Covid-19: US will not join WHO in developing vaccine

Yielding to pressure

Stephen Hahn, head of the US Food and Drug Administration, told the Financial Times on 30 August that he might approve the emergency use of a US vaccine against covid-19 before phase III trials were completed. The next day he insisted, “Science and data drive our decisions.”45

Hahn has been criticized for yielding to pressure from Trump to approve treatments for covid-19 too quickly, before the 3 November election. Peter Marks, head of the FDA’s Center for Biologics Evaluation and Research, said earlier that he would quit if the Trump administration pressed for too quick an approval of a vaccine.6

Early release of vaccines in the past has shown that problems can arise. In 1955 the injectable polio vaccine was approved, but a batch produced by Cutter Laboratories contained live virus. Several hundred children were paralyzed, and a few died.7 In 1976 President Gerald Ford—like Trump, facing an election—promoted a vaccination campaign against swine flu despite controversy over the vaccine’s safety. About 500 cases of Guillain-Barre syndrome occurred in people who had received that vaccine.8

Phases for allocation

Trump has repeatedly said that a covid vaccine will be available very soon, perhaps before the US election. Public health experts such as Anthony Fauci, head of the National Institute of Allergy and Infectious Diseases, have said that a vaccine may be possible by the end of the year but that some time in the first six months of 2021 is more likely.

Hahn had given early approval to the use of hydroxychloroquine as a treatment for covid- 19. Trump praised the drug and said that he had taken it himself for two weeks. The FDA later retracted the approval, cautioning about the risk of serious cardiac adverse effects.9 Hahn has also been criticized for overstating the effectiveness of convalescent plasma as a treatment at a press conference. That statement was corrected on 1 September to show more modest benefit.10

On the same day, the National Academies of Science released a preliminary report on guidelines for allocating a vaccine when one becomes available. It suggested four phases, which were based on the risk of acquiring infection, the risk of severe illness, the effect on societal functioning, and the risk of transmitting disease.11

In the first of these phases the vaccine would go to high risk healthcare workers, people whose conditions put them at high risk for serious illness, and older people living in nursing homes. In the second phase essential workers in critical industries and teachers and school staff would get the vaccine. The first two phases would include about half of the US population of 330 million.

In the third phase the vaccine would go to young adults and essential workers at increased risk who were not included in the earlier groups. The fourth phase would include everyone else.