The US Food and Drug Administration has released a set of guidelines outlining the approval process for future COVID-19 vaccines, stating that any product will need to prevent or decrease the severity of the disease by at least 50 percent.
The new guidelines were released during a June 30 briefing with the Senate Health, Education, Labor and Pensions Committee during which senators sought assurances from FDA Commissioner Stephen Hahn, National Institute of Allergy and Infectious Diseases Director Anthony Fauci, and other high-ranking health officials that the expedited speed of development wouldn’t compromise the integrity of the final product.
“I want the American people to hear me when I say we will use the science and data from those trials, and will ensure that our high levels of standards for safety and efficacy are met,” Hahn said during the briefing.
Currently, more than 145 vaccines are being tested worldwide, The New York Times reports, and a leading US candidate developed by the biotech company Moderna is slated to begin Phase III clinical trials this month.
President Donald Trump announced in May the formation of Operation Warp Speed, a government initiative to hasten the development of a vaccine within the next 12 to 18 months, Reuters reports. In contrast, most vaccines can take more than a decade to be fully developed and brought to bear against a disease.
Responses to the FDA’s report are mixed. Gregory Poland, the director of the Mayo Vaccine Research Group, tells Reuters the efficacy guidelines are standard compared to other vaccines. “They look pretty much like influenza vaccine guidelines,” Poland says. “I don’t think that’s a high bar. I think that’s a low to . . . appropriate bar for a first-generation COVID-19 vaccine.” The effectiveness of the annual flu shot, for example, generally ranges between 40 percent and 60 percent, according to The Washington Post.
Peter Hotez, a vaccine expert at the Baylor College of Medicine, tells the Post the 50 percent threshold is low, a sign that the FDA recognizes “our first vaccine won’t be our best.” Ultimately, he says, vaccine developers should aim for 70–75 percent efficacy.
In contrast, Stephen Ostroff, a former acting FDA commissioner, says the 50 percent figure is too high. Given that the virus “is rampaging through a lot of parts of the United States, I would certainly consider a vaccine with less than 50 percent efficacy,” he says.
During yesterday’s briefing, Fauci discussed efforts to combat misinformation about vaccines, which many Americans view with distrust. Only 45 percent of Americans get the flu shot each year, The Hill reports, and Fauci claims that 75 percent to 80 percent of the public will need to be vaccinated to stop the spread of the coronavirus. Already, efforts are being made to engage with people at the community level.
“It is a reality. A lack of trust in authority, a lack of trust in government, and a concern about vaccines in general,” Fauci said. “We need to engage the community by boots on the ground, and particularly those populations that have not always been treated fairly by the government—minority populations, African Americans, Latinx, and Native Americans."