#CDC DEATHS FROM COVID VACCINE TRIAL#

adolescents aged 12–17 years who received Pfizer-BioNTech vaccine during December 14, 2020–July 16, 2021. VAERS and v-safe data were assessed by sex, age group, and race/ethnicity for U.S. †† If a report indicated medical attention was sought, VAERS staff members contacted the reporter and encouraged completion of a VAERS report, if indicated. Adolescents who receive a COVID-19 vaccine are eligible to enroll in v-safe, through self-enrollment or as a dependent of a parent or guardian, and receive scheduled text reminders about online health surveys.** Health surveys sent in the first week after vaccination include questions about local injection site and systemic reactions and health impacts. CDC physicians reviewed available information for each decedent to form an impression about cause of death.ĬDC established v-safe, a voluntary smartphone-based active safety surveillance system, to monitor adverse events after COVID-19 vaccination. ¶ Reports of serious adverse events receive follow-up to obtain additional information, including medical records for reports of death, death certificates and autopsy reports are obtained, if available. § VAERS reports are classified as serious if any of the following are reported: hospitalization or prolongation of hospitalization, life-threatening illness, permanent disability, congenital anomaly or birth defect, or death. † Signs, symptoms, and diagnostic findings in VAERS reports are assigned Medical Dictionary for Regulatory Activities (MedDRA) preferred terms by VAERS staff members. Under COVID-19 vaccine EUA requirements, health care providers must report certain adverse events after vaccination to VAERS, including death. VAERS accepts reports from anyone, including health care providers, vaccine manufacturers, and members of the public.

VAERS is a passive vaccine safety surveillance system comanaged by CDC and FDA that monitors adverse events after vaccination ( 7). CDC and FDA continue to monitor vaccine safety and provide data to ACIP to guide COVID-19 vaccine recommendations. Systemic reactions were more common after dose 2. adolescents aged 12–17 years enrolled in v-safe after Pfizer-BioNTech vaccination they reported local (63.4%) and systemic (48.9%) reactions with a frequency similar to that reported in preauthorization clinical trials. adolescents aged 12–17 years had received Pfizer-BioNTech vaccine.* VAERS received 9,246 reports after Pfizer-BioNTech vaccination in this age group 90.7% of these were for nonserious adverse events and 9.3% were for serious adverse events, including myocarditis (4.3%).

As of July 16, 2021, approximately 8.9 million U.S. adolescents aged 12–17 years during December 14, 2020–July 16, 2021. To further characterize safety of the vaccine, adverse events after receipt of Pfizer-BioNTech vaccine reported to the Vaccine Adverse Event Reporting System (VAERS) and adverse events and health impact assessments reported in v-safe (a smartphone-based safety surveillance system) were reviewed for U.S. On June 23, 2021, CDC’s Advisory Committee on Immunization Practices (ACIP) reviewed available data and concluded that the benefits of COVID-19 vaccination to individual persons and the population outweigh the risks for myocarditis and recommended continued use of the vaccine in persons aged ≥12 years ( 6). Beginning in June 2021, cases of myocarditis and myopericarditis (hereafter, myocarditis) after receipt of Pfizer-BioNTech vaccine began to be reported, primarily among young males after receipt of the second dose ( 4, 5).

#CDC DEATHS FROM COVID VACCINE TRIAL#

The Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for Pfizer-BioNTech vaccine for use in persons aged ≥16 years on Decem( 1) the EUA was expanded to include adolescents aged 12–15 years on ( 2), based on results from a Phase 3 clinical trial ( 3). As of July 30, 2021, among the three COVID-19 vaccines authorized for use in the United States, only the Pfizer-BioNTech BNT162b2 mRNA COVID-19 vaccine is authorized for adolescents aged 12–17 years.

Cdc deaths from covid vaccine