Cardiovascular Risk Not Increased with Bivalent COVID-19 Vaccine, Finds Population-Based Study
A population-based study has found no evidence of an increased risk of cardiovascular events among individuals who received the bivalent COVID-19 vaccine as compared with those who received the monovalent vaccine. The study, conducted by researchers from France's National Health Data System and published in the New England Journal of Medicine, included all individuals aged 50 and over who had received a booster dose between October 6 and November 9, 2022, during which time both vaccines were being administered in France. Of the 470,962 vaccine recipients studied, 97,234 received the monovalent vaccine and 373,728 received the bivalent vaccine. After 21 days, researchers found no significant difference in the risk of ischemic stroke, hemorrhagic stroke, myocardial infarction, or pulmonary embolism between the two groups. The results provide reassurance regarding the continued use of the bivalent vaccine.
The study matched each recipient of the monovalent vaccine with up to five randomly sampled recipients of the bivalent vaccine on the same day, and recipients were followed until 21 days after vaccination. Sociodemographic and health-status characteristics were well balanced between the two groups. The evaluated events included ischemic stroke, hemorrhagic stroke, myocardial infarction, pulmonary embolism, and all four events combined.
The bivalent vaccine, which combines the Pfizer-BioNTech and Moderna vaccines, has been approved for use in several countries, including France, in an effort to simplify the vaccine rollout and reduce logistical challenges. The study's findings provide important reassurance regarding the safety of this approach, particularly for individuals aged 50 and over who may be at higher risk of cardiovascular events. The study's comprehensive data and large sample size lend further credibility to its results.
The study's findings come at a critical time, as countries around the world continue to grapple with the COVID-19 pandemic and work to increase vaccination rates. The bivalent vaccine may offer a promising solution for increasing vaccine coverage and simplifying the vaccination process, particularly in areas with limited resources or logistical challenges. The study's results provide important reassurance that this approach is safe and effective, and may pave the way for wider use of the bivalent vaccine in the future.
Overall, the study underscores the importance of ongoing research and monitoring of COVID-19 vaccines, particularly as new variants emerge and vaccination strategies continue to evolve. As the global community continues to navigate the pandemic, studies like this one will be critical for ensuring the safety and efficacy of COVID-19 vaccines, and for helping to guide public health policy and practice.
0. “Stroke, Myocardial Infarction, and Pulmonary Embolism after Bivalent Booster | NEJM” nejm.org, 29 Mar. 2023, https://www.nejm.org/doi/full/10.1056/NEJMc2302134
1. “French Data Reassure on Bivalent COVID Booster and Stroke Risk” Medpage Today, 29 Mar. 2023, https://www.medpagetoday.com/infectiousdisease/covid19vaccine/103778