For February 2021, we have selected: Polack F.P. et al. Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine. N Engl J Med. 2020; 383:2603-2615. doi: 10.1056/NEJMoa2034577.
Our COVID-19 paper of the month is focused on the BNT162b2 messenger RNA COVID-19 Vaccine, which is a lipid nanoparticle–formulated, nucleoside-modified RNA vaccine encoding a prefusion stabilised, membrane-anchored SARS-CoV-2 full length spike protein.
The pandemic condition has involved all countries of the world causing millions of deaths and it is still an ongoing major issue worldwide. Therefore, developing a vaccine was a mandatory need for all healthcare systems.
Polack et al. developed a multinational, placebo-controlled, observer-blinded, pivotal efficacy trial to evaluate the efficacy and the safety of BNT162b2 vaccine.
43,548 participants 16 years of age or older were randomly assigned to either the placebo or vaccine group. 43,448 participated to the trial in a 1:1 ratio between the two groups. Each participant received two doses of placebo or vaccine at 21 days’ interval.
8 cases of COVID-19 with onset at least 7 days after the second dose were documented in the vaccine group and 162 cases among those participants assigned to placebo. Of note, one case of severe COVID-19 with onset after the first
dose was observed in the vaccine group and 9 severe cases occurred in the placebo group after the first injection.
Our paper of the month demonstrated that BNT162b2 vaccine has 95% efficacy in preventing COVID-19 (95% credible interval, 90.3 to 97.6). Importantly, there were no statistical differences between participants on the basis of age, sex, race, ethnicity, baseline body-mass index, or presence of coexisting conditions.
Safety was documented by similar rate of adverse events in both groups. Fatigue, headache and pain on the site of the injection occurred in the vaccine group.
In the context of the current, still expanding pandemic, the BNT162b2 vaccine, together with other public health measures, provides the possibility of reducing the impact of this devastating illness.