Pfizer Inc’s oral antiviral COVID-19 pill is approved by the US Food and Drug Administration for at-risk people aged 12 and up, making it the first at-home therapy for the coronavirus and a potentially key tool in the fight against the fast-spreading Omicron form.
Pfizer’s antiviral regimen, Paxlovid, was 90 percent successful in reducing hospitalizations and deaths in patients at high risk of severe illness, as per data from a clinical trial. According to Pfizer, recent lab data indicates that the medication is still effective against Omicron.
“This authorization provides a new tool to combat COVID-19 at a critical time in the pandemic as new variants emerge and promises to make antiviral treatment more accessible to patients at high risk of progression to severe COVID 19,” said Patrizia Cavazzoni, director of the US Food and Drug Administration’s Centre for Drug Evaluation and Research.
Pfizer is ready to begin immediate delivery of the medication in the United States, with a two-drug regimen that comprises a new medicine and an older antiviral called ritonavir, and that it had increased its manufacturing predictions for 2022 to 120 million courses from 80 million.
The decision comes as the country fights a COVID-19 outbreak caused by the Omicron variant, with US President Joe Biden announcing plans for new federal vaccination and testing locations. The government of the United States has purchased 10 million courses of the Pfizer medication at a cost of $530 each course.
The oral medicine has been approved for emergency use in adults and children patients 12 years and older with mild-to-moderate COVID-19 who are at high risk of progressing to severe COVID-19, according to the FDA.
The medicine is only accessible by prescription and should be started as soon as possible following a COVID-19 diagnosis and within five days of the onset of symptoms, according to the CDC. The pills should be taken every 12 hours for five days, starting as soon as symptoms appear.
The second medication, ritonavir, is known to interact with a number of other prescription medications. According to Pfizer, this should be manageable, and most patients should be able to reduce their other prescription doses while being treated with COVID-19.
In 2022, Pfizer aims to submit a new medication application to the FDA for full regulatory approval.
When compared to Pfizer’s therapy, a rival tablet from Merck & Co, which is now being reviewed by the FDA, has showed poorer efficacy. In a clinical trial of high-risk patients, Merck’s medication, molnupiravir, reduced hospitalizations and fatalities by roughly 30%.