Washington, Dec 23: As Omicron variant spreads globally, the US Food and Drug Administration (FDA) has issued an emergency use authorisation (EUA) for the Pfizer antiviral pill to treat Covid-19 along with caution for people with certain pre-existing conditions — heralding a new era for the future, over-the-counter treatment of the deadly respiratory disease that has killed millions.
Pfizer’s Paxlovid (nirmatrelvir tablets and ritonavir tablets, co-packaged for oral use) has been approved for the treatment of mild-to-moderate coronavirus disease (Covid-19) in adults and paediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 testing.
The pill has also been approved for those at high risk for progression to severe Covid-19, including hospitalisation or death.
Paxlovid is available by prescription only and should be initiated as soon as possible after diagnosis of Covid-19 and within five days of symptom onset, the FDA said in a statement late on Wednesday.
“The 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,” said Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research.
“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.
Paxlovid is not authorised for the pre-exposure or post-exposure prevention of Covid or for initiation of treatment in those requiring hospitalisation due to severe or critical Covid-19.
The pill is also not a substitute for vaccination in individuals for whom Covid-19 vaccination and a booster dose are recommended. (IANS)
