"The signal detected for myocarditis or pericarditis is consistent with that reported in peer-reviewed publications demonstrating an elevated risk of myocarditis or pericarditis following mRNA vaccines, especially among younger males aged 12 to 29 years," the researchers noted.
"Our meta-analysis highlights a link between SARS-CoV-2 vaccination and new onset or worsening of inflammatory and autoimmune skin diseases," the study authors write.
However, a recent U.K. community-based population study found that those who have previously been infected with SARS-CoV-2, which causes COVID-19, demonstrate a lower rate of new Omicron BA.4/BA.5 infections compared to those who were vaccinated.
The FDA analysts also raised concerns about whether women with medical conditions that should preclude them from taking the pill, primarily breast cancer and undiagnosed vaginal bleeding, would avoid the product.
The study discovered that "the overall risk of retinal vascular occlusion in the vaccinated cohort was 2.19 times higher than that in the unvaccinated cohort at 2 years (95% Cl 2.00–2.39)."