FDA approves convalescent plasma for COVID-19 patients

Convalescent plasma has shown promising efficacy in hospitalized patients with COVID-19, whose benefits outweigh the risks, FDA said in a statement Emergency use permit (EUA) Such products on Sunday.

of EUA granted To the assistant secretary’s office for preparation and response within the Ministry of Health and Human Services. This is not a specific convalescent plasma product and was collected by an FDA-registered blood facility from individuals whose plasma contained anti-SARS-CoV-2 antibodies and met all donor eligibility requirements. When, Fact sheet for healthcare providers..

“The FDA’s independent experts who reviewed the entire data set,” including more than 12 published studies, “recovered plasma is safe and shows promising efficacy, thereby setting the standard for emergency use approval. I will meet,” said FDA Commissioner Dr. Stephen Hahn. Sunday night press conference.

Institutions found that the EUA had historical evidence of convalescent plasma in previous respiratory virus outbreaks, preclinical evidence, a small study conducted during the outbreak (including some in China), and Mayo Pointed out that it is based on an ongoing National Expanded Access Protocol (EAP) sponsoring clinic.

The FDA also found that “high titers” of COVID-19 convalescent plasma may be effective in reducing mortality in hospitalized patients, but at the discretion of the healthcare provider, low titer units Added that it could also be used. In fact, convalescent plasma is defined only as “human plasma whose plasma is taken from an individual containing anti-SARS-CoV-2 antibodies” and meets all donor eligibility requirements. The labels on the preparations must indicate whether they contain high or low titers.

In that statement, the authorities said, “It makes sense to believe that COVID-19 convalescent plasma is effective in reducing the severity of some inpatients or reducing the length of COVID-19 disease.” “

However, “as COVID-19 convalescent plasma does not represent a new standard of evidence-based therapy currently available,” the institution recommended a randomized trial.

Hahn said at a news conference that the Mayo Clinic EAP, with federal support, has been continuing to treat convalescent plasma patients since April. More than 100,000 COVID-19 patients have been enrolled and nearly 70,000 have been treated.

The institutional turning point appeared to be the “optimal” patient treated with the highest “convalescent plasma” [antibody] “Titer” represents a “significant clinical benefit” that improves survival by 35% and “clearly meets the published criteria for the EUA,” added Hahn.

“That means 100 people are sick and 35 people are [would have] It was saved by convalescent plasma.”

According to data from clinical trials, patients who received treatment within 3 days of being diagnosed benefited the most from treatment, said Alex Hazard of the Department of Health and Human Services (HHS). Patients under the age of 80 who did not receive mechanical ventilation also benefited.

President Trump welcomed the announcement as “truly historical” and said “it will save countless lives.”

“Based on science and data, the FDA has determined that treatment is safe and highly effective,” the president said.

of New York Times Reported last week were MD Anthony Fauci, MD, Director of National Institute of Allergy and Infectious Diseases (NIAID), and Francis Collins, NIH Director, Mayo Clinic convalescent plasma data. Not strong enough to support emergency approvalThat is, the results were not confirmed in the randomized trial.

Saturday, President Trump tweeted“Deep in the FDA, or anyone, makes it very difficult for drug companies to get people to test vaccines and therapeutics. Obviously, they postpone the answer until November 3rd. Hopefully, save speed, and save lives!” He also mentioned Hahn’s FDA Twitter handle in a tweet.

However, on Sunday President Trump praised the FDA at a press conference, officials said, “especially in the last few days it really strengthened.” However, he added, “the FDA may postpone this process,” he added, “it is politically related.”

Hahn’s only reference to the controversy so far was in the opening remarks when the president “sought to reduce red tape at the FDA.”

He said the study on convalescent plasma will continue, including in randomized clinical trials, but the EUA will also enable it to meet plasma demand from “national physicians.”

However, it is unclear how much will be available at any given time, or if it will be available to all eligible patients.

Dosing suggestions include starting with about 200 mL of 1 unit convalescent plasma and adding additional units based on physician judgment and patient response. Patients with cardiac dysfunction and heart failure may need shorter or longer infusion times, officials said.

Plasma may be contraindicated in patients with a history of “severe allergic reactions or anaphylaxis” to plasma transfusions. Side effects include transfusion infections such as HIV, hepatitis B and C, allergic reactions, and anaphylactic reactions.

Risks include increased antibody-dependent infections, which are exacerbated in the presence of certain antibodies. For example, authorities theoretically stated that “antibodies against one type of coronavirus may enhance infections in another strain.” Administration of antibodies can also weaken the immune response and make patients more susceptible to reinfection, officials said.

Convalescent plasma safety and efficacy has not been evaluated in the pediatric or pregnant population or in nursing mothers.