If an EUA for #COVID19 vaccine is managed like today’s convalescent plasma announcement, we are in trouble. We need to know the process for evaluating safety/efficacy is based on science not politics. Today’s announcement did not provide that assurance. We must do better. 1/x
CP may work. It is unlikely to be a game-changer, but it may have modest impact. Unanswered questions: does it reduce mortality, who will benefit most, what dose/duration is best, what kind of antibodies matter. We still don’t have quality data to answer these questions. 2/x
Regardless of whether CP works, the integrity of the evaluation process also matters. Process is what makes the difference between public trust and public skepticism. If people distrust the evaluation process with treatments, they may question the process with vaccines. 3/x
Today’s announcement was not supported by leading government and non govt scientists and former FDA commissioners in both R and D Administrations - because the data was not convincing. That should give us pause. It means we need more scientific dialogue and better data. 4/x
If we're committed to leading w/ science, we have to be transparent with data, let scientists speak directly to the public, and make evidence-based decisions. Publicly berating the FDA and rushing an EUA despite scientific concerns is inconsistent with a scientific approach. 5/x
The consequences of politicizing the evaluation process for therapeutics and vaccines is enormous. Public trust lost is not easily regained. If that comes to pass, our ability to take on current and future pandemics will be deeply compromised. (end)
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