![]() The Moderna trial exhibited a 6 % higher risk of serious adverse events in the vaccine group: risk difference 7.1 per 10,000 (95 % CI -23.2 to 37.4) risk ratio 1.06 (95 % CI 0.84 to 1.33). The Pfizer trial exhibited a 36 % higher risk of serious adverse events in the vaccine group risk difference 18.0 per 10,000 vaccinated (95 % CI 1.2 to 34.9) risk ratio 1.36 (95 % CI 1.02 to 1.83). ![]() Combined, the mRNA vaccines were associated with an excess risk of serious adverse events of special interest of 12.5 per 10,000 vaccinated (95 % CI 2.1 to 22.9) risk ratio 1.43 (95 % CI 1.07 to 1.92). Pfizer and Moderna mRNA COVID-19 vaccines were associated with an excess risk of serious adverse events of special interest of 10.1 and 15.1 per 10,000 vaccinated over placebo baselines of 17.6 and 42.2 (95 % CI -0.4 to 20.6 and -3.6 to 33.8), respectively. Secondary analysis of serious adverse events reported in the placebo-controlled, phase III randomized clinical trials of Pfizer and Moderna mRNA COVID-19 vaccines in adults ( NCT04368728 and NCT04470427), focusing analysis on Brighton Collaboration adverse events of special interest. ![]() We adapted the Brighton Collaboration list to evaluate serious adverse events of special interest observed in mRNA COVID-19 vaccine trials. In 2020, prior to COVID-19 vaccine rollout, the Brighton Collaboration created a priority list, endorsed by the World Health Organization, of potential adverse events relevant to COVID-19 vaccines.
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