President Donald Trump has apparently moved on from endorsing hydroxychloroquine as the latest coronavirus breakthrough. Instead, on Aug. 23, the Federal Drug Administration, with Trump’s blessing and/or insistence, gave emergency approval to use convalescent plasma treatment as a way to help COVID-19 patients recover faster.
On Aug. 23, the FDA gave its approval, writing in a press release: “Based on scientific evidence available, the FDA concluded, as outlined in its decision memorandum, this product 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.”
The FDA said it has extensively reviewed the science and data of convalescent plasma treatment from the past several months and decided it could be safe and effective—and that it gave COVID-19 patients a 35% better chance for survival (though the New York Times reported that scientists are bewildered about where that number came from and are saying the FDA might have embellished it).
“I am committed to releasing safe and potentially helpful treatments for COVID-19 as quickly as possible in order to save lives,” FDA Commissioner Dr. Stephen Hahn said in a statement. “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. 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.”
The idea behind convalescent plasma treatment is that those who have already been infected with COVID-19 develop antibodies in their blood to keep themselves safe from another infection. Thus, they could donate their antibody-rich plasma to help others who are infected recover more quickly. After the red and white cells are stripped away from a donor’s blood, what’s left is a pale yellow liquid known as convalescent plasma. As Stat News explained, “the antibodies [the plasma] contains can help fight the virus early in an infection until the patient’s own immune system generates its own antibodies in sufficient quantities to beat back COVID-19.”
In June, the Mayo Clinic said that the plasma was safe for use in people who had already been infected. That study, though, hasn’t been peer-reviewed and did not have a placebo group, and, according to Stat News, it “had serious scientific limitations that make interpreting the findings difficult.”
Earlier in August, Dr. Anthony Fauci, the nation’s most recognizable infection disease expert, and Dr. Francis Collins, the director of the National Institutes of Health, questioned the data that convalescent plasma treatment was successful. They also reportedly temporarily kept the FDA from giving emergency approval.
The emergency approval of the treatment on Aug. 23 came the day before the Republican National Convention began, and as the New York Times noted, it could give Trump a positive talking point when he speaks about his administration’s response to the coronavirus pandemic, which had killed more than 175,000 Americans by the start of the RNC. Especially since the Democrats consistently ripped Trump during the DNC the week before for his lack of response to the pandemic.
Trump also said on Aug. 23 that some in the FDA were members of the “deep state,” leading political pundits to wonder how much of the FDA’s announcement was simply the result of constant political pressure by the president.
Only a day after the emergency approval was given, Hahn partially walked back some of his quotes, based on the data he used. “I have been criticized for remarks I made Sunday night about the benefits of convalescent plasma. The criticism is entirely justified,” Hahn said. “What I should have said better is that the data show a relative risk reduction not an absolute risk reduction.” Hahn also said the FDA’s approval was not politically motivated.
Despite Trump’s opinion earlier in the summer that taking hydroxychloroquine was a game-changer in fighting the virus, more and more studies showed the drug was unhelpful. It remains to be seen whether convalescent plasma treatment will be any better for those who are suffering from COVID-19—or for Trump’s reelection chances.