Tag: safety

Are Vaccines Only Tested for 4 or 5 Days?

Where do some folks get the idea that vaccines are only tested for 4.5 days?

Anti-vax protestors often carry signs that say vaccines are only tested for 4.5 days. Don't believe them.
Anti-vax protestors often carry signs that say vaccines are only tested for 4.5 days. Don’t believe them.

The usual suspects…

Are Vaccines Only Tested for 4 or 5 Days?

But who gave them the idea to put it on their sign?

Again, the usual suspects…

Did the idea that vaccines are only tested for 4.5 days come from JB Handley, Children’s Health Defense Director and Co-Founder of Generation Rescue?
Did the idea that vaccines are only tested for 4.5 days come from JB Handley, Children’s Health Defense Director and Co-Founder of Generation Rescue?

Before we actually look to see if the original clinical trials for the hepatitis B vaccines only “solicited adverse reactions” for four or five days after vaccination, lets see what the safety studies have shown since these vaccines were approved in the 1980s.

These and other studies have shown that the hepatitis B vaccines are safe.

What about the idea that we only know what happens in the first four or five days after the vaccine is given?

Hepatitis B Vaccine Safety Testing

That’s not true. There are plenty of long term studies and safety studies typically collect safety information for weeks and months after a child is vaccinated.

“Open-ended diaries were provided to the parent(s) or guardian of the child before the vaccination program began in which to record any health problems that occurred 1 month before and 1 month following each of the 3 doses of vaccine, whether or not a health professional was consulted.”

De Serres et al on Importance of attributable risk in monitoring adverse events after immunization: hepatitis B vaccination in children.

Still, it is important to note that the further you get from a vaccination, the less likely that an adverse event is actually going to be caused by the vaccine though.

Consider the study by De Serres, Importance of attributable risk in monitoring adverse events after immunization: hepatitis B vaccination in children, in which they looked at the reports of adverse events both before and after vaccination and concluded that “postimmunization incidence systematically overestimates the risk of adverse events.”

Vaccines are tested very carefully, starting with small phase I and phase II trials, before moving to larger and longer lasting phase III trials.
Vaccines are tested very carefully, starting with small phase I and phase II trials, before moving to larger and longer lasting phase III trials.

It is also very important to note that like other vaccines, the hepatitis B vaccine was well tested before it was approved.

Although this was an efficacy trial, it included a double blind, placebo control and the researchers did notice any side effects.
Although this was an efficacy trial, it included a double blind, placebo control and the researchers did notice any side effects.

And many of the studies did include a placebo group.

A lot of folks in the placebo group for the hepatitis B vaccine trials got hepatitis B.
A lot of folks in the placebo group for the hepatitis B vaccine trials got hepatitis B.

Unfortunately, a lot of the folks in the placebo groups ended up getting hepatitis B.

In one study, Hepatitis B vaccine: efficacy in high-risk settings, a two-year study, which included an unvaccinated control group – “The control group was comprised of 31 patients and 24 staff members who had not been in contact with HBV until they entered the units and who did not wish to be vaccinated.”

What happens when you do a vaccinated vs unvaccinated study?
What happens when you do a vaccinated vs unvaccinated study?

Importantly, this study found “no local or general reaction to the immunization. A monthly biological and clinical survey of the vaccinated subjects showed no evidence of complication due to vaccination, especially no sign of auto­immunity.”

So why do we still hear the myth that vaccines are only tested for 4.5 days?

Anti-vax folks need to convince their followers that vaccines aren’t safe.

A careful look at all that went into the development of the hepatitis B vaccines shows that they are.

It also shows that vaccines are very necessary.

More on Hepatitis B Vaccine Safety Testing

Did the AAP Say That Vaccines Cause Severe Brain Injury?

Bob Sears is telling folks that the American Academy of Pediatrics says severe brain injuries are caused by vaccines.

Bob Sears doesn't mention that measles is much more likely to cause severe brain injury and death, or more recent studies that counter his post.
Bob Sears doesn’t mention that measles is much more likely to cause severe brain injury and death, or more recent studies that counter his post.

Did the AAP say that?

“A causal relationship they say.”

Bob Sears

No, they didn’t.

The researchers in Pediatrics didn’t even say that…

Did the AAP Say That Vaccines Cause Severe Brain Injury?

What did they say?

“This clustering suggests that a causal relationship between measles vaccine and encephalopathy may exist as a rare complication of measles immunization.”

Weibel et al on Acute Encephalopathy Followed by Permanent Brain Injury or Death Associated With Further Attenuated Measles Vaccines: A Review of Claims Submitted to the National Vaccine Injury Compensation Program

The study was about reports to VAERS

Over 23 years, the researchers (in 1998) found reports of 48 cases of acute encephalopathy among about 75,000,000 children who were vaccinated, some clustered in the second week after they received a measles containing vaccine.

Does that mean that those measles containing vaccines caused the encephalopathy?

“In the absence of a specific test to determine vaccine causation, these 48 cases may include some nonvaccine cases representing background rates.”

Weibel et al on Acute Encephalopathy Followed by Permanent Brain Injury or Death Associated With Further Attenuated Measles Vaccines: A Review of Claims Submitted to the National Vaccine Injury Compensation Program

No, it doesn’t.

It was a signal that got some attention though.

And as it has been further investigated, there has been no evidence that measles containing vaccines cause encephalitis, at least not above 1 in a million background rates.

What does cause encephalitis?

“About 1 child out of every 1,000 who get measles will develop encephalitis (swelling of the brain) that can lead to convulsions and can leave the child deaf or with intellectual disability.”

Complications of Measles

Measles.

Measles, a life-threatening vaccine-preventable disease, causes encephalitis.

Are your kids vaccinated and protected with two doses of MMR?

More on Vaccines and Severe Brain Injury

Why is the Tdap Vaccine in Category C?

The Tdap vaccine is routinely recommended for all pregnant women, so why would it be in the FDA Category C?

The FDA has actually removed the pregnancy categories.

We should start by stating that “risk-benefit decisions regarding use of a drug during pregnancy are more complex than the category designations suggest.”

Why is the Tdap Vaccine in Category C?

Anyway, the category designations are no longer being used on new drugs and vaccines.

“In December of 2014, the FDA published the Content and Format of Labeling for Human Prescription Drug and Biological Products; Requirements for Pregnancy and Lactation Labeling, referred to as the “Pregnancy and Lactation Labeling Rule” (PLLR or final rule). The PLLR removes pregnancy letter categories – A, B, C, D and X. Instead, under the final rule, narrative summaries of the risks of a drug during pregnancy and discussions of the data supporting those summaries are required in labeling to provide more meaningful information for clinicians.”

Guidelines for Vaccinating Pregnant Women

So is it still Category C?

Yes, for now. Few vaccines have converted to the new labeling system yet, which still leaves us with:

  • Pregnancy Category B: Tdap (Boostrix) – Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women OR Animal studies have shown an adverse effect, but adequate and well-controlled studies in pregnant women have failed to demonstrate a risk to the fetus during the first trimester (and there is no evidence of risk in later trimesters).
  • Pregnancy Category C: Tdap (Adacel) – Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks OR Animal reproduction studies have not been conducted and there are no adequate and well-controlled studies in humans.

Of course, the Vaccine Safety Datalink has published more than 14 studies “related to pregnancy and vaccination during pregnancy” and has used “data to study the health of children born to women who were vaccinated during pregnancy.”

And many of these studies are about the Tdap vaccine!

“There are no theoretical or proven concerns about the safety of the Tdap vaccine (or other inactivated vaccines like Tdap) during pregnancy. The shot is safe when given to pregnant women.”

Frequently Asked Questions for Pregnant Women Concerning Tdap Vaccination

This will likely be reflected when we get new labels for these vaccines, with wording that makes it clear that Tdap vaccines are safe in pregnancy.

what to know about the tdap vaccines and their category c designation

Tdap vaccines still have a Category C designation simply because their labels haven’t been updated to reflect the latest safety studies.

More on Tdap Vaccines and Category C

Understanding the Vaccine Injury Table

The Vaccine Injury Table was created by the National Childhood Vaccine Injury Act of 1986.

“The Table makes it easier for some people to get compensation. The Table lists and explains injuries/conditions that are presumed to be caused by vaccines. It also lists time periods in which the first symptom of these injuries/conditions must occur after receiving the vaccine. If the first symptom of these injuries/conditions occurs within the listed time periods, it is presumed that the vaccine was the cause of the injury or condition unless another cause is found.”

What You Need to Know about the National Vaccine Injury Compensation Program

A table injury is an illness, disability, injury or condition covered by the National Vaccine Injury Compensation Program.

“For example, if you received the tetanus vaccine and had a severe allergic reaction (anaphylaxis) within 4 hours after receiving the vaccine, then it is presumed that the tetanus vaccine caused the injury if no other cause is found.”

What You Need to Know about the National Vaccine Injury Compensation Program

To quality as a table injury, the illness, disability, injury or condition has to occur within a specific “time period for first symptom or manifestation of onset or of significant aggravation after vaccine administration.”

Understanding the Vaccine Injury Table

So if there is a Vaccine Injury Table, then that proves that vaccine injuries are real, right?

The Vaccine Injury Table is easier to understand if you actually look at the table.
The Vaccine Injury Table is easier to understand if you actually look at the table.

Wait, does anyone dispute that vaccine injuries are real?

No one says that vaccines are 100% safe, so yes, of course, it is known that they have risks and cause adverse effects. While most of these adverse effects are usually mild, they can rarely be severe or even life threatening.

The idea the vaccine injuries are common is what is misunderstood and misrepresented by anti-vaccine folks.

It's no joke, studies have shown fewer side effects after the second dose of MMR!
It’s no joke, studies have shown fewer side effects after the second dose of MMR!

Consider the above post by Bob Sears

Yes chronic arthritis after a rubella containing vaccine is a table injury, but it is very rare. Arthritis after the rubella vaccine is typically mild and temporary, lasting just a few days.

While rubella containing vaccines can cause arthritis, they do not cause lifelong rheumatoid arthritis. So even if you were to be one of the very rare people who developed chronic arthritis after a rubella containing vaccine, a table injury, it would still not be the same thing as rheumatoid arthritis.

“The association between rubella vaccination and chronic arthritis is less clear. Most recently published research, has shown no increased risk of chronic arthropathies among women receiving RA27/3 rubella vaccine and do not support the conclusion of the IOM (Slater et al., 1995; Frenkel et al., 1996; Ray et al., 1997). These studies have included a large retrospective cohort analysis which showed no evidence of any increased risk of new onset chronic arthropathies and a double-blind historical cohort study. One randomised placebo-controlled, double-blind study of rubella vaccination in sero-negative women demonstrated that the frequency of chronic (recurrent) arthralgia or arthritis was marginally increased (1.58 [1.01-2.45], p = 0.042) (Tingle et al., 1997). In 2011, the United States Institute of Medicine (IOM) reviewed available research and concluded that the evidence is inadequate to accept or reject a causal relationship between MMR vaccine and chronic arthralgia in women.”

Information Sheet Observed Rate of Vaccine Reactions Measles, Mumps and Rubella Vaccines

And it wouldn’t even be clear if your chronic arthritis was caused by the vaccine!

“The Table lists and explains injuries and/or conditions that are presumed to be caused by vaccines unless another cause is proven.”

What You Need to Know about the National Vaccine Injury Compensation Program

To be added to the Vaccine Injury Table, there only has to be scientific evidence that a condition could be caused by a vaccine.

“Where there is credible scientific and medical evidence both to support and to reject a proposed change (addition or deletion) to the Table, the change should, whenever possible, be made to the benefit of petitioners.”

Guiding Principles for Recommending Changes to the Vaccine Injury Table

That makes sense, as the NVICP is a “is a no-fault alternative to the traditional legal system for resolving vaccine injury petitions” for VICP-covered vaccines.

Vaccines Covered by the Vaccine Injury Table

Most routinely used vaccines are covered by the Vaccine Injury Table, including vaccines that protect against:

  • diphtheria, tetanus, and pertussis – DTaP, Tdap, Td
  • measles, mumps, and rubella – MMR, ProQuad
  • chickenpox – Varivax, ProQuad
  • polio – IPV, OPV
  • hepatitis B
  • hepatitis A
  • Hib
  • rotavirus
  • pneumococcal disease – Prevnar
  • influenza – seasonal flu vaccines
  • meningococcal disease – MCV4, MenB
  • human papillomavirus – HPV4, HPV9

In fact, “any new vaccine recommended by the Centers for Disease Control and Prevention for routine administration to children, after publication by the Secretary of a notice of coverage” is automatically included, at least for Shoulder Injury Related to Vaccine Administration and vasovagal syncope.

New vaccines are also covered if they are already “under a category of vaccines covered by the VICP.”

Immunizations given to pregnant women are also covered.

A few others, including vaccines that protect against pandemic flu, smallpox, and anthrax are covered by the Countermeasures Injury Compensation Program (CICP).

Vaccines Not Covered by the Vaccine Injury Table

What about vaccines that aren’t routine?

Other vaccines that are used in special situations, including vaccines that protect against rabies, yellow fever, Japanese encephalitis, cholera, and typhoid aren’t listed in the Vaccine Injury Table and aren’t covered by the National Vaccine Injury Compensation Program.

Have you seen any TV ads for lawsuits against the shingles vaccine, which isn't in the vaccine injury table.
Have you seen any TV ads for lawsuits against the first shingles vaccine?

Shingles vaccines and the older pneumococcal vaccine, Pneumovax, aren’t covered either.

And since they are not covered by the National Vaccine Injury Compensation Program, there are no restrictions on lawsuits against the manufacturers of these vaccines or the health providers who administer them.

So much for the idea that you can’t sue a vaccine manufacturer or that vaccine manufacturers have no liability for vaccines…

Why weren’t these vaccines covered?

Remember, the NVICP and Vaccine Injury Table were created by the National Childhood Vaccine Injury Act of 1986. The vaccines that aren’t covered are not on the routine childhood immunization schedule.

“There are no age restrictions on who may receive compensation in the VICP. Petitions may be filed on behalf of infants, children and adolescents, or by adults receiving VICP-covered vaccines.”

National Vaccine Injury Compensation Program Frequently Asked Questions

Still, since many of the covered vaccines can be given to adults, they are included, even if some of the vaccines adults routinely get aren’t covered.

Will they ever be covered?

“They found a low liability burden for these vaccines, that serious adverse events were rare, and that no consensus existed among stakeholders. After considering the staff report, NVAC chose, in 1996, not to advise the Department of Health and Human Services to include adult vaccines in VICP.”

Loyd-Puryear et al on Should the vaccine injury compensation program be expanded to cover adults?

Adding more adult vaccines to the Vaccine Injury Compensation Program (VICP) is something that has been looked at in the past, but it wasn’t thought to be necessary.

What to Know About the Vaccine Injury Table

The Vaccine Injury Table is a list of conditions set up to make it easier for people to get compensated from the National Vaccine Injury Compensation Program.

More on Understanding the Vaccine Injury Table