![]() ![]() adolescents aged 12-17 years who received the Pfizer-BioNTech COVID-19 vaccine between Dec. The analysis reviewed VAERS and v-safe data on U.S. In the MMWR study, researchers analyzed data from the Vaccine Adverse Event Reporting System, which is comanaged by the CDC and FDA, and v-safe, a voluntary smartphone-based system developed by the CDC in response to the pandemic. A month later, the FDA revised the vaccine’s patient and provider fact sheets to include additional information regarding a suggested increased risk of myocarditis and pericarditis following vaccination. The agency expanded the EUA on May 10, 2021, to include adolescents aged 12-15 years. ![]() The FDA issued an emergency use authorization for the Pfizer-BioNTech vaccine for use in people aged 16 and older on Dec. The study also found that while adverse events occurred in roughly one out of every 1,000 patients vaccinated, the majority of those events were considered not serious. ![]() The results indicated that administration of the Pfizer-BioNTech COVID-19 vaccine in adolescents aged 12-17 years produced reactions consistent with those reported in preauthorization clinical trials. 6, analyzed safety data from two different vaccine safety surveillance systems. The study, posted as a Morbidity and Mortality Weekly Report Early Release July 30 and then published in MMWR Aug. ![]()
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