Pfizer Seeks FDA Authorization For COVID-19 Pill
In this photo illustration, a medicine pill is seen in a... UKRAINE - 2021/10/17: In this photo illustration, a medicine pill is seen in a hand dressed in a medical glove with a Pfizer logo in the background. (Photo Illustration by Pavlo Gonchar/SOPA Images/LightRocket via Getty Images) SOPA Images / Contributor
Pavlo Gonchar/SOPA Images/LightRocket via Getty Images

Drug company Pfizer has submitted its COVID-19 pill treatment to the U.S. Food and Drug Administration (FDA) for authorization to be used for certain people.

On Tuesday, Pfizer announced that “it is seeking Emergency Use Authorization (EUA) of its investigational oral antiviral candidate, PAXLOVID™ […] for the treatment of mild to moderate COVID-19 in patients at increased risk of hospitalizations or death.” 

“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 announcement noted.

The Wall Street Journal reported, “Initial supplies of Pfizer’s pill would be limited. Pfizer projects it will manufacture more than 180,000 courses of treatment this year, and plans to increase production to at least 50 million courses next year.”

“With more than 5 million deaths and countless lives impacted by this devastating disease globally, there is an urgent need for life-saving treatment options. 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,” said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. “We are moving as quickly as possible in our effort to get this potential treatment into the hands of patients, and we look forward to working with the U.S. FDA on its review of our application, along with other regulatory agencies around the world.”

As previously reported by The Daily Wire, Pfizer announced results from an interim analysis reportedly showing its new pill designed to treat COVID-19 minimized the risk of death or hospitalization by 89%.

In an announcement, the company stated at the time:

  • PAXLOVID™ […] was found to reduce the risk of hospitalization or death by 89% compared to placebo in non-hospitalized high-risk adults with COVID-19
  • In the overall study population through Day 28, no deaths were reported in patients who received PAXLOVID™ as compared to 10 deaths in patients who received placebo
  • Pfizer plans to submit the data as part of its ongoing rolling submission to the U.S. [Food and Drug Administration] for Emergency Use Authorization (EUA) as soon as possible

“If authorized or approved, PAXLOVID will be administered at a dose of 300mg (two 150mg tablets) of [the pill] with one 100mg tablet of ritonavir, given twice-daily for five days,” the Tuesday announcement added.

Earlier this month, President Joe Biden said, “If authorized by the FDA we may soon have pills that treat the virus in those who become infected,” noting, “We’ve already secured millions of doses. The therapy would be another tool in our toolbox to protect people from the worst outcomes of COVID.”

As The Daily Wire reported, in a separate agreement announced on Tuesday, Pfizer will also permit its COVID-19 pill treatment to be manufactured and sold in countries that might not be able to otherwise afford the treatment. 

The deal includes Pfizer working with Medicines Patent Pool (MPP), “a United Nations-backed public health organization working to increase access to life-saving medicines for low- and middle-income countries.” 

Through the agreement, MPP will be able to “facilitate additional production and distribution of the investigational antiviral, pending regulatory authorization or approval, by granting sub-licenses to qualified generic medicine manufacturers, with the goal of facilitating greater access to the global population.” 

In a statement about the arrangement, Pfizer said it will allow other companies to provide its COVID pill, along with ritonavir, with which it is administered, to 95 countries, which would include up to around 53% of the population of the world. 

The company noted that “[t]his includes all low- and lower-middle-income countries and some upper-middle-income countries in Sub-Saharan Africa as well as countries that have transitioned from lower-middle to upper-middle-income status in the past five years,” adding that it “will not receive royalties on sales in low-income countries and will further waive royalties on sales in all countries covered by the agreement while COVID-19 remains classified as a Public Health Emergency of International Concern by the World Health Organization.”

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