Pfizer Applies for FDA Emergency Approval of COVID-19 Oral Treatment (Comprehensive)

Booster shots to be available for all adults starting as early as this weekend

[Image source=Reuters Yonhap News]

[Asia Economy Reporter Cho Hyun-ui] On the 16th (local time), American pharmaceutical company Pfizer applied to the U.S. Food and Drug Administration (FDA) for emergency use authorization of the oral COVID-19 treatment Paxlovid. Paxlovid is expected to become the second oral form of COVID-19 treatment following Merck's molnupiravir.

Albert Bourla, CEO of Pfizer, said in a statement on the day, "There is an urgent need for life-saving treatments," adding, "We are moving as quickly as possible to provide this treatment to patients."

Paxlovid is an oral antiviral in pill form, and Pfizer's own clinical trial results showed that taking it within 3 days of symptom onset reduces the risk of hospitalization and death by up to 89%. Amid growing concerns about a resurgence in winter, it is characterized by the convenience of treatment through pill intake without the need to visit a hospital even if infections surge.

As the Biden administration in the U.S. is expected to officially announce plans to purchase 10 million doses of Paxlovid this week, FDA approval is anticipated within the year. If approved by the FDA, it will be the first oral antiviral treatment for COVID-19 in the United States.

The Wall Street Journal (WSJ) predicted, "By the end of the year, people will be able to take the treatment at home." Pfizer plans to produce 180,000 doses of this treatment by the end of next month and at least 50 million doses by the end of next year once FDA approval is obtained.

Additionally, prior to the FDA application on the same day, Pfizer signed a licensing agreement with the United Nations-supported medical organization, the International Medicines Patent Pool (MPP), allowing the manufacture of generic versions of this treatment in 95 low- and middle-income countries. As a result, this treatment can be used royalty-free in countries where more than half of the world's population resides.

[Image source=AP Yonhap News]

Meanwhile, the FDA is expected to approve Pfizer booster shots for all adults as early as the 18th. The New York Times (NYT), citing a source familiar with the FDA's plans, reported this and added, "Following the FDA, the U.S. Centers for Disease Control and Prevention (CDC) committee composed of vaccine experts is scheduled to discuss the safety and efficacy of the booster shot on the 19th."

If both the FDA and CDC approve the booster shot within this week, adults who have completed their second dose at least six months ago will be able to receive an additional vaccination starting this weekend.

This content was produced with the assistance of AI translation services.