Upstate Medical University’s Chief of Infectious Disease Stephen J. Thomas, MD, is co-author of a paper published today in the New England Journal of Medicine about the effectiveness of the COVID-19 vaccine developed by Pfizer/BioNTech. Thomas is the coordinating principal investigator for the world-wide Pfizer/BioNTech vaccine trial. 

The paper, “Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine,” is authored by 12 doctors and medical experts from around the world. The New England Journal of Medicine is among the most prestigious peer-reviewed medical journals in the world. Thomas said the study’s publication is an important step to ensure transparent and objective review of the vaccine’s performance. 

“Publication is another level of external peer review,” Thomas said. “The people who are going to be administering this vaccine consume information in the medical literature. They read the press release from the company, but they rely on the medical literature to make medical decisions. The reviewers are external to the company and the project.”

“If a vaccine is going to start rolling out any time soon it is absolutely in the best interest of everybody for these companies to publish their data.”

The paper cites the specifics of the vaccine’s clinical trials, which took place at 152 sites around the world. The trial involved 43,448 participants who received injections – 21,720 with the vaccine and 21,728 with the placebo. The vaccine, BNT162b2 “was 95% effective in preventing Covid-19. Among 10 cases of severe Covid-19 with onset after the first dose, 9 occurred in placebo recipients and 1 in a BNT162b2 recipient.

“The safety profile of BNT162b2 was characterized by short-term, mild-to-moderate pain at the injection site, fatigue, and headache. The incidence of serious adverse events was low and was similar in the vaccine and placebo groups.”

The paper says that when combined with other public health efforts, the vaccine could be a very effective tool to combat the pandemic. 

“In the context of the current, still expanding pandemic, the BNT162b2 vaccine combined with public health measures could reduce the devastating loss of life, protect our health care system, and allow our society to recover.”