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Infectious Disease Coronavirus Therapies And Interventions Industry News

FDA Now Approves Expanded Plasma Treatment After Halt

3 years, 10 months ago

12459  0
Posted on Aug 24, 2020, 1 p.m.

Just days after putting a halt on the expanded emergency use of plasma to treat COVID-19 patients due to efficacy concerns and the data behind it cited by Dr. Fauci, Dr. Lane and Dr. Collins, prompting a stronger review of the available data, the FDA has now given the emergency use approval for the expanded uses of antibody rich blood plasma to help those who have been hospitalized with the disease. 

President Trump has been pressuring the FDA to move faster to address the outbreak, as such he cited this approval in a recent media conference briefing, in which he described this therapy as “a powerful therapy” made possible “by marshaling the full power of the federal government.” Later on adding that the agency had “really stepped up,” especially “over the last few days.” "Based on the science and the data, the FDA has made the determination that the treatment is safe and very effective," the President said.

Just as a refresher emergency use authorizations do not require the same level of evidence of a full approval; and plasma has been used since the 1890s to treat infectious disease with a highly credentialed community of microbiologists and immunologists eager to once more prove the usefulness. This community includes the Mayo Clinic which has already published analysis on tens of thousands of patients in their expanded access program showing how safe the treatment is.

The approval, which is a notable advancement in the expanded use of convalescent plasma, allows for the expanded use of this therapy that has already been given to over 70,000 patients, which in the previous halt was cited by the FDA as only having benefits for some people. Additionally plasma is not able to be manufactured in millions of doses, it is limited by blood donations. As such President Trump is urging everyone that has recovered from COVID-19 to donate plasma to the nationwide collection campaign. Additionally, the president is pledging to cut red tape and speed up the approval of other treatments and vaccines as a necessary response to this public health emergency. 

This EUA was granted to the Office of Assistant Secretary for Preparedness and Response within the Department of Health and Human Services. It is not for any particular convalescent plasma product, but rather any such preparation "collected by FDA registered blood establishments from individuals whose plasma contains anti-SARS-CoV-2 antibodies, and who meet all donor eligibility requirements," according to a fact sheet for healthcare providers.

"Independent experts at the FDA who reviewed the totality of data" including more than a dozen published studies "concluded convalescent plasma is safe and shows promising efficacy, thereby meeting criteria for an emergency use authorization," FDA commissioner Stephen Hahn, MD, said at a press conference on Sunday night.

To those saying that there has been no robust studies to show benefit from convalescent plasma the FDA said that the data to date which includes over a dozen recent studies shows 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.

Recent data from the Mayo Clinic program involved over 35,000 COVID-19 patients, many of which were on ventilators in intensive care units suggests that plasma administered within 3 days of diagnosis reduced mortality rates. A month after infusions the death rate of those who received infusions within 3 days(21.6%) was 5.1% lower than those who received that plasma later(26.7%).

Dr. Peter Marks, who is the director of the FDA’s Center For Biologics, Evaluation and Research cited study showing that COVID-19 patients under the age of 80 who had received plasma with a high level of antibodies within 3 days of diagnosis that were not on a respirator were 35% more likely to be alive a month later compared to those receiving plasma with low levels of antibodies; meaning that is was shown to reduce mortality by about 35% so that out of 100 people who are sick, 35 could have been saved by convalescent plasma.

According to Dr. Marks over 70,000 patients have had this therapy under a special agency program. This authorization means that even more doctors will be able to use this therapy based on analysis of months of data suggesting that when given early in the course of the disease it “can improve outcomes and decrease mortality.”

“We’re confident that convalescent plasma is safe to use in this setting,”  Dr. Marks said, after reviewing results from the first 20,000 patients who received it.

Of the authorization, FDA Commissioner Dr. Stephan Hahn says in a phone call with reporters that the decision to authorize was made “solely on the basis of the science and the data and on nothing else,” and that the agency will continue to work with researchers to study this therapy, and might update the authorization. Additionally, he is encouraging the continuation of randomized trials to prove effectiveness. “This is not the end,” he said. 

For those who have recovered from COVID-19 and would like to possibly help others by donating their plasma here are a few resources to inquire with:

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