To catch you up, here’s a recap of what happened at the U.S. Food and Drug Administration (FDA) over the weekend and what the country’s top health officials are saying about convalescent plasma.
First, what is convalescent plasma? In simplest terms, convalescent plasma is the part of the blood that contains COVID-19 antibodies. Doctors think they can take plasma donated by people who have recovered from COVID-19, inject it into other patients, and transfer some kind of immunity or help them fight the virus until they create their own antibodies or get a vaccine. (STAT News has an explainer.)
Last week, the prospects for emergency authorization of convalescent plasma for the treatment of COVID-19 dimmed when leading scientists at the NIH expressed concerns about its utility, as The New York Times reported.
Yesterday, however, the FDA issued the emergency authorization, on the grounds that it “may be effective in treating COVID-19 and that the known and potential benefits of the product outweigh the known and potential risks of the product,” per the agency’s press release.
Meanwhile, President Trumphad implied that any resistance to approval of COVID-19 vaccines or therapies could be politically motivated. We at BIO stand strongly against any non-scientific pressure on the process.
What they’re saying: “I am committed to releasing safe and potentially helpful treatments for COVID-19 as quickly as possible in order to save lives. We’re encouraged by the early promising data that we’ve seen about convalescent plasma. The data from studies conducted this year shows that plasma from patients who’ve recovered from COVID-19 has the potential to help treat those who are suffering from the effects of getting this terrible virus,” said FDA Commissioner Dr. Stephen Hahn. “At the same time, we will continue to work with researchers to continue randomized clinical trials to study the safety and effectiveness of convalescent plasma in treating patients infected with the novel coronavirus.”
Former FDA Commissioners Dr. Scott Gottlieb and Dr. Mark McClellan also weighed in,writing an op-ed in The Wall Street Journal in support. Dr. Gottlieb tweeted, “The FDA professional staff supported this. It’s their decision.”
Dr. Michelle’s Diagnosis: BIO stands firmly on the side of science and scientists across America working hard to bring an end to the COVID-19 pandemic. There is no silver bullet to ending COVID-19, and convalescent plasma is just one piece of the complex puzzle. We need to continue to research a wide variety of therapeutics and vaccines, including plasma. Furthermore, we need to ensure the scientists at FDA are allowed to do their work, independently, and that FDA officials’ decisions are allowed to stand. The science, not politics, should drive these decisions. – BIO President and CEO Dr. Michelle McMurry-Heath
More Health Care News:
Biopharma Dive: Coronavirus vaccine Pfizer, BioNTech chose for late-stage testing appears safer than first
“The data disclosed Thursday support their decision, showing the selected vaccine, dubbed BNT162b2, in particular led to fewer cases of fever than the first version.”
Reuters: Johnson & Johnson to test coronavirus vaccine in 60,000 volunteers
“The phase 3 trial will likely lock off in late September, with the first vaccines available for use by early 2021.”
The Wall Street Journal: Antibody drugs advancing to fill COVID-19 treatment gap
“Companies including Regeneron and Eli Lilly are testing drugs to help protect people infected with the virus from developing serious cases.”
Dallas Morning News (Opinion): Global pharmaceutical models would destroy U.S. medical innovation
“The companies who would be hurt the most by this proposed move would be small biotech businesses,” said Tom Kowalski, Chief Executive Officer of the Texas Healthcare and Bioscience Institute.
