Health and Human Services. Otherwise, occurrence of severe adverse events involving system organ classes and specific preferred terms were balanced between vaccine and placebo groups. The remaining SAEs were considered by FDA to be unrelated to the study vaccine. Share on Pinterest Twelve-year-old twins Brooklyn (left) and Brielle (right) Lieberman were two participants in Moderna's COVID-19 vaccine trial for children ages 12 to 17. All information these cookies collect is aggregated and therefore anonymous. FDA used the Multi-Item Gamma Poisson Shrinker algorithm to calculate the Empirical Bayes Geometric Mean and its associated 90% confidence interval (EB05, EB95). Vomiting and diarrhea were exceptions, and similar between vaccine and placebo groups and regardless of dose. Thirteen participants (0.9%) in the vaccine group and 1 participant (0.1%) in the placebo group had events of lymphadenopathy. aMild: does not interfere with activity; moderate: some interference with activity; severe: prevents daily activity; Grade 4: emergency room visit or hospitalization for severe fatigue, severe headache, severe muscle pain, or severe joint pain. Cardiovascular serious adverse events were balanced between vaccine and placebo groups. Although participants and study staff were blinded to intervention assignments, they may have inferred receipt of vaccine or placebo based on reactogenicity. All children aged 5 (on or before 31 August 2022) and over can get a 1st and 2nd dose of the coronavirus (COVID-19) vaccine. By age group, 88.7% in the younger group (aged 18 to 55 years) and 79.7% in the older group (aged >55 years) reported at least one local reaction. Pain at the injection site was the most frequent and severe solicited local reaction among vaccine recipients and was slightly more common after dose 2. Fewer than 1% of adolescents aged 1217 years required medical care in the week after receipt of either dose; 56 adolescents (0.04%) were hospitalized. Redness was reported slightly more frequently in the older age group than the younger age group (10.9% vs 7.5% after dose 3). All HTML versions of MMWR articles are generated from final proofs through an automated process. No grade 4 local reactions were reported. b Mild: does not interfere with activity; moderate: some interference with activity; severe: prevents daily activity; Grade 4: emergency room visit or hospitalization Reports of lymphadenopathy were imbalanced with 58 more cases in the vaccine group (64) than the placebo group (6); lymphadenopathy is plausibly related to the vaccine. Systemic reactions in persons aged 12-15 years, Pfizer-BioNTech COVID-19 vaccine and placebo a Mild: does not interfere with activity; moderate: some interference with activity; severe: prevents daily activity; Grade 4: emergency room visit or hospitalization for severe fatigue, severe headache, severe muscle pain, or severe joint pain. Data were reviewed from one Phase II/III randomized controlled trial using data provided by the sponsor [7]. Side effects of COVID-19 vaccine in children: Cases of myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the outer lining of the heart) have been reported after Pfizer-BioNTech COVID-19 vaccination of children ages 12 to 17 years. The effects noted are from an analysis of the evaluable efficacy population with outcomes assessed at least 7 days post dose 2 among persons who received two doses and had no evidence of prior SARS-CoV-2 infection. MMWR Morb Mortal Wkly Rep 2021;70:1053-1058. However, their reactions to vaccination are expected to be similar to those of young adults who were included. The Pfizer/BioNTech COVID-19 vaccine is the only approved vaccine under EUA for those ages 12-15. The critical benefit of interest was prevention of symptomatic laboratory-confirmed COVID-19. The Pfizer-BioNTech and Moderna COVID-19 vaccines are now available for kids aged 6 months and over, and the Novavax shot is available for those 12 and up. The most commonly reported conditions and diagnostic findings among reports of serious events were chest pain (56.4%), increased troponin levels (41.7%), myocarditis (40.3%), increased c-reactive protein (30.6%), and negative SARS-CoV-2 test results (29.4%) (Table 2); these findings are consistent with a diagnosis of myocarditis. She suffered a severe systemic adverse reaction to her second dose of the shot, however, and struggled through 11 ER visits and four hospital admissions in the year and a half that followed. Mild local and systemic reactions are common among adolescents following Pfizer-BioNTech vaccine, and serious adverse events are rare. COVID-19 vaccines side effects are generally mild to moderate in children. On July 30, 2021, this report was posted online as an MMWR Early Release. Saving Lives, Protecting People, Advisory Committee on Immunization Practices (ACIP). Systemic reactions were more common after dose 2. We take your privacy seriously. Among all study vaccine recipients aged 511 years, 86.2% reported at least one local injection site reaction in the 7 days after vaccination. Among the serious reports, myocarditis and other conditions that might be associated with myocarditis were among the most common terms reported; however, these terms did not account for a large proportion of VAERS reports overall. Search terms included coronavirus, COVID-19, SARS-CoV-2, respiratory (symptom, disease, illness, condition), vaccine, immunization, trial, double blind, single blind, placebo, comparative study, phase I, phase II, phase III, immunogenicity, efficacy, effective, adverse, evidence, and variations on these terms (see Appendix 2 for details). Vomiting and diarrhea were exceptions, and similar between vaccine and placebo groups and regardless of dose. bBased on data cutoff March 13, 2021; participants had a median of two months follow-up. 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 1217 years. Market data provided by Factset. The most common solicited systemic adverse reaction after any dose was irritability (43.6% 51.2%) among ages 6 23 months and fatigue (24.5% 29.7%) among ages 2 4 years. The Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for Pfizer-BioNTe Should vaccination with Pfizer-BioNTech COVID-19 vaccine (2-doses, IM) be recommended for persons 12-15 years of age and older under an Emergency Use Authorization? Silver Spring, MD: US Department of Health and Human Services, Food and Drug Administration; 2020. The most commonly observed adverse events were consistent with those reported as local and systemic reactions and/or were consistent with events frequently reported in this age group, including infections and injuries, that were not considered related to vaccination. Oliver S, Gargano J, Scobie H, et al. This was observed with a median follow-up of two months, prompting concern for indirectness due to the short duration of follow-up (i.e., observed outcome of vaccine efficacy at two months does not directly inform vaccine efficacy for any duration longer than two months). The Pfizer-BioNTech COVID-19 vaccine reduced risk of symptomatic laboratory-confirmed COVID-19 when compared to no COVID-19 vaccination (crude VE: 100%; using continuity correction, VE: 97.1%; 95% CI: 51.0%, 99.8%; based on RR: 0.03; 95% CI: 0.00, 0.49) (Table 3a, Table 4). d Mild: 2 to 3 loose stools in 24 hours; moderate: 4 to 5 loose stools in 24 hours; severe: 6 or more loose stools in 24 hours; Grade 4: emergency room visit or hospitalization. The results of the GRADE assessment were presented to ACIP on May 12, 2021. The Wisconsin senator noted that some adverse reactions were detailed in Pfizer's and Moderna's Food and Drug Administration (FDA) emergency use authorization (EUA) memorandums following early clinical trials. d Symptomatic illness defined as least one respiratory or other COVID-19-related symptom (fever, cough, shortness of breath, chills, muscle pain, loss of taste/smell, sore throat, diarrhea, vomiting), confirmed with PCR during or +/-4 days of symptom onset. A small number of v-safe participants reported they were hospitalized after vaccination; however, v-safe does not record reason for hospitalization, and it cannot be determined whether hospitalization was related to vaccination. Cookies used to make website functionality more relevant to you. cMild: 2 to 3 loose stools in 24 hours; moderate: 4 to 5 loose stools in 24 hours; severe: 6 or more loose stools in 24 hours; Grade 4: emergency room visit or hospitalization for severe diarrhea. Trial participants who received vaccine (1,131 aged 1215 years; 537 aged 1625 years) reported local and systemic reactions that were mostly mild (i.e., did not interfere with activity) or moderate (some interference with activity); no serious adverse events related to vaccination were reported (3). 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. adolescents aged 1217 years during December 14, 2020July 16, 2021. The average duration of lymphadenopathy was approximately 10 days. 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. Serious side effects are very rare. After title and abstract screening of 5,378 records, 38 studies were identified as eligible for full-text review. OR severe acute respiratory syndrome*.ti,ab,kw. Family members look on as Jack Frilingos, 12, is inoculated with Pfizer's vaccine against coronavirus disease (COVID-19) after Georgia authorized the vaccine for ages over 12 years, at Dekalb . An Ohio mother is. aNo events were observed in study identified in the review of evidence. This was rated as not serious. cMild: 2 to 3 loose stools in 24 hours; moderate: 4 to 5 loose stools in 24 hours; severe: 6 or more loose stools in 24 hours; Grade 4: emergency room visit or hospitalization for severe diarrhea. https://www.meddra.org/how-to-use/basics/hierarchyexternal icon, Based on the Code of Federal Regulations Title 21. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?frexternal icon. * Signs and symptoms in VAERS reports are assigned MedDRA preferred terms by VAERS staff members. bNone of these SAEs were assessed by the FDA as related to study intervention. VAERS and v-safe data were assessed by sex, age group, and race/ethnicity for U.S. adolescents aged 1217 years who received Pfizer-BioNTech vaccine during December 14, 2020July 16, 2021. Cookies used to make website functionality more relevant to you. They help us to know which pages are the most and least popular and see how visitors move around the site. A MedDRA-coded event does not indicate a medically confirmed diagnosis. No potential conflicts of interest were disclosed. Second, medical review of reported deaths following vaccination is dependent on availability of medical records, death certificates, and autopsy reports, which might be unavailable or not available in a timely manner. 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. We identified studies in Medline, Embase, and Cochrane Library, written in English, and limited to studies published from 2020 to April 11, 2021. Use of trade names and commercial sources is for identification only and does not imply endorsement by the U.S. Department of The initial GRADE evidence level was type 1 (high) for each outcome because the body of evidence was from randomized controlled trials (Table 4). The. One vaccine recipient reported two SAEs (fever and pain in extremity requiring hospitalization) which were considered potentially related by the investigator and FDA. 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. The GRADE assessment across the body of evidence for each outcome was presented in an evidence profile. Redness and swelling were more common after dose 2 than dose 1 or 3. A medical expert answers common questions about having children younger than 12 years old vaccinated against COVID-19. Each VAERS report might be assigned more than one MedDRA preferred term, which can include normal diagnostic findings. So far, the only FDA-authorized emergency-licensed COVID-19 vaccine for children 12 and older is Pfizer-BioNTech. Grade 4: requires emergency room visit or hospitalization. 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. Cookies used to enable you to share pages and content that you find interesting on CDC.gov through third party social networking and other websites. Vaccine 2015;33:4398405. At 11-12 years old, your preteen should receive routinely recommended vaccines to protect them from the following diseases: Meningococcal disease (one dose of MenACWY vaccine) HPV (two doses of vaccine) Tetanus, diphtheria, and whooping cough (pertussis) (one dose of Tdap vaccine) Influenza (Flu) (one dose of vaccine every year) 1 user here now 'Nanobody' Nasal Spray Could Stop Spread Of COVID-19 Virus . She has atube to get her nutrition," De Garay said to Carlson. bMild: does not interfere with activity; moderate: interferes with activity; severe: prevents daily activity; Grade 4: emergency room visit or hospitalization. You will be subject to the destination website's privacy policy when you follow the link. Pfizer and Moderna mRNA vaccines are approved for youth 12 years of age and older. 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. The RCT excluded persons with prior COVID-19 diagnosis, pregnant or breastfeeding women, and persons who were immunocompromised. Pediatrics 2021;e2021052478. The Moderna EUA memo included reactions such as nervous system disorders, vascular disorders and musculoskeletal and connective tissue disorders, according to Johnson's letter. Among all vaccine recipients, 90.7% reported at least one systemic reaction in the 7 days after vaccination. c Mild: 1 to 2 times in 24 hours; moderate: >2 times in 24 hours; severe: requires intravenous hydration; Grade 4: emergency room visit or hospitalization No SAEs were judged by FDA to be related to vaccination (Table 3c). . Outcomes of interest included individual benefits and harms (Table 2). No grade 4 local reactions were reported. Children who turned 5 on or after 1 September 2022 can only get a 1st and 2nd dose of a COVID-19 vaccine if they're either: at high risk due to a health condition or . These cookies perform functions like remembering presentation options or choices and, in some cases, delivery of web content that based on self-identified area of interests. Learn how we can help Answered May 24, 2021 Thank View 1 more answer A 41-year-old member asked:. Fourth, this study was not designed to identify all cases of myocarditis; only reports that listed the MedDRA term myocarditis were included. Weekly / August 6, 2021 / 70(31);1053-1058. 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. These surveillance activities were reviewed by CDC and conducted consistent with applicable federal law and CDC policy.. Lymphadenopathy occurred in the arm and neck region and was reported within 2 to 4 days after vaccination. VAERS reports for adolescents aged 1215 years were excluded if vaccination occurred before EUA age expansion on May 10, 2021. Both companies say side effects for babies and toddlers are. If you need to go back and make any changes, you can always do so by going to our Privacy Policy page. Characteristics of the included study are shown in Appendix 1. Among all study vaccine recipients aged 1215 years, 90.9% reported at least one local injection site reaction in the 7 days after vaccination. N Engl J Med 2021;385:23950. In the hours following the news, some conspiratorial Twitter users began to speculate that the cause of Presley's death at the age of 54 was a COVID-19 vaccine or booster shot. 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. 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