The SARS-CoV-2 virus continues to infect millions of people, and the world is still looking forward to the first effective COVID-19 vaccine. An ongoing trial of the BNT162b2 mRNA COVID-19 is being conducted. This study aims to evaluate the safety and efficacy of BNT162b2 mRNA.
This placebo-controlled, observer-blinded, multinational, pivotal efficacy trial included a total of 43,448 participants aged 16 years or older. The participants were randomly assigned in a 1:1 ratio to receive two doses (21 days apart) of either the BNT162b2 vaccine or a placebo. The primary outcomes of the study were the efficacy and safety of the vaccine.
Among patients who were assigned to the BNT162b2 vaccine, 8 cases of COVID-19 onset at least 7 days after the second dose were observed. A total of 162 cases among participants who were assigned to placebo were recorded. The findings suggested that BNT162b2 was 95% effective in preventing COVID-19. The same results were seen across subgroups divided by age, gender, and ethnicity. Adverse outcomes of the vaccine included pain at the injection site, headache, and fatigue.
The research concluded that the BNT162b2 vaccine was 95% effective against COVID-19 and had a tolerable safety profile.
Ref: https://www.nejm.org/doi/full/10.1056/NEJMoa2034577
