FDA authorises use of Pfizer-made pill to treat Covid-19

The pill will be available by prescription to eligible patients

Graig Graziosi
Wednesday 22 December 2021 18:55
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FDA Set to Authorize Pfizer, Merck COVID-19 Pills

The US Food and Drug Administration has issued an emergency use authorisation for a pill made by Pfizer that can be used to treat Covid-19.

The agency issued the statement on Wednesday, announcing that Paxlovid, a Pfizer produced pill, could be used to treat mild-to-moderate Covid-19 in adults and children 12 years and older, so long as they have tested positive for the virus and are at high risk of severe Covid symptoms.

The pill is only available by prescription and is meant to be taken immediately after being diagnosed with the virus, and no more than five days after symptoms appear.

“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,” Dr Patrizia Cavazzoni, the director of the FDA’s Center for Drug Evaluation and Research, 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 announcement emphasised that the pills are not a replacement for vaccination, and continued to recommend both the initial doses of the shots and a booster.

The Paxlovid pills work through the use of nirmatrelvir, which inhibits a Covid-19 protein to stop the virus from replicating, and ritonavir, which slows down the first drug's breakdown so it can do its work in the body for a longer time.

The drug is not recommended for people with severe liver or kidney damage.

According to the FDA, during trials the drug "significantly reduced proportion of people with Covid-19 related hospitalisation or death from any cause by 88 per cent" when compared to trial participants who had been given a placebo.

Only 0.8 per cent of the 1,039 patients who received Paxlovid died in the following 28 days, while 6 per cent of the 1,046 patients given the placebo died during the following month.

The drug does come with some potential side effects, including an impaired sense of taste, diarrhea, high blood pressure and muscle aches.

The pills are expected to be in high demand as health officials anticipate a new wave of infections caused by the highly transmissible omicron variant, which has become the dominant strain in the US.

Joe Biden announced on Tuesday that the administration would also make 500 million at-home tests available to Americans for free. Deliveries of those tests will begin in January.

In addition to the free tests, FEMA officials will also be deployed to assess needs at hospitals around the country and to establish pop-up clinics in places with high infection rates.

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