With the FDA’s required safety milestone notched in their phase III study of COVID-19 vaccine candidate BNT-162b2, Pfizer Inc. and Biontech SE said they will request emergency use authorization “within days.”

The new data were an echo of Biontech CEO and co-founder Ugur Sahin’s Nov. 10 prediction of getting the right safety data to support an EUA submission “as early as the third week of November.”

The final efficacy analysis numbers on the COVID-19 vaccine jumped to 95% from the 90% found in a Nov. 9 interim analysis. The phase III study showed 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.

Ugur Sahin, co-founder and CEO, Biontech

Efficacy results in patients older than 65 were more than 94%. No serious safety concerns for any patients were reported by the data monitoring committee.

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.

When Angela Hwang, Pfizer’s Biopharmaceutical Group president, was asked about the final phase III data at the Wolfe Research Healthcare Conference on Nov. 18, she said her company and Moderna have set the standard.

“I think that this efficacy bar of 90-plus percent, 95% is a real one,” she said. “And I think that when you have a product that is as efficacious as this and that this efficacy is important because this is what we need to create the herd immunity around the world so that we can end this pandemic, I do think it sets a bar that will raise questions around, what if you're not 90% or what if you're substantially less, what is the role that you can play?”

Angela Hwang, Biopharmaceutical Group president, Pfizer

Storage and distribution are logistics that Hwang said she feels confident about. Pfizer’s vaccine must be stored at -70 degrees Celsius (-158 Fahrenheit) while Moderna’s storage temperature is -4 Celsius (-39.2 Fahrenheit).

Not a problem, she said.

“We have, to date, 152 sites around the world who are receiving this vaccine as part of our clinical trial. So we know that the distribution and the logistics system that we have created to date for our clinical trials work,” Hwang said. “And so we have proof of concept that the logistics and the distribution are not insurmountable. In fact, they're doable. We're doing it every day now.”

For vaccine administrators or sites, the -80-degree storage is not necessary, she added, because the company created thermal shippers designed as storage units, leaving company facilities with dry ice that can be replenished if necessary.

The companies plan to produce up to 50 million doses before the year ends and as many as 1.3 billion doses before the end of 2021.

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’s stock (NYSE:PFE) closed Nov. 18 at $36.32, up 28 cents. Biontech’s stock (NASDAQ:BNTX) jumped 4% to close at $90.44.

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