The data from Pfizer Inc. and Biontech SE keeps getting better as final efficacy analysis numbers on their COVID-19 vaccine jumped to 95% from the 90% found in the Nov. 9 interim analysis.
The phase III study of their mRNA candidate, BNT-162b2, met all the primary efficacy endpoints with a p value of <0.0001 for those without a prior SARS-CoV-2 infection, which was the first primary objective, and also for patients with and without a prior SARS-CoV-2 infection, the second primary objective. The vaccine’s efficacy began 28 days after the first dose.
Efficacy results in patients older than age 65 were more than 94%. No serious safety concerns for any patients were reported by the data monitoring committee.
With the safety milestone required by the FDA achieved, the two companies said they will request emergency use authorization “within days.”
On Nov. 9, Pfizer reported interim phase III data showing that BNT-162b2, which encodes an optimized SARS-CoV-2 full-length spike glycoprotein, posted 90% efficacy in preventing infection.
The final 95% efficacy from Pfizer-Biontech is a half percentage point higher than the 94.5% found in the phase III study of Moderna Inc.’s COVID-19 vaccine candidate, mRNA-1273, reported on Nov. 17.
SVB Leerink analyst Geoffrey Porges wrote Nov. 18 that the nearly identical numbers from the two different studies were “a remarkable coincidence of science or statistics.”
Moderna also said it plans to submit for an EUA in the coming weeks, basing the application on the final analysis of 151 cases. The study had a roster of more than 30,000 U.S. participants.
Mizuho Group analyst Vamil Divan estimated Nov. 18 that a successful vaccine could bring sales of about $875 million in 2020 and about $7.25 billion in 2021, then trending downward to between $700 million and $800 million in the model’s outer years.
“The speed with which Pfizer has moved to develop this vaccine candidate is also encouraging to us, and suggests Pfizer may be able to meet its stated objectives of being a faster-moving, more nimble biopharmaceutical company now that the sale of their Upjohn division has been completed,” Divan added.
The Pfizer-Biontech phase III began July 27 and has enrolled 43,661 participants, with 41,135 of them receiving a second dose by Nov. 13. About 42% of the worldwide participants and 30% in the U.S. participants have racially and ethnically diverse backgrounds, the companies said.
Pfizer stock (NYSE:PFE) jumped 2% when the market opened Nov. 18. Biontech stock (NASDAQ:BNTX) also posted early gains, with stocks selling 3.3% higher.