Bivalent vaccines against Covid-19 do not increase the risk of a serious cardiovascular event (heart attack, stroke and pulmonary embolism) in people aged 50 or over, according to a French EPI-PHARE study.
- According to an EPI-PHARE study, bivalent Comirnaty vaccines against Covid-19 do not increase the risk of a serious cardiovascular event compared to the monovalent Comirnaty vaccine.
- The work was carried out after US authorities warned of a possible increase in strokes after an injection of a bivalent vaccine for over 50s.
- “The continued use of bivalent mRNA vaccines against Covid-19 is supported by these reassuring results”, concludes the EPI-PHARE study.
The bivalent Comirnaty vaccines against Covid-19 do not increase the risk of a serious cardiovascular event compared to the monovalent Comirnaty vaccine. Here is the conclusion of the study conducted by EPI‑PHARE (ANSM-Cnam scientific interest group in the epidemiology of health products).
Bivalent anti-Covid vaccine: no increase in cardiovascular problems
The work, published in the New England Journal of Medicine, were launched after an alert from the Food and Drug Administration and the Vaccine Safety Datalink of the North American Centers for Disease Control and Prevention. Last January, the American health authorities warned against the possible existence of an increased risk of having an ischemic stroke within 21 days after receiving a bivalent Comirnaty vaccine for those over 65 years of age.
However, the analyzes carried out using data from the National Health Data System (SNDS) to assess the increased risk of occurrence of a serious cardiovascular event (myocardial infarction, stroke or pulmonary embolism) after vaccination with the offending injection n have not demonstrated the existence of such a link.
“No increased risk of ischemic stroke, hemorrhagic stroke, myocardial infarction, pulmonary embolism, or any of the four events combined within 21 days of administration of a bivalent Comirnaty vaccine in comparison with the administration of the monovalent vaccine”ensures the ANSM in a press release sent on March 30, 2023.
Covid-19: bivalent vaccines can continue to be used
Bivalent mRNA vaccines are not new vaccines, but injections suitable for several strains at the same time. In France, two bivalent products, developed by the Pfizer/BioNtech laboratories, are currently used as a booster in people aged over 12 who have previously received at least one primary vaccination against Covid-19:
- one targets SARS-CoV-2 and the Omicron BA.1 subline;
- the other targets the original strain and the BA.4 and BA.5 subvariants.
According to the data studied by the experts, 1,148,036 individuals over the age of 50 received a booster dose in France, with the monovalent Comirnaty vaccine or one of the bivalent Comirnaty vaccines, between October 6 and November 9, 2022. “Each person who received the monovalent vaccine was matched with a maximum of five people who received the bivalent vaccine on the same day. After matching on the day of vaccine administration, 470,962 people were finally included in the study, of whom 97,234 ( 20.6%) had received the monovalent Cominarty vaccine and 373,728 (79.4%) one of the bivalent Cominarty vaccines.”
The data did not show a link between vaccination with bivalent products and cardiovascular events. “The continued use of bivalent mRNA vaccines against Covid-19 is supported by these reassuring results”concludes the ANSM.
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