The FDA Is Slowing Down COVID-19 Vaccine Approval. That Could Be Good for Public Health

New U.S. Food and Drug Administration (FDA) guidance means a COVID-19 vaccine likely will not be approved by Election Day—which could actually be a good thing for public health. On Oct. 6, the agency posted an industry guidance document on its website asking pharmaceutical companies applying for emergency-use authorization of a COVID-19 vaccine to monitor study subjects for at least two months after vaccination, so they can look for side effects that may arise over time and get a better sense of the shot’s efficacy. That means it’s unlikely any manufacturer will receive authorization before Election Day on Nov. 3, as President Donald Trump has repeatedly pushed for. Despite reports to the contrary, White House representatives told ABC News they never tried to block the FDA’s policy. Still, Trump tweeted his displeasure on Tuesday night. “New FDA Rules make it more difficult for them to speed up vaccines for approval before Election Day,” he wrote, tagging FDA Commissioner Dr. Stephen Hahn. “Just another political hit job!” New FDA Rules make it more difficult for them to speed up vaccines for approval before Election Day. Just another political hit job! @SteveFDA — Donald J. Trump (@realDonaldTrump) October 7, 2020 Also on Oct. 6, Moncef Slaoui, co-chair of the Trump Administration’s Operation Warp Speed vaccine development project, said the group urged pharmaceutical companies not to apply for emergency-use auth...
Source: TIME: Health - Category: Consumer Health News Authors: Tags: Uncategorized COVID-19 Source Type: news