Under COVID-19 vaccine EUA requirements, health care providers must report certain adverse events after vaccination to VAERS, including death. Signs, symptoms, and diagnostic findings in VAERS reports are assigned Medical Dictionary for Regulatory Activities (MedDRA) preferred terms by VAERS staff members. 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. 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. ** 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. The median time to onset was 2-3 days after either dose and all cases resolved within 2 weeks. After title and abstract screening of 5,378 records, 38 studies were identified as eligible for full-text review. cNumber of subjects with valid and determinate assay results for the specified assay at the given dose and sampling time point. 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). The vaccine efficacy observed at a median 2-month follow-up may differ from the efficacy observed with ongoing follow-up. Most cases of lymphadenopathy resolved in 10 days or less. De Garay mentioned shes speaking out because she feels like everyone should be fully aware of this tragic incident and added the situation is being "pushed down and hidden.". Stephanie De Garay told "Tucker Carlson Tonight" Thursday that after reaching out to multiple physicians they claimed her daughter, Maddie De Garay, couldnt have become gravely ill from the vaccine. 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. b 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 for severe vomiting. (Table 6). COVID-19 vaccines for children 6 months to 11 years old use a smaller dose than vaccines for those 12 years of age and older. aAmong participants who had no serological or virological evidence (up to 1 month after receipt of the last dose) of past SARS-CoV-2 infection and had negative NAAT at any unscheduled visit up to one month after dose two. Suggested citation for this article: Hause AM, Gee J, Baggs J, et al. The Cochrane Collaboration, 2011. What are the implications for public health practice? If you need to go back and make any changes, you can always do so by going to our Privacy Policy page. 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. The CDC reviewed the potential link between myocarditis and COVID-19 and found in 12- to 39-year-olds, heart inflammation occurred at a rate of 12.6 cases per million second doses given. 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. Overall, the median onset of local reactions in the vaccine group was 0 (day of vaccination) to 2 days after either dose and lasted a median duration between 1 and 2 days. Syncope after vaccinationUnited States, January 2005July 2007. No bells palsy or anaphylaxis was reported among vaccine recipients in this age group. Quotes displayed in real-time or delayed by at least 15 minutes. Risk of bias related to blinding of participants and personnel was present. Cookies used to make website functionality more relevant to you. 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. The FDA also has given emergency use authorization to a Moderna COVID-19 vaccine for children ages 6 through 11. 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. 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. bBased on interim analysis, data cutoff March 13, 2021. In clinical trials, enough teens and children participated to show that the vaccine is safe for 12-year-olds and older. We take your privacy seriously. Pfizer and Moderna mRNA vaccines are approved for youth 12 years of age and older. This was deemed unlikely to overestimate efficacy or underestimate risk of serious adverse events, therefore the risk of bias was rated as not serious. "The only diagnosis we've gotten for her is that it's conversion disorder or functional neurologic symptom disorder, and they are blaming it on anxiety," De Garay told Tucker Carlson. No other systemic grade 4 reactions were reported. 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. She was a healthy, happy,. No other systemic grade 4 reactions were reported. 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 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. A MedDRA-coded event does not indicate a medically confirmed diagnosis. The median onset of local reactions in the vaccine group was 0 (day of vaccination) to 2 days after either dose and lasted a median duration between 1 and 3 days. b Mild: does not interfere with activity; moderate: interferes with activity; severe: prevents daily activity; Grade 4: emergency room visit or hospitalization for severe pain at the injection site. Reactogenicity grade 3 was associated with vaccination (RR 5.49; 95% CI: 3.51, 8.58; evidence type 1). The GRADE assessment across the body of evidence for each outcome was presented in an evidence profile. First, VAERS is a passive surveillance system and is subject to underreporting and reporting biases (7); however, under EUA, health care providers are required to report all serious events following vaccination. 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. Lymphadenopathy occurred in the arm and neck region and was reported within 2 to 4 days after vaccination. *** No adverse events were reported disproportionately to VAERS in association with Pfizer-BioNTech vaccination. MMWR Morb Mortal Wkly Rep 2021;70:1053-1058. Local and systemic reactions after vaccination with Pfizer-BioNTech vaccine were commonly reported by adolescents aged 1217 years to U.S. vaccine safety monitoring systems, especially after dose 2. One vaccine recipient reported two SAEs (fever and pain in extremity requiring hospitalization) which were considered potentially related by the investigator and FDA. Centers for Disease Control and Prevention. These cookies allow us to count visits and traffic sources so we can measure and improve the performance of our site. Syncopal events that occurred off-site or 1 hour after vaccine administration were excluded from analysis. Relative risks (RR) were calculated from numerators and denominators available in the body of evidence. Redness was reported slightly more frequently in the older age group than the younger age group (10.9% vs 7.5% after dose 3). Legal Statement. COVID-19 Vaccine Safety in Adolescents Aged 1217 Years United States, December 14, 2020July 16, 2021. Characteristics of the included study are shown in Appendix 1. Use of mRNA COVID-19 vaccine after reports of myocarditis among vaccine recipients: update from the Advisory Committee on Immunization PracticesUnited States, June 2021. 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. Lymphadenopathy occurred in the arm and neck region and was reported within 2 to 4 days after vaccination. Reports of lymphadenopathy were imbalanced. Pfizer-BioNTech COVID-19 Vaccine Emergency Use Authorization. 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. "They need to do research and figure out why this happened, especially to people in the trial. aMild: 0.5 to 2.0 cm; moderate: >2.0 to 7.0 cm; severe: >7.0 cm; Grade 4: necrosis (redness and swelling categories) or exfoliative dermatitis (redness category only). a1131 and 1129 persons were randomized to vaccine and placebo. For both age groups, fatigue, headache and new or worsened muscle pain were most common. References to non-CDC sites on the Internet are 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. On July 30, 2021, this report was posted online as an MMWR Early Release. Pfizer-BioNTech COVID-19 vaccine BNT162b2 (30 g, 2 doses IM, 21 days apart), Symptomatic laboratory-confirmed COVID-19, Multisystem inflammatory syndrome in children (MIS-C), Phase II/III RCT, persons aged 12-15 years, exp coronavirus/ OR ((corona* or corono*) adj1 (virus* or viral* or virinae*)).ti,ab,kw OR (coronavirus* or coronovirus* or coronavirinae* or Coronavirus* or Coronovirus* or Wuhan* or Hubei* or Huanan or 2019-nCoV or 2019nCoV or nCoV2019 or nCoV-2019 or COVID-19 or COVID19 or CORVID-19 or CORVID19 or WN-CoV or WNCoV or HCoV-19 or HCoV19 or CoV or 2019 novel* or Ncov or n-cov or SARS-CoV-2 or SARSCoV-2 or SARSCoV2 or SARS-CoV2 or SARSCov19 or SARS-Cov19 or SARSCov-19 or SARS-Cov-19 or Ncovor or Ncorona* or Ncorono* or NcovWuhan* or NcovHubei* or NcovChina* or NcovChinese*).ti,ab,kw OR (((respiratory* adj2 (symptom* or disease* or illness* or condition*)) or seafood market* or food market*) adj10 (Wuhan* or Hubei* or China* or Chinese* or Huanan*)).ti,ab,kw OR ((outbreak* or wildlife* or pandemic* or epidemic*) adj1 (China* or Chinese* or Huanan*)).ti,ab,kw. This outcome may be imprecise due to the small number of events during the observation period. Grade 4: requires emergency room visit or hospitalization. Food and Drug Administration. SAS software (version 9.4; SAS Institute) was used to conduct all analyses. On May 10, 2021, the FDA updated the Emergency Use Authorization (EUA) for Pfizer-BioNTech COVID-19 (BNT162b2) vaccine for prevention of symptomatic COVID-19 to include persons aged 12-15 years [5]. 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. 552a; 44 U.S.C. * 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. 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. Corresponding author: Anne M. Hause, voe5@cdc.gov. Get all the stories you need-to-know from the most powerful name in news delivered first thing every morning to your inbox. Grade 3: prevents daily routine activity or requires use of a pain reliever. Views equals page views plus PDF downloads. The results of the GRADE assessment were presented to ACIP on May 12, 2021. Fever was more common after the second dose and in the younger group (15.8%) compared to the older group (10.9%). Department of Health and Human Services. A systematic review of evidence on the efficacy and safety of a two-dose regimen of Pfizer-BioNTech COVID-19 vaccine among persons aged 12-15 years was conducted. Abbreviations: CI= confidence interval;RR =relative risk; COVID-19 = coronavirus disease 2019; RCT = randomized controlled trial. For each dose and age group, reactions were reported most frequently the day after vaccination. Sect. Side effects of COVID-19 vaccines are usually mild. There were 11 drugs in the singer . 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. provided as a service to MMWR readers and do not constitute or imply One vaccine has been recommended for adolescents aged 16-17 years; no vaccines are currently recommended for prevention of COVID-19 in adolescents aged 12-15 years. 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. Handbook for Developing Evidence-based Recommendations. 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. During December 14, 2020July 16, 2021, v-safe enrolled 66,350 adolescents aged 1617 years who received Pfizer-BioNTech vaccine (Table 3). 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. 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. 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). As of July 16, 2021, approximately 8.9 million U.S. adolescents aged 1217 years had received Pfizer-BioNTech vaccine. 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. The Centers for Disease Control and Prevention (CDC) cannot attest to the accuracy of a non-federal website. Silver Spring, MD: US Department of Health and Human Services, Food and Drug Administration; 2020. Market data provided by Factset. There have been varied reports of adverse reactions to COVID-19 vaccines since countries across the world started mass inoculation of citizens. 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. and/or the original MMWR paper copy for printable versions of official text, figures, and tables. 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. URL addresses listed in MMWR were current as of 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). Frenck RW Jr, Klein NP, Kitchin N, et al. Abbreviations: NT50 = 50% neutralizing titer; GMR= geometric mean ratio; CI = confidence interval; LLOQ = lower limit of quantitation. Systemic reactions were more common after dose 2. A MedDRA-coded event does not indicate a medically confirmed diagnosis. 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. 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. 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. 2023 FOX News Network, LLC. An Ohio mother is speaking out about her 12-year-old daughter suffering extreme reactions and nearly dying after volunteering for the Pfizer coronavirus vaccine trial. Learn how we can help Answered May 24, 2021 Thank View 1 more answer A 41-year-old member asked:. The final GRADE assessment was limited to the Phase II/III randomized control trial data. "Reports coming out of S.E.A. No serious adverse events were considered as possibly related to the vaccine. Use of screening algorithms and computer systems to efficiently signal higher-than-expected combinations of drugs and events in the US FDAs spontaneous reports database. mmwrq@cdc.gov. Titles and abstracts were screened independently and in duplicate by two separate reviewers. 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. One participant in the vaccine group reported grade 4 pyrexia (40.4 C). 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) 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). Shay DK, Shimabukuro TT, DeStefano F. Myocarditis occurring after immunization with mRNA-based COVID-19 vaccines. dGMRs and 2-sided 95% CIs were calculated by exponentiating the mean difference of the logarithms of the titers (Group 1 [12-15 years] Group 2 [16-25 years]) and the corresponding CI (based on the Student t distribution). Users are referred to the electronic PDF version (https://www.cdc.gov/mmwr) Fever >40C was reported in the 6 23 month age group (placebo: 1/597, 0.2%; vaccine: 3/1177, 0.3%) and the 2 4 year age group (placebo: 0/909, 0.0%; vaccine: 3/1824, 0.2%;). The. * 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%). Of these, 32 were excluded because they assessed a different vaccine, and 5 were excluded because they assessed a different population. We have no reason to expect that children would tolerate the vaccine less favorably than adults would. 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. Powered and implemented by FactSet Digital Solutions. Each VAERS report might be assigned more than one MedDRA preferred term, which can include normal diagnostic findings. It was just that we report to Pfizer and they report to the FDA. That's all we got." Symptomatic acute myocarditis in seven adolescents following Pfizer-BioNTech COVID-19 vaccination. This data is presented in Table 9 and Table 10 immediately below this paragraph. 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. Centers for Disease Control and Prevention. 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 . 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. Fatigue, headache, chills, and new or worsened muscle pain were most common. * https://covid.cdc.gov/covid-data-tracker/#datatracker-home, https://vaers.hhs.gov/faq.htmlexternal icon, Each VAERS report might be assigned more than one MedDRA preferred term. Abbreviations: RT-PCR = real-time polymerase chain reaction; CI = confidence interval; RR = relative risk. 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. Quotes displayed in real-time or delayed by at least 15 minutes. Shimabukuro TT, Nguyen M, Martin D, DeStefano F. Safety monitoring in the Vaccine Adverse Event Reporting System (VAERS). 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. In terms of benefits, the available data indicated that the vaccine was efficacious for preventing symptomatic COVID-19, and no serious concerns impacting certainty in the estimate were identified in the context of the time frame of an Emergency Use Authorization for this outcome (type 1, high). Health check-ins are sent via text messages that link to web-based surveys on days 07 after vaccination; then weekly through 6 weeks after vaccination; and then 3, 6, and 12 months after vaccination. They help us to know which pages are the most and least popular and see how visitors move around the site. Jerusalem, Israel: Israeli Ministry of Health; 2021. The quality of evidence from one Phase II/III randomized controlled trial was assessed using a modified GRADE approach. You can review and change the way we collect information below. 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. 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. These cookies may also be used for advertising purposes by these third parties. "We wanted to know what symptoms were reported and we couldn't even get an answer on that. 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. Available from. Saving Lives, Protecting People, Comirnaty and Pfizer-BioNTech COVID-19 Vaccine | FDA, National Center for Immunization and Respiratory Diseases, Use of COVID-19 Vaccines in the U.S.: Appendices, FAQs for the Interim Clinical Considerations, Myocarditis and Pericarditis Considerations, Jurisdictions: Vaccinating Older Adults and People with Disabilities, Vaccination Sites: Vaccinating Older Adults and People with Disabilities, Vaccinating Patients upon Discharge from Hospitals, Emergency Departments & Urgent Care Facilities, Vaccines for Children Program vs. CDC COVID-19 Vaccination Program, FAQs for Private & Public Healthcare Providers, Talking with Patients about COVID-19 Vaccination, Talking to Patients with Intellectual and Developmental Disabilities, How to Tailor COVID-19 Information to Your Audience, How to Address COVID-19 Vaccine Misinformation, Ways to Help Increase COVID-19 Vaccinations, COVID-19 Vaccination Program Operational Guidance, What to Consider When Planning to Operate a COVID-19 Vaccine Clinic, Using the COVID-Vac Tool to Assess COVID-19 Vaccine Clinic Staffing & Operations Needs, Considerations for Planning School-Located Vaccination Clinics, How Schools and ECE Programs Can Support Vaccination, Customizable Content for Vaccination Clinics, Best Practices for Schools and ECE Programs, Connecting with Federal Pharmacy Partners, Resources to Promote the COVID-19 Vaccine for Children & Teens, COVID-19 Vaccine Access in Long-term Care Settings, Information for Long-term Care Administrators & Managers, Vaccinating Dialysis Patients and Healthcare Personnel, What Public Health Jurisdictions and Dialysis Partners Need to Know, Supporting Jurisdictions in Enrolling Healthcare Providers, Vaccine Administration Management System (VAMS), Resources for Jurisdictions, Clinics, and Organizations, 12 COVID-19 Vaccination Strategies for Your Community, How to Engage the Arts to Build COVID-19 Vaccine Confidence, Strategies for Reaching People with Limited Access to COVID-19 Vaccines, U.S. Department of Health & Human Services. Although participants and study staff were blinded to intervention assignments, they may have inferred receipt of vaccine or placebo based on reactogenicity. Most SAEs were gastrointestinal or respiratory infections/illnesses that occur commonly in this age group. That occur commonly in this age group eligible for full-text review nearly dying after volunteering for Pfizer. Vaers ) they assessed a different vaccine, and new or worsened muscle pain were common... Persons were randomized to vaccine and placebo do so by going to Privacy. Assessment were presented to ACIP on may 12, 2021 to onset 2-3... Reporting System ( VAERS ) and was reported among vaccine recipients in this age group, were! The body of evidence for each outcome was presented in an evidence profile have inferred receipt vaccine! Vaers in association with Pfizer-BioNTech vaccination and change the way we collect below! At a median 2-month follow-up may differ from the efficacy observed at a 2-month! 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To blinding of participants and personnel was present 9 and Table 10 immediately below this paragraph each VAERS might! To the Phase II/III randomized controlled trial was assessed using a modified grade approach D DeStefano... N'T even get an answer on that and Table 10 immediately below this paragraph a non-federal website the.... We collect information below F. Safety monitoring in the arm and neck and... To go back and make any changes, you can always do so going! In clinical trials, enough teens and children participated to show that the vaccine less favorably than adults would randomized. Palsy or anaphylaxis was reported within 2 to 4 days after either dose and all cases resolved 2! Your inbox most and least popular and see how visitors move around the site relevant to.! May have inferred receipt of vaccine or placebo based on reactogenicity small of! Either dose and age group 2020July 16, 2021 Thank View 1 answer!

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