The FDA has issued an emergency use authorization for Pfizer’s COVID-19 antiviral pill, Paxlovid.
Since the beginning of the pandemic, Pfizer has been at the forefront of the fight against COVID-19. The pharmaceutical company has not only designed an effective COVID-19 vaccine, but also an antiviral pill designed to treat the infection. Pfizer first announced trials for its oral pill Paxlovid in May of this year. Now, Paxlovid has become the first COVID-19 antiviral pill to receive an FDA authorization.
Today’s authorization introduces the first treatment for COVID-19 that is in the form of a pill that is taken orally — a major step forward in the fight against this global pandemic.
Dr, Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research
In a recent press release, the FDA issued an emergency use authorization (EUA) for Pfizer’s Paxlovid. Adults and pediatric patients aged above 12 years, with mild-to-moderate COVID-19, can receive the oral drug. However, researchers do not recommend it for patients hospitalized from severe COVID-19. Instead, only those at risk of progression to severe disease can access the treatment. However, it is only available via prescription at the moment.
What is Paxlovid?
Paxlovid consists of two drugs packaged together: nirmatrelvir and ritonavir. While nirmatrelvir inhibits replication of SARS-CoV-2, the second drug slows down its breakdown so as to further elongate its effect. As part of the treatment, one must take three pills – two of nirmatrelvir and one of ritonavir – twice daily for five days, for a total of 30 tablets. However, it cannot be taken for longer than five days.
FDA’s issuance of a EUA was based on data from the pill’s clinical trials. According to the results of the Phase 2/3 EPIC-HR trial, the oral pill caused an 89% reduction in the risk of hospitalization or death. Furthermore, researchers did not report any adverse side effects among the trial participants.
However, the oral antiviral pill is not an alternative to vaccines or booster doses. The FDA is, therefore, urging the public to continue with their vaccine schedule and receive a booster if eligible for one. The emergence of the Omicron variant has also pushed health regulators to
Source: FDA
