Pfizer’s COVID-19 Vaccine Won’t Be Ready for EUA This Month, CEO Says

Pfizer CEO Albert Bourla announced Tuesday that the company won’t have the necessary phase 3 trial data required to submit its COVID-19 vaccine candidate for Emergency Use Authorization (EUA) this month, despite previous projections.

Although the Pfizer chief said in August that the company’s ongoing phase 3 trial of its vaccine candidate, BNT162, would very likely show whether it is safe and effective in October (DID, Aug. 7), the data are not ready yet. Bourla said that the required data — two months of safety data on half of the trial participants following administration of a final dose — are now expected in the third week of November.

“We may know whether or not the vaccine demonstrates efficacy soon,” he said. “In case of a conclusive result, positive or negative, we will inform the public as soon we complete the necessary administrative work, which we estimate will be completed one week from the time we know.”

The trial’s data monitoring committee has conducted no interim efficacy analyses so far, Bourla said, adding that from here on out, the company does not plan to discuss interim analyses publicly until the committee reaches a conclusive result.

The phase 3 trial spans approximately 150 sites in six countries and has enrolled more than 42,000 participants, with nearly 36,000 having received their second vaccine dose as of Monday, he said. Pfizer plans to enroll approximately 44,000 participants in total, allowing additional patient populations to be evaluated, including patients as young as 12 and patients with chronic stable HIV, hepatitis B and hepatitis C.

Bourla also gave an update on Pfizer’s yet-unnamed antiviral COVID-19 treatment candidate, a protease inhibitor, that may show antiviral activity against SARS-CoV-2, according to preliminary data previously announced by the company in April.

Currently, that antiviral is being evaluated in a phase 1b trial and is expected to enter a pivotal phase 2/3 study late this year or early next year, Bourla said. Pfizer hopes to submit the antiviral for approval in the second half of 2021, he said. — James Miessler