28 Jul Comprehensive Study Again Shows Vaccines Are Remarkably Safe

MedicalResearch.com Interview with:

Rabin Medical Center

Daniel Shepshelovich MD
Professor, Department of Medicine
Rabin Medical Center
Israel

MedicalResearch.com: What is the background for this study?

Response: The study was initiated as part of a research project aiming to assess the quality of post marketing surveillance of various medical interventions. This includes drugs

(file:///C:/Users/danielshep/Downloads/jamainternal_ross_2019_en_190008.pdf), medical devices (accepted to a leading medical journal, still under embargo) and additional studies in specific settings (e.g. cancer drugs, immune-modulating drugs).

Through this perspective, vaccines are clearly safer as a group than drugs or medical devices, with significantly less post-marketing safety issues, most of which were not clinically important, and a more effective post-marketing surveillance program.

 MedicalResearch.com: What are the main findings?

Response: In our article, we review the approval of all new vaccines in a 20 year period (1996-2015).

• We show that during this long period of time, the aggregation of hundreds of thousands of reports from the public and healthcare professionals to the FDAs Vaccine Adverse Event Reporting System (VAERS) following hundreds of millions of administered vaccines have not resulted in the identification of clinically important safety data. This supports the quality and thoroughness of the FDAs mechanism for the approval of new vaccines.
• Furthermore, most new safety data were identified through VAERS, underlining the quality of the FDAs postmarketing surveillance of vaccine side effects. The only vaccine withdrawal (a rotavirus vaccine, 1998) due to a rare (1:5000-1:10,000 vaccinated infants) but potentially dangerous side effect was swiftly identified and removed from market following identification of safety signals from VAERS. 

MedicalResearch.com: What should readers take away from your report?

• This report is the most comprehensive study of postmarketing vaccine safety published, and it shows that vaccines are remarkably safe, and that the current vaccine approval and postmarketing surveillance processes are robust and effective.
• The reported findings do not support vaccine hesitancy; rather, the aggregated data clearly shows that vaccines are safe, and that public vaccination should remain as a major public health strategy.

MedicalResearch.com: What recommendations do you have for future research as a result of this work?

Response: One of the most common post-marketing safety issues was identifications of specific populations potentially at a higher risk for specific vaccines- pregnant women, preterm infants etc.

Future research could focus on finding ways to define these populations before marketing approval or to identify them more rapidly following marketing approval through focused post-marketing surveillance.

MedicalResearch.com: Is there anything else you would like to add?

Response:

• While our study was initiated before the COVID-19 pandemic, we believe it might have implications for the upcoming COVID-19 vaccine.
• Vaccines are one of the greatest achievements of modern public health, saving countless lives and all but eliminating once prevalent diseases such as mumps, measles and poliomyelitis. Vaccination hesitancy has reduced vaccination rates. Outbreaks linked to intentional unvaccination have been reported in recent years. The current COVID-19 pandemic is a frightening reminder of life with contagious infectious diseases without an effective vaccine.
• While we cannot deduce from this study that the expected COVID-19 vaccine will be safe as the development and approval process will likely be considerably more rapid than any previous vaccine, our study does show that the regulatory body responsible for vaccine approval is competent and well aware of the importance of approving safe vaccines, both for preventing direct harm and for preventing decline of trust in other vaccines. I’m sure that regulators are well aware of the public focus on the upcoming vaccine and will balance the urgent need for marketing approval with the need to make sure the vaccine is safe. Another COVID-19 related implication of our study is that the post-marketing vaccine safety surveillance is effective, so that any rare\unexpected side effect will be identified and addressed quickly. Basically, we show that the people in charge of approving, regulating and following vaccines have proved that they can be trusted with this responsibility. They have done this (many times) before.

Any disclosures?

• No relevant conflict of interest for any of the authors.

Citation:

Postmarketing Safety of VaccinesApproved by the U.S. Food andDrug AdministrationA Cohort Study
Noam Tau, Dafna Yahav, and Daniel Shepshelovich
Annals of Internal Medicine 0 0:0

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Last Updated on July 28, 2020 by Marie Benz MD FAAD