Pharma execs say FDA will not lower standards for coronavirus vaccine

Drug company executives sought to reassure House Democrats that the federal government is not lowering its approval standards, and any coronavirus vaccine that gains approval will be safe.

Executives from Moderna, Janssen, Merck, AstraZeneca and Pfizer told lawmakers during an Energy and Commerce subcommittee hearing Tuesday that despite the unprecedented speed, any vaccine candidate will be safe.

“We do believe it’s possible to develop a safe and effective vaccine,” said Macaya Douoguih, head of clinical development at Janssen. “A lot needs to be done in parallel, but it can be done safely and without compromising any of the standards we usually undertake for any clinical trial.”

Top Democrats expressed concern that the Food and Drug Administration (FDA) will be pressured by the Trump administration to approve a vaccine even if it doesn’t work. 

“Historically, I have been very confident in the FDA. But now that Trump is president, I still think there’s a real possibility he will pressure the FDA to lower the standards,” said Rep. Frank Pallone Jr. (D-N.J.). 

The agency released guidance last month that outlines conditions for approving a COVID-19 vaccine. Those include requiring any vaccine to be at least 50 percent more effective than a placebo in preventing the disease.

The executives said they do not believe the FDA would lower its standards and approve a vaccine if it were not at least 50 percent more effective. 

“I think, given the speed we are working, it’s understandable people may ask questions about whether anyone is cutting corners,” said Mene Pangalos, an executive vice president at AstraZeneca. 

“Despite the speed we are working at, we are neither cutting corners and regulators are not lowering their standards. So I feel comfortable that if there are vaccines that are effective, they will be safe and effective, and it’ll be good to go in terms of getting regulatory approval,” Pangalos said.  

Most of the drugmakers said they hope to have some sort of regulatory approval by this fall, but cautioned that there are many uncertainties.

Stephen Hoge, president of Moderna, said if the company is able to enroll 30,000 people in its clinical trial, he is optimistic about bringing forward a vaccine by the “fall or toward the end of the year.”

“We would also hope at that point to have millions of doses of vaccines available,” Hoge said.

Almost all of the executives said they are planning to rely on the federal government to distribute a vaccine when it becomes available.

Rep. Joe Kennedy III (D-Mass.) said that was unacceptable.

“All of you are relying on a government that couldn’t procure proper PPE [personal protective equipment] for wide swaths of the population,” Kennedy said. “That’s great, you’re saying you’re relying on the federal government … clearly the federal government has failed here multiple times over. The consequence of not doing this right is going to be dramatic.”