No Conclusive Evidence On Convalescent Plasma Use Against COVID-19, NIH Says After FDA Emergency Use Approval
The National Institutes Of Health said Tuesday that after reviewing available evidence from published and unpublished data on convalescent plasma therapy for COVID-19, it had concluded there is no case for recommending or advising against such a treatment.
What Happened: The COVID-19 Treatment Guidelines Pane, a part of the NIH, said that convalescent plasma shouldn't be considered standard of care for the treatment of patients with the disease, according to a statement.
“Prospective, well-controlled, adequately powered randomized trials are needed to determine whether convalescent plasma is effective and safe for the treatment of COVID-19,” said NIH.
Why It Matters: The United States Food and Drug Administration had issued an emergency use authorization for convalescent plasma for treatment of hospitalized COVID-19 patients in August.
The treatment involves infusing antibody rich plasma from recovered people into patients afflicted with COVID-19 in the hope that it elicits a positive immune response, according to Stat News.
The FDA decision to go ahead with approving the treatment on an emergency basis is said to have political connotations related to the revival of President Donald Trump’s political fortunes, as per Politico.
Similarly, the administration is also reportedly pushing for fast-tracking a coronavirus vaccine, most likely one made by AstraZeneca plc (NYSE: AZN), ahead of the presidential election in November.
FDA Chairman Stephen Hahn told the Financial Times that the agency is willing to expedite the COVID-19 vaccine authorization process, to approve a candidate before it completes Phase 3 trials.
Vaccines undergoing similar late-stage human tests, or nearing them, include ones made by Pfizer Inc (NYSE: PFE), Johnson and Johnson (NYSE: JNJ), Moderna Inc (NASDAQ: MRNA), and Inovio Pharmaceuticals Inc (NASDAQ: INO).
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