US Health Secretary Targeting FDA Chief?
US press reports quote top administration officials as saying the Secretary has secretly floated the idea to confidantes, even to the point of suggesting replacements for Hahn. Names mentioned include Brett Giroir, head of testing at HHS, as well as FDA Principal Deputy Commissioner Amy Abernethy and longtime regulatory official Janet Woodcock.
Azar as well as Trump are said to be unhappy about Hahn’s insistence that a Covid vaccine must meet safety standards so strict as to prevent the president from fulfilling his much-touted plan to have a candidate approved before the Nov. 3 election, now only a week away.
The health secretary has disputed any disagreement with Hahn, saying the two have a very close productive relationship. “As I have made very clear and the commissioner has made clear,” Azar – a former Eli Lilly executive –added that “the FDA will make the decision whether to approve therapeutics or vaccines according to their science, data, regulatory and legal standards.”
Outside the administration, Hahn has come under fire during the pandemic for bending to White House pressure and issuing emergency use authorizations (EUAs) for hydroxychloroquine or convalescent plasma, for example, to treat Covid-19. The agency has since given full approval to Gilead Sciences’ antiviral drug remdesivir as a treatment for the virus.
Vaccine advisory committee hold first meeting
The FDA vaccine advisory committee met remotely in an all-day session on Oct. 22 to discuss approval standards for Covid vaccines, along with the federal government’s decision to invest in scaling up number of vaccines.
Officially called the Vaccines and Related Biological Products Advisory Committee, the panel made up mostly of academic experts in infectious diseases, immunology and biostatistics, is also expected to weigh in on topics such as the effects of vaccines in specific populations and how to continue clinical trials after a vaccine is authorized.
Future meetings will consider applications from vaccine manufacturers, which could come as early as mid-November. The first Covid-19 vaccines to be marketed in the US are thought likely to be cleared by EUAs, which require less time and documentation than full approvals.
Before a vaccine is authorized, the FDA guidelines will require it to be at least 50% effective, as well as that at least five people receiving the placebo develop severe cases of Covid-19. Also, there must be at least two months of follow-up on half of the study participants.
Author: Dede Williams, Freelance Journalist