VAERS accepts reports of postvaccination adverse events from health care providers, vaccine manufacturers, and members of the public. § CDC’s v-safe call center contacts registrants who indicate that medical care was sought after vaccination and encourages completion of a VAERS report, if indicated. Health surveys sent daily during the first week after administration of each dose include questions about local injection site and systemic reactions and health impacts. The v-safe platform allows existing registrants to report receipt of a COVID-19 booster dose and new registrants to enter information about all doses received ( ). CDC recommends that health care providers and patients be advised that local and systemic reactions are expected after a second booster dose, and that serious adverse events are uncommon. VAERS received 8,515 reports of adverse events after second mRNA booster doses among adults aged ≥50 years, including 8,073 (94.8%) nonserious and 442 (5.1%) serious events. Among registrants who reported homologous vaccination, injection site and systemic reactions were less frequent after the second booster dose than after the first booster dose. † Among 286,380 v-safe registrants aged ≥50 years who reported receiving a second booster of an mRNA vaccine, 86.9% received vaccines from the same manufacturer for all 4 doses (i.e., homologous vaccination). During March 29–July 10, 2022, approximately 16.8 million persons in the United States aged ≥50 years received a fourth dose. passive surveillance system for monitoring adverse events after vaccination, managed by CDC and FDA ( 3). active surveillance system that monitors adverse events occurring after COVID-19 vaccination. V-safe is a voluntary smartphone-based U.S. To characterize the safety of a second mRNA booster dose among persons aged ≥50 years, CDC reviewed adverse events and health impact assessments reported to v-safe and the Vaccine Adverse Event Reporting System (VAERS) after receipt of a second mRNA booster dose during March 29–July 10, 2022.
The Advisory Committee on Immunization Practices (ACIP) recommends that all persons aged ≥5 years receive 1 booster dose of a COVID-19 vaccine after completion of their primary series.* On March 29, 2022, the Food and Drug Administration (FDA) authorized a second mRNA booster dose ≥4 months after receipt of a first booster dose for adults aged ≥50 years and persons aged ≥12 years with moderate to severe immunocompromise ( 1, 2).
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