Pfizer/BioNTech COVID vaccine trial data in New England Journal of Medicine

 

• Pfizer Inc. (PFE) and BioNTech SE (BNTX) announce the publication of their pivotal COVID-19 vaccine trial data in the New England Journal of Medicine.
• In the phase 3 trial, the two-dose regimen of 30 μg BNT162b2, given 21 days apart, was well-tolerated and demonstrated an efficacy of 95% against COVID-19, seven days or more after the second dose in those without prior-infection to COVID-19, the company said.
• Data from 43,448 participants, half of whom received BNT162b2 and the other half received placebo, indicate it was well tolerated, and the Partial protection began as early as 12 days after the first dose.
• “As COVID-19 cases continue to rise and ravage the lives of so many people, we hope that these data will build confidence in the global health opportunity for vaccines to help us combat this devastating pandemic,” said Kathrin U. Jansen, Ph.D., Senior Vice President and Head of Vaccine Research & Development, Pfizer.
• “Sharing further data from the Phase 3 trial in a renowned peer-reviewed journal underlines our commitment to transparency and scientific rigor” added Özlem Türeci, M.D., Chief Medical Officer and Co-founder of BioNTech.
• The most common adverse events were transient, mild to moderate pain at the injection site, fatigue, and headache, which were resolved within two days. They were less common and milder in older adults than younger adults.
• The ongoing placebo-controlled, randomized, observer-blinded study has already vaccinated the vast majority of the targeted 44,000 participants with the second dose, and currently, the vaccine candidate is undergoing an expert panel review in the U.S. to win emergency use authorization by the FDA.
• https://seekingalpha.com/news/3643350-pfizer-biontech-covidminus-19-vaccine-trial-data-published-in-new-england-journal-of-medicine