The hold came after a group of federal health officials — including National Institutes of Health Director Dr. Francis Collins, NIAID Director Dr. Anthony Fauci and Lane — stepped in to argue the emerging data on the treatment was too weak, the Times reported Wednesday, citing two senior administration sources.
“The three of us are pretty aligned on the importance of robust data through randomized control trials, and that a pandemic does not change that,” Lane told the Times.
CNN reached out to the FDA and was told “per policy, we are not able to comment on whether or not we will take any action regarding emergency use authorization for convalescent plasma.”
Emergency use authorization from the FDA does not require the same level of evidence as full FDA approval. The agency previously gave an EUA to hydroxychloroquine and chloroquine for Covid-19 treatment, then rescinded it in June after the antimalarials were found to be ineffective against coronavirus.
At the end of March, the FDA created a pathway for scientists to try convalescent plasma with patients and study its impact. Physicians have been using the treatment since. USCovidPlasma.org reports nearly 67,000 people have been infused with the treatment and nearly 14,000 physicians are using it as part of a Mayo Clinic-run program, but it’s still not clear if it works. Several studies are underway.
President Donald Trump and US health leaders, including Fauci and other White House Coronavirus Task Force Members, and even celebrities like Dwayne “The Rock” Johnson, have encouraged people who survived Covid-19 to donate plasma. Two weeks ago, on a tour of the Red Cross, Trump implored people to donate plasma, saying, “We have a lot of people that would heal, would get better. As soon as you can, please.”
Early results from some small studies have looked promising.
But there was no placebo group in the study. Without that comparison, it’s still hard to know if the treatment made the difference.
“Convalescent plasma has not yet been proven to work with the trials that we want to see, these randomized control trials,” Dr. Ian Lipkin, the director of the Center for Infection and Immunity at Columbia University Mailman School of Public Health, said in an interview on Monday. “Although there is a lot of reason for optimism there, too, it’s not been shown and until that’s done, there’s always going to be a healthy skepticism in the community, despite all the background information that suggests it’s likely to work.”