Convalescent plasma treatments became the latest potential COVID-19 treatment the Food and Drug Administration (FDA) gave emergency use authorization (EUA) for this week.
This isn’t the first potential treatment the FDA has given such an authorization for in the quest to fight COVID-19. So what’s different about this one? The VERIFY team dug in.
WHAT WE FOUND
The FDA issued a letter of authorization for convalescent plasma treatments on August 23. Doing so allows doctors to administer the treatment to hospitalized patients with their consent even if they’re not participating in the clinical trial.
The letter explains that these treatments take plasma from someone with SARS-CoV-2 antibodies and gives them to a hospitalized patient. Put another way, someone who recovered from COVID-19 donates blood that is given to someone currently suffering from it.
It has been authorized because “based on the totality of scientific evidence available to FDA, it is reasonable to believe that COVID-19 convalescent plasma may be effective in treating COVID-19, and that, when used under the conditions described in this authorization, the known and potential benefits of COVID-19 convalescent plasma when used to treat COVID19 outweigh the known and potential risks of such products.” The FDA adds, “there is no adequate, approved, and available alternative” to the plasma treatments.
So the FDA is approving it because it shows promise in potentially treating hospitalized patients and even noted in its guidance regarding the plasma treatments that such treatments were also studied for use in similar outbreaks. The FDA’s decision memorandum clarifies that evidence suggests that the administration of the plasma treatment showed better results “in the early course of the disease,” which is before intubation.
None of that means that the safety of this treatment is a done deal, however. That’s why it has been given emergency use authorization rather than full approval. In its letter authorizing its use, the FDA said, “Adequate and well-controlled randomized trials remain necessary for a definitive demonstration of COVID-19 convalescent plasma efficacy and to determine the optimal product attributes and appropriate patient populations for its use.”
The FDA has seen good results from the treatments in small-scale trials thus far. It needs to see that continue in larger-scale trials before it has the confidence to broadly approve the treatment.
The FDA reiterates that on its guidance page. It says, “Although promising, convalescent plasma has not yet been shown to be safe and effective as a treatment for COVID-19. Therefore, it is important to study the safety and efficacy of COVID-19 convalescent plasma in clinical trials.”
Potential side effects of convalescent plasma include allergic reactions, transfusion-associated circulatory overload and transfusion associated lung injury, as well as the potential for transfusion-transmitted infections, according to the FDA’s press release. Still, it believes the potential benefit outweighs the risk.
Outside the side effects, some experts have raised other concerns about this EUA -- namely that it could take away from existing clinical trials. Dr. Payal Kohli has a fellowship-training in clinical research and explained to VERIFY that clinical trials are key to getting meaningful data on this treatment.
“The problem with the FDA giving this authorization is that it really disincentivizes people to enroll in clinical trials, as they now can get this treatment from their doctor,” she explained.
Nonetheless, Dr Kohli encouraged any patients who've recovered from COVID to consider donating their plasma for treatments or clinical trials.
“As soon as you recover from the symptoms of your infection, reach out to your local blood bank and let them know that you’ve recovered, that you would like to donate your antibodies. I would highly encourage anyone who’s gone through it to take their pain and suffering and potentially turn it into something that can help somebody else.”