With 95% Efficacy in Final Analysis, Pfizer To Seek EUA Approval Immediately

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Final analysis of the Phase 3 trial of Pfizer's COVID-19 vaccine suggests it is 95% effective, even for adults 65 and over who are most at risk of dying from the novel coronavirus. The pharmaceutical giant plans to submit data to the FDA for Emergency Use Authorization (EUA) within days.

If the FDA grants EUA approval, Pfizer’s mRNA-based vaccine, BNT162b2, will be the first vaccine off the line designed specifically in response to the global pandemic. BNT162b2 will also become the first-ever mRNA-based vaccine approved in the U.S. Pfizer says it is sharing data with international regulators to begin the submission process for approval in Europe, the U.K. and Canada, as well.

Before filing for an EUA, Pfizer had to meet new safety guidelines recently put forth by the FDA that required a minimum of two months of follow-up safety data after vaccinating volunteers. That milestone has now been reached with a final analysis showing the vaccine was “well tolerated” among a randomized set of 8,000 participants who received both doses. Most adverse events were mild and resolved shortly after vaccination. Fatigue after both doses and headache after dose 2 were the most common recorded side effects. Importantly, adults 65 and over reported fewer and milder adverse events following vaccination than the younger demographic.

“These achievements highlight the potential of mRNA as a new drug class. Our objective from the very beginning was to design and develop a vaccine that would generate rapid and potent protection against COVID-19 with a benign tolerability profile across all ages. We believe we have achieved this with our vaccine candidate BNT162b2 in all age groups studied so far,” said Ugur Sahin, M.D., CEO and co-founder of BioNTech, who has co-developed the vaccine with Pfizer.

In the final analysis, 170 cases of COVID-19 were detected in trial participants—162 in the placebo group versus 8 in the BNT162b2 group. The subsequent vaccine efficacy rate of 95% was seen in volunteers without prior SARS-CoV-2 infection—the primary trial endpoint—as well as in participants with prior SARS-CoV-2 infection, which was the trial’s second primary objective. All participants were measured 7 days after the second dose of BNT162b2. Additionally, 10 severe cases of COVID-19 were observed throughout the trial, 9 in the placebo group and 1 in the vaccinated group.

“The study results mark an important step in this historic 8-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,” said Albert Bourla, Pfizer Chairman and CEO.

Once analysis of the data is complete, Pfizer and BioNTech said they plan to submit both efficacy and safety data to a peer-reviewed journal.

In a press release discussing the trial results, Pfizer said it is “confident in its vast experience, expertise and existing cold-chain infrastructure to distribute the vaccine around the world.” BNT162b2 is the only vaccine that requires ultra-cold temperatures of -70 to -80˚C to remain effective until dosing. To compensate, Pfizer designed temperature-controlled shipping packages that use dry ice to keep vaccine vials stable for 15 days. Each suitcase-sized shipping container is equipped with a GPS-enabled thermal sensor to track both the location and temperature of the vaccine vials. The pharmaceutical manufacturer said it will rely on “pre-set routes that leverage Pfizer’s broad distribution network” to ensure safe vaccine shipment.

Today’s announcement comes on the heels of initial data showing Moderna’s COVID-19 vaccine candidate is 94.5% effective. That vaccine, also mRNA-based, has shown no significant safety concerns thus far. If that holds true for another few weeks until Moderna meets the required two-month safety follow-up period, the biotechnology company will follow in the footsteps of Pfizer and file for an EUA. A little more than a week ago, Pfizer released initial data that showed BNT162b2 was 90% effective.

Based on current projections, Pfizer said it expects to produce up to 50 million vaccine doses worldwide in 2020 and up to 1.3 billion doses in 2021. Excluding Moderna and Pfizer’s vaccine candidates, there are 9 more in late-stage testing around the world, four of them centered in the United States.