Rajeev Choudhury

The U.S. Food and Drug Administration (FDA) issued an emergency use authorisation (EUA) on December 22, 2021, for Pfizer’s nirmatrelvir tablets and ritonavir tablets (Paxlovid), co-packaged for oral use for the treatment of mild-to-moderate COVID19 in adults and paediatric patients of 12 years of age and older  with positive results of direct SARS-CoV-2 testing, and who are at high risk for progression to severe COVID19, including hospitalisation or death, a statement released by the FDA said.

Paxlovid is available by prescription only and should be initiated as soon as possible after the diagnosis of COVID19 and within five days of symptom onset, the statement added.

“Today’s authorisation introduces the first treatment for COVID19 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 said.

“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,”  she added.

However, Paxlovid is not authorized for the pre-exposure or post-exposure prevention of COVID19 or for initiation of treatment in those requiring hospitalisation due to severe or critical COVID19 and it is not a substitute for vaccination in individuals for whom COVID-19 vaccination and a booster dose are recommended. The FDA has approved one vaccine and authorized others to prevent COVID-19 and serious clinical outcomes associated with a COVID19 infection, FDA said.

Under the EUA, fact sheets that provide important information about using Paxlovid in the treatment of COVID19 as authorised must be made available to healthcare providers and to patients and caregivers. These fact sheets include dosing instructions, potential side effects, drug interactions and information about who is able to prescribe Paxlovid, the statement added.

“Today’s authorisation of Paxlovid represents another tremendous example of how science will help us ultimately defeat this pandemic, which, even two years in, continues to disrupt and devastate lives across the world,” Albert Bourla, Chairman and Chief Executive Officer of Pfizer said.

In an official statement released to the media, he expressed the hope that this breakthrough therapy, will change the way COVID19 is being treated currently, and help reduce some of the significant pressures facing the healthcare and hospital systems around the world.

“Pfizer stands ready to begin delivery in the U.S. immediately to help get Paxlovid into the hands of appropriate patients as quickly as possible,” Bourla added.