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Phase III trial of BNT 162b2 in COVID-19 published in NEJM.- Pfizer + BioNTech
Pfizer Inc. and BioNTech SE announced that the New England Journal of Medicine has published safety and final efficacy results from the pivotal Phase III trial of BNT 162b2, their mRNA-based COVID-19 vaccine candidate. In the trial of 43,448 participants, who were 16 years and older, 21,720 of whom received BNT 162b2 and 21,728 placebo, the two-dose regimen of 30 ?g BNT162b2, which was given 21 days apart, was well-tolerated and demonstrated vaccine efficacy of 95% against COVID-19. In the pivotal study, vaccine efficacy similar to that observed in the overall population was generally consistent among subgroups defined by age, gender, race, ethnicity, obesity, or presence of a comorbidity. Among 36,523 participants who had no evidence of existing or prior SARS-CoV-2 infection by the time of the immunizations, there were 170 cases of COVID-19 observed with onset at least 7 days after the second dose; 8 cases occurred in vaccine recipients, and 162 in placebo recipients, corresponding to 95.0% vaccine efficacy (95% credible interval [CI, 90.3, 97.6]). Among participants with and without evidence of prior SARS CoV-2 infection, there were 9 cases of COVID-19 among vaccine recipients and 169 among placebo recipients, corresponding to 94.6% vaccine efficacy (95% CI [89.9, 97.3]). The cumulative incidence of COVID-19 cases over time among placebo and vaccine recipients began to diverge by 12 days after the first dose, and 52.4% vaccine efficacy (95% confidence interval: 29.5, 68.4) was observed between dose 1 and dose 2, indicating the early onset of a partially protective effect of immunization. Two doses of vaccine provide the maximum protection observed. Ten cases of severe COVID-19 were observed with onset after the first dose. Nine cases occurred among placebo recipients and one among BNT162b2 recipients. BNT 162b2 exhibited a favorable tolerability and safety profile. Based on a data cut-off date of October 9, 2020, 37,706 participants had a median of at least two months of safety data available after dose 2 and contributed to the main safety dataset. Among these participants, 49% were female; 83% were White; 9% were Black or African American; 28% were Hispanic/Latinx; 35% were obese (BMI at least 30.0 kg/m2); and 21% had at least one underlying comorbidity. The median age was 52 years, and 42% were older than 55 years. The most common adverse events of BNT162b2 were transient, mild to moderate pain at the injection site, fatigue and headache, and these generally resolved within two days. These reactions were less common and milder in older adults than younger adults.See: "Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine." Fernando P. Polack et al. NEJM December 10, 2020 DOI: 10.1056/NEJMoa2034577
Condition: Coronavirus/COVID-19 Infection
Type: drug