These reactions are rare; in one study, the risk of myocarditis after the second . . January 12, 2023 3:04pm. The body of evidence does not provide certainty that rare serious adverse events were captured due to the median 2-month follow-up and the sample size. All death reports were reviewed by CDC physicians; impressions regarding cause of death were pulmonary embolism (two), suicide (two), intracranial hemorrhage (two), heart failure (one), hemophagocytic lymphohistiocytosis and disseminated Mycobacterium chelonae infection (one), and unknown or pending further records (six). The Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for Pfizer-BioNTe There were no conflicts of interest reported by CDC and ACIP COVID-19 Vaccines Work Group members involved in the GRADE analysis. * Percentage of enrollees who reported a reaction or health impact at least once during days 07 post-vaccination. Systemic reactions in persons aged 12-17 years, Moderna mRNA-1273 COVID-19 vaccine and placebo a Severe: prevents daily activity; Grade 4: emergency room visit or hospitalization b Severe: any use of prescription pain reliever or prevents daily activity; Grade 4: emergency room visit or hospitalization b Mild: does not interfere with activity; moderate: some interference with activity; severe: prevents daily activity; Grade 4: emergency room visit or hospitalization Health and Human Services. VAERS reports are classified as serious if any of the following are reported: hospitalization, prolongation of hospitalization, life-threatening illness, permanent disability, congenital anomaly or birth defect, or death. Few SAEs were reported from dose 1 to data cutoff (April 29, 2022) among the vaccine and placebo groups, (1.4% and 2.3%, respectively in the younger age group and 0.7% and 0.9%, respectively in the older age group). Common conditions among all reports included dizziness (1,862; 20.1%), syncope (1,228; 13.3%), and headache (1,027; 11.1%). The frequency and severity of systemic adverse events was higher after dose 2 than dose 1. The most common side effects of the Pfizer-BioNTech vaccine in kids ages 12 to 15 are "tiredness, headache, chills, muscle pain, fever and joint pain," according to the FDA statement about the. cNumber of subjects with valid and determinate assay results for the specified assay at the given dose and sampling time point. Centers for Disease Control and Prevention. Absolute risk estimates should be interpreted in this context. mmwrq@cdc.gov. 1600 Clifton Road, N.E., Mailstop A27 No SAEs were judged by FDA to be related to vaccination (Table 3c). The certainty in the estimate of the effect for serious adverse events was downgraded one point due to serious concern of indirectness related to the median two months follow-up and two points for imprecision due to the width of the 95% confidence interval (type 4, very low certainty). Redness and swelling were more common after dose 2 than dose 1 or 3. No serious concerns impacted the certainty in the estimate of reactogenicity (type 1, high) (Table 4). Syncope was among the events most commonly reported to VAERS in this age group and is common among adolescents after any vaccination (9). CDC established v-safe, a voluntary smartphone-based active safety surveillance system, to monitor adverse events after COVID-19 vaccination. A medical expert answers common questions about having children younger than 12 years old vaccinated against COVID-19. Corresponding author: Anne M. Hause, voe5@cdc.gov. Shimabukuro TT, Nguyen M, Martin D, DeStefano F. Safety monitoring in the Vaccine Adverse Event Reporting System (VAERS). After title and abstract screening of 5,378 records, 38 studies were identified as eligible for full-text review. Among all vaccine recipients, 90.7% reported at least one systemic reaction in the 7 days after vaccination. Linking to a non-federal website does not constitute an endorsement by CDC or any of its employees of the sponsors or the information and products presented on the website. CDC and FDA will continue to monitor for adverse events, including myocarditis, after mRNA COVID-19 vaccination and share available data with ACIP to guide risk-benefit assessments for all COVID-19 vaccines. Pfizer and Moderna both have COVID vaccines for children as young as 6 months old which may begin going in arms next week. Safety, immunogenicity, and efficacy of the BNT162b2 Covid-19 vaccine in adolescents. Overall, 8,383 (90.7%) VAERS reports were for nonserious events, and 863 (9.3%) for serious events, including death; 609 (70.6%) reports of serious events were among males, and median age was 15 years. The majority of systemic events were mild or moderate in severity, after both doses. So far, the only FDA-authorized emergency-licensed COVID-19 vaccine for children 12 and older is Pfizer-BioNTech. Users are referred to the electronic PDF version (https://www.cdc.gov/mmwr) In preauthorization trials of the Pfizer-BioNTech COVID-19 vaccine, adolescents aged 1217 years reported local and systemic mild and moderate reactions. As part of the process employed by the ACIP, a systematic review and GRADE evaluation of the evidence for Pfizer-BioNTech COVID-19 vaccine was conducted and presented to ACIP. Research shows that this vaccine is about 91% effective in preventing COVID-19 in this age group. One study was reviewed that provided data on outcomes specified for GRADE (Appendix1). part 56; 42 U.S.C. Among those who met the syncope case definition, 147 (16.3%) reported a history of anxiety around needles, and 145 (16.1%) were transported to an emergency department for further evaluation. Overall, the median onset of systemic adverse events in the vaccine group in general was 1 to 4 days after either dose and lasted a median duration of 1 day. Syncope after vaccinationUnited States, January 2005July 2007. The majority of systemic events were mild or moderate in severity, after both doses and in both age groups. If you do not allow these cookies we will not know when you have visited our site, and will not be able to monitor its performance. Carlson asked whether any officials from the Biden administration or representatives from Pfizer company have reached out to the family. All rights reserved. The FDA also has given emergency use authorization to a Moderna COVID-19 vaccine for children ages 6 through 11. Abbreviations: RCT = randomized controlled trial; COVID-19 = coronavirus disease 2019. a. eVaccine efficacy calculated using the standard continuity correction of 0.5. to <50% efficacy). Side effects of COVID-19 vaccines are usually mild. Get all the stories you need-to-know from the most powerful name in news delivered first thing every morning to your inbox. Lymphadenopathy occurred in the arm and neck region and was reported within 2 to 4 days after vaccination. These cookies may also be used for advertising purposes by these third parties. All rights reserved. ** Health surveys sent in the first week after vaccination include questions about local injection site and systemic reactions and health impacts. If a report indicated medical attention was sought, VAERS staff members contacted the reporter and encouraged completion of a VAERS report, if indicated. aAny fever= 38.0C This material may not be published, broadcast, rewritten, Silver Spring, MD: US Department of Health and Human Services, Food and Drug Administration; 2020. If you need to go back and make any changes, you can always do so by going to our Privacy Policy page. Participants in v-safe self-identify the severity of their symptoms, defined as mild (noticeable, but not problematic), moderate (limit normal daily activities), or severe (make daily activities difficult or impossible). COVID-19 Vaccine Safety in Adolescents Aged 1217 Years United States, December 14, 2020July 16, 2021. Pfizer-BioNTech COVID-19 vaccine emergency use authorization review memorandum. CDC reviewed VAERS reports of syncope for additional information. Food and Drug Administration. the date of publication. (Table 5). d Mild: easily consolable; moderate: requiring increased attention; severe: inconsolable; crying cannot be comforted; Grade 4: emergency room visit or hospitalization, aAny fever= 38.0C Mutual Fund and ETF data provided by Refinitiv Lipper. In addition, reactogenicity data from adolescents aged 12-15 years were obtained and reviewed, and were similar to those from adults aged 18-55 years. Parents should ensure that they are scheduling appointments . These cookies allow us to count visits and traffic sources so we can measure and improve the performance of our site. Saving Lives, Protecting People, https://covid.cdc.gov/covid-data-tracker/#datatracker-home, https://www.meddra.org/how-to-use/basics/hierarchy, https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr, https://www.fda.gov/media/150386/download, https://www.fda.gov/media/144416/download, https://www.fda.gov/media/148542/download, https://doi.org/10.1001/jamacardio.2021.2821, https://www.gov.il/en/departments/news/01062021-03, https://doi.org/10.1016/j.vaccine.2015.07.035, https://doi.org/10.2165/00002018-200225060-00001, Centers for Disease Control and Prevention, COVID-19 Vaccine Effectiveness and Safety, U.S. Department of Health & Human Services, Product administered to patient outside of indicated age range, Unable to perform normal daily activities. After dose 1, the older age group (2 4 years) reported pain/tenderness more frequently than the younger age group (6 23 months) (30.8% vs 16.6%); a similar pattern was observed after dose 2 and 3 (31.0% vs 15.0% and 26.7% vs 16.0%, respectively). In addition, efforts were made to obtain unpublished and other relevant data by hand-searching reference lists, and consulting with vaccine manufacturers and subject matter experts. The majority of systemic events were mild or moderate in severity, but there was a higher occurrence of grade 3 or higher reactions in the vaccine group. No serious concerns impacted the certainty of the estimate of reactogenicity. For evaluation of potential harms, data were reviewed from the Phase II/III randomized controlled trial. aDeath, life-threatening event, hospitalization, incapacity to perform normal life functions, medically important event, or congenital anomaly/birth defect. Impressions regarding cause of death did not indicate a pattern suggestive of a causal relationship with vaccination; however, cause of death for some decedents is pending receipt of additional information. No other systemic grade 4 reactions were reported. Among all study vaccine recipients aged 1215 years, 90.9% reported at least one local injection site reaction in the 7 days after vaccination. Some reactogenicity outcomes may also have been reported as serious adverse events, and experiences of reactions immediately after vaccination could have influenced recall or reporting of subsequent serious adverse events. They help us to know which pages are the most and least popular and see how visitors move around the site. The proportions of participants who reported at least 1 serious adverse event were 0.4% in the vaccine group and 0.2% in the placebo group. Mother Stephanie De Garay joins Tucker Carlson Tonight to discuss how her 12-year-old daughter volunteered for the Pfizer vaccine trial and is now in a wheelchair. Photography courtesy . Her neck pulls back.". The critical benefit of interest was prevention of symptomatic laboratory-confirmed COVID-19. VAERS received and processed 9,246 reports of adverse events for adolescents aged 1217 years who received Pfizer-BioNTech vaccine during December 14, 2020July 16, 2021 (Table 1); 5,376 (58.1%) were in adolescents aged 1215 years and 3,870 (41.9%) in persons aged 1617 years. provided as a service to MMWR readers and do not constitute or imply So far, mRNA vaccines from Pfizer and Moderna have received approval in the U.S. for children over 12 years of age, with the Pfizer vaccine approved for 5-12-year-olds at the end of. Cookies used to make website functionality more relevant to you. The Advisory Committee on Immunization Practices conducted a risk-benefit assessment and continues to recommend the Pfizer-BioNTech COVID-19 vaccine for all persons aged 12 years. A Grading of Recommendations, Assessment, Development and Evaluation (GRADE) review of the evidence for benefits and harms for Pfizer-BioNTech coronavirus disease 2019 (COVID-19) vaccine for persons aged 12-15 years was presented to the Advisory Committee for Immunization Practices (ACIP) on May 12, 2021.