Two top US public health officials have played down the chances of having a coronavirus vaccine before the election, despite Donald Trump’s insistence that one will be available “within weeks”.
During a hearing before the Senate health committee, Anthony Fauci, the head of the National Institute of Allergy and Infectious Diseases, and Stephen Hahn, the commissioner of the Food and Drug Administration, both insisted drug companies still face hurdles to authorising a vaccine.
Dr Fauci said he expected a vaccine to be authorised by November at the earliest, while Dr Hahn stressed that the FDA would soon issue a number of additional guidelines, which experts say will make it all but impossible to achieve authorisation any sooner.
The comments run counter to assurances from the US president that a Covid-19 vaccine is imminent, and threaten to exacerbate tensions between Mr Trump and his administration’s most senior medical officials.
Dr Fauci told the committee: “We feel cautiously optimistic that we will be able to have a safe and effective vaccine, although there is never a guarantee of that.
“Early studies in animals and in human phase 1 and phase 2 [trials] indicate that individuals induce a response that is comparable to, if not better than, natural infection. And so as these trials go on we predict that sometime by the end of this year — let’s say November or December — we will know whether or not these are safe and effective.”
Four companies currently have a coronavirus vaccine in phase 3 clinical trials, which involve testing tens of thousands of people around the world.
Dr Hahn told the Financial Times last month he was willing to grant an emergency authorisation to a vaccine before the end of those trials, if there was enough data to be sure that the benefits of doing so outweighed the risks.
Since then, however, his agency has been working on additional guidelines for drugmakers which would make it very difficult to secure an authorisation before November.
Three people with knowledge of those guidelines told the Financial Times this week that the guidelines would include waiting until about half of trial participants had been monitored for at least two months after receiving their last injection before declaring a vaccine to be safe.
Experts say such a standard would make it highly unlikely that any company would be ready to apply for authorisation before the US presidential election on November 3.
Dr Hahn told the committee on Wednesday: “[The FDA] will work to provide additional information, so that it is clear what we expect to see should a sponsor choose to submit an emergency use application [EUA].
“FDA also expects that an EUA request would include a plan for active follow-up to monitor safety among individuals who receive the vaccine. In the end, FDA will not authorise or approve a vaccine that we would not feel comfortable giving to our families.”