Pfizer Submits COVID-19 Pill Treatment to FDA for Authorization

eamesBot / shutterstock.com
eamesBot / shutterstock.com

Well, this story is going to heat things up even more regarding the vaccination debate. The drug company Pfizer has recently submitted their COVID-19 pill treatment to the U.S. Food and Drug Administration (FDA) for authorization to be used for certain people.

On Tuesday, the Pfizer company announced that it was seeking Emergency Use Authorization (EUA) of its investigational oral antiviral candidate called PAXLOVID

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. They explained that the pill would be for treatment of mild to moderate cases of COVID-19 in patients at increased risk of hospitalizations or death.

The announcement also explained, “If authorized or approved, PAXLOVID would be the first oral antiviral of its kind … that could be prescribed as an at-home treatment to high-risk patients at the first sign of infection, potentially helping patients avoid severe illness which can lead to hospitalization and death.”

The Wall Street Journal reported that initial supplies of the Pfizer pill would be limited. The company is projecting that it will manufacture more than 180,000 courses of treatment in 2021 and that it projects increasing production to at least 50 million courses in 2022.

Albert Bourla, the chairman and chief executive officer of Pfizer, said that there have been more than 5 million deaths and countless lives impacted by COVID-19 around the globe and there is an urgent need for more life-saving options in the treatment of the disease.

Bourla said, “The overwhelming efficacy achieved in our recent clinical study of PAXLOVID, and its potential to help save lives and keep people out of the hospital if authorized, underscores the critical role that oral antiviral therapies could play in the battle against COVID-19.”

He also explained that Pfizer was moving as quickly as possible in their effort to get this potential treatment into the hands of patients. And the company looks forward to working with the FDA as it reviews different applications. They will also work with other regulatory agencies around the world.

It was previously reported in news outlets like The Daily Wire that Pfizer announced results from an interim analysis that showed the new pill designed to treat COVID-19 minimized the risk of death or hospitalization by 89%.

The company announcement included these findings:

1). PAXLOVID

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was found to reduce the risk of hospitalization or death by 89% in comparison to the placebo effect.

2). In the study population through Day 28, no patient deaths were reported in those who received PAXLOVID

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(in comparison to the 10 deaths that occurred for those given the placebo).

3). Pfizer will be submitting the data as part of its ongoing submissions to the FDA for Emergency Use Authorization (EUA).

If everything goes as planned with the approval of PAXLOVID, it will be administered at a dose of 300mg (two 150mg tablets) with one 100mg tablet of ritonavir. This will be taken twice daily for five days, according to the announcement.

President Joe Biden said previously that if this was authorized by the FDA, the country may soon have pills that treat the virus in those who become infected. He also noted that the U.S. had already secured millions of doses and this regimen would become another tool in the toolbox to protect people from the worst outcomes of the disease.

There was a second agreement also reported that Pfizer would allow the COVID-19 pill treatment to be manufactured and sold in countries that might not be able to otherwise afford the treatment. The company added that they would not receive royalties on sales in low-income countries and will further waive royalties on sales in all countries covered by the agreement.

That’s great. Does that mean we don’t need the vaccine anymore? Well, we know that the Dems don’t like to listen to science, regardless of the fact that the vaccines don’t prevent breakthrough cases. And, we also know that it’s really about control, not about protecting us from COVID. But, time will tell.

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