In this file photo, taken on March 16, 2020, Neal Browning receives a vaccine at the Kaiser Permanente Washington Health Research Institute in Seattle, in the first phase of a study on a possible vaccine for COVID-19, the disease caused for the coronavirus. (The Associated Press)
Washington – The U.S. Food and Drug Administration released safety standards for COVID-19 vaccines on Tuesday after the White House blocked its formal release, the latest chapter in a push and pull between the Trump administration and public health scientists.
In the new guidelines published on its website, the agency known as the FDA for its acronym in English said that vaccine manufacturers must monitor their test participants for at least two months to rule out safety problems before requesting an emergency approval. . That requirement would almost certainly rule out the introduction of a vaccine before November 3, the day of the presidential election.
President Donald Trump has repeatedly insisted that a COVID-19 vaccine be authorized before the election, despite government scientists saying it is unlikely. On Monday, Trump said in a video recorded after returning to the White House that the vaccines would arrive “from one moment to the next.”
Former FDA officials have warned that public perception that a vaccine is being rushed for political reasons could derail plans to vaccinate millions of people in the country.
A senior government official confirmed Monday that the White House had blocked FDA plans to formally release safety guidelines based on the two-month data requirement, saying there was no “clinical or medical reason” for it.
But on Tuesday, the agency released the guidelines on its website, making it clear that regulators plan to impose safety standards for any vaccine that requests an expedited approval path.
FDA Commissioner Stephen Hahn said in a statement that he hoped the guidelines would help “the public to understand our science-based decision-making process that ensures the quality, safety and efficacy of vaccines.”
The standards are aimed at companies seeking rapid approval through the FDA's emergency clearance pathway. This accelerated process, reserved for health emergencies, allows medical products to reach the market after satisfying lower requirements than in the traditional process. But the FDA has made it clear that only vaccines that demonstrate effectiveness and safety will be licensed against the coronavirus.
Former Acting Commissioner Dr. Stephen Ostroff said the requirements seem reasonable given the agency is in uncharted territory in terms of considering the emergency use of a vaccine. The agency has previously approved only one vaccine by that method: in 2005, for anthrax.
For weeks now, Commissioner Hahn has tried to bolster public confidence in the agency's vaccine review, vowing that professional scientists, not politicians, will decide whether injections are safe and effective for mass vaccination.