US Food and Drug Administration (FDA) on Wednesday authorised Pfizer’s antiviral pill, Paxlovid to treat COVID-19 in high-risk people aged 12 and over, a major milestone in the pandemic that will allow millions to access the treatment.
This is the first antiviral COVID-19 pill authorised for sick people to take at home before they are sick enough to be hospitalised.
“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,” said FDA scientist, Patrizia Cavazzoni.
Paxlovid combines a new antiviral drug named nirmatrelvir and an older one called ritonavir and is administered as three pills given twice a day for five days.
Pfizer’s treatment during clinical trial showed that the pill reduced the risk of hospitalizations and deaths among at-risk people by 88 percent.
In a statement on Wednesday, the FDA said those eligible for the pill include high-risk individuals age 12 and older who weigh at least 88 pounds and have a positive SARS-CoV-2 test are eligible.
It said 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.
Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, said the pill is a major step forward in the fight against this global pandemic.
She said;
This authorization 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.
The agency, however, warned that;
Paxlovid is not authorized for the pre-exposure or post-exposure prevention of COVID-19 or for initiation of treatment in those requiring hospitalization 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 FDA has approved one vaccine and authorized others to prevent COVID-19 and serious clinical outcomes associated with a COVID-19 infection, including hospitalization and death. The FDA urges the public to get vaccinated and receive a booster if eligible.
It said the side effects of Paxlovid include impaired sense of taste, diarrhea, high blood pressure and muscle aches, adding that using the pill at the same time as certain other drugs may result in potentially significant drug interactions.In an unusual move, the FDA did not convene its customary panel of independent experts to review in depth data surrounding Pfizer’s pill ahead of authorization.
Pfizer’s treatment has previously been authorized in the European Union. US has already paid for 10 million courses.
The authorization comes as cases are surging across the United States, driven by Omicron, the most infectious variant seen to date.
The highly-mutated variant is better able to bypass immunity conferred by prior infection, and health authorities are urging the public to get boosted with mRNA vaccines in order to restore a higher degree of protection.
Unlike vaccines, the COVID-19 pill does not target the ever-evolving spike protein of the coronavirus, which it uses to invade cells. It should in theory be more variant proof, and Pfizer has said preliminary studies have backed up that hypothesis.
Authorization is still awaited for another Covid pill, developed by Merck, which is also taken over five days and has been shown to reduce the same outcomes by 30 percent among high-risk people.
Independent experts voted in favor of that treatment by a narrow margin, but expressed concerns surrounding its safety, such as potential harm to fetuses and possible damage to DNA.
The two treatments work in different ways inside the body, and Pfizer’s pill is not thought to carry the same level of concerns.
Merck’s treatment has been greenlit by Britain and Denmark.
