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). 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. * 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. These cookies allow us to count visits and traffic sources so we can measure and improve the performance of our site. 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. One case involves Maddie de Garay, who was a healthy 12-year-old when she signed up for Pfizer's COVID-19 trial for 12- to 15-year-olds. b Mild: does not interfere with activity; moderate: some interference with activity; severe: prevents daily activity; Grade 4: emergency room visit or hospitalization The final GRADE assessment was limited to the Phase II/III randomized control trial data. An updated letter of authorization for the Pfizer-BioNTech COVID-19 vaccine is available at https://www.fda.gov/media/150386/downloadexternal icon. part 46, 21 C.F.R. There were 11 drugs in the singer . Epub June 29, 2021. Pfizer-BioNTech COVID-19 vaccine EUA amendment review memorandum. Weekly / August 6, 2021 / 70(31);1053-1058. Side effects of COVID-19 vaccines are usually mild. 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. Abbreviation: VAERS=Vaccine Adverse Event Reporting System. Fatigue, headache, chills, and new or worsened muscle pain were most common. Legal Statement. Frenck RW Jr, Klein NP, Kitchin N, et al. There were 11 drugs in the singer's blood at the time of his death. (Table 6). CDC physicians reviewed available information for each decedent to form an impression about cause of death. These reactions are rare; in one study, the risk of myocarditis after the second . 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. Drug Saf 2002;25:38192. Advisory Committee on Immunization Practices (ACIP). a1131 and 1129 persons were randomized to vaccine and placebo. No grade 4 local reactions were reported. The frequency and severity of systemic adverse events was higher after dose 2 than dose 1. Abbreviations: NT50 = 50% neutralizing titer; GMR= geometric mean ratio; CI = confidence interval; LLOQ = lower limit of quantitation. No potential conflicts of interest were disclosed. It contains a lower amount of mRNA than the Pfizer-BioNTech COVID-19 vaccine used for people age 12 and older. The ACIP adopted a modified GRADE approach in 2010 as the framework for evaluating the scientific evidence that informs recommendations for vaccine use. 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. 100,000 people each year develop myocarditis . 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). No serious concerns impacted the certainty in the estimate of reactogenicity (type 1, high) (Table 4). Systemic reactions were more common after dose 2. (Table 5). Data were reviewed from one Phase II/III randomized controlled trial using data provided by the sponsor [7]. She has atube to get her nutrition," De Garay said to Carlson. All authors have completed and submitted the International Committee of Medical Journal Editors form for disclosure of potential conflicts of interest. The Centers for Disease Control and Prevention (CDC) cannot attest to the accuracy of a non-federal website. 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. 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. 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. 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. A medical expert answers common questions about having children younger than 12 years old vaccinated against COVID-19. COVID-19 vaccines side effects are generally mild to moderate in children. All HTML versions of MMWR articles are generated from final proofs through an automated process. There was serious concern of indirectness because the body of evidence does not provide certainty that rare serious adverse events were captured due to the short follow-up and sample size. Thirteen participants (0.9%) in the vaccine group and 1 participant (0.1%) in the placebo group had events of lymphadenopathy. 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. The frequency of systemic adverse events was higher in the younger than the older age group (82.8% vs 70.6%). Although participants and study staff were blinded to intervention assignments, they may have inferred receipt of vaccine or placebo based on reactogenicity. When children will be offered the COVID-19 vaccine. While the child in the video had just been vaccinated against COVID-19, his fainting was unrelated to side effects from the vaccine. For each dose and age group, reactions were reported most frequently the day after vaccination. Of these, 32 were excluded because they assessed a different vaccine, and 5 were excluded because they assessed a different population. Report of boy's death after second vaccine shot comes the same week a CDC panel considered reports of heart inflammation mostly in teen boys and concluded COVID-19 is still riskier to kids. Systemic reactions were more common after dose 2. The Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for Pfizer-BioNTech vaccine for use in persons aged 16 years on December 11, 2020 (1); the EUA was expanded to include adolescents aged 1215 years on May 10, 2021 (2), based on results from a Phase 3 clinical trial (3). This data is presented in Table 7 below. Among a safety expansion cohort (over 2250 children randomized 2:1 vaccine to placebo), 6 participants (0.4%) in the vaccine arm and 3 participants (0.4%) in the placebo arm had events of lymphadenopathy. bBased on data cutoff March 13, 2021; participants had a median of two months follow-up. Within each age group, the frequency and severity of systemic adverse events was higher after dose 2 than dose 1. One study was reviewed that provided data on outcomes specified for GRADE (Appendix1). 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. Fourth, this study was not designed to identify all cases of myocarditis; only reports that listed the MedDRA term myocarditis were included. These supplemental immunobridging data indicate that the immune response in adolescents is at least as strong as that observed in adults. Risk of bias related to blinding of participants and personnel was present. The majority of systemic events were mild or moderate in severity, after both doses. A MedDRA-coded event does not indicate a medically confirmed diagnosis. 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. The Ohio mother added her daughter experienced additional symptoms that included gastroparesis, nausea, vomiting, erratic blood pressure, heart rate, and memory loss. and/or the original MMWR paper copy for printable versions of official text, figures, and tables. Quotes displayed in real-time or delayed by at least 15 minutes. The frequency and severity of systemic adverse events was higher after dose 2 than dose 1. The Pfizer and Moderna vaccines are absolutely safe for children over 12 years. No reports of death to VAERS were determined to be the result of myocarditis. 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). There have been varied reports of adverse reactions to COVID-19 vaccines since countries across the world started mass inoculation of citizens. Eligibility and timing of vaccination The NHS is offering COVID-19 vaccine to children and young people aged 12 to 17 years. On June 23, 2021, CDCs 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). Cookies used to make website functionality more relevant to you. Reactogenicity grade 3 was associated with vaccination (RR 5.49; 95% CI: 3.51, 8.58; evidence type 1). MMWR Morb Mortal Wkly Rep 2021;70:97782. 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. Grade 4: requires emergency room visit or hospitalization. The primary policy question was, Should vaccination with Pfizer-BioNTech COVID-19 vaccine be recommended for persons 12-15 years of age and older during an Emergency Use Authorization? (Table 1). 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). In preauthorization trials of the Pfizer-BioNTech COVID-19 vaccine, adolescents aged 1217 years reported local and systemic mild and moderate reactions. Evidence of benefits and harms were reviewed based on the GRADE approach [1]. Szarfman A, Machado SG, ONeill RT. If you need to go back and make any changes, you can always do so by going to our Privacy Policy page. a larger proportion of those who received a positive test result said they believed receiving a COVID -19 vaccine had made their long-term symptoms better (28. . 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). Marshall M, Ferguson ID, Lewis P, et al. 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. Myocarditis was listed among 4.3% (397) of all VAERS reports. FDA noted that the events were also consistent with viral myositis. Cookies used to track the effectiveness of CDC public health campaigns through clickthrough data. 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. bNone of these SAEs were assessed by the FDA as related to study intervention. SAS software (version 9.4; SAS Institute) was used to conduct all analyses. . The Centers for Disease Control and Prevention (CDC) cannot attest to the accuracy of a non-federal website. 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. "They need to come up with something that's going to treat these people early because all they're going to do is keep getting worse.". The majority of systemic events were mild or moderate in severity, after both doses and in both age groups. Serious adverse events were defined as any untoward medical occurrence that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, or resulted in persistent disability or incapacity. Among all vaccine recipients, 66.6% reported at least one systemic reaction in the 7 days after vaccination. A MedDRA-coded event does not indicate a medically confirmed diagnosis. eVaccine efficacy calculated using the standard continuity correction of 0.5. Absolute risk was calculated using the observed risk among placebo recipients in the available body of evidence. ** 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. Shimabukuro TT, Nguyen M, Martin D, DeStefano F. Safety monitoring in the Vaccine Adverse Event Reporting System (VAERS). 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. They help us to know which pages are the most and least popular and see how visitors move around the site. DOI: http://dx.doi.org/10.15585/mmwr.mm7031e1external icon. 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. 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. You will be subject to the destination website's privacy policy when you follow the link. 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. 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? bSampling time point was one month after dose two. Atlanta, GA 30329-4027 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 . The initial GRADE evidence level was type 1 (high) for each outcome because the body of evidence was from randomized controlled trials (Table 4). Those reactions included nervous system disorders and musculoskeletal and connective tissue disorders for the Pfizer EUA memo. This data is presented in Table 8 below. When to vaccinate children and youth. 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. Abbreviations: RCT = randomized controlled trial; COVID-19 = coronavirus disease 2019. a. A standard continuity correction of 0.5 was used when zero events were observed in one or both arms [6]. Among all vaccine recipients asked to complete diaries of their symptoms during the 7 days after vaccination, 77.4% reported at least one systemic reaction. . 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. Kids typically experience mild side effects, if any, from the COVID-19 vaccine. *** No adverse events were reported disproportionately to VAERS in association with Pfizer-BioNTech vaccination. provided as a service to MMWR readers and do not constitute or imply Fever was more common after the second dose and in the younger group (15.8%) compared to the older group (10.9%). 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. bBased on interim analysis, data cutoff March 13, 2021. aAny fever= 38.0C Injection site swelling following either dose was reported less frequently. 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). Pfizer and Moderna both have COVID vaccines for children as young as 6 months old which may begin going in arms next week. The available data indicated that serious adverse events were more common in vaccine recipients, but certainty in the estimate was very low (RR 2.50; 95% CI: 0.49, 12.84; evidence type 4, serious concern for indirectness, very serious concern for imprecision), and none of these SAEs were assessed by the Food and Drug Administration (FDA) as related to study intervention. 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. aReactogenicity outcome includes local and systemic events, grade 3. Abbreviations:RR = relative risk; CI = confidence interval; RCT = randomized controlled trial. Market data provided by Factset. 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%;). After dose 1, the younger age group reported pain more frequently than the older age group (83.1% vs 71.1%); a similar pattern was observed after dose 2 (77.8% vs 66.1%). The remaining SAEs were considered by FDA to be unrelated to the study vaccine. The critical harm of interest was serious adverse events, including vaccine-associated enhanced disease; reactogenicity grade 3 was deemed an important harm. This material may not be published, broadcast, rewritten, The initial safety findings of Pfizer-BioNTech vaccine administered to U.S. adolescents aged 1217 years are similar to those described in the clinical trials, with the exception of myocarditis, a rare serious adverse event associated with receipt of mRNA-based COVID-19 vaccines; follow-up of reported myocarditis cases is ongoing (6). Jerusalem, Israel: Israeli Ministry of Health; 2021. All children and youth aged 6 months to 17 years can receive a COVID-19 vaccine. The Advisory Committee on Immunization Practices Interim Recommendation for Use of Janssen COVID-19 Vaccine United States, February 2021. "We wanted to know what symptoms were reported and we couldn't even get an answer on that. 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. CDC and FDA continue to monitor vaccine safety and provide data to ACIP to guide COVID-19 vaccine recommendations. 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 COVID-19 Vaccine Safety in Adolescents Aged 1217 Years United States, December 14, 2020July 16, 2021. TUCKER CARLSON: IF PUBLIC OFFICIALS KEEP ACTING LIKE THIS, THERE MAY BE A REVOLUTION, "The response with the person that's leading the vaccine trial has been atrocious," she said. 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. Outcomes of interest included individual benefits and harms (Table 2). CDC is not responsible for the content cNumber of subjects with valid and determinate assay results for the specified assay at the given dose and sampling time point. (Malaysia) that this 12 year old was having an adverse reaction to the 'vaccine,'" text in the video reads. January 13, 2023 7:55am. 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). Approximately 129,000 U.S. adolescents aged 1217 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. 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) 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. This material may not be published, broadcast, rewritten, or redistributed. 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. Fatigue, headache, chills, and new or worsened muscle pain were most common. or redistributed. 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]. Food and Drug Administration. There was also very serious concern for imprecision, due to the width of the confidence interval. 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). 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. 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. 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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. //Www.Fda.Gov/Media/150386/Downloadexternal icon / August 6, 2021 / 70 ( 31 ) ; 1053-1058 for vaccine use shimabukuro TT Nguyen. 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