Pfizer-BioNTech's COVID-19 Vaccine Is 90% Effective, EUA Filing Likely By Late November

As expected, Pfizer Inc. PFE/BioNTech SE – ADR BNTX became the first among the vaccine developers to release interim results from the largescale final phase clinical results, with the first interim analysis yielding solid efficacy results.

What Happened: The mRNA vaccine candidate, codenamed BNT162b2, developed by the combo was found to be more than 90% effective in preventing COVID-19 in healthy volunteers, Pfizer/BioNTech said, citing first interim analysis of the large-scale Phase 3 study.

The analysis was done after 94 confirmed cases of COVID-19 cases in trial participants. The study protocol released by the company earlier indicated four interim analyses, after accrual of 32, 62, 92 and 120 cases.

"Today is a great day for science and humanity. The first set of results from our Phase 3 COVID-19 vaccine trial provides the initial evidence of our vaccine's ability to prevent COVID-19," said Albert Bourla, Pfizer Chairman and CEO.

The companies said Monday they had chosen to drop the 32-case interim analysis following discussions with the FDA, and upon conclusion of the discussions, 94 cases had accrued. The data monitoring committee, or DMC, therefore performed its first interim analysis on all cases.

"The case split between vaccinated individuals and those who received the placebo indicates a vaccine efficacy rate above 90%, at 7 days after the second dose," the companies said.

This suggested achievement of protection 28 days after the initiation of the vaccination, which consists of a 2-dose schedule.

More importantly, the companies also noted the DMC has not reported any serious safety concerns and has greenlighted the continuation of the study for collecting additional safety and efficacy data, as planned.

The Phase 3 study has enrolled 43,538 participants, with 42% having diverse participants.

Related Link: The Week Ahead In Biotech: Supernus, Sanofi Await FDA Decisions

What's Next: Pfizer and BioNTech plan to discuss the data with regulatory authorities worldwide.

With the DMC recommending the study continue to collect additional safety and efficacy data, as planned, the companies plan to continue collecting further data as the trial continues to enroll for a final analysis planned when a total of 164 confirmed COVID-19 cases have accrued.

The companies said they estimate a median of two months of safety data following the second dose of the vaccine candidate, which is the amount of safety data specified by the FDA in its guidance for potential emergency use authorization, will be available by the third week of November.

Additionally, participants will continue to be monitored for long-term protection and safety for an additional two years after their second dose.

Up to 50 million vaccine doses will be made available in 2020 and up to 1.3 billion doses in 2021, the companies estimate.

The companies also plan to submit data from the full Phase 3 study for scientific peer-review publication.

If Pfizer reports positive data at the first interim analysis, the stock will trade even higher, with all else being equal, Cantor Fitzgerald analyst Louise Chen said in an early November note. If the vaccine candidate becomes a worldwide, recurring revenue stream for Pfizer, it will likely augment net present value by about $5 per share.

In pre-market trading, Pfizer shares were soaring 14.01% to $41.50 and BioNTech shares were jumping 24.26% to $114.32.