In Ongoing Hahn-Azar Feud, Azar Denies Plotting Hahn’s Ouster

HHS Secretary Alex Azar denies a report that he and colleagues are plotting the ouster of FDA Commissioner Stephen Hahn over Hahn’s holding fast to stricter, more time-consuming rules for makers of novel COVID-19 vaccines than what the White House wants.

In a televised interview, Azar said the allegations were “absolutely untrue. Commissioner Hahn and I speak almost every day,” Azar said. “We have a very close, productive relationship.”

FDA is also pooh-poohing the report. An FDA spokesman told FDAnews, “Commissioner Hahn enjoys a good relationship with Secretary Azar and speaks with him regularly.”

But that’s not what has played out in both officials’ public comments. The latest in the tit-for-tat between the two had Hahn saying on Wednesday that the FDA has no specific timeline for reviewing a COVID-19 vaccine but hopes to have one available by springtime and Azar saying one day later that the U.S. is likely to have enough safe and effective vaccines available for the most vulnerable Americans by the end of 2020.

The White House has been at odds with the FDA for months over Emergency Use Authorizations (EUAs) for COVID therapeutics that President Trump favored (including hydroxychloroquine and convalescent plasma), and the White House seeking to hurry vaccine candidates through regulatory hurdles, preferably before the Nov. 3 presidential election.

The FDA has been standing its ground on vaccine approvals. Though the White House objected, the FDA told vaccine makers earlier this month not to seek approvals or EUAs until they have monitored at least 50 percent of their trial participants for two months after vaccination. This is the timeframe when other vaccine trials tended to see significant adverse events.

Hahn said at a conference this week that the agency very much wants to expedite promising vaccine candidates, but he intimated that he will continue to resist pressure from the White House.

“At the end of the day, only our career scientists in the Center for Biologics Evaluation and Research will be making this decision, and they will be making it solely upon the science and data that come from the clinical trials,” Hahn said.

He emphasized that the FDA also wants a vaccine as soon as possible. Hahn explained that FDA officials have been interacting regularly with drugmakers since each began working on their vaccine candidates rather than waiting to review all data at the conclusion of trials.

“We need to make sure that there’s quality and consistency and that every lot has the same ability to provide protection to all of Americans,” Hahn said. “We have a lot of confidence in the manufacturing of these developers, and we will be doing our part with respect to working with them to make sure that manufacturing can be ramped up as quickly as possible.”

Azar, for his part, reiterated Thursday that though he has no idea when trial data will become available for leading vaccine candidates, he still has a timeline in mind.

“We believe by the end of this year we would have enough FDA-authorized vaccine to vaccinate our most vulnerable people, by the end of January enough vaccine for all of our seniors as well as our healthcare workers and first responders, and by the end of March to early April — enough for all Americans,” Azar said. — Suz Redfearn