FDA puts COVID-19 blood plasma therapy on hold

FDA puts COVID-19 blood plasma therapy on hold

WASHINGTON — A New York Times report says that the clinical director for the National Institute of Allergy and Infectious Diseases has decided to wait on the emergency authorization of convalescent plasma in the treatment of COVID-19.

Deputy Director for Clinical Research and Special Projects at NIAID, Dr. H. Clifford Lane, said that the authorization to use convalescent plasma is on hold, according to the Times.

The Food and Drug Administration had been closely considering if the evidence was good enough to allow so-called emergency use of convalescent plasma.

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Top health officials, including Dr. Anthony Fauci, Dr. Francis Collins, director of the National Institutes of Health, and Dr. H. Clifford Lane, were concerned that the data wasn’t strong enough for emergency approval.

“The three of us are pretty aligned on the importance of robust data through randomized control trials, and that a pandemic does not change that,” Lane told the Times

Last week, The Associated Press reported that the Mayo Clinic study could not yet prove the plasma was the reason for improvement.

There’s no solid evidence yet that it fights the coronavirus, and if so, how best to use it. But preliminary data from 35,000 coronavirus patients treated with plasma offers what Mayo lead researcher Dr. Michael Joyner on Friday called “signals of efficacy.”

There were fewer deaths among people given plasma within three days of diagnosis, and also among those given plasma containing the highest levels of virus-fighting antibodies, Joyner and colleagues reported.

The problem: This wasn’t a formal study. The patients were treated in different ways in hospitals around the country as part of a FDA program designed to speed access to the experimental therapy. That so-called “expanded access” program tracks what happens to the recipients, but it cannot prove the plasma — and not other care they received — was the real reason for improvement.

Rigorous studies underway around the country are designed to get that proof by comparing similar patients randomly assigned to get plasma or a dummy infusion in addition to regular care. But those studies have been difficult to finish as the virus waxes and wanes in different cities. Also, some patients have requested plasma rather than agreeing to a study that might give them a placebo instead.

“For 102 years we’ve been debating whether or not convalescent plasma works,” said Dr. Mila Ortigoza, of New York University, referring to plasma’s use in the 1918 flu pandemic. This time around, “we really need undisputable evidence.”

Ortigoza is co-leading one such study, which this week is expanding to three other states — Connecticut, Florida and Texas. Her team also is working to pool data with several other clinical trials in other regions in hopes of faster answers.

“There’s concern about when there will be a clear answer,” agreed infectious disease specialist Dr. Jeffrey Henderson, of Washington University in St. Louis.

He’s hopeful the clinical trials will push forward but said the Mayo report is consistent with smaller, earlier plasma studies and “an example of making the best you can of the data that’s available.”

When the body encounters a new germ, it makes proteins called antibodies that are specially targeted to fight that particular infection. The antibodies float in plasma, which is the yellowish, liquid part of blood. Because it takes a few weeks for antibodies to form, the hope is that transfusing someone else’s antibodies could help patients fight the virus before their own immune system kicks in.

The Mayo findings were posted online ahead of scientific peer review. They show that 20% of people given high-antibody plasma within three days of diagnosis had died within 30 days compared with 30% of people treated later with low-antibody plasma.

Tens of thousands of COVID-19 survivors have donated their plasma, and blood banks have issued calls for even more to meet the demand as the coronavirus continues to ravage the U.S. According to the American Association of Blood Banks, a quarter of hospitals it checks weekly are reporting wait times of more than 24 hours in obtaining requested plasma.

The Associated Press contributed to this story.