Therapy Areas: Vaccines
Pfizer partners with BioNTech to file EUA request to FDA for launch of COVID-19 vaccine
23 November 2020 -

Healthcare company Pfizer Inc (NYSE:PFE) and its partner BioNTech SE (Nasdaq:BNTX) plan to submit a request to the US Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) of the mRNA vaccine candidate, BNT162b2 against SARS-CoV-2, which will potentially enable use of the vaccine in high-risk populations in the US by the middle to end of December 2020, the companies announced on Friday.

The partnerships' FDA EUA submission is based on a vaccine efficacy rate of 95% demonstrated in the Phase 3 clinical study in participants without prior SARS-CoV-2 infection (first primary objective) and in participants with and without prior SARS-CoV-2 infection (second primary objective), in each case measured from seven days after the second dose.

This submission is supported by solicited safety data from the companies' randomized subset of 8,000 participants ≥18 years of age and unsolicited safety data from approximately 38,000 trial participants who have been followed for a median of two months following the second dose of the vaccine candidate. The submission includes solicited safety data on approximately 100 children 12-15 years of age.

Approximately 42% of global participants and 30% of US participants in the Phase 3 study have racially and ethnically diverse backgrounds, and 41% of global and 45% of US participants are 56-85 years of age, added the company.

In conjunction, the partnership has initiated rolling submissions with the EMA and the Medicines & Healthcare Products Regulatory Agency (MHRA) in the UK and intend to submit applications to other regulatory agencies worldwide in the coming days. The governments may have regulatory pathways similar to an EUA. It will be ready to distribute the vaccine candidate within hours after authorization.