FDA Chief Hahn hits back at Trump, says Covid-19 vaccine could not have been chosen earlier

The US Food and Drug Administration commissioner disagreed Sunday with President Donald Trump’s claims that the Pfizer-BioNTech vaccine could have been released a week ago.

The commissioner, Dr. Stephen Hahn, said the FDA’s decision Friday to authorize the vaccine for emergency use was made as quickly as possible while still ensuring that the vaccine was safe and effective.

“We do not feel that this could have been out a week earlier,” Hahn said on the ABC News program “This Week.” “We went through our process. We promised the American people that we would do a thorough review of the application and that’s what we did.”

Pfizer and BioNTech’s vaccine has been developed and has cleared those regulatory hurdles faster than any other vaccine the FDA has evaluated. Work on it began shortly after the coronavirus was identified in Wuhan, China, less than a year ago.

The first of roughly 3 million doses of Pfizer’s vaccine began their journeys Sunday morning to sites across the country, where they will be administered to health workers and nursing home residents and employees starting this week.

Hahn has faced mounting public rebukes and pressure from Trump, including insulting tweets, and from White House officials to speedily approve treatments and vaccines that are under development, including Pfizer’s and Moderna’s. Pressed in the television interview about whether Mark Meadows, the White House chief of staff, had threatened his job, Hahn said he did not want to get into individual discussions.

In a separate interview on Fox News Sunday, Moncef Slaoui, the scientific head of the administration’s vaccine effort, known as Operation Warp Speed, was asked if political interference had caused problems with vaccine development.

Slaoui described reports of political pressure as “not helpful” and “not needed,” adding that they could cloud discussions on the vaccine’s safety and efficacy. He noted that the past week had been filled with experts being “remarkably transparent” about the scientific data supporting the vaccine’s performance.

“If that phone call happened,” he said, referring to reports that Meadows contacted Hahn, “I think it was useless and unfortunate, and so are some of the tweets.”

Slaoui predicted that 100 million people in the United States would be vaccinated by the end of the first quarter of 2021. He noted that Pfizer’s product was highly unlikely to be the only vaccine to be ready for use soon, and pointed to the similar vaccine developed by Moderna. An independent panel of FDA experts is scheduled to review that vaccine Thursday, and Slaoui predicted that it would receive authorization for use as early as Friday.

Some 75% or 80% of Americans will need to be immunized before enough people are resistant to the virus to substantially slow its spread, a phenomenon called herd immunity, Slaoui said.

That benchmark could perhaps be met by the start of next summer. But Slaoui expressed concern about the degree of vaccine hesitancy that still pervades the country — a sense of skepticism that has not been helped, he noted, by rampant politicization of vaccination efforts or by rumors that powerful political figures had pressed government agencies to rush the timeline of vaccine clearance.

Last week, the FDA released a review of Pfizer’s data from its clinical trials, which indicated that its vaccine can effectively prevent symptomatic cases of Covid-19. Few serious side effects were reported. Researchers will continue to monitor people who receive the vaccine to ensure its safety, but its promising performance in clinical trials has many experts hopeful.

“We hope that, now that all the data is out and available to be discussed in detail, that people will keep their mind open,” Slaoui said. “This is a very effective and safe vaccine.”

Dr. Megan Ranney, an emergency physician in Rhode Island, echoed Slaoui’s concerns. “The vaccine is great, but only if it gets in people’s arms,” she said.

Ranney was eagerly anticipating getting her own shot. “Vaccines are one of the greatest miracles of modern medicine,” she said. “I cannot wait to get vaccinated myself and see my community vaccinated.”