not add tics as an injury to the Table. They also didn’t add asthma or PANDAS to the vaccine injury table, despite some folks petitioning them to do so.

Tics have not been added as a table injury.
Tics have not been added as a table injury.

That’s likely not a surprise to folks who know that vaccines are safe.

What to Know About Tics and Tourette Syndrome

Anti-Vaxxers Should Be Able to Answer These Questions Correctly

There is a new meme going around suggesting that folks have no business telling anyone to vaccinate and protect their kids unless they can answer a series of questions.

I bet answers from anti-vaccine folks aren't the same as the answers from the rest of us...
I bet answers from anti-vaccine folks aren’t the same as the answers from the rest of us…

While it is certainly good to be educated about vaccines, their questions seem rather loaded.

Anti-Vaxxers Should Be Able to Answer These Questions Correctly

Since it is immoral and dangerous to push misinformation that scares parents away from vaccinating and protecting their kids, it would be nice if anti-vaccine folks would answer these questions before they tried to persuade anyone to not get vaccinated:

  1. Name 5 vaccine ingredients that you think are toxic and how exactly they can be toxic at the amounts present in vaccines.
  2. Name 5 possible complications of a vaccine-preventable disease.
  3. Are doctors and alternative health care providers who push non-standard, parent-selected, delayed protection vaccine schedules able to be held liable if their intentionally unvaccinated child suffers a vaccine-preventable disease or starts an outbreak, infecting other people?
  4. How many children died of vaccine-preventable diseases in the early 1980s, before the vaccine schedule grew to include the new vaccines we give today?
  5. Is it true that no one can force you to get vaccinated?
  6. What percentage of reports to VAERS are actually caused by vaccine reactions?
  7. How many doses of vaccines have been given since the Vaccine Court began paying for vaccine injury cases?
  8. Which vaccines must be avoided because of shedding or other concerns if you have a child with an immunodeficiency in your home?
  9. Why do some folks think that many vaccines still contain thimerosal?
  10. If today’s vaccines already contain far fewer antigens than they did in the old days, what would be the extra benefit of splitting them up even further into separate shots for each vaccine-preventable disease?
  11. Have you read all of studies on the safety and effectiveness of combination vaccines, including those that are double-blinded and placebo controlled, and the current vaccine schedule?
  12. Can you give me one other interesting fact about vaccines or vaccine-preventable diseases that was not already asked or discussed?

What’s my interesting fact?

Many on-the-fence and vaccine hesitant parents do change their mind about vaccines and decide to make the right choice and get their kids vaccinated and protected.

More Things Anti-Vaxxers Should Know

VigiAccess Numbers in Context

Most people are familiar with VAERS, the Vaccine Adverse Event Reporting System.

They sometimes forget that it is only the Vaccine Adverse Event Reporting System for the United States.

Other countries have their own vaccine safety systems.

VigiAccess Numbers in Context

One of the biggest is VigiBase, the World Health Organization’s  global database for suspected adverse drug reactions, maintained by the Uppsala Monitoring Centre in Sweden.

“Information on suspected ADR should not be interpreted as meaning that the medicinal product in question, or the active substance(s), generally causes the observed effect or is unsafe to use.”

Not surprisingly, folks misuse VigiBase numbers, just like they misuse VAERS reports.

JB Handley needs help understanding VigiAccess reports.
JB Handley needs help understanding VigiAccess reports.

To look at the VigiBase reports, you can use VigiAccess.

“VigiAccess has a search interface that allows visitors to retrieve summary statistics on suspected adverse reactions to medicines and vaccines.”

Uppsala Monitoring Centre

While VigiBase “is at the heart of UMC’s signal detection and scientific research,” you aren’t going to learn much from VigiAccess.

“Geographically, only continent-level statistics are shown, due to issues relating to patient confidentiality and data protection in individual countries.”

Uppsala Monitoring Centre

The biggest problem?

You don’t know how many vaccines were given to all of those people.

For example, while it might sound like there have been a lot of adverse drug reaction reports for the DTaP vaccine, with 179,447 reports in VigiAccess, since those are worldwide reports since 1968, it is likely among many billions of doses of vaccines being given.

Most importantly though, as with VAERS, “The reports in VigiBase result from suspicions of a relationship between a drug and a reaction. No causal relation has been confirmed.”

So how do you put the numbers from VigiBase and VigiAccess in context?

If you consider that reports and safety signals from VigiBase, VigiMatch, VigiRank, and other tools used by the Uppsala Monitoring Centre continue to find that vaccines are safe, then to put the DTaP numbers in context, they help us know that vaccines are being well monitored for safety.

And since we know that these diseases haven’t disappeared, any further context, if you need it, would be that since vaccines are safe and necessary, then you should get yourself and your family vaccinated and protected.

More on VigiBase and VigiAccess