Solicited systemic adverse reactions were most common in the vaccine group than the placebo group. bSampling time point was one month after dose two. 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. The observed frequency of reported Bells palsy in the vaccine group is consistent with the background rate in the general population, and there is no basis upon which to conclude a causal relationship. Children will not receive the COVID-19 vaccine without consent from a parent or guardian, who should be present at the time of both vaccine doses for any adolescent age 12-17 years old. This material may not be published, broadcast, rewritten, or redistributed. Among all study vaccine recipients aged 1215 years, 90.9% reported at least one local injection site reaction in the 7 days after vaccination. The Centers for Disease Control and Prevention (CDC) cannot attest to the accuracy of a non-federal website. All authors have completed and submitted the International Committee of Medical Journal Editors form for disclosure of potential conflicts of interest. Data source: Comirnaty and Pfizer-BioNTech COVID-19 Vaccine | FDA. 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. 241(d); 5 U.S.C. Centers for Disease Control and Prevention. 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. 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. After Pfizer-BioNTech vaccine was authorized for adolescents aged 1215 years (beginning May 10, 2021), v-safe enrolled 62,709 adolescents in this age group. Corresponding author: Anne M. Hause, [email protected]. Legal Statement. part 56; 42 U.S.C. However, their reactions to vaccination are expected to be similar to those of young adults who were included. Therefore, v-safe data might not be generalizable to the overall vaccinated adolescent population. Side effects should only last a few days. https://www.meddra.org/how-to-use/basics/hierarchyexternal icon 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. The median onset of local reactions in the vaccine group was 1 to 2 days after either dose and lasted a median duration between 1 and 2 days. As of May 12, 2021, three vaccines have been recommended in adults (aged 18 years) for prevention of COVID-19, caused by the SARS-CoV-2 virus which emerged in late 2019 [2,3,4]. VAERS reports for adolescents aged 1215 years were excluded if vaccination occurred before EUA age expansion on May 10, 2021. Lisa Marie turned to her and Elvis' friend, 80-year-old talent manager Jerry Schilling, and told him . Anne M. Hause, PhD1; Julianne Gee, MPH1; James Baggs, PhD1; Winston E. Abara, MD1; Paige Marquez, MSPH1; Deborah Thompson, MD2; John R. Su, MD, PhD1; Charles Licata, PhD1; Hannah G. Rosenblum, MD1,3; Tanya R. Myers, PhD1; Tom T. Shimabukuro, MD1; David K. Shay, MD1 (View author affiliations). All HTML versions of MMWR articles are generated from final proofs through an automated process. Available from. The initial GRADE evidence level was type 1 (high) for each outcome because the body of evidence was from randomized controlled trials (Table 4). These cookies may also be used for advertising purposes by these third parties. The geometric mean ratio (GMR) for antibodies in 12-15 year-olds compared to 16-25 year-olds was 1.76 (95% CI:1.47, 2.10), and met the noninferiority criteria (i.e., lower bound of the 2-sided 95% confidence interval for GMR >0.67) (Table 3b). These cookies may also be used for advertising purposes by these third parties. a Mild: >2.0 to 5.0 cm; moderate: >5.0 to 10.0 cm; severe: >10.0 cm; Grade 4: necrosis (redness and swelling categories) or exfoliative dermatitis (redness category only). Pfizer and Moderna both have COVID vaccines for children as young as 6 months old which may begin going in arms next week. Pediatrics 2021;e2021052478. Sen. Ron Johnson, R-Wis., has sent letters to the CEOs of Pfizer and Moderna seeking answers about adverse reactions to the COVID-19 vaccine following a June 28 press conference with affected individuals. ", CHINESE WHISTLEBLOWER EXPOSES COVID-19'S ORIGINS ON 'TUCKER CARLSON TODAY', De Garay explained that after receiving the second coronavirus vaccine dose, her daughter started developing severe abdominal and chest pains. References to non-CDC sites on the Internet are There were no conflicts of interest reported by CDC and ACIP COVID-19 Vaccines Work Group members involved in the GRADE analysis. Approximately 129,000 U.S. 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. Patient-important outcomes (including benefits and harms) for assessment were selected by the Work Group during Work Group calls and via online surveys where members were asked to rate and rank the importance of relevant outcomes. We take your privacy seriously. More On: lisa marie presley . the date of publication. OR exp Coronavirus Infections/, novel coronavir* OR novel corona virus* OR 2019 coronavirus OR coronavirus disease OR coronavirus 2019 OR covid19 OR covid 19 OR nCoV OR novel CoV OR CoV 2 OR CoV2 OR sarscov2 OR sars-cov* OR sarscov OR 2019nCoV OR 2019-nCoV, Ahmed F. U.S. A MedDRA-coded event does not indicate a medically confirmed diagnosis. N Engl J Med 2021;385:23950. About 11% of vaccine recipients and 2% of placebo recipients reported any grade 3 local or systemic reactions following either dose 1 or dose 2. These reactions are rare; in one study, the risk of myocarditis after the second . The Advisory Committee on Immunization Practices Interim Recommendation for Use of Moderna COVID-19 Vaccine United States, December 2020. We take your privacy seriously. Among 8.9 million adolescents vaccinated during the study period, VAERS reports were received for approximately one per 1,000 vaccinees, and 90% of these reports were for nonserious conditions. VAERS accepts reports from anyone, including health care providers, vaccine manufacturers, and members of the public. Most recent search conducted April 11, 2021. There were 11 drugs in the singer's blood at the time of his death. 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). . Pfizer and Moderna mRNA vaccines are approved for youth 12 years of age and older. 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. All information these cookies collect is aggregated and therefore anonymous. The majority of systemic events were mild or moderate in severity, after both doses. Quotes displayed in real-time or delayed by at least 15 minutes. Four grade 4 fevers (>40.0C) were reported, two in the vaccine group and two in the placebo group. bMild: 1 to 2 times in 24 hours; moderate: >2 times in 24 hours; severe: requires intravenous hydration; Grade 4: emergency room visit or hospitalization for severe vomiting. 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). 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. 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. Although participants and study staff were blinded to intervention assignments, they may have inferred receipt of vaccine or placebo based on reactogenicity. Among the decedents, four were aged 1215 years and 10 were aged 1617 years. Thank you for taking the time to confirm your preferences. 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. Common conditions among all reports included dizziness (1,862; 20.1%), syncope (1,228; 13.3%), and headache (1,027; 11.1%). Young people at greater risk of serious illness if they catch. Thank you for taking the time to confirm your preferences. 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. The findings summarized in this report are consistent with the safety data observed in preauthorization trials for Pfizer-BioNTech after vaccination among persons aged 1225 years, with the exception of myocarditis, a serious adverse event detected in postauthorization safety monitoring (3). VAERS is a passive vaccine safety surveillance system comanaged by CDC and FDA that monitors adverse events after vaccination (7). As of May 12, 2021, three vaccines have been recommended in adults (aged 18 years) for prevention of COVID-19, caused by the SARS-CoV-2 virus which emerged in late 2019 [ 2,3,4 ]. Jerusalem, Israel: Israeli Ministry of Health; 2021. 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. 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. Surveillance of myocarditis (inflammation of the heart muscle) cases between December 2020 and May 2021 [Press release]. * Percentage of enrollees who reported a reaction or health impact at least once during days 07 post-vaccination. Higgins JPT, Green S (editors). Pain at the injection site was the most frequent and severe solicited local reaction among vaccine recipients and was slightly more common after dose 1. Finally, v-safe is a voluntary self-enrollment program that requires children aged <15 years be enrolled by a parent or guardian and relies on vaccine administrators to promote the program. Other important outcomes included prevention of hospitalization due to COVID-19, prevention of MIS-C, SARS-CoV-2 seroconversion to a non-spike protein, and asymptomatic SARS-CoV-2 infection. Similarly, local and systemic reactions were commonly reported by U.S. adolescents aged 1217 years who enrolled in v-safe; a minority (<25%) reported they were unable to perform normal daily activities the day after receipt of dose 2. Epub June 29, 2021. 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. One participant in the vaccine group reported grade 4 pyrexia (40.4 C). 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. 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. Absolute risk was calculated using the observed risk among placebo recipients in the available body of evidence. The ACIP adopted a modified GRADE approach in 2010 as the framework for evaluating the scientific evidence that informs recommendations for vaccine use. The two pre-specified harms were serious adverse events (critical) and reactogenicity grade 3 (important). No other systemic grade 4 reactions were reported. CDC. Risk of bias related to blinding of participants was present. Although participants and study staff were blinded to intervention assignments, they may have inferred receipt of vaccine or placebo based on reactogenicity. and/or the original MMWR paper copy for printable versions of official text, figures, and tables. No Bells palsy, anaphylaxis or myocarditis was reported among vaccine recipients in this age group. FDA used empirical Bayesian data mining to monitor for disproportional reporting of adverse events by vaccine among VAERS reports for persons aged 1217 years (8). 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. part 46, 21 C.F.R. In addition to data on symptomatic COVID-19 cases, immunobridging data comparing GMTs in 12-15 year-olds to those in 16-25 year-olds in whom clinical efficacy was previously established was provided in support of efficacy. The proportions of participants who reported at least 1 serious adverse event were 0.6% in the vaccine group and 0.5% in the placebo group. Other conditions associated with vasovagal response to vaccination were also frequently reported. 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). 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. The Pfizer and Moderna vaccines are absolutely safe for children over 12 years. 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. 45 C.F.R. CDC is not responsible for Section 508 compliance (accessibility) on other federal or private website. The most common serious adverse events in the vaccine group which were numerically higher than in the placebo group were appendicitis (7 in vaccine vs 2 in placebo), acute myocardial infarction (3 vs 0), and cerebrovascular accident (3 vs 1). They help us to know which pages are the most and least popular and see how visitors move around the site. We take your privacy seriously. Injection site redness and swelling following either dose were reported less frequently than injection site pain. 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? "We wanted to know what symptoms were reported and we couldn't even get an answer on that. 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. bMild: does not interfere with activity; moderate: interferes with activity; severe: prevents daily activity; Grade 4: emergency room visit or hospitalization. The median onset for most systemic events in the 2 4 year age group was 2 days after any dose and all events resolved with a duration of 1 2 days after onset. Outcomes of interest included individual benefits and harms (Table 2). Two serious adverse events were considered by U.S. Food and Drug Administration (FDA) as possibly related to vaccine: shoulder injury possibly related to vaccine administration or to the vaccine itself, and lymphadenopathy involving the axilla contralateral to the vaccine injection site. Mom describes daughters bad COVID vaccine reaction, says shes now in wheelchair. Fever was more common after the second dose than after the first dose. Israeli Ministry of Health. Atlanta, GA 30329-4027 No grade 4 local reactions were reported. 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 track the effectiveness of CDC public health campaigns through clickthrough data. 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. Fourth, this study was not designed to identify all cases of myocarditis; only reports that listed the MedDRA term myocarditis were included. Food and Drug Administration. Vaccine efficacy based on relative risk of 0.03 (95% CI 0.00, 0.49) differs from calculations provided by the sponsor and FDA, which do not include a continuity correction and are based on person-time analyses. All children and youth aged 6 months to 17 years can receive a COVID-19 vaccine. Local reactions were reported by half (48%) of vaccine recipients and at higher rates than placebo recipients. This conversion might result in character translation or format errors in the HTML version. 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. eVaccine efficacy calculated using the standard continuity correction of 0.5. Lisa Marie Presley was 9 years old when her father died of a heart attack on August 16, 1977. A MedDRA-coded event does not indicate a medically confirmed diagnosis. For both age groups, fatigue, headache and new or worsened muscle pain were most common. An EB05 2 (more than twice expected) was considered the threshold for defining a vaccine-event pair reported disproportionately. Sect. * 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. ACIP conducted a risk-benefit assessment based in part on the data presented in this report and continues to recommend the Pfizer-BioNTech COVID-19 vaccine for all persons aged 12 years (6). A lower risk of symptomatic COVID-19 was observed with vaccination compared to placebo (relative risk [RR] 0.03, 95% confidence interval [CI]: 0.00, 0.49, evidence type 1). Photography courtesy . 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). Evidence of benefits and harms were reviewed based on the GRADE approach [1]. CDC is not responsible for Section 508 compliance (accessibility) on other federal or private website. Szarfman A, Machado SG, ONeill RT. Otherwise, occurrence of severe adverse events involving system organ classes and specific preferred terms were balanced between vaccine and placebo groups. 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