US FDA to Approve Pfizer and Merck Oral COVID-19 Treatments This Week

[Image source=Reuters Yonhap News]

[Asia Economy Reporter Kwon Jae-hee] U.S. health authorities are expected to approve two oral COVID-19 treatments from pharmaceutical companies Pfizer and Merck within this week.

According to a report by Bloomberg News on the 21st (local time), citing sources, the U.S. Food and Drug Administration (FDA) is reportedly considering announcing emergency use authorization for Pfizer's and Merck's oral COVID-19 treatments, 'Paxlovid' and 'Molnupiravir,' as early as the 22nd.

Bloomberg interpreted, "Once these treatments are distributed, it will be a significant turning point in the fight against COVID-19."

Antiviral drugs inhibit the replication of the virus within the body, preventing infected individuals from developing severe symptoms.

In particular, since these two treatments are prescribed for high-risk patients to take at home over several days, they are expected to greatly assist medical facilities burdened by shortages of intensive care unit beds and other resources.

Eric Topol, director of the Scripps Research Institute, a U.S. medical research institution, described the oral treatments as "the second biggest event after vaccines in this pandemic."

The FDA is expected to grant conditional emergency use authorization.

Earlier, on the 30th of last month, the FDA advisory committee, the Antimicrobial Drugs Advisory Committee (ADAC), recommended approval of Molnupiravir. However, some members raised safety concerns regarding its use in pregnant women and others.

The White House stated that although the situation in the U.S. is rapidly evolving, it respects the FDA's decision, which maintains its independence.

White House Press Secretary Jen Psaki said, "Once antiviral drugs become available, it will add an important element to fighting COVID-19, resolving the pandemic, and returning to normal."

Psaki added, "The government is ready to deploy like the Boy Scouts or Girl Scouts to ensure antiviral drugs are reliably distributed to the public."

The U.S. government has ordered 10 million prescriptions of Paxlovid and 3 million prescriptions of Molnupiravir.

Paxlovid, developed by Pfizer, showed effectiveness in clinical trials but did not undergo review by the FDA advisory committee ADAC.

In clinical trials targeting patients within three days of symptom onset, those who took Paxlovid had an 89% lower risk of hospitalization due to severe symptoms compared to those given a placebo. No deaths occurred among those who took the drug.

Molnupiravir was found to be less effective in clinical trials, and safety concerns have been raised in academia regarding its use in pregnant or breastfeeding women due to potential adverse effects on fetuses or infants.

This content was produced with the assistance of AI translation services.