Patients who were likely immunocompromised based on diagnosis codes were also excluded. VE was estimated using a case-control test-negative design comparing the odds of a positive SARS-CoV-2 test result between vaccinated (received 2 doses 14 days earlier or 3 doses 7 days earlier) and unvaccinated (received no doses) patients using multivariable logistic regression models*** (7). More info. Other race includes Asian, Native Hawaiian or other Pacific islander, American Indian or Alaska Native, Other not listed, and multiple races. Partners contributing data on medical events were in California (vaccine availability: April 30, 2021), Colorado (May 22, 2021), Indiana (April 27, 2021), Minnesota and Wisconsin (April 21, 2021), New York (April 27, 2021), Oregon and Washington (April 28, 2021), Texas (March 29, 2021), Utah (April 9, 2021). Evaluation of the BNT162b2 Covid-19 vaccine in children 5 to 11 years of age. *** Chronic nonrespiratory condition was defined as the presence of discharge code for heart failure, ischemic heart disease, hypertension, other heart disease, stroke, other cerebrovascular disease, diabetes type I or II, other diabetes, metabolic disease, clinical obesity, clinically underweight, renal disease, liver disease, blood disorder, immunosuppression, organ transplant, cancer, neurologic disorder, musculoskeletal disorder, Down Syndrome, congenital heart disease, neurologic conditions, muscular dystrophy, sickle cell disease, prematurity (<24 weeks), developmental delay, technology dependence, or chronic gastrointestinal disease/irritable bowel syndrome. Health and Human Services. Pfizer's document released by the U.S. Food and Drug Administration contains information about adverse events that occurred following vaccination. Among adolescents aged 1217 years during the full study period including pre-Delta, Delta, and Omicron predominant periods, 2-dose VE estimates were higher (76%83%) 14149 days after receipt of a second dose, and significantly lower (38%46%) at 150 days postvaccination. This includes significant technology enhancements, and process The report by the FDA indicates that the COVID-19 Pfizer vaccine has over 1 200 side effects, that were not disclosed to the public, until last week. Two doses protect against COVID-19associated emergency department and urgent care encounters among children and adolescents. References to non-CDC sites on the Internet are That shot is from Sanofi and AstraZeneca and has already been approved in Europe, NBC News reported. Zakes Bantwini talks about how it feels to bring a Grammy home and repre "This is the start of many things to come for KZN" -Dr Gcina Mhlophe. Among adolescents aged 1215 and 1617 years, VE 14149 days after dose 2 was 92% and 94%, respectively; VE 150 days after dose 2 was 73% and 88%, respectively. That vaccine reduced the risk of severe illness in infants by 82% through the first 90 days of life, NBC News reported. The odds of reporting an adverse reaction or health impact after dose 2 and booster dose were compared using a multivariable generalized estimating equations model; p<0.05 was defined as statistically significant. VAERS reports for adolescents who received a Pfizer-BioNTech booster dose during December 9, 2021February 20, 2022, were described by serious and nonserious classification, demographic characteristics (i.e., sex and age), and MedDRA preferred terms. An FDA decision on that is expected in August. These findings are also consistent with data showing a decline in mRNA VE over time since receipt of the second dose among adolescents and adults (810). 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). Users are referred to the electronic PDF version (https://www.cdc.gov/mmwr) The study noted: There have been three reports of patients having hepatic failure, with one case being acute, after receiving the Pfizer/BioNTech BNT162b2 mRNA vaccine in the United Kingdom between September 12, 2020, and September 4, 2021. An absolute SMD 0.20 indicates a nonnegligible difference in variable distributions between medical events for vaccinated versus unvaccinated patients; single SMD calculated by averaging pairwise comparisons of each vaccinated category versus unvaccinated and separately for patients with SARS-CoV-2positive versus SARS-CoV-2negative test results. You can review and change the way we collect information below. If approved, 20vPnC would have the potential to cover more of the clinically significant remaining burden of infant pneumococcal disease than any other available pneumococcal conjugate vaccine. The content is provided for information purposes only. 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%. 2022 Nov 25;10(12):2012. doi: 10.3390/vaccines10122012. *** Chronic nonrespiratory condition was defined as the presence of discharge code for heart failure, ischemic heart disease, hypertension, other heart disease, stroke, other cerebrovascular disease, diabetes type I or II, other diabetes, metabolic disease, clinical obesity, clinically underweight, renal disease, liver disease, blood disorder, immunosuppression, organ transplant, cancer, neurologic disorder, musculoskeletal disorder, Down Syndrome, congenital heart disease, neurologic conditions, muscular dystrophy, sickle cell disease, prematurity (<24 weeks), developmental delay, technology dependence, or chronic gastrointestinal disease/irritable bowel syndrome. Centers for Disease Control and Prevention. PRAC hi ghlights of March 2022. 1Kaiser Permanente Vaccine Study Center, Kaiser Permanente Northern California Division of Research, Oakland, California; 2Division of Child and Adolescent Health, Department of Pediatrics, Columbia University Vagelos College of Physicians and Surgeons, New York, New York; 3Department of Population and Family Health, Columbia University Mailman School of Public Health, New York, New York; 4NewYork-Presbyterian Hospital, New York, New York; 5Westat, Rockville, Maryland; 6Baylor Scott & White Health, Temple, Texas; 7Texas A&M University College of Medicine, Temple, Texas; 8Childrens Minnesota, Minneapolis, Minnesota; 9Center for Health Research, Kaiser Permanente Northwest, Portland, Oregon; 10Department of Pediatrics, University of Colorado Anschutz Medical Campus, Aurora, Colorado; 11Center for Biomedical Informatics, Regenstrief Institute, Indianapolis, Indiana; 12Indiana University School of Medicine, Indianapolis, Indiana; 13Division of Infectious Diseases and Clinical Epidemiology, Intermountain Healthcare, Salt Lake City, Utah; 14CDC COVID-19 Emergency Response Team; 15HealthPartners Institute, Minneapolis, Minnesota; 16Fairbanks School of Public Health, Indiana University, Indianapolis, Indiana; 17Department of Biomedical Informatics, Columbia University Irving Medical Center, New York, New York;18Regenstrief Institute, Indianapolis, Indiana; 19Vanderbilt University Medical Center, Nashville, Tennessee. 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. The patient was observed and tested for seven days before being transferred to a liver transplant center for further investigation and management. For children aged 511 and persons aged 1215 years, the study period began 5 weeks after the Pfizer-BioNTech vaccine was authorized for each age group (November 2, 2021, and May 12, 2021, respectively). Local reactions like pain at the injection site are the most common. A 55 000-page set of documents revealed the Pfizer Covid vaccine, Comirnaty, has 1,291 side effects. One code in any of the four categories was sufficient for inclusion. Prof Tulio answers. Figure 1. More information: Frenck RW Jr, Klein NP, Kitchin N, et al. provided as a service to MMWR readers and do not constitute or imply On January 3, 2022, authorization was expanded to include persons aged 1215 years, and for all persons aged 12 years, the interval between dose 2 and booster dose was shortened to 5 months (1). ; Overcoming Covid-19 Investigators. Sect. Among 39,217 eligible encounters at 306 ED and UC facilities, 23.4%, 46.2%, and 30.3% were among persons aged 511, 1215, and 1617 years, respectively (Table 1). All authors have completed and submitted the International Committee of Medical Journal Editors form for disclosure of potential conflicts of interest. Vaccines (Basel). Thompson MG, Stenehjem E, Grannis S, et al. 8600 Rockville Pike Percentage of registrants who reported a reaction or health impact at least once during days 07 after vaccination. CDC. CDC. CDC and FDA will continue to monitor vaccine safety and will provide updates as needed to guide COVID-19 vaccination recommendations. Pfizer has also tested its RSV vaccine in pregnant women. Effectiveness of COVID-19 Pfizer-BioNTech BNT162b2 mRNA Vaccination in Preventing COVID-19Associated Emergency Department and Urgent Care Encounters and Hospitalizations Among Nonimmunocompromised Children and Adolescents Aged 517 Years VISION Network, 10 States, April 2021January 2022. SAS software (version 9.4; SAS Institute) was used to conduct all analyses. Safety, immunogenicity, and efficacy of the BNT162b2 Covid-19 vaccine in adolescents. These cookies may also be used for advertising purposes by these third parties. 2020;26:39. The findings in this report also align with studies among adults that report lower VEs during Omicron variant predominance (9,10) and an increase in VE after receipt of a third vaccine dose (9,10). * Registrants aged 15 years must be enrolled by a parent or guardian. 2022 Dec 27;11(1):62. doi: 10.3390/vaccines11010062. Among adolescents aged 1617 years, VE increased to 86% 7 days after dose 3 (booster dose). You can unsubscribe at any time. The most common adverse events reported to VAERS in this age group were administration errors and events, including dizziness, related to syncope, a vasovagal response to vaccination that is common among adolescents after any vaccination (8). The study noted: Adverse events have been mild-to-moderate local reactions and transient systemic symptoms such as fatigue, nausea and headache. You may have also noted that there were reports that there was an intention to suppress the data, explains Semete-Makokotlela. Finally, assessment of myocarditis reports to VAERS is ongoing, and counts are subject to change. This conversion might result in character translation or format errors in the HTML version. Myocarditis cases reported after mRNA-based COVID-19 vaccination, United States, December 2020August 2021. Sect. This may include adverts from us and 3rd parties based on our understanding. Safety Monitoring of COVID-19 Vaccine Booster Doses Among Persons Aged 1217 Years United States, December 9, 2021February 20, 2022. official website and that any information you provide is encrypted Among the 64 VAERS reports of myocarditis, a rare adverse event that has been associated with mRNA-based COVID-19 vaccines (3), after Pfizer-BioNTech booster dose vaccination among adolescents, 32 cases were confirmed at the time of this report. ** 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. Reports of serious adverse events receive follow-up by VAERS staff to obtain additional information, including medical records and, for reports of death, death certificates and autopsy reports, if available. Corresponding author: Nicola P. Klein, Nicola.Klein@kp.org. Partners contributing data on medical events were in California (vaccine availability: April 30, 2021), Colorado (May 22, 2021), Indiana (April 27, 2021), Minnesota and Wisconsin (April 21, 2021), New York (April 27, 2021), Oregon and Washington (April 28, 2021), Texas (March 29, 2021), Utah (April 9, 2021). Pfizer's document is dated April 2021, and the FDA recently released it in response to a Freedom of Information Act (FOIA) request from Public Health and Medical Professionals for Transparency,. Suggested citation for this article: Hause AM, Baggs J, Marquez P, et al. VISION Network VE methods have been previously published (7). Safety, immunogenicity, and efficacy of the BNT162b2 Covid-19 vaccine in adolescents. Polack FP, Thomas SJ, Kitchin N, et al. Centers for Disease Control and Prevention. Hause AM, Baggs J, Marquez P, et al. Vaccination was defined as having received the listed number of doses of an mRNA-based COVID-19 Pfizer-BioNTech vaccine 14 days (for 2 doses) or 7 days (for 3 doses) before the medical event index date, which was the date of respiratory specimen collection associated with the most recent positive or negative SARS-CoV-2 test result before medical event or the admission date if testing only occurred after the admission. allergic reaction; biontech covid-19 vaccine; bnt162b2 vaccine. The total number of participants in the 14 studies was 10,632 participants. Nat Commun. -, Clinical characteristics of coronavirus disease 2019 in China. part 56; 42 U.S.C. The Centers for Disease Control and Prevention (CDC) cannot attest to the accuracy of a non-federal website. The FDA turned over thousands of documents related to its review of Pfizer-BioNTech's COVID-19 vaccine last week, marking the first of several releases mandated by a court in Texas earlier this year. Federal government websites often end in .gov or .mil. The Pfizer-BioNTech vaccine is the first mRNA-based vaccination that enhances immunity. BNT162b2 [COMIRNATY (COVID-19 vaccine, mRNA)] booster (third) dose. N Engl J Med. Among adolescents aged 1617 years, VE after receipt of a third dose 7 days earlier increased to 86%, significantly higher than the VE of 2 doses received 150 days earlier. VE was not calculated for exposure categories with fewer than 20 encounters or with no SARS-CoV-2 testpositive cases. Pfizer-BioNTech COVID-19 Vaccine is a monovalent COVID-19 vaccine that is authorized for emergency use to prevent COVID-19 as: The first two doses of the three-dose primary series for children 6 . A MedDRA PT does not indicate a medically confirmed diagnosis. 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. 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. Local injection site reactions were more commonly reported after booster dose (82.0%) than dose 2 (77.8%) (p<0.001), and systemic reactions were similarly reported after booster dose (77.8%) and dose 2 (77.2%) (p = 0.48) (Figure). Alamer E, Alhazmi A, Qasir NA, Alamer R, Areeshi H, Gohal G, Qadri M, Hashem AM, Algaissi A. Cookies used to track the effectiveness of CDC public health campaigns through clickthrough data. Allison L. Naleway reports institutional support from Pfizer for unrelated study of meningococcal B vaccine safety during pregnancy. part 56. Acute myocarditis was defined as presence of signs and symptoms (one or more new or worsening of the following: chest pain/pressure/discomfort, dyspnea/shortness of breath/pain with breathing, palpitations, or syncope; or two or more of the following in children aged 11 years: irritability, vomiting, poor feeding, tachypnea, or lethargy); and one or more new finding of elevated troponin, electrocardiogram findings consistent with myocarditis, abnormal cardiac function or wall motion on echocardiogram, cardiac magnetic resonance imaging findings consistent with myocarditis, or histopathologic findings consistent with myocarditis; and no other identifiable cause for these findings. Reis BY, Barda N, Leshchinsky M, et al. During that period, the FDA asserts it conducted an intense, robust, and thorough analysis of those documents to assure the public that the Pfizer vaccine was safe and effective. Nevertheless, on 8 March 2022, social media birthed a new hashtag - #pfizerdocuments. Vaccination was defined as having received the listed number of doses of COVID-19 Pfizer-BioNTech vaccine 14 days (for 2 doses) or 7 days (for 3 doses) before the medical event index date, which was the date of respiratory specimen collection associated with the most recent positive or negative SARS-CoV-2 test result before medical event or the admission date if testing only occurred after the admission. provided as a service to MMWR readers and do not constitute or imply 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. During December 9, 2021February 20, 2022, VAERS received and processed 914 reports of adverse events after receipt of a Pfizer-BioNTech booster dose for adolescents; the median age was 16 years, and 459 (50.2%) reports were for adolescent girls. 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