The Food and Drug Administration on Sunday gave emergency approval for expanded use of antibody-rich blood plasma to help hospitalized coronavirus patients, allowing President Trump, who has been pressuring the agency to move faster to address the pandemic, to claim progress on the eve of the Republican convention.
Mr. Trump cited the approval, which had been held up by concerns among top government scientists about the data behind it, as welcome news in fighting a disease that has led to 176,000 deaths in the United States and left the nation lagging far behind most others in the effectiveness of its response.
At a news briefing, he described the treatment as “a powerful therapy” made possible “by marshaling the full power of the federal government.”
The decision will broaden use of a treatment that has already been administered to more than 70,000 patients. But the F.D.A. cited benefits for only some patients. And, unlike a new drug, plasma cannot be manufactured in millions of doses; its availability is limited by blood donations. Mr. Trump urged everyone who has recovered from the virus to donate plasma, saying there is a nationwide campaign to collect it.
Mr. Trump has portrayed his demands to cut red tape and speed approval of treatments and vaccines as a necessary response to a public health emergency.
But Sunday’s announcement came a day after he repeated his unfounded claim that the F.D.A. was deliberately holding up decision-making until after the election, this time citing a “deep state.” That accusation exacerbated concerns among some government scientists, outside experts and Democrats that the president’s political needs could undermine the integrity of the regulatory process, hurt public confidence in safety and introduce a different kind of public health risk.
No randomized trials of the sort researchers consider most robust have yet shown benefit from convalescent plasma. But the F.D.A. said the data it had so far, including more than a dozen published studies, showed that “it is reasonable to believe” that the treatment “may be effective in lessening the severity or shortening the length of Covid-19 illness in some hospitalized patients,” in particular those who receive it early.
Patients less than 80 years old who received plasma with a high level of virus-fighting antibodies within three days of diagnosis, and who were not on a respirator, were about 35 percent more likely to be alive a month later compared with those who received plasma with a low level of the antibodies, according to Dr. Peter Marks, the director of F.D.A.’s center for biologics, evaluation and research.
Mr. Trump stripped away the agency’s nuanced language during his appearance before reporters at the White House, saying that convalescent plasma has been “proven to reduce mortality by 35 percent.”
The F.D.A., which is responsible for approving new medicines, delayed the authorization for about a week after top health officials, including Dr. Francis S. Collins, the director of the National Institutes of Health, and Dr. Anthony S. Fauci, the top infectious disease specialist, questioned whether the data was sufficient.
Mr. Trump complained in a tweet on Saturday, claiming without any evidence that officials were “hoping to delay the answer until after November 3rd” — Election Day — and urging the F.D.A. to “focus on speed, and saving lives!”
Mark Meadows, the White House chief of staff, also accused government regulators over the weekend of slow-walking the approval, calling it “a fumble.” Mr. Meadows said Mr. Trump was not trying to “cut corners,” but had “a real frustration with some of the bureaucrats who think they can just do this the way they normally do it.”
At his news conference, Mr. Trump struck a more positive note, saying the agency had “really stepped up,” especially “over the last few days.”
Democrats and some health experts said the president’s criticism of federal regulators undermined public confidence and threatened the credibility of the agency charged with determining whether drugs and medicines are safe and effective.
Nancy Pelosi, the House speaker, called Mr. Trump’s Saturday tweet “very dangerous.”
White House officials have been urging speedy approval not just of Covid-19 treatments, but of vaccines. Their public statements that a safe and effective vaccine could be just around the corner have alarmed scientists who fear that White House pressure will result in premature approval timed to increase the president’s re-election chances.
In a July 30 meeting with Ms. Pelosi and Senator Chuck Schumer of New York, the Democratic minority leader, top administration officials suggested the administration might grant emergency approval for a vaccine before Phase 3 trials in the United States are complete, perhaps as early as September, according to two people briefed on the discussion. Such a move would be highly unusual and most likely prompt more concern about whether the administration was pressuring the F.D.A. to approve drugs for political purposes.
During the discussion in Ms. Pelosi’s conference room, the people briefed on it said, Mr. Meadows indicated that a vaccine being developed by AstraZeneca and Oxford University was the most likely candidate for early approval. Their discussion was first reported by The Financial Times.
AstraZeneca is conducting Phase 3 trials in Britain, South Africa and Brazil, but only began its Phase 3 clinical trial in the United States a few days ago.
Senior administration officials disputed the account of the meeting, saying Mr. Meadows and Treasury Secretary Steven Mnuchin were either being misquoted or had been misunderstood on every major point.
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Frequently Asked Questions
Updated August 24, 2020
What are the symptoms of coronavirus?
- In the beginning, the coronavirus seemed like it was primarily a respiratory illness — many patients had fever and chills, were weak and tired, and coughed a lot. Those who seemed sickest had pneumonia or acute respiratory distress syndrome — which caused their blood oxygen levels to plummet — and received supplemental oxygen. In severe cases, they were placed on ventilators to help them breathe. By now, doctors have identified many more symptoms and syndromes. (And some people don’t show many symptoms at all.) In April, the C.D.C. added to the list of early signs sore throat, fever, chills and muscle aches. Gastrointestinal upset, such as diarrhea and nausea, has also been observed. Another telltale sign of infection may be a sudden, profound diminution of one’s sense of smell and taste. Teenagers and young adults in some cases have developed painful red and purple lesions on their fingers and toes — nicknamed “Covid toe” — but few other serious symptoms. More serious cases can lead to inflammation and organ damage, even without difficulty breathing. There have been cases of dangerous blood clots, strokes and brain impairments.
Why does standing six feet away from others help?
- The coronavirus spreads primarily through droplets from your mouth and nose, especially when you cough or sneeze. The C.D.C., one of the organizations using that measure, bases its recommendation of six feet on the idea that most large droplets that people expel when they cough or sneeze will fall to the ground within six feet. But six feet has never been a magic number that guarantees complete protection. Sneezes, for instance, can launch droplets a lot farther than six feet, according to a recent study. It’s a rule of thumb: You should be safest standing six feet apart outside, especially when it’s windy. But keep a mask on at all times, even when you think you’re far enough apart.
I have antibodies. Am I now immune?
- As of right now, that seems likely, for at least several months. There have been frightening accounts of people suffering what seems to be a second bout of Covid-19. But experts say these patients may have a drawn-out course of infection, with the virus taking a slow toll weeks to months after initial exposure. People infected with the coronavirus typically produce immune molecules called antibodies, which are protective proteins made in response to an infection. These antibodies may last in the body only two to three months, which may seem worrisome, but that’s perfectly normal after an acute infection subsides, said Dr. Michael Mina, an immunologist at Harvard University. It may be possible to get the coronavirus again, but it’s highly unlikely that it would be possible in a short window of time from initial infection or make people sicker the second time.
I’m a small-business owner. Can I get relief?
- The stimulus bills enacted in March offer help for the millions of American small businesses. Those eligible for aid are businesses and nonprofit organizations with fewer than 500 workers, including sole proprietorships, independent contractors and freelancers. Some larger companies in some industries are also eligible. The help being offered, which is being managed by the Small Business Administration, includes the Paycheck Protection Program and the Economic Injury Disaster Loan program. But lots of folks have not yet seen payouts. Even those who have received help are confused: The rules are draconian, and some are stuck sitting on money they don’t know how to use. Many small-business owners are getting less than they expected or not hearing anything at all.
What are my rights if I am worried about going back to work?
- Employers have to provide a safe workplace with policies that protect everyone equally. And if one of your co-workers tests positive for the coronavirus, the C.D.C. has said that employers should tell their employees — without giving you the sick employee’s name — that they may have been exposed to the virus.
Nonetheless, their remarks suggested to at least some participants that the administration was hoping that robust results from AstraZeneca’s overseas trials would lead to early emergency authorization, using the same authority the F.D.A. used to green-light the use of convalescent plasma. An aide to Ms. Pelosi said she warned officials at the meeting against taking short cuts.
The F.D.A. typically requires clinical trials with American patients before approving vaccines for use in this country. Although there have been exceptions to that rule, experts said, approval of a coronavirus vaccine on the basis of overseas trials would present challenging issues for regulators, partly because of differences in demographics as well as in the size of the trials.
One senior administration official briefed on the meeting, who declined to speak about the discussion on the record, said neither Mr. Meadows nor Mr. Mnuchin suggested a vaccine could be approved as early as late September. The official said the administration would not approve a vaccine solely on the basis of foreign clinical trials.
Spokespeople for both Mr. Meadows and Mr. Mnuchin said neither man discussed AstraZeneca.
On Sunday, Mr. Trump again raised hopes for a successful vaccine, saying, “You’ll be hearing about” that “very soon, very shortly.” Dr. Collins, the N.I.H. director, has said it “would be astounding” if a vaccine was ready for approval by October — and that even November or December is highly optimistic.
The decision by the White House to publicly increase the pressure on the F.D.A. injected a political element into what some scientists called a notable advance in expanding the use of convalescent plasma. Other experts sounded a note of caution, saying the evidence was still preliminary.
In a statement, the president of the Infectious Disease Society of America, Dr. Thomas M. File Jr., said that the data on the treatment shows “some positive signals,” but that “we lack the randomized controlled trial data we need to better understand its utility in Covid-19 treatment.”
In a phone call with reporters on Sunday, Dr. Stephen Hahn, the F.D.A.’s commissioner, said the agency would continue working with researchers studying the treatment and might update the authorization. He encouraged the continuation of randomized trials to prove the treatment’s effectiveness.
“This is not the end,” he said.
Dr. Hahn softened the president’s claim that the treatment reduces mortality by 35 percent, saying that will be true “if the data continue to pan out.” It was not immediately clear where the 35 percent figure came from; it did not appear to be included in technical documents released by the agency in support of the decision.
Dr. Marks told reporters that more than 70,000 patients had already received convalescent plasma under a special agency program. The decision to authorize the treatment so that even more doctors could use it was based on an analysis of months of data that suggested that when given early in the course of the disease, plasma “can improve outcomes and decrease mortality,” he said.
“We’re confident that convalescent plasma is safe to use in this setting,” he said, after reviewing results from the first 20,000 patients who received it.
Dr. Hahn said that the decision to authorize the treatment was made “solely on the basis of the science and the data and on nothing else.”
Reporting was contributed by Katie Rogers, Nicholas Fandos, Andrew Jacobs and Carl Zimmer.
