FDA has just updated the COVID-19 vaccines’ safety signals, and we suggest that you check out more important data about the matter below.
FDA updates safety signals for COVID-19 vaccines
According to a recent study conducted by the US Food and Drug Administration (FDA), the updated COVID-19 vaccines may result in heart inflammation and severe allergic shock.
The study was carried out by the FDA, the US National Institutes of Health, and companies like CVS who analyzed health care databases to determine if there were any indications that the Moderna and Pfizer bivalent COVID-19 vaccines could lead to any health problems.
The researchers discovered some safety signals, including myocarditis (a type of heart inflammation) and pericarditis following Pfizer vaccination in adults aged 18 to 35. They also found that Moderna and Pfizer vaccination in people aged 18 to 64 may lead to anaphylaxis, which is a severe form of allergic shock.
The signals were detected in a database by Carelon Research.
According to their study, after Pfizer vaccination, the incidence rate for anaphylaxis was 74.5 cases per 100,000 person-years, whereas after Moderna vaccination, the incidence rate was 109.4 cases per 100,000 person-years.
Regarding myocarditis/pericarditis, the incidence rate after a Pfizer shot was determined to be 131.4 cases per 100,000 person-years. However, the study did not stratify the data by gender, despite previous studies suggesting that myocarditis disproportionately affects males.
Person-years is a measure that this study used. It includes all the time during post-vaccination periods of risk intervals, which vary depending on the health outcome. For anaphylaxis, the risk interval was 0 to 1 day; for myocarditis/pericarditis, it was 0 to 7 days or 0 to 21 days.
The study analyzed data from August 2022 to July 2023 of people aged 6 months and above. It identified some additional issues in the four databases analyzed, but none of them were considered a safety signal. The criteria for safety signal is an indicator that a vaccine is causing an issue.
The bivalent shots were replaced with updated vaccines as their effects were already low and observational studies showed that they wane over time.
The researchers only included individuals who were continuously enrolled in an insurance plan and didn’t suffer any health issues during the “clean interval”. If the health outcome in question did not occur during a certain interval, it was also considered.
However, the authors noted that references for the clean interval could not be found in the literature and were based on clinician input. Pfizer and Moderna, which make COVID-19 shots that use modified messenger RNA (mRNA), did not respond to inquiries.