US FDA approves first COVID-19 antiviral pill – Paxlovid by Pfizer

The US Food and Administration Administration (FDA) has approved the first antiviral pill, Pfizer’s Paxlovid. According to the US FDA, Pfizer’s Paxlovid (nirmatrelvir tablets and ritonavir tablets, co-packaged for oral use) can be used for the treatment of mild-to-moderate coronavirus disease (COVID-19) in adults and pediatric patients (12 years of age and older weighing at least 40 kilograms or about 88 pounds) with positive results of direct SARS-CoV-2 testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death.

The FDA however said that Paxlovid is not authorized for the pre-exposure or post-exposure prevention of COVID-19 or for initiation of treatment in those requiring hospitalization due to severe or critical COVID-19. It is also not a substitute for vaccination in individuals for whom COVID-19 vaccination and a booster dose are recommended.

Paxlovid consists of nirmatrelvir, which inhibits a SARS-CoV-2 protein to stop the virus from replicating, and ritonavir, which slows down nirmatrelvir’s breakdown to help it remain in the body for a longer period at higher concentrations. Paxlovid is administered as three tablets (two tablets of nirmatrelvir and one tablet of ritonavir) taken together orally twice daily for five days, for a total of 30 tablets. Paxlovid is not authorized for use for longer than five consecutive days.

The world woke up late in November 2021 to the news of a new COVID variant which the World Health Organisation (WHO) has now tagged “Omicron”. It was first reported to the WHO from South Africa on 24 November, and has also been identified in Botswana, Belgium, Hong Kong and Israel.

Cases of COVID-19 have been rising around the world, with the United States nearing 800,000 deaths related to the virus – and several European countries including France, Spain and Germany have introduced travel restrictions as the Omicron variant spreads.

It is suspected that the Paxlovid pills may remain as effective against the omicron variant of the coronavirus as against other variants, like delta.