FDA OKs Pfizer’s Paxlovid, the US’s First COVID Pill

Drug for Coronavirus Covid-19. Pill destroying Covid19 virus | FDA OKs Pfizer’s Paxlovid, the US’s First COVID Pill | featured

On Wednesday, the US Food and Drug Administration approved Paxlovid, Pfizer’s antiviral COVID pill. This is the first oral and at-home treatment designed to fight COVID-19.

RELATED: Pfizer Files for FDA Approval for Its COVID Pill

FDA Approves Paxlovid, Pfizer’s Antiviral COVID Pill

Flat lay of medicine pills shape as word covid 19 with syringe and pills | COVID Pill

The FDA granted emergency use authorization for Paxlovid for use by Americans aged 12 and older at risk of severe illness.

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As a result of the EUA, Paxlovid becomes the first oral and at-home treatment for the coronavirus. It also signifies the start of introducing remedies against COVID that’s not in vaccine form.

Pfizer officials also hope that Paxlovid will also serve as a new tool against the fast-spreading Omicron variant.

Regardless, the drug showed 90% effectiveness in preventing hospitalizations and death in high-risk COVID patients.

This is according to the data submitted by Pfizer to FDA officials. This includes recent lab data that suggests effectiveness against Omicron.

Pfizer To Increase Its Mass Production

As a result, the company boosted its 2022 production targets from 80 million to 120 million courses of treatment.

Pfizer also said that it can start delivery immediately in the United States. A single treatment course includes a new medicine and a second antiviral, ritonavir.

Pfizer declared it already holds 180,000 treatment courses ready for shipment this year. The US government’s contract with Pfizer is for 10 million courses. Each course carries a $530 price tag.

Meanwhile, the US government will make 265,000 treatment courses available by January. Pfizer will ramp up the supply in the next few months.

According to White House COVID-19 response coordinator Jeff Zients, the US government expects to receive its 10 million courses order within six months. 

Pandemic Becoming More Manageable With COVID Pill

Health experts see the introduction of COVID treatments instead of vaccines as a breakthrough.  Amesh Adalja, a senior scholar at the Johns Hopkins Institute for Health Security, said the new drug is the next logical step.

“Paxlovid’s approval is a major milestone that marks another step towards making COVID-19 a much more manageable infection,” he said.  

However, Adalja warned things won’t be as easy as popping pills. “There are two key issues, however, that remain: It will be scarce in the coming weeks and its optimal use requires prompt diagnosis,” he said. These issues can prove difficult with the current testing problems plaguing the world, Adalja added. 

COVID’s Omicron Strain Gets Loose in the US

The FDA”s decision to issue emergency authorization for Paxlovid comes as the country combats a surge in COVID cases. The Omicron strain comprises a majority of the new cases.  

With winter already here, health officials are bracing for yet another COVID surge. Meanwhile, Biden wants more federal vaccination and testing sites.

The COVID pill treatment can fill a gap opened by Omicron. This is according to William Schaffner, an infectious disease expert from the Vanderbilt University School of Medicine.

At present, popular monoclonal antibody treatments show little effect against Omicron. For the one treatment that works well, supplies remain very limited.

Monoclonal antibodies are not as common as COVID vaccines. Hospitals usually administer them intravenously. Apart from availability, antibodies are also prohibitively expensive. 

For now, Paxlovid will only be made available via prescription only. Patients need to take the COVID pill treatment immediately after a positive test.

They should also start the treatment within five days of symptom onset. Patients need to take an oral pill every 12 hours for five days. 

Watch the CNBC Television news video reporting that Pfizer Covid antiviral pill Paxlovid receives emergency authorization:

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