FDA to tighten coronavirus vaccine trial standards before election

Washington: The US Food and Drug Administration is expected to soon announce new, higher standards for an emergency authorisation of a coronavirus vaccine, lowering the chances that a vaccine might be cleared before the November 3 election, according to a US media report.

The agency is issuing the guidance to boost transparency and public trust as health experts have become increasingly concerned that the Trump administration might be interfering in the approval process.

Safety reviews of coronavirus vaccine candidates will be slowed by the FDA.Credit:AP

The report, published in the Washington Post, said the FDA is expected to ask vaccine manufacturers seeking an emergency authorisation to follow trial participants for a median of at least two months after they receive a second vaccine shot. It also said the agency is asking that trials identify a specific number of cases of severe COVID-19, the disease caused by the coronavirus, in patients treated with a placebo.

Few vaccine developers were expected to have definitive trial results before the election, but Pfizer Inc has said it might have data for the FDA to review by late October — although that timetable could slip with the new guidance. Moderna has said it is unlikely to have data in October. AstraZeneca's trial in the United States is halted while investigators try to determine whether a serious neurological problem in one participant in Britain was caused by the vaccine.

The percentage of people who said they would get the vaccine if it were available today has dropped to just over 50 per cent; it was 72 per cent in May.

Moderna and Pfizer began their trials on July 27, and took about a month to enroll 15,000 people, the halfway point for their planned enrolment of 30,000 people. The trials are designed for people to receive their second shot either three or four weeks later. Two months of follow-up would make it unlikely the companies would have enough data before mid-November.

Polls show that the politicisation of the race to develop a vaccine is taking its toll. Pew Research Centre recently reported that the percentage of people who said they would get the vaccine if it were available today has dropped to just over 50 per cent; it was 72 per cent in May.

"Things are so revved up right now that there is quite a possibility that the American public won't accept a vaccine because of all the things that are going on," said Peter Hotez, dean of the National School of Tropical Medicine at Baylor College of Medicine.

Reuters, Washington Post

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