COVID vaccine safety surveillance

The medical safety net ensuring vaccine safety is historic, says Henry Bernstein, DO, MHCM, FAAP, a voting member of the Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control and Prevention (CDC), and a professor of pediatrics at the Donald and Barbara Zucker School of Medicine at Hofstra/Northwell. 

00:55 - Dr. Bernstein explains his role on the ACIP

03:02 - He explains the four reporting programs they use to monitor and learn from data on possible reactions to vaccines. Three of those have been around for many years, with the CDC's V-safe after vaccination health checker a new addition during COVID-19. 

1. V-safe: a text messaging-based system that enables people who received the COVID-19 vaccine to report any post-vaccine side effects via a free app. Users receive weekly messages for up to six weeks; then three-, six-, and 12-month check ins after the final dose of vaccine. Users are also reminded to get the second vaccine dose and a check-in afterward about their experience.
2. VAERS (Vaccine Adverse Event Reporting System): a national database to which providers, vaccine manufacturers and the public can report side effects. The "early warning system" provides the CDC and FDA with information that helps identify health concerns and ensure vaccine safety.

3. Clinical Immunization Safety Assessment Project (CISA): a national network of vaccine safety experts from the CDC’s Immunization Safety Office (ISO) and medical research centers. There are seven centers around the county that serve as consultants around these less common events and also do research relating to vaccine safety, as well as work with health care providers when vaccine safety questions arise, or adverse events following immunization occur domestically.

4. Vaccine Safety Datalink (VSD): yet another monitoring system created by the CDC that gathers electronic health record data from nine participating integrated health care organizations on more than 12 million people each year.

07:34 - Dr. Bernstein shares insights from recent ACIP meetings reviewing reports of myocarditis and pericarditis following vaccination with either the Pfizer or Moderna mRNA vaccines. 

10:57 - ACIP's latest meeting in July focused on reports of Guillain-barre syndrome (GBS) after inoculation using the J&J vaccine. Of the roughly 100 reported cases of GBS in the US among recently vaccinated individuals (with the J&J vaccine), not all cases have been confirmed as GBS. 

13:41 - In both cases - myocarditis, pericarditis and GBS, patients recover well. Emergency use authorization fact sheets, available to the public, now contain information about these findings to help inform individuals getting the vaccines. 

16:33 - The 3 guiding principles of the CDC Advisory Committee on Immunization Practices (ACIP).

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In addition to a professor of pediatrics, Dr. Bernstein is an Ex-Officio member of the American Academy of Pediatrics’ (AAP) Committee on Infectious Disease (COID Red Book Committee) and Associate Editor of Red Book Online. He is board certified by the American Board of Pediatrics.