First and Second Safety Profiles of Monovalent and Bivalent BNT162b2 mRNA Booster Vaccines in Older Adults

In a recent study posted on Lancet preprint*, investigators evaluated the safety profile of booster doses of the monovalent and bivalent messenger ribonucleic acid (mRNA) coronavirus disease 2019 (COVID-19) vaccine BNT162b2 in adults aged 60 years and older.

Background

Although the development of various COVID-19 vaccines has successfully reduced morbidity and mortality from severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection worldwide, the disease remains largely unaffected. countries continue to pose a risk to older people. Many countries have made booster doses of monovalent and bivalent mRNA vaccines available to the elderly. However, vaccine coverage appears to be decreasing, perhaps due to safety concerns about these booster doses.

The United States (US) Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) have reported an increased risk of ischemic stroke associated with booster doses of the bivalent COVID-19 vaccine from Pfizer-BioNTech, The European Medicines Agency (EMA) has reported no such association. A better understanding of the safety profiles of monovalent and bivalent booster vaccines can therefore help reduce vaccine hesitation and improve vaccination coverage.

About research

In the current study, the team conducted a large-scale retrospective analysis of the medical records of over 800,000 individuals aged 60 and over enrolled in Israel’s largest medical institution. These individuals received his first two, possibly three booster doses of the monovalent or bivalent mRNA COVID-19 vaccine BNT162b2 between the end of July 2021 and the beginning of his November 2022. I was receiving

Researchers analyzed the association between 27 adverse events, particularly cardiovascular events, and non-COVID-19-related hospitalizations and booster vaccines. Risk differences 28 days before and after vaccination were assessed for each of the 27 adverse reactions.

The primary outcomes measured were cumulative non-COVID-19 hospitalizations, non-COVID-19 hospitalizations due to cardiovascular events, and 1st and 2nd monovalent BNT162b2 boosters or Bivalent BNT162b2 booster dose. Risk differences were calculated pairwise for each individual and each adverse event.

In addition, a sensitivity analysis was performed evaluating the risk difference between baseline and 1, 2, 3, and 4 weeks post-vaccination. Subgroup analyzes were also performed to further divide the study population based on age and cardiovascular status, including individuals aged 60–70, 70–80, and ≥80 years and individuals with cardiovascular problems. A group was created consisting of individuals with and without

result

Results: Of the 863,886 people included in the study, 702,490 received a first booster dose of monovalent vaccine, 369,859 received a second booster monovalent vaccine, and 49,502 received a bivalent booster dose. The findings reported no association between monovalent or bivalent booster vaccines and an increased risk of non-COVID-19 related hospitalization events.

Of the 27 adverse events investigated in this study, pericarditis showed a weak association with booster vaccines, but no significant association was found between booster doses and other adverse events such as myocardial infarction, ischemic stroke, or heart failure. In addition, subgroup analyzes confirmed the results and showed no association between booster vaccine dose and adverse events based on age or cardiovascular background.

The study also showed that vaccine uptake was associated with age and cardiovascular status, and that individuals who received a second booster dose of monovalent or bivalent booster vaccines were more likely to receive the first booster than those who received the first booster vaccine. also reported that they were generally older and more likely to have a background. of cardiovascular events.

In addition, the number of non-COVID-19 related hospitalizations after bivalent booster administration was 72, 10 fewer than at baseline. The risk difference for hospitalizations not related to COVID-19 was -2.02 and for hospitalizations due to cardiovascular events not related to COVID-19 was -3.03.

Conclusion

In summary, this retrospective study analyzed the medical records of Israeli individuals aged 60 years and older who received 1, 2, or 3 doses of monovalent or bivalent vaccines to determine the relationship between booster vaccination and non-COVID-19 risk. evaluated for relevance. 19 associated hospitalizations and side effects.

Overall, the results showed no correlation between booster vaccines and increased risk of adverse reactions, including various cardiovascular events. The authors concluded that BNT162b2 monovalent and bivalent mRNA vaccines can be safely administered to her 60-year-old individual.

*Important Notices

Preprints with The Lancet publishes non-peer-reviewed, preliminary scientific reports and therefore should not be considered definitive, to guide clinical practice/health-related actions, or to be treated as established information. Shouldn’t.