President Donald Trump says FDA hold on granting emergency use of a blood treatment therapy is politically motivated.
“I hear great things about it ... that’s all I can tell you,” Trump said during a White House press briefing referring to convalescent plasma therapy. “It could be a political decision because you have a lot of people over there who don’t want to rush things because they want to do it after November 3, and you’ve heard that one before.”
FDA (US Food and Drug Administration) allegedly placed its emergency use authorization for the blood treatment therapy on hold last week after several health officials, including White House coronavirus advisor Dr. Anthony Fauci and Dr. Francis Collins expressed concern over the data on the potential treatment, according to a New York Times report.
The experimental treatment utilizes the blood from recovered Covid-19 patients who have developed antibodies against the diseases and injects it into people with coronavirus to prevent severe disease, according to the Mayo Clinic, which currently studying the treatment.
“People are dying, and we should have it approved if it’s good,” Trump said. “And I’m hearing it’s good, I heard from people at the FDA that it’s good.” He added that he would “check” on the report after the press briefing.
While there are no FDA-approved treatment or vaccines against Covid-19, the US government has issued emergency use authorization to allow unapproved products to be used as treatment for Covid-19 patients.
Based on the National Institute of Health treatment guidelines, there is “insufficient data” to regard convalescent plasma as a coronavirus treatment, though thousands of patients in the US have taken the treatment as part of clinical trials.
Trump mentioned that the success rates for convalescent plasma “way over 50%” and said the White House would recommend the therapy’s use if the “numbers are as good” as he is hearing.
“I don’t want delays. I don’t want people dying,” Trump said.
Coronavirus vaccine
FDA says it would only authorize a Covid-19 vaccine that is safe and at least 50% effective.
“We all want a vaccine tomorrow. That’s unrealistic. And we all want a vaccine that’s 100% effective. Again, unrealistic,” said Dr. Stephen Hahn, the agency’s commissioner, during an interview with Dr. Howard Bauchner of the Journal of the American Medical Association.
“But we said 50%, and the reason was because we felt that that was a reasonable floor given the pandemic,” Hahn said.
He explained that requiring the minimum of 50% effectiveness for any Covid-19 vaccine provided guidance for manufacturers on designing their clinical trials.
The vaccine candidates from Moderna and Pfizer have entered their phase three trials earlier this week. The companies aim to register about 30,000 participants to prove the safety and effectiveness of the coronavirus vaccines in a large population.
Hahn hopes that the Covid-19 vaccine or vaccines that would be authorized will be proven more than 50% effective. However, there is a possibility that the US come up with a vaccine that, on average, lessens a person’s risk of an infection by only 50%.
“We really felt strongly that that had to be the floor,” he said, adding that it’s “been batted around among medical groups.” “But for the most part, I think, infectious disease experts have agreed that that’s a reasonable floor, of course hoping that the actual effectiveness will be higher.”
