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Last week, the United States Food and Drug Administration (FDA) planned to release an Emergency Use Clearance (EUA) for blood plasma as a treatment for COVID-19. But the authorization is now on hold after leading experts Dr Anthony Fauci and Dr Francis Collins allegedly said the evidence was not strong enough to do so at the time, according to a new report.
Dr H. Clifford Lane, deputy clinical director at the National Institute of Allergy and Infectious Diseases, said authorization had been “on hold for the time being” while other data was being reviewed. However, emergency approval is still possible; Lane noted that it “may still be released in the near future,” according to the New York Times report.
An FDA spokesperson did not immediately return Fox News’ request for comment on Wednesday.
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Fauci, the nation’s leading infectious disease expert, and Collins, director of the National Institutes of Health, reportedly urged FDA officials to ‘delay’ clearance, citing new data on Mayo’s plasma transfusions Clinic. The study found that convalescent plasma with higher antibody levels transfused to hospitalized COVID-19 patients “significantly reduced mortality” compared to plasma transfused with low antibody levels. However, Fauci and Collins believe the study lacks strong enough data to warrant an emergency use authorization.
Doctors hailed plasma transfusions as an effective treatment for the coronavirus for months. (iStock)
Doctors hailed plasma transfusions as an effective treatment for the coronavirus for months, and hospitals and the American Red Cross have recruited volunteers to donate plasma to coronavirus patients. The idea is that the antibodies in the plasma from recovered COVID-19 cases transfused to critically ill COVID-19 patients will help fight or neutralize the disease.
The FDA approves emergency use authorizations during public health emergencies to expedite unapproved medical products (or unapproved uses of such) to treat or prevent serious illness when there is no other suitable and available alternatives. For example, on May 1, President Trump announced that the FDA had cleared the emergency use of Gilead Science’s investigational antiviral drug remdesivir to treat coronavirus patients after the first results of a study clinically reported that the drug helped speed healing.
In addition, in mid-June, the FDA revoked the emergency use authorization of chloroquine and hydroxychloroquine given to the National Strategic Stockpile to treat certain hospitalized patients with coronavirus, because it determined that the two drugs were unlikely to be effective in treating COVID-19 for uses in EUA.
Louis Casiano and James Rogers of Fox News contributed to this report.
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