USA TODAY: FDA faces vaccine test
The authority has taken questionable actions under pressure from the White House
In recent years the antivaccine movement in the US has become something of a disease itself, finding willing hosts in both the conspiracy theorists of the Right and Big Pharma doubters of the Left. In a CNN poll early in October, only about half of Americans said they would try to get a Covid-19 vaccine once one is available.
This makes it vital that government officials avoid sowing further doubt about a vaccine, which is needed to help the nation return to some sort of normalcy. The only way to do that is to insist that all vaccines are thoroughly tested in clinical trials to ensure they are safe and effective.
The good news on this front is that the Food and Drug Administration (FDA) published guidelines in October requiring vaccine makers to monitor their clinical trial patients for at least two months after administering their last dose. These two months are necessary to ensure people don’t have delayed reactions to the vaccine.
The bad news: getting to this step took work. The White House reportedly held up the guidelines, trying to finagle some politically motivated announcement before election day. And when science ultimately prevailed, President Donald Trump responded by calling the FDA guidelines a “political hit job”.
The FDA, which has approval authority for new vaccines, deserves credit for sticking up for principle in this case. But it too has taken some questionable actions under pressure from the White House. It authorised (and then revoked) emergency use of the unproven drug hydroxychloroquine to treat Covid-19 patients, and in August it granted emergency authorisation for the use of convalescent plasma as a treatment even though outside doctors said the evidence from trials was still somewhat ambiguous.
The FDA will be tested again in the next days as it is under political pressure to approve another type of treatment using so-called monoclonal antibodies. Eli Lilly and Regeneron both make such a treatment, and the latter was given to the president himself after he was diagnosed with Covid-19. It is time to stop politically motivated discussions of vaccines and treatments and begin a sober and professional discussion of what lies ahead. /McLean, October 12
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