FDA announces EUA for plasma to treat coronavirus

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The FDA said more than 70,000 patients have been treated with convalescent plasma, made from the blood of people who have recovered from coronavirus infections.

“Today, I am happy to make a truly historic announcement in our battle against the Chinese virus that will save countless lives,” President Trump said during a White House briefing. “Today’s action will dramatically increase access to this treatment.”

Trump last week accused some health officials of making policy regarding an EUA for convalescent plasma. Asked whether the FDA did not grant an EUA, Trump said the reason was political.

On Sunday, a source close to the White House Coronavirus Task Force told CNN that the FDA had reviewed additional data to inform its impending EUA decision. This official did not personally review the data. They added that the FDA has no obligation to consult anyone outside the agency about its decision.

Convalescent plasma is taken from the blood of people who have recovered from Covid-19. At the end of March, the FDA set up a path for scientists to try convalescent plasma with patients and study its impact. It has already been used to treat more than 60,000 patients with Covid-19.

However, like blood, convalescent plasma is in limited supply and must come from donors. And while there are promising signals from some studies, there is no data yet from convalescent plasma randomized clinical trials to treat Covid-19. Some of these trials are ongoing.

Impact of an EUA

The New York Times reported last week that an FDA emergency use authorization for blood plasma to treat Covid-19 was pending after NIH officials intervened. The shutdown came after a group of federal health officials – including the director of the National Institutes of Health, Dr Francis Collins, the director of the National Institute of Allergy and Infectious Diseases, Dr Anthony Fauci and NIAID deputy director Dr H. Clifford Lane – stepped in to argue that emerging treatment data was too weak, The Times reported Wednesday, citing two administration sources.

FDA blood plasma emergency clearance for Covid-19 pending, New York Times says

In response to CNN, Dr Anand Shah, the FDA’s deputy commissioner for medical and scientific affairs, said he couldn’t comment but suggested the NIH was out of place.

“In general, the NIH is not involved in the decision-making process at the FDA and does not have all of the confidential data that the FDA uses to make these regulatory decisions,” Shah said in a statement sent. at CNN.

“We take seriously our mandate to follow the data and science on the review of medical products to prevent or treat COVID-19 based on the legal and regulatory standards set by the agency,” Shah added, saying that the FDA appreciated the work of the NIH and would collaborate with its sister agency.

A senior administration official told CNN’s Jim Acosta on Sunday that the planned announcement of the emergency use authorization was an important development.

“If you’re one of the 35 out of a hundred people who survive severe symptoms of COVID from recovering plasma, it’s definitely a breakthrough,” the official said.

“And it’s certainly a progress that over a 5-month period during a pandemic, we have safety data based on 70,000 COVID patients treated with convalescent plasma,” the official added.

Ben Corb, director of public affairs for the American Society for Biochemistry and Molecular Biology, said in a statement that the president showed a “reluctance” to listen to medical experts, and that “breakthroughs require data collection” to ensure the safety and effectiveness of treatments.

“This process is necessary to ensure our safety and to ensure that a treatment is no worse than the disease,” Corb’s statement read. “I am deeply concerned about this action and concerned about the timing.”

Demand for plasma ‘has exceeded anyone’s expectations’

Emergency use clearance from the FDA does not require the same level of evidence as full FDA approval, but it can have a significant effect on demand for and use of treatment during a public health emergency.

Dr James Musser, chairman of the Houston Methodist Department of Pathology and Genomic Medicine, said emergency use authorization could simplify the administration of convalescent plasma to Covid-19 patients.

“If they do issue an EUA, my opinion is that it’s good for patients in the future,” said Musser, who has studied convalescent plasma in Covid-19 patients. “But again, it will really depend on the parameters of the EUA.”

An EUA, which could open up treatment to more patients, could also have the effect of limiting recruitment into clinical trials that determine its effectiveness.

Trump, without evidence, accuses FDA of delaying coronavirus vaccine trials, presses agency chief

On Thursday, Dr Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, said doctors had treated so many Covid-19 patients with recovering plasma that it was difficult to determine whether the treatment was working.

“The problem with convalescent plasma is its great enthusiasm,” said Woodcock in an online conversation about the latest science behind monoclonal antibody treatments and convalescent plasma. “He exceeded anyone’s expectations for the request.”

Woodcock, who has traveled to lead therapeutic efforts in the Trump administration’s Operation Warp Speed, said the plasma showed promise in early studies, but said Thursday that there was not yet enough evidence of its effectiveness.

Her team counted 162 prospective studies and several other observational studies, but said only six met the standard that could produce actionable results. There is no data from randomized clinical trials yet, she said, but some of those trials are ongoing.

“We continue to have clues that this is an effective treatment for this particular virus,” said Woodcock, adding that the NIH would launch or step up further trials to find out, she said.

Even though this approach works, convalescent plasma has limitations.

“There is a limited donor pool – it is disappearing as the epidemic diminishes,” Woodcock said. “This is not a standardized procedure and requires blood group matching for administration, which can be problematic in many settings.”

CNN’s Jim Acosta, Elizabeth Cohen, Jen Christensen and John Bonifield contributed to this report.

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