The Food and Drug Administration (FDA) said on Monday, Feb. 7 that US Pharmaceutical company Pfizer has already applied for an emergency use authorization (EUA) for its coronavirus disease (COVID-19) pill Paxlovid.
FDA-Officer-In-Charge Director-General Oscar Gutierrez reported that the application is currently under review.
Last December, Pfizer received a US-FDA EUA for the COVID-19 oral antiviral treatment. It has been authorized for emergency use in both high-risk adults and high-risk pediatric patients 12 years of age and older in the US.
Pfizer mentioned in its statement that the antiviral pill is 89 percent effective in preventing hospitalizations and deaths in patients at high risk of severe illness based on clinical trial results.
Meanwhile, Gutierrez also reported that another lab has been given a special certification for a home-administered test kit. He mentioned that it is made in the US.
Gutierrez has explained that once the product such as the self-test kit which was given special certification reaches the market, they still conduct continuous monitoring, wherein they collect samples and send them back to the Research Institute for Tropical Medicine (RITM) to test them for actual use.