Uncertainty Looms Over Pfizer's Oral COVID-19 Antiviral Pill - Doubts Over Commercial Approval

Pfizer Inc's PFE CEO Albert Bourla provided an update on the status of the company's oral antiviral COVID-19 treatment, Paxlovid, during his speech at the Cantor Fitzgerald Annual Healthcare Conference. 

Bourla revealed that approximately 250,000 courses of Paxlovid are being administered each week as the U.S. grapples with a surge in COVID-19 cases.

Paxlovid, designed to be taken for five days starting shortly after the onset of symptoms, is crucial in treating adults at high risk of severe illness and hospitalization due to COVID-19. 

Despite the increased weekly administration numbers, Bourla highlighted that Pfizer remains uncertain when Paxlovid will gain approval for commercial sale in the U.S. market, Reuters noted. 

Currently, the drug is being distributed exclusively by the government.

Addressing concerns regarding Pfizer's COVID-19 vaccines, Bourla reassured the public that the company is well-prepared to transition smoothly into the commercial market. 

He emphasized, "There is enough product that has been already manufactured, and we keep manufacturing. We are very confident that the market will be very well supplied."

However, the initial rollout of updated COVID-19 vaccines in the U.S. encountered challenges, with reports of individuals being turned away from pharmacies for vaccinations. 

Pfizer has supplied nearly 24 million courses of Paxlovid to the U.S. government, but only about 15 million courses have been distributed thus far, as per data from the U.S. Department of Health and Human Services.

While Paxlovid initially saw a surge in prescriptions, with approximately 217,000 in the week of September 1st, it has experienced a decline since then, according to IQVIA data cited by research analysts.

Price Action: PFE shares are up 0.12% at $32.44 during the premarket session on the last check Wednesday.