![]() These findings supported progression of the BNT162b2 vaccine candidate into phase 3. In addition, the reactogenicity profile of BNT162b2 represented mainly short-term local (i.e., injection site) and systemic responses. 8 The 50% neutralizing geometric mean titers elicited by 30 μg of BNT162b2 in older and younger adults exceeded the geometric mean titer measured in a human convalescent serum panel, despite a lower neutralizing response in older adults than in younger adults. 7 Findings from studies conducted in the United States and Germany among healthy men and women showed that two 30-μg doses of BNT162b2 elicited high SARS-CoV-2 neutralizing antibody titers and robust antigen-specific CD8+ and Th1-type CD4+ T-cell responses. We previously reported phase 1 safety and immunogenicity results from clinical trials of the vaccine candidate BNT162b2, 4 a lipid nanoparticle–formulated, 5 nucleoside-modified RNA (modRNA) 6 encoding the SARS-CoV-2 full-length spike, modified by two proline mutations to lock it in the prefusion conformation. 3 Safe and effective prophylactic vaccines are urgently needed to contain the pandemic, which has had devastating medical, economic, and social consequences. Recent data show increasing rates of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and Covid-19 in other populations, including younger adults. 2 Older adults, persons with certain coexisting conditions, and front-line workers are at highest risk for Covid-19 and its complications. Safety and Efficacy of the BNT162b2 Covid-19 VaccineĬoronavirus disease 2019 (Covid-19) has affected tens of millions of people globally 1 since it was declared a pandemic by the World Health Organization on March 11, 2020. (Funded by BioNTech and Pfizer number, NCT04368728.) Introduction Safety over a median of 2 months was similar to that of other viral vaccines. ConclusionsĪ two-dose regimen of BNT162b2 conferred 95% protection against Covid-19 in persons 16 years of age or older. The incidence of serious adverse events was low and was similar in the vaccine and placebo groups. The safety profile of BNT162b2 was characterized by short-term, mild-to-moderate pain at the injection site, fatigue, and headache. Among 10 cases of severe Covid-19 with onset after the first dose, 9 occurred in placebo recipients and 1 in a BNT162b2 recipient. Similar vaccine efficacy (generally 90 to 100%) was observed across subgroups defined by age, sex, race, ethnicity, baseline body-mass index, and the presence of coexisting conditions. There were 8 cases of Covid-19 with onset at least 7 days after the second dose among participants assigned to receive BNT162b2 and 162 cases among those assigned to placebo BNT162b2 was 95% effective in preventing Covid-19 (95% credible interval, 90.3 to 97.6). ResultsĪ total of 43,548 participants underwent randomization, of whom 43,448 received injections: 21,720 with BNT162b2 and 21,728 with placebo. The primary end points were efficacy of the vaccine against laboratory-confirmed Covid-19 and safety. BNT162b2 is a lipid nanoparticle–formulated, nucleoside-modified RNA vaccine that encodes a prefusion stabilized, membrane-anchored SARS-CoV-2 full-length spike protein. In an ongoing multinational, placebo-controlled, observer-blinded, pivotal efficacy trial, we randomly assigned persons 16 years of age or older in a 1:1 ratio to receive two doses, 21 days apart, of either placebo or the BNT162b2 vaccine candidate (30 μg per dose). Safe and effective vaccines are needed urgently. Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and the resulting coronavirus disease 2019 (Covid-19) have afflicted tens of millions of people in a worldwide pandemic. The most trusted, influential source of new medical knowledge and clinical best practices in the world. Information and tools for librarians about site license offerings. Valuable tools for building a rewarding career in health care. The authorized source of trusted medical research and education for the Chinese-language medical community. The most advanced way to teach, practice, and assess clinical reasoning skills. Information, resources, and support needed to approach rotations - and life as a resident. The most effective and engaging way for clinicians to learn, improve their practice, and prepare for board exams. NEW! Peer-reviewed journal featuring in-depth articles to accelerate the transformation of health care delivery.Ĭoncise summaries and expert physician commentary that busy clinicians need to enhance patient care. NEW! A digital journal for innovative original research and fresh, bold ideas in clinical trial design and clinical decision-making.
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