Corresponding author: Nicola P. Klein, Nicola.Klein@kp.org. Guan WJ, Ni ZY, Hu Y, et al. provided as a service to MMWR readers and do not constitute or imply of the Moderna COVID-19 Vaccine and the Pfizer-BioNTech COVID-19 Vaccine to authorize bivalent formulations of the vaccines for use as a single . 3501 et seq. Inability to attend school was more frequently reported after a booster dose than after dose 2; however, for many in this age group, receipt of dose 2 occurred during a period of remote learning or summer vacation, which might have affected reporting. Accorsi EK, Britton A, Fleming-Dutra KE, et al. VAERS accepts reports from health care providers, vaccine manufacturers, and members of the public. VAERS reports are classified as serious if there are any reports of hospitalization, prolongation of hospitalization, life-threatening illness, permanent disability, congenital anomaly or birth defect, or death. Figure 1. A 55 000-page set of documents revealed the Pfizer Covid vaccine, Comirnaty, has 1,291 side effects. ** For children aged 511 years and adolescents aged 1215 years, the study period began 5 weeks after the Pfizer-BioNTech vaccine was recommended for their age group. The dates when the Delta and Omicron variants became predominant (accounted for >50% of sequenced viruses) were determined for each study site based on state and national surveillance data. Patients were excluded if they 1) were vaccinated before the CDC recommendation date for their age group, 2) received a third dose before booster doses were recommended for their age group, 3) received a booster dose <5 months after dose 2, 4) received 1 or >3 doses of the vaccine, or 5) if <14 days had elapsed since receipt of dose 2 or <7 days since dose 3. Other race includes Asian, Native Hawaiian or other Pacific islander, American Indian or Alaska Native, Other not listed, and multiple races. The v-safe platform allows current registrants to report receipt of a booster dose of COVID-19 vaccine and new registrants to enter information about all doses received. The study noted: Adverse events have been mild-to-moderate local reactions and transient systemic symptoms such as fatigue, nausea and headache. allergic reaction; biontech covid-19 vaccine; bnt162b2 vaccine. The purpose of this report is to raise awareness of this uncommon but potentially life-threatening side effect". Overall, 2-dose VE against COVID-19associated hospitalization was 73%94%. The vaccine, known as RENOIR, was developed by pharmaceutical giant Pfizer Inc. No other potential conflicts of interest were disclosed. *** Reporting rates for myocarditis were stratified by sex and age group. Pfizer participants reported headaches, while the GSK participants reported more frequent side effects, according to NBC News. In a tight vote, U.S. Food and Drug Administration advisors on Tuesday recommended the approval of an RSV vaccine that could be used in Americans ages 60 and up. A peer reviewed case report detailed a case of hepatotoxicity after receiving a COVID-19 vaccine. If the FDA follows the recommendation of its advisors, which it typically does, Pfizer's vaccine would be the first shot to guard against RSV infection, NBC News reported. Published March 11, 2022 1:57 p.m. PST Share The Food and Drug Administration (FDA) has lost a court battle, to protect the documents they used to approve the company's COVID-19 vaccine. COVID-19 vaccines: comparison of biological, pharmacological characteristics and adverse effects of Pfizer/BioNTech and Moderna Vaccines. What are the implications for public health practice? The exhaustive clinical and laboratory evaluation failed to establish any other plausible etiology besides the vaccine. Cookies used to track the effectiveness of CDC public health campaigns through clickthrough data. A Pfizer document recently released by the Food and Drug Administration describes adverse events reported following vaccination and attests to the continued safety of the company's COVID-19. The same panel of advisors will weigh the potential approval of another respiratory syncytial virus (RSV) vaccine . VAERS reports are classified as serious if there are any reports of hospitalization, prolongation of hospitalization, life-threatening illness, permanent disability, congenital anomaly or birth defect, or death. For adolescents aged 1617 years, the study period began when COVID-19 vaccines were recommended and became available to persons aged 16 years at each study site (AprilMay 2021). All eligible children and adolescents should remain up to date with recommended COVID-19 vaccinations, including a booster dose for those aged 1217 years. All authors have completed and submitted the International Committee of Medical Journal Editors form for disclosure of potential conflicts of interest. JAMA 2022. If you feel any of these symptoms in the days or weeks after the vaccine, you should see a healthcare professional, such as a GP, afterhours service or emergency department - there will be no charge for the consultation. Prof Tulio advises U.S. Food and Drug Administrations (FDAs), Center for Biologics Evaluation and Research (CBER), Worried about the long-term effects of the vaccine? 2020;92:14841490. Pfizer participants reported headaches, while the GSK participants reported more frequent side effects, according to NBC News. You will be subject to the destination website's privacy policy when you follow the link. National Library of Medicine During December 9, 2021February 20, 2022, approximately 2.8 million U.S. adolescents received a Pfizer-BioNTech booster dose. During this period, receipt of 3,418 Pfizer-BioNTech booster doses were reported to v-safe for adolescents. Among 1,699 eligible hospitalizations at 164 hospitals, 16.8%, 43.6%, and 39.6% were among children and adolescents aged 511, 1215 and 1617 years, respectively (Table 3). Click here to sign in with If you need to go back and make any changes, you can always do so by going to our Privacy Policy page. MMWR Morb Mortal Wkly Rep. 2021 Dec 31;70(5152):1755-1760. doi: 10.15585/mmwr.mm705152a1. Most (91.6%) reports to VAERS for adolescents after a Pfizer-BioNTech booster dose were nonserious and generally similar to those reported for this age group after primary series vaccination (4). Accessibility 8600 Rockville Pike El-Shitany NA, Bagher AM, Binmahfouz LS, Eid BG, Almukadi H, Badr-Eldin SM, El-Hamamsy M, Mohammedsaleh ZM, Saleh FM, Almuhayawi MS, Alghamdi SA, Arab RA, Ali SS, Harakeh S, Alghamdi BS. regarding Pfizer/BioNTech'sproposal for the clinical and post-authorization safety data package for the Biologics License Application (BLA) for ourinvestigational COVID-19 Vaccine (BNT162b2). * Funded by CDC, the VISION Network includes Baylor Scott & White Health (Texas), Columbia University Irving Medical Center (New York), HealthPartners (Minnesota and Wisconsin), Intermountain Healthcare (Utah), Kaiser Permanente Northern California (California), Kaiser Permanente Northwest (Oregon and Washington), Regenstrief Institute (Indiana), and University of Colorado (Colorado). Vials labelled "COVID-19 Coronavirus Vaccine" and sryinge are seen in front of displayed Pfizer logo in this illustration taken, February 9, 2021. -, Clinical characteristics of coronavirus disease 2019 in China. Registrants aged 15 years must be enrolled by a parent or guardian. 2020;26:39. Safety, immunogenicity, and efficacy of the BNT162b2 Covid-19 vaccine in adolescents. Health care providers, parents, and adolescents should be advised that local and systemic reactions are expected among adolescents after Pfizer-BioNTech booster vaccination and that serious adverse events are rare. In partnership with CDC, the VISION Network* examined 39,217 emergency department (ED) and urgent care (UC) encounters and 1,699 hospitalizations among persons aged 517 years with COVID-19like illness across 10 states during April 9, 2021January 29, 2022, to estimate VE using a case-control test-negative design. Among adolescents aged 1215 and 1617 years, VE of 2 doses 14149 days earlier against COVID-19associated ED and UC encounters was 83% and 76%, respectively; VE was significantly lower for 2 doses received 150 days earlier (38% and 46%, respectively). The patient was observed and tested for seven days before being transferred to a liver transplant center for further investigation and management. Views equals page views plus PDF downloads. Prof Tulio answers. The efficacy of the BNT162b2 (Pfizer-BioNTech) vaccine against laboratory-confirmed COVID-19 exceeded 90% in clinical trials that included children and adolescents aged 511, 1215, and 1617 years (13). Reactions were mostly mild to moderate in severity and most frequently reported the day immediately after vaccination. Centers for Disease Control and Prevention. Other commonly reported side effects of the Pfizer-BioNTech COVID-19 vaccine include fatigue, headache, and muscle pain. Fatigue, headache, muscle pain. Serious reports to VAERS were reviewed by CDC physicians to form a clinical impression. Careers. Before ** The Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for the Pfizer-BioNTech vaccine for persons aged 16 years on December 11, 2020 (https://www.fda.gov/news-events/press-announcements/fda-takes-key-action-fight-against-covid-19-issuing-emergency-use-authorization-first-covid-19external icon), and CDC recommended the Pfizer-BioNTech vaccine on December 12, 2020 (https://www.cdc.gov/media/releases/2020/s1213-covid-vaccine.html). For adolescents aged 1617 years, the study period began when COVID-19 vaccines became available to all persons aged 16 years at each study site. Meo SA, Bukhari IA, Akram J, Meo AS, Klonoff DC. Kanizsai A, Zavori L, Molnar T, Tks-Fzesi M, Szalai Z, Berecz J, Varnai R, Peterfi Z, Schwarcz A, Csecsei P. Vaccines (Basel). These cookies may also be used for advertising purposes by these third parties. On 1 March 2022 Pfizer . Safety Monitoring of COVID-19 Vaccine Booster Doses Among Persons Aged 1217 Years United States, December 9, 2021February 20, 2022. WEDNESDAY, March 1, 2023 (HealthDay News) -- In a tight vote, U.S. Food and Drug Administration advisors on Tuesday recommended the approval of an RSV vaccine that could be used N Engl J Med 2021;385:21013. ; pfizer vaccine; side effects. All 32 reports were among adolescent boys and 27 (84.4%) patients were hospitalized; as of February 20, 2022, all had been discharged, 18 had recovered, and nine were recovering. In addition, the age SMD calculation comparing negative SARS-CoV-2 test result and positive SARS-CoV-2 test result was generated by directly calculating the SMD for negative SARS-CoV-2 test result and positive SARS-CoV-2 test result. * VE was calculated as [1 odds ratio] x 100%, estimated using a test-negative design, adjusted for age, geographic region, calendar time (days since January 1, 2021), and local virus circulation (percentage of SARS-CoV-2positive results from testing within the counties surrounding the facility on the date of the encounter) and weighted for inverse propensity to be vaccinated or unvaccinated. Among adolescents, reports to v-safe and VAERS after receipt of a booster dose were generally similar to those previously described after a primary series dose, reinforcing that vaccination among this population is safe (4,5). Views equals page views plus PDF downloads. Hepatotoxicity is the medical term fordamage to the liver caused by a medicine, chemical, or herbal or dietary supplement. More info. During December 9, 2021February 20, 2022, v-safe recorded a total of 3,418 Pfizer-BioNTech booster doses administered to adolescents, including 1,952 administered to persons aged 1215 years and 1,466 to those aged 1617 years. HHS Vulnerability Disclosure, Help The number of participants in each study who received the Pfizer-BioNTech vaccine and, MeSH Use of trade names and commercial sources is for identification only and does not imply endorsement by the U.S. Department of Although RSV infection is mild for for many people, the disease can be very serious for infants and older adults. Finally, assessment of myocarditis reports to VAERS is ongoing, and counts are subject to change. Reactions were reported to v-safe with equal or slightly higher frequency after receipt of a booster dose than after dose 2, were primarily mild to moderate in severity, and were most frequently reported the day after vaccination. One code in any of the four categories was sufficient for inclusion. This includes significant technology enhancements, and process official website and that any information you provide is encrypted The average side effects after the first dose were 79% compared with 84% after the second dose. Finally, although the facilities in this study serve heterogeneous populations in 10 states, the findings might not be generalizable to the U.S. population. MMWR Morb Mortal Wkly Rep 2022;71:352358. N Engl J Med 2020;383:260315. 1CDC COVID-19 Emergency Response Team; 2Food and Drug Administration, Silver Spring, Maryland. As of February 20, 2022, only BNT162b2 (Pfizer-BioNTech) COVID-19 vaccine has been authorized for use in persons aged 1217 years in the United States (1). 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. Phase 3 study (NCT04382326), which support the FDA application. They help us to know which pages are the most and least popular and see how visitors move around the site. Health surveys are sent daily during the first week after administration of each dose and include questions about local injection site and systemic reactions and health impacts. CDCs v-safe call center contacts registrants who indicate that medical care was sought after vaccination and encourages completion of a VAERS report, if indicated. Two doses of Pfizer-BioNTech vaccine provided protection against COVID-19 in persons aged 1217 years during Delta predominance, but data during Omicron predominance and among children aged 511 years are lacking. However, we do not guarantee individual replies due to the high volume of messages. N Engl J Med 2022;386:71323. Compared with the Delta predominant period, estimated 2-dose VE for adolescents aged 1215 and 1617 years declined significantly once Omicron became the predominant variant: among adolescents aged 1617 years, VE of 2 doses received 150 days earlier against COVID-19associated ED and UC encounters declined from 77% during Delta predominance to a null VE (3%) during Omicron predominance; however, effectiveness of a third dose received 7 days earlier against COVID-19associated ED and UC encounters during Omicron predominance was 81%. VAERS is a U.S. national passive vaccine safety surveillance system managed by CDC and FDA that monitors adverse events after vaccination (2). CDC will follow up on myocarditis reports at 36 months after onset to assess health and functional status. Moreover, there have been 17 reported cases of liver injury, with two cases being drug-induced.. Evaluation of the BNT162b2 Covid-19 vaccine in children 5 to 11 years of age. Pre-Delta refers to the period before Delta predominance. Further information can be found in the . All dose 2 and booster dose comparisons were statistically significant, except any systemic reaction and needed medical care. Clinician-ordered molecular assays (e.g., real-time reverse transcriptionpolymerase chain reaction) for SARS-CoV-2 occurring 14 days before to <72 hours after the encounter date were included. *** This analysis excluded reports to v-safe or VAERS of persons aged 1215 and 1617 years who were vaccinated before authorization for a booster dose for their age group (January 3, 2022, and December 9, 2021, respectively). For adolescents aged 1617 years, the study period began when COVID-19 vaccines became available to all those aged 16 years at each study site. Among children aged 511 years, VE against laboratory-confirmed COVID-19associated ED and UC encounters 1467 days after dose 2 (the longest interval after dose 2 in this age group) was 46%. The reporting rate of confirmed cases of myocarditis among adolescent boys after Pfizer-BioNTech booster dose vaccination (11.4 per 1 million doses administered) was lower than for dose 2 Pfizer-BioNTech vaccination for boys aged 1215 years (70.7 per 1 million doses administered) or 1617 years (105.9 per 1 million doses administered) (3). The number of observations was insufficient to estimate 3-dose VE for adolescents aged 1215 years. 552a; 44 U.S.C. Clinician-ordered molecular assays (e.g., real-time reverse transcriptionpolymerase chain reaction) for SARS-CoV-2 occurring 14 days before to <72 hours after the encounter date were included. Among children aged 511 years during the full study period, VE of 2 doses (1467 days earlier) against COVID-19associated ED or UC encounters was 46%, which was significantly lower than overall estimates for adolescents aged 1217 years. Pfizer-BioNTech COVID-19 vaccine letter of authorization. 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