![]() ![]() Local reactions in persons ages 2 – 5 years, Moderna mRNA-1273 COVID-19 vaccine and placebo Local reactions in persons ages 6-23 months, Moderna mRNA-1273 COVID-19 vaccine and placeboĪxillary (or groin) swelling or tenderness b, n (%)Īsevere: > 50 mm Grade 4: necrosis or exfoliative dermatitisīsevere: prevents daily activity Grade 4: emergency room visit or hospitalization Table 2. Local reactions in persons ages 6-23 months, Moderna mRNA-1273 COVID-19 vaccine and placebo Overall, the median onset of local reactions in the vaccine group was 1 day after either dose, with a median duration of 2 days. No grade 4 local reactions were reported. Redness and swelling were more common after dose 2. ![]() Injection site redness and swelling following either dose were reported less frequently. Axillary (or groin) swelling or tenderness was reported slightly more frequently in the younger age group than the older age group (9.3% vs 9.1% after dose 2). Axillary (or groin) swelling or tenderness was the second most frequently reported local reaction. After dose 1, the older age group reported pain more frequently than the younger age group (61.4% vs 37.4%) a similar pattern was observed after dose 2 (71.4% vs 46.2%). Pain at the injection site was the most frequent and severe reported solicited local reaction among vaccine recipients. The frequency of local reactions was higher in the older age group (ages 2 to 5 years) than the younger age group (ages 6-23 months) (73.4% vs 54.4% after dose 2). Vaccine recipients reported higher rates of local reactions after dose 2 than dose 1. Local reactions were reported by the majority of vaccine recipients and at higher rates than placebo recipients. All rights reserved.Persons Aged 6 Months – 5 Years Local Reactions These analyses will require public release of participant level datasets.Īdverse events of special interest Brighton Collaboration COVID-19 COVID-19 vaccines Coalition for Epidemic Preparedness Innovations Moderna COVID-19 vaccine mRNA-1273 NCT04368728 NCT04470427 Pfizer-BioNTech COVID-19 vaccine BNT162b2 SARS-CoV-2 Safety Platform for Emergency vACcines Serious adverse events Vaccines mRNA vaccines.Ĭopyright © 2022 Elsevier Ltd. ![]() The excess risk of serious adverse events found in our study points to the need for formal harm-benefit analyses, particularly those that are stratified according to risk of serious COVID-19 outcomes. Combined, there was a 16 % higher risk of serious adverse events in mRNA vaccine recipients: risk difference 13.2 (95 % CI -3.2 to 29.6) risk ratio 1.16 (95 % CI 0.97 to 1.39). ![]() 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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