President Donald Trump announced on Sunday that the FDA has granted emergency use authorization (EUA) to convalescent plasma, or blood from recovered COVID-19 patients, for the treatment of hospitalized COVID-19 patients. The EUA is not a full approval and is granted when the FDA believes that the known and potential benefits of the treatment outweighs its risks. It is believed that convalescent plasma contains antibodies can fight off the disease, help COVID-19 patients recover faster, and not make them seriously ill.
Several studies are ongoing to see if the plasma of patients who have recovered from COVID-19 can be used to treat those who have been infected with the virus. FDA said that early data from studies have shown that convalescent plasma has the potential to do so.
The FDA’s EUA for plasma therapy comes at a time when Trump’s prospects for re-election in November have been clouded by the coronavirus pandemic. President Donald Trump last week publicly expressed frustration at the slow pace of approval for coronavirus treatments/vaccines by the FDA for political reasons.
Though several patients have been given plasma therapy infusions, the effectiveness of convalescent plasma has not yet been proved in clinical studies. More than 70,000 patients have already received the treatment. Meanwhile, some experts have questioned its efficacy saying that this treatment option comes with its side effects. The side effects of using COVID-19 convalescent plasma could be transmission-associated lung injury, circulatory (volume) overload, and infections. Some health officials believe that there is not enough evidence to prove that plasma therapy can be effective in helping coronavirus patients recover. It is being speculated that FDA rushed with the announcement for the EUA on Sunday under pressure from Trump.
Another drug that has been granted EUA for COVID-19 treatment is Gilead’s GILD investigational antiviral, remdesivir. Gilead is conducting phase III studies on remdesivir for COVID-19 treatment.
In June, the FDA revoked its emergency use authorization (EUA) for generic medicines chloroquine and hydroxychloroquine for COVID-19, saying it no longer recognized health benefits. Hydroxychloroquine is currently approved for treating malaria, lupus and rheumatoid arthritis.
COVID-19, probably the biggest global health crisis, has infected 5.8 million people in the United States and resulted in 0.18 million deaths. It has put world economies on a standstill, and all are hoping that the drug/pharma players discover a treatment/vaccine to put an end to this “new normal” way of life. Companies like Pfizer PFE, Lilly, J&J JNJ, AstraZeneca AZN, to name a few, are developing drugs, antibodies and vaccines to treat COVID-19.
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