FDA discloses vaccine guidelines that was blocked by White House

WASHINGTON >> The Food and Drug Administration released updated safety standards Tuesday for makers of COVID-19 vaccines after the White House blocked their formal release, the latest political tug- of-war between the Trump administration and the government’s public health scientists.

In the new guidelines posted on its website, the FDA said vaccine makers should follow trial participants for at least two months to rule out safety issues before seeking emergency approval. That requirement would almost certainly preclude the introduction of a vaccine before Nov. 3.

President Donald Trump has repeatedly insisted a vaccine could be authorized before Election Day, even though top government scientists working on the effort have said that timeline is very unlikely. On Monday Trump said vaccines are coming “momentarily,” in a video recorded after he returned to the White House.

Former FDA officials have warned that public perception that a vaccine was being

rushed out for political reasons could derail efforts to vaccinate millions of Americans. A senior administration official confirmed Monday that the White House had blocked FDA’s plans to formally publish the safety guidelines based on the twomonth data requirement, arguing there was “no clinical or medical reason” for it.

But on Tuesday, the FDA posted the guidance on the

agency’s website, making clear that regulators plan to impose the safety standards for any vaccine seeking an expedited path to market.

FDA Commissioner Stephen Hahn said in a statement that he hoped the guidelines would help “the public understand our science-based decision-making process that assures vaccine quality, safety and efficacy.”

The requirements are

aimed at companies seeking rapid approval through the FDA’s emergency authorization pathway. That accelerated process, reserved for health emergencies, allows medical products onto the market based on a lower bar than traditional FDA approval. But FDA has made clear only vaccines that are shown to be safe and effective will be authorized against COVID-19.

JACQUELYN MARTIN — THE ASSOCIATED PRESS FILE On Aug. 2, 2018, the U.S. Food and Drug Administration building is seen behind FDA logos at a bus stop on the agency’s campus in Silver Spring, Md.