Dread Expressed by Public Health Experts on Hurried FDA Signoff on COVID-19 Vaccine
July 29, 2020
Eighty-nine sites are enrolling patients in the landmark Phase 3 trial for Moderna Therapeutics vaccine kicked off on Monday, July 27, with the target goal of 30,000 people total, and 15,000 by the end of this week. Dr. Anthony Fauci, infectious disease expert and advisor to the White House, stated it is “conceivable” (albeit doubtful) to have an answer on the vaccine efficacy in October.
Other experts worry about the accelerated pace and the possibility of truncating the phase 3 trial, although Vice-President Pence stated that there will be no shortcuts or cutting corners.
“The fear is that you wind up doing to a vaccine what [Trump has] already done with [opening] school,” said Dr. Joshua Sharfstein, a former FDA deputy commissioner and a professor at Johns Hopkins University in Baltimore. “Take an important, difficult question and politicize it. That’s what you want to avoid.”
Congressional representatives are preparing a bill requiring FDA to have an expert panel review COVID vaccine trial data and issue a recommendation before FDA Commissioner Stephen Hahn makes a decision on approval. Committee review is common with past vaccines, relying on examination of all evidence prior to voting on approval and issuing a recommendation to FDA.
Hahn is in the hot-seat with some members of Congress after undercutting confidence in FDA independence when he issued the declaration for hydroxychloroquine for Emergency Authorization Use as a cure for COVID-19.
Data on 30,000 patients may not be necessary for early efficacy detection. Fauci stated that it is possible that 150-160 cases of disease may give insight. If about 2/3 of these cases occur in non-vaccinated people, statisticians could deduce that the vaccine had above-60% efficacy. If efficacy is higher (e.g., 80-90% effective) with an annual rate of infection of >4%, an efficacy signal could be deduced in such a trial with just 50 cases and as soon as three months, reported Ira Longini, a University of Florida biostatistician who designs vaccine trials.
More here. https://khn.org/news/public-health-experts-fear-a-hasty-fda-signoff-on-vaccine
