Pfizer-BioNTech Plan Vaccine Emergency Use Filing Within Days After Final Analysis Confirm Efficacy, Safety

Pfizer Inc. PFE andBioNTech SE – ADR BNTX have managed to stay ahead in the vaccine race by a hair's breadth.

Within days after Moderna Inc MRNA released its first interim analysis, the U.S.-German combo announced results from the final analysis of their late-stage study of their jointly-developed mRNA vaccine, codenamed BNT162b2.

"This is clearly good news and supports the potential for a vaccine rollout before year-end," Cantor Fitzgerald analyst Louise Chen said in a note. The analyst estimate sBLA approval could come by mid-2021.

Key Findings of Final Analysis: BNT162b2 met both the first and second primary objectives of the late-stage study, and showed tolerable safety profile, Pfizer and BioNTech said in a statement.

Here're the key findings:

• Vaccine efficacy rate was 95% in participants with and without prior SARS-CoV-2 infection, and also in participants with or without prior SARS-CoV-2 infection (efficacy measured 7 days after the second dose)
• Observed efficacy of over 94% in adults over 65 years
• Efficacy consistent across age, gender, race and ethnicity demographics
• No safety concerns related to vaccine reported by the Data Monitoring Committee
• Safety milestone required by FDA achieved

"The study results mark an important step in this historic eight-month journey to bring forward a vaccine capable of helping to end this devastating pandemic. We continue to move at the speed of science to compile all the data collected thus far and share with regulators around the world," said Albert Bourla, Pfizer Chairman and CEO.

Pfizer announced earlier this week a pilot program for vaccine distribution in four U.S. states.

Related Link: Pfizer Analysts Raise Odds Of Success For Coronavirus Vaccine Candidate To 100%

No Safety Scare: Unblinded reactogenicity data from at least 8,000 volunteers, ages 18 years and older, in the Phase 2/3 study showed the vaccine was well tolerated, with most solicited adverse events resolving shortly after vaccination.

The only Grade 3 solicited adverse events greater than or equal to 2% in frequency after the first or second dose was fatigue and headache, the companies said. Older adults were also found to report fewer and milder solicited adverse events following vaccination.

EUA Filing With Days: The companies plan to submit an Emergency Use Authorization within days, while also sharing the data with other regulatory agencies around the world.

The companies have already initiated rolling BLA submission with the European Medicines Agency.

What's Next: Pfizer and BioNTech expect to produce globally up to 50 million vaccine doses in 2020 and up to 1.3 billion doses by the end of 2021

The companies have developed specially designed, temperature-controlled thermal shippers utilizing dry ice to maintain temperature conditions of -70°C±10°C.

The efficacy and safety data from the study will be submitted for peer-review in a scientific journal once analysis of the data is completed.

The FDA scheduled an ACIP meeting for Nov. 23 to discuss COVID-19 vaccines and the regulators have said they would convene to discuss EUAs for COVID-19 vaccines ahead of EUA authorization, Chen said.

In premarket trading, Pfizer shares were adding 3% to $37.12 sand BioNTech was rallying 6.20% to $92.32.