Dr. Anthony Fauci has said experimental coronavirus vaccines should not be given emergency use authorization (EUA)—especially if their effectiveness has not been proven—as it could undermine the development of others.
Speaking to Reuters, the director of the National Institute of Allergy and Infectious Diseases and a coronavirus taskforce member was asked about the potential for a vaccine to be given a EUA. “The one thing that you would not want to see with a vaccine is getting an EUA before you have a signal of efficacy,” he said. “One of the potential dangers if you prematurely let a vaccine out is that it would make it difficult, if not impossible, for the other vaccines to enroll people in their trial.”
His comments follow the U.S. Food and Drugs Administration (FDA) decision to give convalescent plasma therapy EUA—a decision seen as controversial by many scientists, who say there is not enough evidence the treatment works for COVID-19. Plasma therapy involves using antibodies taken from the blood of people who have had the virus to treat people who are suffering with it. By providing them with antibodies, it is thought they would be better able to fight off the infection.
In a statement emailed to Newsweek, Howard Koh, who was assistant secretary for health under President Barack Obama, said: “My major concern is that the EUA now hampers ability to conduct the necessary trials to definitively prove that convalescent plasma transfusions save lives. The investigators have underscored all along that their program does not represent a definitive clinical trial. And it is not. More rigorous studies require randomized trials with a control group and peer-reviewed evaluation. The announcement… overstated the current role of convalescent plasma for treatment.”
Fauci’s remarks also follow rumors that the Trump administration hopes to approve an experimental vaccine before the U.S. presidential election in November. Anonymous sources told the Financial Times the administration hopes to push through the AstraZeneca/Oxford University vaccine. Officials denied these claims. Sources also told CNN White House officials say it is possible a vaccine could be given an EUA before late-stage trials are finished. This was denied by Michael Caputo, the assistant secretary for public affairs at the US Department of Health and Human Services.
The use of EUA by the FDA has been pushed into the spotlight throughout the coronavirus pandemic. Because it is an entirely new disease, there are no officially approved pharmaceutical tools to treat it. This has led to various drugs being given EUA status while trials and studies take place. One of the most controversial drugs to be given an EUA was hydroxychloroquine, which Trump was a strong advocate for. The EUA for hydroxychloroquine was later revoked by the FDA after the agency determined the drug was “unlikely to be effective in treating COVID-19.”
Discussing the use of EUA for plasma therapy and for any potential vaccine, Koh, the Harvey V. Fineberg Professor of the Practice of Public Health Leadership at the Harvard T. H. Chan School of Public Health, said: “This announcement shakes the confidence of the medical community that the criteria for decision-making is being held at the highest scientific level.
“We need public and professional trust to be at the highest possible standard for any future COVID vaccine efforts to be successful. The future of global health depends on it.”
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