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S&P Global – Biden, US FDA gear up for new path forward on COVID-19, seek to reassure public

S&P Global – Biden, US FDA gear up for new path forward on COVID-19, seek to reassure public

President-elect Joe Biden and the head of the U.S. Food and Drug Administration’s vaccines unit each said they were gearing up for the next phase of the nation’s response to the COVID-19 pandemic, as the number of American infections, hospitalizations and deaths continued to soar.

The FDA is preparing for what is expected to be an influx of COVID-19 vaccine marketing applications in the coming weeks and months, Peter Marks, head of the agency’s Center for Biologics Evaluation and Research, said during an Nov. 9 online forum hosted by Friends of Cancer Research and Prevision Policy.

Pfizer Inc. and BioNTech SE are expected to be the first to seek emergency use authorization, or EUA, from the FDA after the companies reported interim phase 3 results Nov. 9 showing their experimental vaccine had an efficacy rate above 90% at seven days after the second dose was administered.

Pfizer and BioNTech said they plan to submit an EUA application to the FDA in the third week of November if they meet the agency’s requirement of accumulating a median of two months of safety data for their vaccine.

By the time Biden takes office on Jan. 20, 2021, it is possible that the FDA may have authorized one or more vaccines for the U.S. market, though widespread availability of those products is not expected until well into next year, the president-elect and Marks both emphasized.

Until then, Biden pleaded with Americans to be patient and wear masks when outside the home.

“As we work toward a safe and effective vaccine, we know that the single most effective thing we can do to stop the spread of COVID is wear a mask,” Biden said during a Nov. 9 address from Wilmington, Del. “We can save tens of thousands of lives if everyone would just wear a mask for the next few months. Not Democrat or Republican lives. American lives.”

Biden’s remarks came shortly after he met virtually for the first time with his newly convened 13-member COVID-19 advisory board, which is being led by a former U.S. surgeon general, a past FDA commissioner and an expert in health disparities.

“There’s a need for bold action to fight this pandemic. We’re still facing a very dark winter,” Biden said, noting that the U.S. has surpassed 10 million COVID-19 infections and nearly 240,000 Americans are now dead from the disease — four times the number of U.S. soldiers killed during the Vietnam War.

As many as 200,000 more lives could be lost in the coming months before a vaccine can be made widely available, Biden said.

“So we can’t forgo the important work that needs to be done between now and then to get our country through the worst wave yet in this pandemic to reduce the spread, to save lives,” Biden said, noting that he is relying on some of the top infectious diseases and health policy experts in the U.S. to help him devise his COVID-19 plan of attack.

Changing the discourse

After coming under repeated criticism from President Donald Trump — who said the FDA’s scientists were part of a “deep state” effort to undermine his 2020 political campaign — Marks said the agency is preparing for the next administration by laying the groundwork to “fundamentally change the discourse here from one of distrust and suspicion to one of confidence,” particularly for COVID-19 vaccines.

Trump is challenging the election outcomes in several states.

The FDA wants to reassure the public that “there is a group of individuals here who are science-based, who are public health professionals, who are going to make it their business to make sure that whatever comes through this process is safe and effective and it’s something that everyone should feel comfortable taking,” Marks said.

He emphasized that the FDA is not perfect and mistakes may still be made but “we will put the best minds together to do our absolute best to make sure that what comes forward is the best possible product and has been really gone through with a fine-tooth comb to make sure that we’ve done everything to try to ferret out any problems that could preclude it from being that safe and effective product that we want to see.”

Marks said the FDA’s efforts over the past several months have been a reflection of “the best in crisis management,” with regulators and scientists who have been willing to come together across the agency’s divisions.

“They don’t ask, ‘What’s mine, what’s yours?’ They just realize we need to get through and get the work done,” Marks said. “That’s been a really wonderful thing to see happen.”

That spirit of cooperation is expected to continue over the coming months as a “large bolus of a lot of work” comes in as biopharmaceutical companies file EUA applications for their COVID-19 vaccines, he said.

Marks emphasized the FDA must first convene its panel of outside advisers before it will make any determination on an EUA or licensure of a COVID-19 vaccine, though he anticipated that process to happen fairly rapidly.

A key question for the advisers will be whether a company granted an EUA should unblind their phase 3 study so that all volunteers who are getting the placebo can receive the vaccine.

At an Oct. 22 meeting to discuss COVID-19 vaccines in general terms, most on the FDA’s panel said companies should try to keep trial participants in their respective study arms for as long as possible, Marks noted. Many of the panelists also said they wanted more than a median of two months follow-up for safety data.

“I think there will be an even further robust discussion of those issues as they consider specific products,” Marks said.…