Pfizer requesting emergency approval in United States for COVID-19 pill

According to CEO Albert Bourla, the tablet might significantly reduce fatalities and hospitalizations. The Biden administration is expected to declare that at least 10 million doses of the drug would be ordered.
Pfizer CEO Albert Bourla said on Tuesday that the pharmaceutical firm was seeking accelerated approval from the US Food and Drug Administration (FDA) for its newly developed COVID-19 tablet.

The company said that the pill had been shown to reduce hospitalizations and deaths by 89% amongst newly-infected high risk patients.

“With more than five million deaths and countless lives impacted by this devastating disease globally, there is an urgent need for life-saving treatment options,” Bourla said.

“We are moving as quickly as possible in our effort to get this potential treatment into the hands of patients.”

Pfizer is seeking what is known as an emergency use authorization (EUA) on the basis of initial results from a clinical trial comprising hundreds of COVID-19 patients who were not hospitalized but considered at high risk of progression to severe disease.

Biden administration to order millions of doses

The pharmaceutical giant is the second company to ask the FDA for an EUA after German firm Merck made its request a few weeks ago.

Pfizer said that its pill, which is called Paxlovid, led to side effects in one out of five patients, but that they were mild.

Paxlovid treatment takes five days. The company has said it will deliver 180,000 courses of its Paxlovid pill this year and at least 50 million by next year.

President Joe Biden’s administration is expected to announce that it is purchasing 10 million courses of the pill, according to The Washington Post. They’ve already made an order for 3.1 courses of the Merck pill, Molnupiravir.

Given the timeline between application for an EUA and subsequent authorization, the pills could be available to at-risk patients by late this year or early next.

The pills’ development has been hailed by experts who see strong COVID-19 treatments, alongside vaccines, as necessary to ending the pandemic.