Blood plasma, taken from patients who have recovered from COVID-19 and rich in antibodies, may offer benefits to those battling the disease. But the evidence has not been conclusive as to how it works or how best to administer it.
Many scientists and doctors believe that convalescent plasma might provide some benefit, but it is far from a breakthrough. It is rich in antibodies that could be useful in the fight against the coronavirus, but the evidence so far has not been conclusive as to its effectiveness, when it is given and in the dose needed.
In a letter describing the emergency clearance, FDA Chief Scientist Denise Hinton noted, “COVID-19 convalescent plasma should not be viewed as a new standard of care for treating patients with the disease. of COVID-19. Additional data will be provided. further analyzes and clinical trials underway and well controlled in the coming months. ”
The White House had become restless with the pace of plasma approval, but the slowing charges, which were presented without evidence, were just the latest attack by Trump’s team on “state bureaucracy.” deep”. White House Chief of Staff Mark Meadows did not go into specifics but said that “we have looked at a number of people who are not as diligent as they should be to get to the bottom. things “.
“This president wants to cut red tape,” Meadows said in an interview on This week on ABC. “He had to make sure they felt the heat. If they can’t see the light, they need to feel the heat because Americans are suffering. ”
The push on Sunday came a day after Trump tweeted fierce criticism of the process for dealing with the virus, which has killed more than 175,000 Americans and jeopardized his chance for reelection. The White House has invested vast resources in a fast-track vaccine development process, and Trump aides have bet it would be an “October surprise” that could help the president catch up on time. surveys.
“The deep state, or whoever, at the FDA, makes it very difficult for drug companies to get people to test vaccines and therapies,” Trump tweeted. “Obviously, they’re hoping to delay the response until November 3. You have to focus on speed and save lives! “
No strong evidence of effectiveness
Earlier this month, researchers at the Mayo Clinic reported a strong clue that blood plasma from COVID-19 survivors is helping other infected patients recover. But it was not considered proof.
More than 70,000 patients in the United States have received convalescent plasma, a century-old approach to fighting influenza and measles ahead of vaccines. It’s a go-to tactic when new diseases appear, and history suggests that it works against some infections, but not all.
There is not yet strong evidence that it fights the coronavirus and, if so, how to best use it.
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The Mayo Clinic reported preliminary data from 35,000 coronavirus patients treated with plasma. He said there were fewer deaths among people receiving plasma within three days of diagnosis and also among those receiving plasma containing the highest levels of anti-virus antibodies.
But it was not a formal study. Patients have been treated in different ways in hospitals across the country as part of an FDA program designed to speed access to experimental therapy. This “expanded access” program tracks what happens to recipients, but it cannot prove that the plasma – and not the other care they received – was the real reason for the improvement.
Administration officials, on a call with reporters on Sunday, discussed a benefit for patients who were within three days of being admitted to hospital, were not on ventilators and were given plasma “high titer” convalescent cells containing higher concentrations of antibodies. They were then compared to similar patients who received lower titer plasma. The results suggest that deaths were 35 percent lower in the high-level group.
There is little data on its effectiveness or whether it should be given early enough in a disease to make a significant difference, said Dr. William Schaffner, an infectious disease expert at Vanderbilt University in Nashville.
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In an effort to avoid a possible run on convalescent plasma after the announcement, government officials worked to secure plasma and partner with partner companies and nonprofits to generate interest from previously infected patients to donate.
FDA chief Stephen Hahn said Trump had not told him about the timing of the announcement, which comes just ahead of a pivotal week for the president’s chances of re-election. Hahn said “this has been going on for several weeks” and came after a data validation the agency was waiting for.
Rigorous studies underway across the country are designed to obtain this evidence, comparing similar patients randomly assigned to receive plasma or dummy infusion in addition to regular care. But these studies have been difficult to complete as the virus is growing and decreasing in different cities. In addition, some patients have requested plasma rather than accepting a study that might give them a placebo instead.