Multicenter Study

. 2022 Feb 24;386(8):713-723.

doi: 10.1056/NEJMoa2117995. Epub 2022 Jan 12.

Effectiveness of BNT162b2 Vaccine against Critical Covid-19 in Adolescents

Samantha M Olson¹, Margaret M Newhams¹, Natasha B Halasa¹, Ashley M Price¹, Julie A Boom¹, Leila C Sahni¹, Pia S Pannaraj¹, Katherine Irby¹, Tracie C Walker¹, Stephanie P Schwartz¹, Aline B Maddux¹, Elizabeth H Mack¹, Tamara T Bradford¹, Jennifer E Schuster¹, Ryan A Nofziger¹, Melissa A Cameron¹, Kathleen Chiotos¹, Melissa L Cullimore¹, Shira J Gertz¹, Emily R Levy¹, Michele Kong¹, Natalie Z Cvijanovich¹, Mary A Staat¹, Satoshi Kamidani¹, Brandon M Chatani¹, Samina S Bhumbra¹, Katherine E Bline¹, Mary G Gaspers¹, Charlotte V Hobbs¹, Sabrina M Heidemann¹, Mia Maamari¹, Heidi R Flori¹, Janet R Hume¹, Matt S Zinter¹, Kelly N Michelson¹, Laura D Zambrano¹, Angela P Campbell¹, Manish M Patel¹, Adrienne G Randolph¹; Overcoming Covid-19 Investigators

Collaborators, Affiliations

Collaborators

Overcoming Covid-19 Investigators:
Michele Kong, Meghan Murdock, Mary Glas Gaspers, Katri V Typpo, Connor P Kelley, Katherine Irby, Ronald C Sanders, Masson Yates, Chelsea Smith, Melissa A Cameron, Katheryn Crane, Natalie Z Cvijanovich, Geraldina Lionetti, Juliana Murcia-Montoya, Matt S Zinter, Denise Villarreal-Chico, Pia S Pannaraj, Adam L Skura, Daniel Hakimi, Harvey Peralta, Aline B Maddux, Justin M Lockwood, Emily Port, Brandon M Chatani, Satoshi Kamidani, Keiko M Tarquinio, Laila Hussaini, Nadine Baida, Kelly N Michelson, Bria M Coates, Samina S Bhumbra, Courtney M Rowan, Mary Stumpf, Tamara T Bradford, Marla S Johnston, Adrienne G Randolph, Margaret M Newhams, Benjamin J Boutselis, Suden Kucukak, Sabrina R Chen, Amber O Orzel, Edie Weller, Laura Berbert, Jie He, Sabrina M Heidemann, Heidi R Flori, Janet R Hume, Ellen R Bruno, Lexie A Goertzen, Emily R Levy, Supriya Behl, Noelle M Drapeau, Charlotte V Hobbs, Lora Martin, Robert Santos, Lacy Malloch, Jennifer E Schuster, Shannon M Hill, Abigail Kietzman, Melissa L Cullimore, Valerie Rinehart, Lauren A Hoody, Shira J Gertz, Stephanie P Schwartz, Tracie C Walker, Angelo G Navas, Paris C Bennett, Ryan A Nofziger, Nicole A Twinem, Merry L Tomcany, Mary Allen Staat, Chelsea C Rohlfs, Katherine Bline, Kathleen Chiotos, Rebecca L Douglas, Kathlyn Phengchomphet, Elizabeth H Mac, Megan M Bickford, Lauren E Wakefield, Natasha B Halasa, Janet B Nicotera, Meena Golchha, Julia A Boom, Leila C Sahni, Jennifer N Oates, Mia Maamari, Cindy Bowens, Samantha M Olson, Manish M Patel, Ashley M Price, Laura D Zambrano, Angela P Campbell

Affiliation

¹ From the Covid-19 Response Team, Centers for Disease Control and Prevention (S.M.O., A.M.P., L.D.Z., A.P.C., M.M.P.), and the Center for Childhood Infections and Vaccines of Children's Healthcare of Atlanta and the Department of Pediatrics, Emory University School of Medicine (S.K.) - both in Atlanta; the Department of Anesthesiology, Critical Care, and Pain Medicine, Boston Children's Hospital (M.M.N., A.G.R.), and the Departments of Anaesthesia and Pediatrics, Harvard Medical School (A.G.R.) - both in Boston; the Division of Pediatric Infectious Diseases, Department of Pediatrics, Vanderbilt University Medical Center, Nashville (N.B.H.); the Department of Pediatrics, Baylor College of Medicine, Immunization Project, Texas Children's Hospital, Houston (J.A.B., L.C.S.), and the Department of Pediatrics, Division of Critical Care Medicine, University of Texas Southwestern, Children's Medical Center Dallas, Dallas (M.M.); the Division of Infectious Diseases, Children's Hospital Los Angeles and Departments of Pediatrics and Molecular Microbiology and Immunology, University of Southern California, Los Angeles (P.S.P.), the Division of Pediatric Hospital Medicine, UC San Diego-Rady Children's Hospital, San Diego (M.A.C.), the Division of Critical Care Medicine, UCSF Benioff Children's Hospital Oakland (N.Z.C.), and the Department of Pediatrics, Divisions of Critical Care Medicine and Allergy, Immunology, and Bone Marrow Transplant, University of California, San Francisco, San Francisco (M.S.Z.) - all in California; Section of Pediatric Critical Care, Department of Pediatrics, Arkansas Children's Hospital, Little Rock (K.I.); the Department of Pediatrics, University of North Carolina at Chapel Hill Children's Hospital, Chapel Hill (T.C.W., S.P.S.); the Department of Pediatrics, Section of Critical Care Medicine, University of Colorado School of Medicine and Children's Hospital Colorado, Aurora (A.B.M.); the Division of Pediatric Critical Care Medicine, Medical University of South Carolina, Charleston (E.H.M.); the Department of Pediatrics, Division of Cardiology, Louisiana State University Health Sciences Center and Children's Hospital of New Orleans, New Orleans (T.T.B.); the Division of Pediatric Infectious Diseases, Department of Pediatrics, Children's Mercy Kansas City, Kansas City, MO (J.E.S.); the Division of Critical Care Medicine, Department of Pediatrics, Akron Children's Hospital, Akron (R.A.N.), the Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati Children's Hospital Medical Center, Cincinnati (M.A.S.), and the Division of Pediatric Critical Care Medicine, Nationwide Children's Hospital Columbus, Columbus (K.E.B.) - all in Ohio; the Division of Critical Care Medicine, Department of Anesthesiology and Critical Care, Children's Hospital of Philadelphia, Philadelphia (K.C.); the Division of Pediatric Critical Care, Department of Pediatrics, Children's Hospital and Medical Center, Omaha, NE (M.L.C.); the Division of Pediatric Critical Care, Department of Pediatrics, Saint Barnabas Medical Center, Livingston, NJ (S.J.G.); the Divisions of Pediatric Infectious Diseases and Pediatric Critical Care Medicine, Department of Pediatric and Adolescent Medicine, Mayo Clinic, Rochester (E.R.L.), and the Division of Pediatric Critical Care, University of Minnesota Masonic Children's Hospital, Minneapolis (J.R.H.) - both in Minnesota; the Division of Pediatric Critical Care Medicine, Department of Pediatrics, University of Alabama at Birmingham, Birmingham (M.K.), the Division of Pediatric Infectious Diseases, Department of Pediatrics, UHealth/Holtz Children's Hospital, Miami (B.M.C.); the Ryan White Center for Pediatric Infectious Disease and Global Health, Department of Pediatrics, Indiana University School of Medicine, Indianapolis (S.S.B.); University of Arizona, Diamond Children's Banner Children's Medical Center, Tucson (M.G.G.); the Department of Pediatrics, Department of Microbiology, Division of Infectious Diseases, University of Mississippi Medical Center, Jackson (C.V.H.); the Department of Pediatrics, Children's Hospital of Michigan, Central Michigan University, Detroit (S.M.H.), and the Division of Pediatric Critical Care Medicine, Department of Pediatrics, Mott Children's Hospital and University of Michigan, Ann Arbor (H.R.F.); and the Division of Critical Care Medicine, Department of Pediatrics, Northwestern University Feinberg School of Medicine, Ann and Robert H. Lurie Children's Hospital of Chicago, Chicago (K.N.M.).

PMID: 35021004
PMCID: PMC8781318
DOI: 10.1056/NEJMoa2117995

Multicenter Study

Effectiveness of BNT162b2 Vaccine against Critical Covid-19 in Adolescents

Samantha M Olson et al. N Engl J Med. 2022.

. 2022 Feb 24;386(8):713-723.

doi: 10.1056/NEJMoa2117995. Epub 2022 Jan 12.

Authors

Collaborators

Overcoming Covid-19 Investigators:
Michele Kong, Meghan Murdock, Mary Glas Gaspers, Katri V Typpo, Connor P Kelley, Katherine Irby, Ronald C Sanders, Masson Yates, Chelsea Smith, Melissa A Cameron, Katheryn Crane, Natalie Z Cvijanovich, Geraldina Lionetti, Juliana Murcia-Montoya, Matt S Zinter, Denise Villarreal-Chico, Pia S Pannaraj, Adam L Skura, Daniel Hakimi, Harvey Peralta, Aline B Maddux, Justin M Lockwood, Emily Port, Brandon M Chatani, Satoshi Kamidani, Keiko M Tarquinio, Laila Hussaini, Nadine Baida, Kelly N Michelson, Bria M Coates, Samina S Bhumbra, Courtney M Rowan, Mary Stumpf, Tamara T Bradford, Marla S Johnston, Adrienne G Randolph, Margaret M Newhams, Benjamin J Boutselis, Suden Kucukak, Sabrina R Chen, Amber O Orzel, Edie Weller, Laura Berbert, Jie He, Sabrina M Heidemann, Heidi R Flori, Janet R Hume, Ellen R Bruno, Lexie A Goertzen, Emily R Levy, Supriya Behl, Noelle M Drapeau, Charlotte V Hobbs, Lora Martin, Robert Santos, Lacy Malloch, Jennifer E Schuster, Shannon M Hill, Abigail Kietzman, Melissa L Cullimore, Valerie Rinehart, Lauren A Hoody, Shira J Gertz, Stephanie P Schwartz, Tracie C Walker, Angelo G Navas, Paris C Bennett, Ryan A Nofziger, Nicole A Twinem, Merry L Tomcany, Mary Allen Staat, Chelsea C Rohlfs, Katherine Bline, Kathleen Chiotos, Rebecca L Douglas, Kathlyn Phengchomphet, Elizabeth H Mac, Megan M Bickford, Lauren E Wakefield, Natasha B Halasa, Janet B Nicotera, Meena Golchha, Julia A Boom, Leila C Sahni, Jennifer N Oates, Mia Maamari, Cindy Bowens, Samantha M Olson, Manish M Patel, Ashley M Price, Laura D Zambrano, Angela P Campbell

Affiliation

¹ From the Covid-19 Response Team, Centers for Disease Control and Prevention (S.M.O., A.M.P., L.D.Z., A.P.C., M.M.P.), and the Center for Childhood Infections and Vaccines of Children's Healthcare of Atlanta and the Department of Pediatrics, Emory University School of Medicine (S.K.) - both in Atlanta; the Department of Anesthesiology, Critical Care, and Pain Medicine, Boston Children's Hospital (M.M.N., A.G.R.), and the Departments of Anaesthesia and Pediatrics, Harvard Medical School (A.G.R.) - both in Boston; the Division of Pediatric Infectious Diseases, Department of Pediatrics, Vanderbilt University Medical Center, Nashville (N.B.H.); the Department of Pediatrics, Baylor College of Medicine, Immunization Project, Texas Children's Hospital, Houston (J.A.B., L.C.S.), and the Department of Pediatrics, Division of Critical Care Medicine, University of Texas Southwestern, Children's Medical Center Dallas, Dallas (M.M.); the Division of Infectious Diseases, Children's Hospital Los Angeles and Departments of Pediatrics and Molecular Microbiology and Immunology, University of Southern California, Los Angeles (P.S.P.), the Division of Pediatric Hospital Medicine, UC San Diego-Rady Children's Hospital, San Diego (M.A.C.), the Division of Critical Care Medicine, UCSF Benioff Children's Hospital Oakland (N.Z.C.), and the Department of Pediatrics, Divisions of Critical Care Medicine and Allergy, Immunology, and Bone Marrow Transplant, University of California, San Francisco, San Francisco (M.S.Z.) - all in California; Section of Pediatric Critical Care, Department of Pediatrics, Arkansas Children's Hospital, Little Rock (K.I.); the Department of Pediatrics, University of North Carolina at Chapel Hill Children's Hospital, Chapel Hill (T.C.W., S.P.S.); the Department of Pediatrics, Section of Critical Care Medicine, University of Colorado School of Medicine and Children's Hospital Colorado, Aurora (A.B.M.); the Division of Pediatric Critical Care Medicine, Medical University of South Carolina, Charleston (E.H.M.); the Department of Pediatrics, Division of Cardiology, Louisiana State University Health Sciences Center and Children's Hospital of New Orleans, New Orleans (T.T.B.); the Division of Pediatric Infectious Diseases, Department of Pediatrics, Children's Mercy Kansas City, Kansas City, MO (J.E.S.); the Division of Critical Care Medicine, Department of Pediatrics, Akron Children's Hospital, Akron (R.A.N.), the Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati Children's Hospital Medical Center, Cincinnati (M.A.S.), and the Division of Pediatric Critical Care Medicine, Nationwide Children's Hospital Columbus, Columbus (K.E.B.) - all in Ohio; the Division of Critical Care Medicine, Department of Anesthesiology and Critical Care, Children's Hospital of Philadelphia, Philadelphia (K.C.); the Division of Pediatric Critical Care, Department of Pediatrics, Children's Hospital and Medical Center, Omaha, NE (M.L.C.); the Division of Pediatric Critical Care, Department of Pediatrics, Saint Barnabas Medical Center, Livingston, NJ (S.J.G.); the Divisions of Pediatric Infectious Diseases and Pediatric Critical Care Medicine, Department of Pediatric and Adolescent Medicine, Mayo Clinic, Rochester (E.R.L.), and the Division of Pediatric Critical Care, University of Minnesota Masonic Children's Hospital, Minneapolis (J.R.H.) - both in Minnesota; the Division of Pediatric Critical Care Medicine, Department of Pediatrics, University of Alabama at Birmingham, Birmingham (M.K.), the Division of Pediatric Infectious Diseases, Department of Pediatrics, UHealth/Holtz Children's Hospital, Miami (B.M.C.); the Ryan White Center for Pediatric Infectious Disease and Global Health, Department of Pediatrics, Indiana University School of Medicine, Indianapolis (S.S.B.); University of Arizona, Diamond Children's Banner Children's Medical Center, Tucson (M.G.G.); the Department of Pediatrics, Department of Microbiology, Division of Infectious Diseases, University of Mississippi Medical Center, Jackson (C.V.H.); the Department of Pediatrics, Children's Hospital of Michigan, Central Michigan University, Detroit (S.M.H.), and the Division of Pediatric Critical Care Medicine, Department of Pediatrics, Mott Children's Hospital and University of Michigan, Ann Arbor (H.R.F.); and the Division of Critical Care Medicine, Department of Pediatrics, Northwestern University Feinberg School of Medicine, Ann and Robert H. Lurie Children's Hospital of Chicago, Chicago (K.N.M.).

PMID: 35021004
PMCID: PMC8781318
DOI: 10.1056/NEJMoa2117995

Abstract

Background: The increasing incidence of pediatric hospitalizations associated with coronavirus disease 2019 (Covid-19) caused by the B.1.617.2 (delta) variant of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in the United States has offered an opportunity to assess the real-world effectiveness of the BNT162b2 messenger RNA vaccine in adolescents between 12 and 18 years of age.

Methods: We used a case-control, test-negative design to assess vaccine effectiveness against Covid-19 resulting in hospitalization, admission to an intensive care unit (ICU), the use of life-supporting interventions (mechanical ventilation, vasopressors, and extracorporeal membrane oxygenation), or death. Between July 1 and October 25, 2021, we screened admission logs for eligible case patients with laboratory-confirmed Covid-19 at 31 hospitals in 23 states. We estimated vaccine effectiveness by comparing the odds of antecedent full vaccination (two doses of BNT162b2) in case patients as compared with two hospital-based control groups: patients who had Covid-19-like symptoms but negative results on testing for SARS-CoV-2 (test-negative) and patients who did not have Covid-19-like symptoms (syndrome-negative).

Results: A total of 445 case patients and 777 controls were enrolled. Overall, 17 case patients (4%) and 282 controls (36%) had been fully vaccinated. Of the case patients, 180 (40%) were admitted to the ICU, and 127 (29%) required life support; only 2 patients in the ICU had been fully vaccinated. The overall effectiveness of the BNT162b2 vaccine against hospitalization for Covid-19 was 94% (95% confidence interval [CI], 90 to 96); the effectiveness was 95% (95% CI, 91 to 97) among test-negative controls and 94% (95% CI, 89 to 96) among syndrome-negative controls. The effectiveness was 98% against ICU admission and 98% against Covid-19 resulting in the receipt of life support. All 7 deaths occurred in patients who were unvaccinated.

Conclusions: Among hospitalized adolescent patients, two doses of the BNT162b2 vaccine were highly effective against Covid-19-related hospitalization and ICU admission or the receipt of life support. (Funded by the Centers for Disease Control and Prevention.).

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Figures

**Figure 1. Study Enrollment and Outcomes (July 1–October 25, 2021).**
Among the case patients between 12 and 18 years of age who were hospitalized with coronavirus disease 2019 (Covid-19), 37 patients who had a positive result on SARS-CoV-2 testing but were admitted to the hospital for a non–Covid-19 reason were excluded from the analyses. Patients were described as having been fully vaccinated if they had received a second dose of the BNT162b2 vaccine at least 14 days before the onset of illness. Patients were described as having been partially vaccinated if they had received the first dose of the BNT162b2 vaccine at least 14 days before illness onset. Among the 777 control patients, 383 had received negative results on SARS-CoV-2 testing (test-negative) and 394 had no Covid-19 symptoms (syndrome-negative).

**Figure 2. Effectiveness of the BNT162b2 Vaccine against Covid-19 Hospitalization in the Study Population.**
Shown is the effectiveness of the BNT162b2 vaccine against Covid-19 hospitalization in all the case patients as compared with each of the two control groups (test-negative and syndrome-negative) and in the two control groups combined. Vaccine effectiveness was calculated as (1−adjusted odds ratio) × 100, in which the odds ratio is the odds of vaccination (fully or partially vaccinated vs. unvaccinated as referent group) in Covid-19 case patients as compared with control patients.

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Comment in

Sparing of Severe Covid-19 in Vaccinated Adolescents.
Edwards KM. Edwards KM. N Engl J Med. 2022 Feb 24;386(8):789-790. doi: 10.1056/NEJMe2118471. Epub 2022 Jan 12. N Engl J Med. 2022. PMID: 35020983 Free PMC article. No abstract available.

References

1. Food and Drug Administration. Coronavirus (COVID-19) update: FDA authorizes Pfizer-BioNTech COVID-19 vaccine for emergency use in adolescents in another important action in fight against pandemic. FDA new release. 2021. (https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19...).
1. Frenck RW Jr, Klein NP, Kitchin N, et al. Safety, immunogenicity, and efficacy of the BNT162b2 Covid-19 vaccine in adolescents. N Engl J Med 2021;385:239-250. - PMC - PubMed
1. COVID-NET. Laboratory-confirmed COVID-19-associated hospitalizations. 2021. (https://gis.cdc.gov/grasp/covidnet/COVID19_5.html).
1. Delahoy MJ, Ujamaa D, Whitaker M, et al. Hospitalizations associated with COVID-19 among children and adolescents — COVID-NET, 14 states, March 1, 2020–August 14, 2021. MMWR Morb Mortal Wkly Rep 2021;70:1255-1260. - PMC - PubMed
1. Olson SM, Newhams MM, Halasa NB, et al. Effectiveness of Pfizer-BioNTech mRNA vaccination against COVID-19 hospitalization among persons aged 12-18 years — United States, June–September 2021. MMWR Morb Mortal Wkly Rep 2021;70:1483-1488. - PMC - PubMed

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Effectiveness of BNT162b2 Vaccine against Critical Covid-19 in Adolescents

Collaborators

Affiliation

Effectiveness of BNT162b2 Vaccine against Critical Covid-19 in Adolescents

Authors

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Affiliation

Abstract

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