From the 927 confirmed symptomatic cases of COVID-19 in the trial, 850 cases of COVID-19 were in the placebo group and 77 cases were in the BNT162b2 group, corresponding to vaccine efficacy of 91.3% (95% confidence interval ). Results from this analysis of 46,307 trial participants build upon and confirm previously released data and demonstrate strong protection against COVID-19 through six months post-second dose. The updated analysis of the Phase 3 clinical trial was conducted in accordance with guidance from the FDA for all companies investigating COVID-19 vaccines to review safety and efficacy at key milestones. “These data also provide the first clinical results that a vaccine can effectively protect against currently circulating variants, a critical factor to reach herd immunity and end this pandemic for the global population.” “It is an important step to further confirm the strong efficacy and good safety data we have seen so far, especially in a longer-term follow-up,” said Ugur Sahin, CEO and Co-founder of BioNTech. “The high vaccine efficacy observed through up to six months following a second dose and against the variant prevalent in South Africa provides further confidence in our vaccine’s overall effectiveness.” FDA,” said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. “These data confirm the favorable efficacy and safety profile of our vaccine and position us to submit a Biologics License Application to the U.S. Safety data from the Phase 3 study has also been collected from more than 12,000 vaccinated participants who have a follow-up time of at least six months after the second dose, demonstrating a favorable safety and tolerability profile. Centers for Disease Control and Prevention (CDC), and 95.3% effective against severe COVID-19 as defined by the U.S. The vaccine was 100% effective against severe disease as defined by the U.S. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced updated topline results from analysis of 927 confirmed symptomatic cases of COVID-19 observed in their pivotal Phase 3 study through March 13, 2021, showing the Pfizer-BioNTech COVID-19 vaccine, BNT162b2, was 91.3% effective against COVID-19, measured seven days through up to six months after the second dose. NEW YORK & MAINZ, Germany-(BUSINESS WIRE)- Pfizer Inc. The companies plan to share these results with worldwide regulatory agencies soon.Vaccine safety now evaluated in more than 44,000 participants 16 years of age and older, with more than 12,000 vaccinated participants having at least six months follow-up after their second dose.Vaccine was 100% effective in preventing COVID-19 cases in South Africa, where the B.1.351 lineage is prevalent.Centers for Disease Control and Prevention and 95.3% effective in preventing severe disease as defined by the U.S. Vaccine was 100% effective in preventing severe disease as defined by the U.S.Analysis of 927 confirmed symptomatic cases of COVID-19 demonstrates BNT162b2 is highly effective with 91.3% vaccine efficacy observed against COVID-19, measured seven days through up to six months after the second dose.Research and Business Development Partnerships.doi:10.1001/ the next wave of scientific innovations Delayed localized hypersensitivity reactions to the Moderna COVID-19 vaccine: a case series. Johnston MS, Galan A, Watsky KL, Little AJ. Reactogenicity following receipt of MRNA-based COVID-19 vaccines. The second dose of a COVID-19 vaccine: Side effects, why they happen, and how to treat them.Ĭhapin-Bardales J, Gee J, Myers T. 5 exercises to reduce arm soreness after the COVID-19 vaccination. Sheltering Arms Physical Rehabilitation Center. Use of COVID-19 vaccines after reports of adverse events among adult recipients of Janssen (Johnson & Johnson) and mRNA COVID-19 vaccines (Pfizer-BioNTech and Moderna): Update from the Advisory Committee on Immunization Practices - United States, July 2021. Rosenblum HG, Hadler SC, Moulia D, et al. Local reactions, systemic reactions, adverse events, and serious adverse events: Pfizer-BioNTech COVID-19 vaccine. Interim considerations: preparing for the potential management of anaphylaxis after COVID-19 vaccination.Ĭenters for Disease Control and Prevention. Possible side effects after getting a COVID-19 vaccine.Ĭenters for Disease Control and Prevention. doi:10.1001/jamadermatol.2021.1214Ĭenters for Disease Control and Prevention. Delayed localized hypersensitivity reactions to the Moderna COVID-19 vaccine: A case series.
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