This move is expected this week, as the US government seeks to restore the confidence of the population and reassure authorities such as the National Institutes of Health (NIH) that the first vaccines to be approved by the FDA will be safe.

A long scheduled public meeting of the agency’s s advisory panel is scheduled for Oct. 22.

In the latest US opinion polls, fewer people than ever said they would trust a vaccine touted by the government. In one survey, only 39% of respondents said they would definitely let themselves be vaccinated if approval came before the election.

The new FDA guidance, which the newspaper Washington Post said is already being shared with vaccine manufacturers, is expected to be more rigorous than the criteria used for emergency clearance of hydroxychloroquine or convalescent plasma.  Under its terms, vaccine makers ask seeking an EUA would be asked to follow participants in late-stage clinical trials for a median of at least two months.

The observation period would begin after the trial participant receives a second shot of the vaccine, the Post said, citing “two individuals familiar with the situation.” As a sign that the vaccine works, the FDA is expected to look for at least five severe cases of Covid-19 in the placebo group for each trial, as well as some cases of the disease in older people.

Commentators said the tougher standards would lengthen the time companies needed to prepare their applications and for the FDA to review the data. This makes it “highly unlikely” that any vaccine will be authorized before the election, Paul Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia and a member of the FDA’s advisory board on vaccines, said.

Author: Dede Williams, Freelance Journalist

The current discussion follows moves that seemed to presage the health agency’s autonomy being weakened. On Sunday, Sept. 20, the US Secretary of Health and Human Services (HHS), Alex Azar, stripped the FDA and other HHS agencies of the authority to sign new regulations on grounds this would minimizes litigation risk and prevent abuse of authority. But HHS also stressed that the changes would not affect the FDA’s work on vaccines and Covid-19 treatments.

Public confidence in the US health sector already has been undermined by repeated changes of advice on Covid that appeared to vary according to what president Donald Trump said on Twitter that day.  In The Centers for Disease Control and Prevention (CDC) over the past week also made negative headlines when it posted on its website, retracted and then restored again its advice about airborne spread of the disease.

The most recent predictions that a vaccine is unlikely to be ready for deployment by early November dovetail with what many in US scientific and medical circles have been predicting for months, though even the usually cautious among them had appeared more optimistic of late.

Setbacks in AstraZeneca’s clinical trials, halted after a participant in the UK test suffered a serious neurological problem, may have injected an element of uncertainty into the discussion. The Anglo-Swedish drugmaker meanwhile has acknowledged in a public report that the condition was transverse myelitis.

US pharma giant Pfizer and German partner BioNTech expect to have data from their trials by the end of October. Moderna, which began the process later, has said it is unlikely to have efficacy data that soon. AstraZeneca’s vaccine progress still hangs in limbo as US trials have not yet been resumed, in contrast to all other countries, where the tests are again in progress.