FDA panel backs Merck’s COVID pill in a close vote

#covid19 #FDA #HealthCare

The FDA panel vote ended with a tally of 13-10
The drug has not been recommended for pregnant individuals
The Merck pill has already authorised in United Kingdom

Written By:Aman

Updated: November 30 2021 01:05:13 PM ET Washington D.C., DC, USA

Merck’s COVID-19 pill received backing from United States health regulators on Tuesday after a close vote, paving way for possible home treatment of the disease. The United States Food and Drug Administration panel vote ended with a tally of 13-10.

The federal health department, through its vote, ruled that the benefits of the COVID-19 pill outweigh the potential risks, including birth defects if used during pregnancy.

Also Read: Paxlovid vs molnupiravir: How do Pfizer and Merck’s COVID pills compare?

The panel experts reportedly debated on the benefits and risks of Merck’s coronavirus drug for hours. Even though it was given the endorsement, experts stressed that it should not be used by anyone who is pregnant.

The panel further recommended the Food and Drug Administration to issue extra precautionary guidelines along with the drug, if cleared, including pregnancy tests for individuals of child-bearing age.

Most experts also said the drug, which is already authorised in the United Kingdom, should not be used by patients who have been vaccinated against COVID-19, who were not part of the study and haven’t been shown to benefit.

The vote specifically backed the drug for adults with mild-to-moderate COVID-19 who face the greatest risks, including older people and those with conditions like obesity and asthma, according to reports from Associated Press.

However, the United States Food and Drug Administration is not mandated to follow the recommendation given by the expert panel and is likely to make an autonomous decision by the end of 2021.

Also Read: What is Paxlovid? Pfizer’s oral drug to treat COVID-19

The drug, molnupiravir, could provide a much-needed weapon against the virus as colder weather pushes case counts higher and United States officials brace for the arrival of the new Omicron variant, which was first detected in South Africa.

Merck has not specifically tested its drug against the new variant but said it should have some potency based on its effectiveness against other strains of coronavirus.

(With AP inputs)