Last Friday, the FDA officially authorized “emergency use” of the COVID-19 vaccine manufactured by Pfizer. Of the 21 members of the FDA advisory committee, there were four who did not vote in favor.
One of those was Dr. A. Oveta Fuller, an associate professor of Microbiology and Immunology at the University of Michigan Medical School. In interviews, she clarified that “My vote wasn’t ‘No, never,’ my vote was ‘No, not yet.’” Her concerns are the potential long-term health issues not given time to be monitored, including issues of autoimmunity and hyper-immunity.
She also confirmed, as asserted by the two medical professionals quoted in the article in this issue, “COVID VACCINE: “SIGNIFICANT SAFETY CONCERNS” who petitioned the European Medical Association, that a number of crucial questions about the effectiveness of the vaccine to stop infection haven’t been answered.
Specifically, Dr. Fuller asked, “Do we know that they (those getting the vaccine) are not getting infected? Do we know that if they are infected, are they shedding the virus? Can it be transmitted from them to other people?”
A second FDA advisory member voting “No” was the Dean of the Chicago Medical School, Dr. Archana Chatterjee. Dr. Archana stated, “The issue I had was with regard to younger patients, excusing those younger participants, where I felt like the data were limited… And since they are not a high-risk category, at this point in time they’re not high priority for vaccination.”
The other two members of the FDA Advisory Committee who wanted more time to study the efficacy and potential negative health effects of the vaccine were Dr. David Kim, who heads the Division of Vaccines at the U.S. Office of Infectious Disease and HIV/AIDS Policy, and Dr. Michael Kurilla, Clinical Innovations Director at the National Center for Advancing Translational Sciences.
TRENDPOST: According to Science Magazine, the FDA stressed that an Emergency Use Authorization (EUA) is not approval but a temporary stopgap during an emergency. Pfizer said it expected to have enough efficacy and safety data to seek full approval by April 2021. That’s right: full safety data on the safety and efficacy of this vaccine won’t be known until April of next year.
