US: Pfizer's COVID-19 treating pills get FDA authorisation for emergency use

In a major development in the fight against the coronavirus, the US Food and Drug Administration (FDA) has okayed the emergency use authorisation (EUA) for Pfizer’s Paxlovid tablets. Paxolvid consists of Nirmatrelvir and Ritonavir tablets, co-packaged for oral, and can be used for the treatment of mild-to-moderate coronavirus disease in adults and pediatric (12 years of age and older weighing at least 40 kilograms) patients, according to a statement released by the FDA on Wednesday.

The FDA said that the oral medication can be used for the treatment of those who are at high risk for progression to suffer from severe COVID-19, including hospitalisation or death. Though the President Joe Biden-led administration had announced the procurement of the pills in early November this year, the final distribution will be possible either before the end of this year or the first week of 2022.

As per the US FDA, oral pills can be obtained only with a valid prescription from a licensed doctor. It should be initiated as soon as possible after a diagnosis of COVID-19 and within five days of symptom onset, the FDA stated. 

In a press statement, the US regulator quoted Patrizia Cavazzoni, MD, director of the FDA’s Center for Drug Evaluation and Research as saying, "Today’s authorisation 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."

"This authorisation provides a new tool to combat COVID-19 at a crucial time in the pandemic as new variants emerge and promises to make antiviral treatment more accessible to patients who are at high risk for progression to severe COVID-19," Cavazzoni added.

Oral pill not authorised for pre-exposure prevention of COVID-19

Further, Cavazzoni warned that the Paxlovid tablets are not authorised for the pre-exposure or post-exposure prevention of COVID-19 or for initiation of treatment in those requiring hospitalisation due to severe or critical COVID-19. Paxlovid is not a substitute for vaccination in individuals for whom COVID-19 vaccination and a booster dose are recommended, the director of the FDA’s Center for Drug Evaluation and Research noted. 

"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 authorised for use for longer than five consecutive days," FDA said in a statement. 

According to health experts familiar with the development of the vaccine and the oral pills said that the approval of the Paxlovid will be a major boost in the fight against the COVID-19 pandemic, especially when the whole world has started restricting movements due to the emergence of the Omicron variant. As of now, scientists noted that the new COVID variant may have the capability to skip the vaccine. However, the scientists advocated getting the booster jabs as it could obstruct the virus from getting deadlier. 

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