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. SAS software (version 9.4; SAS Institute) was used to conduct all analyses. Estimated date of Delta and Omicron predominance at contributing sites: California (Delta: June 23, 2021; Omicron: December 21, 2021); Colorado (Delta: June 3, 2021; Omicron: December 19, 2021); Indiana (Delta: June 23, 2021; Omicron: December 26, 2021); Minnesota and Wisconsin (Delta: June 28, 2021; Omicron: December 25, 2021); New York (Delta: June 30, 2021; Omicron: December 18, 2021); Oregon and Washington (Delta: June 30, 2021; Omicron: December 24, 2021); Texas (Delta: July 3, 2021; Omicron: December 16, 2021); Utah (Delta: June 1, 2021; Omicron December 24, 2021). 1CDC COVID-19 Emergency Response Team; 2Food and Drug Administration, Silver Spring, Maryland. 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%. Britton A, Fleming-Dutra KE, Shang N, et al. Int J Gen 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. Health care providers are required by COVID-19 vaccine EUAs to report certain adverse events after vaccination to VAERS, including death. Serious reports to VAERS were reviewed by CDC physicians to form a clinical impression. sharing sensitive information, make sure youre on a federal or. 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). Allison L. Naleway reports institutional support from Pfizer for unrelated study of meningococcal B vaccine safety during pregnancy. Medical events with an encounter or discharge code consistent with COVID-19like illness were included, using International Classification of Disease, Ninth Revision and International Classification of Diseases, Tenth Revision. The included searching terms were a combination of "Pfizer vaccine and Side effects," "BioNTech vaccine and side effects," and "BNT162b2 vaccine and side effects," as well as all synonyms. Most encounters among adolescents aged 1215 years and 1617 years occurred during the Delta predominant period (14,491 [79.9%] and 8,800 [74.0%], respectively); among children aged 511 years, most (6,424 [70.0%]) occurred during the Omicron predominant period, reflecting differences in the dates when vaccines became available for the respective age groups. Nicola P. Klein, MD1; Melissa S. Stockwell, MD2,3,4; Maria Demarco, PhD5; Manjusha Gaglani, MBBS6,7; Anupam B. Kharbanda, MD8; Stephanie A. Irving, MHS9; Suchitra Rao, MBBS10; Shaun J. Grannis, MD11,12; Kristin Dascomb, MD13; Kempapura Murthy, MBBS6; Elizabeth A. Rowley, DrPH5; Alexandra F. Dalton, PhD14; Malini B. DeSilva, MD15; Brian E. Dixon, PhD11,16; Karthik Natarajan, PhD4,17; Edward Stenehjem, MD13; Allison L. Naleway, PhD9; Ned Lewis, MPH1; Toan C. Ong, PhD10; Palak Patel, MBBS14; Deepika Konatham6; Peter J. Embi, MD12,18,19; Sarah E. Reese, PhD5; Jungmi Han17; Nancy Grisel, MPP13; Kristin Goddard, MPH1; Michelle A. Barron, MD10; Monica Dickerson14; I-Chia Liao, MPH6; William F. Fadel, PhD11,16; Duck-Hye Yang, PhD5; Julie Arndorfer, MPH13; Bruce Fireman1; Eric P. Griggs, MPH14; Nimish R. Valvi, DrPH11; Carly Hallowell, MPH5; Ousseny Zerbo, PhD1; Sue Reynolds, PhD14; Jill Ferdinands, PhD14; Mehiret H. Wondimu, MPH14; Jeremiah Williams, MPH14; Catherine H. Bozio, PhD14; Ruth Link-Gelles, PhD14; Eduardo Azziz-Baumgartner, MD14; Stephanie J. Schrag, DPhil14; Mark G. Thompson, PhD14; Jennifer R. Verani, MD14 (View author affiliations). Accessibility More information: On January 5, 2022, CDC expanded its recommendation for a booster 5 months after receipt of the second dose of the Pfizer-BioNTech vaccine to include adolescents aged 1215 years (https://www.cdc.gov/media/releases/2022/s0105-Booster-Shot.html). However, vaccine effectiveness (VE) was lower during Omicron predominance and decreased with time since vaccination; a booster dose restored VE to 81% among adolescents aged 1617 years. This systematic review was undertaken to assess the Pfizer-BioNTech vaccine side effects by reviewing the previous studies. 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. References to non-CDC sites on the Internet are
Careers. Nat Commun. It was considered a vital component of living endemically with COVID-19. The purpose of this report is to raise awareness of this uncommon but potentially life-threatening side effect". Evaluation of the BNT162b2 Covid-19 vaccine in children 5 to 11 years of age. Effectiveness of Covid-19 vaccines in ambulatory and inpatient care settings. Preliminary safety findings for booster doses among adolescents are generally similar to those reported after a primary series in this age group. Other commonly reported side effects of the Pfizer-BioNTech COVID-19 vaccine include fatigue, headache, and muscle pain. Abukhalil AD, Shatat SS, Abushehadeh RR, Al-Shami N, Naseef HA, Rabba A. BMC Infect Dis. Among adolescents aged 1617 years, VE increased to 86% 7 days after dose 3 (booster dose). 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). Although RSV infection is mild for for many people, the disease can be very serious for infants and older adults. CDC is not responsible for Section 508 compliance (accessibility) on other federal or private website. ** VAERS staff members assign Medical Dictionary for Regulatory Activities (MedDRA) preferred terms to the signs, symptoms, and diagnostic findings in VAERS reports. Serious reports to VAERS were reviewed by CDC physicians to form a clinical impression based on available data. This includes significant technology enhancements, and process Hause AM, Baggs J, Marquez P, Myers TR, Gee J, Su JR, Zhang B, Thompson D, Shimabukuro TT, Shay DK. 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. 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. Most hospitalizations of adolescents aged 1215 years (613 [82.7%]) and 1617 years (476 [70.7%]) occurred during Delta predominance, whereas two thirds of hospitalizations among children aged 511 years (190 [66.7%]) occurred during Omicron predominance. Health surveys are sent for the most recent dose entered 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. MMWR Morb Mortal Wkly Rep 2008;57:45760. Everything you need to know about #EveryCallerWins and how to win! Hause AM, Baggs J, Marquez P, et al. 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). This is a case of hepatotoxicity in a 14-year-old patient that occurred after receiving the second dose of the Pfizer/BioNTech BNT162b2 mRNA vaccine. The number of observations was insufficient to estimate 3-dose VE for adolescents aged 1215 years. Hepatotoxicity is the medical term fordamage to the liver caused by a medicine, chemical, or herbal or dietary supplement. Suchitra Rao reports grants from GSK and Biofire Diagnostics. Safety, immunogenicity, and efficacy of the BNT162b2 Covid-19 vaccine in adolescents. In clinical trials, two participants in their . "At least now we know why the FDA and Pfizer wanted to keep this data under wraps for 75 years. Effectiveness of BNT162b2 vaccine against Delta variant in adolescents. Stephanie A. Irving and Elizabeth A. Rowley report institutional support from Westat. * Registrants aged 15 years must be enrolled by a parent or guardian. Department of Health and Human Services. One code in any of the four categories was sufficient for inclusion. Figure 1. No other potential conflicts of interest were disclosed. Vials labelled "COVID-19 Coronavirus Vaccine" and sryinge are seen in front of displayed Pfizer logo in this illustration taken, February 9, 2021. Stunningly, Pfizer submitted falsified mRNA analytical reports to multiple health authorities. Oster ME, Shay DK, Su JR, et al. You can review and change the way we collect information below. Updated March 11, 2022, 3:47 p.m. A monoclonal antibody injection designed for babies is also under FDA review. Pfizer participants reported headaches, while the GSK participants reported more frequent side effects, according to NBC News. the date of publication. During the full study period, including pre-Delta, Delta, and Omicron predominant periods, VE against laboratory-confirmed COVID-19associated hospitalization among children aged 511 years was 74% 1467 days after dose 2, with wide CIs that included zero. All dose 2 and booster dose comparisons were statistically significant, except any systemic reaction and needed medical care. 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. *** Reporting rates for myocarditis were stratified by sex and age group. 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. She denied taking other medications including over-the-counter agents and herbal supplements. considered spontaneously reported cases of suspected side effects, i.e. 2022 Nov 25;10(12):2012. doi: 10.3390/vaccines10122012. Also, help reduce vaccine hesitancy among individuals worried about vaccine safety and possible adverse effects. Vaccinations prevented severe clinical complications of COVID-19. The study period began in September 2021 for partners located in Texas. 2021, filed with the SEC on March 30, 2022, . Disclaimer. Covid-19: Doctors sceptical of fourth jab, Covid vaccine: Cardiac arrest is 'suspected side effect', Pfizer vaccine: Adverse events could impact the kidney or liver, Pfizer vaccine: Hepatotoxicity and kidney stones have been found in rare cases relating to vaccine, Cancer: Four 'alarm' symptoms that predict a cancer diagnosis, Statins side effects: Statin users at greater risk of nerve damage, Statins: 'Common' side effects could include bleed in the brain, Cancer warning: The persistent toilet sign signalling a tumour growing inside the colon, Cancer symptoms: Two colours in your urine that are big red flags, according to expert, Tom Hanks health: 'I was a total idiot' - Film star on diagnosis of common condition, Cancer: The 'kissing disease' that may lead to nasopharyngeal cancer symptoms, Pfizer side effects: Four side effects that affect the face, Pfizer vaccine: Side effects could include three tongue conditions, Pfizer vaccine: Thousands of adverse events uncovered. *** With a test-negative design, vaccine performance is assessed by comparing the odds of antecedent vaccination among case-patients with acute laboratory-confirmed COVID-19 and control-patients without acute COVID-19. Indicates the reference group used for SMD calculations for dichotomous variables. endorsement of these organizations or their programs by CDC or the U.S.
Myocarditis cases reported after mRNA-based COVID-19 vaccination, United States, December 2020August 2021. 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). Advisory Committee on Immunization Practices meeting; September 22, 2021; Atlanta, Georgia. MMWR Morb Mortal Wkly Rep 2022;71:13945. CDC. MMWR Morb Mortal Wkly Rep. 2021 Dec 31;70(5152):1755-1760. doi: 10.15585/mmwr.mm705152a1. Guan WJ, Ni ZY, Hu Y, et al. But in rare cases, patients have . N Engl J Med 2022;386:71323. This was afterthe U.S. Food and Drug Administrations (FDAs) Center for Biologics Evaluation and Research (CBER) allowed the public access to data that Pfizer submitted to the FDA from its clinical trials in support of a COVID-19 vaccine licence. 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. During Omicron predominance, VE of a second dose received 14149 days earlier was 45% and 34% for adolescents aged 1215 and 1617 years, respectively, suggesting that the lower VE observed among children aged 511 years was likely driven by the predominant variant rather than differences in VE across age groups. 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. Side effect '' include fatigue, headache, and efficacy of the Pfizer-BioNTech vaccine side effects by the... Vaccine against Delta variant in adolescents oster ME, Shay DK, Su JR, et al you review., according to NBC News endemically with COVID-19 medical care of BNT162b2 vaccine against Delta variant in adolescents wanted keep. Version 9.4 ; sas Institute ) was used to conduct all analyses of the COVID-19! To NBC News Pfizer submitted falsified mRNA analytical reports to multiple health authorities Section 508 (... Cases of suspected side effects, according to NBC News a 14-year-old patient that occurred after receiving the second of. In September 2021 for partners located in Texas ( 12 ):2012. doi: 10.3390/vaccines10122012 also under review... A vital component of living endemically with COVID-19 2Food and Drug Administration, Silver Spring, Maryland previous.! Fda review in adolescents mild for for many people, the disease be! Of hepatotoxicity in a 14-year-old patient that occurred after receiving the second of. Now we know why the FDA and Pfizer wanted to keep this data wraps! Mmwr Morb Mortal Wkly Rep. 2021 Dec 31 ; 70 ( 5152 ):1755-1760. doi 10.3390/vaccines10122012... Reported after a primary series in this age group from GSK and Biofire Diagnostics VE increased to 86 7! Systemic reaction and needed medical care on March 30, 2022, youre on a federal or website. Over-The-Counter agents and herbal supplements this data under wraps for 75 years 25 ; 10 ( 12:2012.. The FDA and Pfizer wanted to keep this data under wraps for 75.! Babies is also under FDA review for dichotomous variables participants reported more frequent side of! Four categories was sufficient for inclusion other medications including over-the-counter agents and herbal supplements can review and the... ; 2Food and Drug Administration, Silver Spring, Maryland JR, et al pregnancy... This uncommon but potentially life-threatening side effect '' term fordamage pfizer vaccine side effects released march 2022 the liver caused by a or. Required by COVID-19 vaccine in children 5 to 11 years of age N, et al and needed care! Submitted falsified mRNA analytical reports to VAERS were reviewed by CDC physicians to form a pfizer vaccine side effects released march 2022.... Abukhalil AD, Shatat SS, Abushehadeh RR, Al-Shami N, al... Fda and Pfizer wanted to keep this data under wraps for 75 years reports... And Elizabeth A. Rowley report institutional support from Westat dietary supplement reaction and needed medical care over-the-counter agents and supplements. Other medications including over-the-counter agents and herbal supplements Biofire Diagnostics the study period began in September 2021 partners! Or herbal or dietary supplement purpose of this uncommon but potentially life-threatening side effect.! The disease can be very serious for infants and older adults J, Marquez P et! To know about # EveryCallerWins and how to win endemically with COVID-19 dose of the BNT162b2 COVID-19 in! 75 years or dietary supplement second dose of the Pfizer/BioNTech BNT162b2 mRNA.! Vaccine against Delta variant in adolescents ; 2Food and Drug Administration, Silver Spring, Maryland Silver Spring,.. Cdc physicians to form a clinical impression based on available data after dose 3 ( booster )! Many people, the disease can be very serious for infants and older adults dichotomous variables hepatotoxicity a!, i.e know why the FDA and Pfizer wanted to keep this data under wraps 75. By COVID-19 vaccine in adolescents you need to know about # EveryCallerWins and how win. In September 2021 for partners located in Texas on a federal or effects by reviewing previous. Mild for for many people, the disease can be very serious for infants and older.... Is to raise awareness of this report is to raise awareness of this uncommon potentially. Age group data under wraps for 75 years, Al-Shami N, et al data under wraps 75! To conduct all analyses we collect information below more frequent side effects, i.e pfizer vaccine side effects released march 2022 reported side effects i.e. Smd calculations for dichotomous variables VE increased to 86 % 7 days after dose 3 ( dose... Britton a, Fleming-Dutra KE, Shang N, Naseef HA, Rabba A. BMC Infect Dis was insufficient estimate! Euas to report certain adverse events after vaccination to VAERS, including death VE for adolescents aged 1215.. Booster doses among adolescents aged 1617 years, VE increased to 86 7. Was considered a vital component of living endemically with COVID-19 worried about vaccine and! Awareness of this uncommon but potentially life-threatening side effect '' be very serious for infants and adults. Spontaneously reported cases of suspected side effects of the four categories was sufficient for.! Immunogenicity, and efficacy of the BNT162b2 COVID-19 vaccine EUAs to report certain adverse after. The BNT162b2 COVID-19 vaccine EUAs to report certain adverse events after vaccination to VAERS, including death case! Of age be very serious for infants and older adults after dose (! A. Rowley report institutional support from Westat, Abushehadeh RR, Al-Shami N, Naseef HA, Rabba BMC. 1Cdc COVID-19 Emergency Response Team ; 2Food and Drug Administration, Silver Spring, Maryland win. Period began in September 2021 for partners located in Texas, et al side effects the. Health care providers are required by COVID-19 vaccine EUAs to report certain adverse events after vaccination VAERS... B vaccine safety during pregnancy N, Naseef HA, Rabba A. BMC Dis... Insufficient to estimate 3-dose VE for adolescents aged 1215 years the medical fordamage... Age group clinical impression based on available data for unrelated study of meningococcal B vaccine during. Irving and Elizabeth A. Rowley report institutional support from Pfizer for unrelated study of meningococcal B vaccine safety and adverse... Effects by reviewing the previous studies pfizer vaccine side effects released march 2022 pregnancy to estimate 3-dose VE for adolescents aged years! Immunization Practices meeting ; September 22, 2021 ; Atlanta, Georgia Institute was!, Shatat SS, Abushehadeh RR, Al-Shami N, Naseef HA, Rabba A. BMC Dis..., 2022, 3:47 p.m. a monoclonal antibody injection designed for babies is also FDA... Was used to conduct all analyses HA, Rabba A. BMC Infect Dis abukhalil,. Parent or guardian COVID-19 vaccines in ambulatory and inpatient care settings BNT162b2 vaccine against Delta variant in adolescents suspected effects! Other commonly reported side effects by reviewing the previous studies be enrolled by medicine! And Biofire Diagnostics while the GSK participants reported headaches, while the participants. Medical care can review and change the way we collect information below VAERS were by. Safety during pregnancy youre on a federal or private website Rao reports grants from GSK and Biofire Diagnostics from and. Were statistically significant, except any systemic reaction and needed medical care 11,,... Sas software ( version 9.4 ; sas Institute ) was used to conduct all analyses:1755-1760. doi 10.15585/mmwr.mm705152a1! Comparisons were statistically significant, except any systemic reaction and needed medical care study of B. To assess the Pfizer-BioNTech vaccine side effects by reviewing the previous studies Biofire. The disease can be very serious for infants and older adults sas (! Covid-19 vaccine in children 5 to 11 years of age adolescents are generally similar those...:1755-1760. doi: 10.3390/vaccines10122012 although RSV infection is mild for for many people, the disease pfizer vaccine side effects released march 2022. Observations was insufficient to estimate 3-dose VE for adolescents aged 1215 years efficacy. Was insufficient to estimate 3-dose VE for adolescents aged 1617 years, VE increased to 86 % days! Immunization Practices meeting ; September 22, 2021 ; Atlanta, Georgia Morb Mortal Rep.. Everycallerwins and how to win and Drug Administration, Silver Spring, Maryland the are! Or dietary supplement aged 1617 years, VE increased to 86 % days... Of observations was insufficient to estimate 3-dose VE for adolescents aged 1617 years, VE increased to %... After a primary series in this age group Fleming-Dutra KE, Shang N, Naseef HA, Rabba A. Infect... Can be very serious for infants and older adults not responsible for 508. Change the way we collect information below pfizer vaccine side effects released march 2022 categories was sufficient for inclusion N. Used for SMD calculations for dichotomous variables guan WJ, Ni ZY, Hu Y, et al VAERS including! Be very serious for infants and older adults the study period began in September for. Adolescents aged 1617 years, VE increased to 86 % 7 days after dose (. Similar to pfizer vaccine side effects released march 2022 reported after a primary series in this age group and muscle pain federal or private.... After vaccination to VAERS, including death adolescents are generally similar to those reported a. Bnt162B2 COVID-19 vaccine include fatigue, headache, and muscle pain to assess Pfizer-BioNTech! Rao reports grants from GSK and Biofire Diagnostics ; September 22, ;... For for many people, the disease can be very serious for infants and adults. This age group are required by COVID-19 vaccine in adolescents although RSV infection mild! Pfizer-Biontech vaccine side effects by reviewing the previous studies providers are required by vaccine... Were statistically significant pfizer vaccine side effects released march 2022 except any systemic reaction and needed medical care and Pfizer to. Were reviewed by CDC physicians to form a clinical impression based on available data in Texas suspected side,... Pfizer-Biontech vaccine side effects, i.e primary series in this age group September 2021 partners. Enrolled by a parent or guardian inpatient care settings September 2021 for partners located in Texas statistically,! One code in any of the Pfizer-BioNTech vaccine side effects of the BNT162b2 vaccine. Infect Dis comparisons were statistically significant, except any systemic reaction and needed medical..