Tag: CISA

Are Fewer Than 1% of Vaccine Injuries Reported to VAERS?

It is a common anti-vaccine argument that fewer than 1% of vaccine injuries are reported to VAERS.

I've found that fewer than 1% of anti-vaccine signs are true...
I’ve found that fewer than 1% of anti-vaccine signs are true…

They even think that they have evidence from Harvard to support their claim!

Are Fewer Than 1% of Vaccine Injuries Reported to VAERS?

Do they?

Are fewer than 1% of vaccine injuries reported to VAERS?

It has long been suspected that reports to VAERS are under-reported, as it is a passive reporting system.

The original claims for under-reporting to VAERS were based on an old study about drug reactions and were not specific to vaccines though.

Is that the Harvard study?

Nope.

“Restructuring at CDC and consequent delays in terms of decision making have made it challenging despite best efforts to move forward with discussions regarding the evaluation of ESP:VAERS performance in a randomized trial and comparison of ESP:VAERS performance to existing VAERS and Vaccine Safety Datalink data. However, Preliminary data were collected and analyzed and this initiative has been presented at a number of national symposia.”

Electronic Support for Public Health–Vaccine Adverse Event Reporting System (ESP:VAERS)

They are talking about a report, Electronic Support for Public Health–Vaccine Adverse Event Reporting System (ESP:VAERS), that was conducted at Harvard Pilgrim Health Care, Inc.

“Preliminary data were collected from June 2006 through October 2009 on 715,000 patients, and 1.4 million doses (of 45 different vaccines) were given to 376,452 individuals. Of these doses, 35,570 possible reactions (2.6 percent of vaccinations) were identified.”

Electronic Support for Public Health–Vaccine Adverse Event Reporting System (ESP:VAERS)

It is very important to note that all the study found is that all possible reactions, including minor reactions, like pain and fever, are not common.

They didn’t actually finish the report to see how commonly those reactions were reported to VAERS.

But we already know that more serious reactions are reported to VAERS much more routinely.

“Sensitivities ranged from 72% for poliomyelitis after the oral poliovirus vaccine to less than 1% for rash and thrombocytopenia after the MMR vaccine.”

Rosenthal et al on The reporting sensitivities of two passive surveillance systems for vaccine adverse events

And there has even been a more recent report, Advanced Clinical Decision Support for Vaccine Adverse Event Detection and Reporting, which also used an ESP-VAERS system, that found great improvements in reporting of adverse events to VAERS.

Even more importantly, even with it’s limitations, VAERS works!

“Despite its limitations, VAERS effectively detected a possible problem soon after introduction of RRV-TV in the United States.”

Lynn R. Zanardi, et al on Intussusception Among Recipients of Rotavirus Vaccine: Reports to the Vaccine Adverse Event Reporting System

Although it would be ideal to have even more reports sent to VAERS, time and again, we have seen that VAERS works.

“On November 23, 2010, the combination of the coding term “febrile convulsion” and the Fluzone(®) TIV product exceeded a predetermined threshold in the VAERS database. By December 10, we confirmed 43 reports of febrile seizure following TIV in children aged 6-23 months. Clinical features of most reports were consistent with typical uncomplicated febrile seizures, and all children recovered. Further epidemiologic assessment of a possible association between TIV and febrile seizures was undertaken in a separate, population-based vaccine safety monitoring system.”

Leroy et al on Febrile seizures after 2010-2011 influenza vaccine in young children, United States: a vaccine safety signal from the vaccine adverse event reporting system.

As we have seen, for VAERS to work, we don’t need all side effects and reactions to be reported.

“VAERS is primarily a safety signal detection and hypothesis generating system. Generally, VAERS data cannot be used to determine if a vaccine caused an adverse event. VAERS data interpreted alone or out of context can lead to erroneous conclusions about cause and effect as well as the risk of adverse events occurring following vaccination.”

Shimabukuro et al on Safety monitoring in the Vaccine Adverse Event Reporting System (VAERS).

Also, VAERS is not the only safety system that we have to make sure that our vaccines are safe.

The other thing that folks should understand? Most reports to VAERS are not actually vaccine injuries

More on the Percentage of Reports to VAERS

Vaccines are Safe

Vaccines have side effects.

Fortunately, they are usually very mild.

And understanding that vaccines are safe, makes getting their kids vaccinated an easy decision for most parents, as they understand that the many benefits of vaccines far outweigh any possible risks.

How Do We Know Vaccines Are Safe?

If you are on the fence about vaccines, simply saying vaccines are safe might not be enough for you.

Would it help to see all of the organizations that work to ensure that vaccines are safe?

Several post-licensure vaccine safety systems at the CDC and FDA monitor for safety issues, including VAERS, the Vaccine Safety Datalink, and the Clinical Immunization Safety Assessment (CISA) Project, in addition to other global vaccine safety systems.

“​Over the previous 40 years the IOM has conducted over 60 vaccine safety studies, including this comprehensive review of the immunization schedule. The IOM committee did not find any evidence of major safety concerns related to receiving on-time vaccinations according to the Recommended Immunization Schedule for children. They concluded that this should help to reassure stakeholders. Further, they noted that while the receiving on-time vaccines was not harmful, it was strongly associated with reducing vaccine-preventable diseases. ​”

American Academy of Pediatrics on Vaccine Safety: Examine the Evidence

Still wondering how we really know vaccines are safe?

A 2013 report about vaccines from the Institute of Medicine uncovered no evidence of major safety concerns.
A 2013 report about vaccines from the Institute of Medicine uncovered no evidence of major safety concerns.
  • vaccines go through a long period of pre-licensure testing and evaluation when being developed to make sure they are safe and that they work before they are approved
  • vaccines are tested together
  • there are long-term studies on vaccine safety
  • vaccines are continually monitored after they are made, to make sure they maintain their potency, are kept at the proper temperature, and other quality testing
  • 40 years of safety reports from the Institute of Medicine (IOM)
  • reports from the Global Advisory Committee on Vaccine Safety, which has reviewed and commented on everything from aluminum adjuvants and the potential for immunogenic overload (too many too soon) to the safety of HPV vaccines

And it is important to know that much of the information that you hear and read that is trying to scare you about vaccines and vaccine ingredients is simply not true and easily debunked.

What to Know About Vaccine Safety

From years and years of pre-licensure vaccine safety testing to continual post-licensure vaccine safety monitoring, we can be confident that vaccines are safe.

More on Knowing Vaccines are Safe

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Vaccine Safety

Vaccines have some risks and cause mild or even moderate side effects or rarely, even more severe reactions.

Still, it is important to understand that vaccines are safe and necessary to keep your kids protected against vaccine-preventable diseases.

Vaccine Safety

Vaccines go through a long process of development and testing to make sure they are safe before they are approved.

“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

But it doesn’t stop then.

We continue to see testing and monitoring for vaccine safety:

  • by monitoring the potency of vaccines after they are manufactured
  • by monitoring the temperatures of the vaccines while they are being shipped and stored
  • continuing to do quality testing, even after the vaccine is released
  • using phase 4 trials and with our post-licensure vaccine safety systems, including VAERS, the Vaccine Safety Datalink, and the Clinical Immunization Safety Assessment (CISA) Project

All of this testing and monitoring has led to some vaccine recalls and the withdrawal of the original rotavirus vaccine because of its association with intussusception.

What to Know About Vaccine Safety

Vaccines are well tested and monitored for safety, both before they are approved and after.

More on Vaccine Safety