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Cited by 889SARS-CoV-2 and COVID-19 ResearchCOVID-19 Clinical Research StudiesVaccine Coverage and Hesitancy

Safety, immunogenicity, and efficacy of the BNT162b2 covid-19 vaccine in adolescents

Open access
Frenck, Robert W., Klein, Nicola P., Kitchin, Nicholas, Gurtman, Alejandra, Absalon, Judith, Lockhart, Stephen, Perez, John L., Walter, Emmanuel B. +18 more·2021·New England Journal of Medicine
DOI 10.1056/nejmoa2107456PMC PMC8174030
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Abstract

BACKGROUND: Until very recently, vaccines against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) had not been authorized for emergency use in persons younger than 16 years of age. Safe, effective vaccines are needed to protect this population, facilitate in-person learning and socialization, and contribute to herd immunity. METHODS: In this ongoing multinational, placebo-controlled, observer-blinded trial, we randomly assigned participants in a 1:1 ratio to receive two injections, 21 days apart, of 30 μg of BNT162b2 or placebo. Noninferiority of the immune response to BNT162b2 in 12-to-15-year-old participants as compared with that in 16-to-25-year-old participants was an immunogenicity objective. Safety (reactogenicity and adverse events) and efficacy against confirmed coronavirus disease 2019 (Covid-19; onset, ≥7 days after dose 2) in the 12-to-15-year-old cohort were assessed. RESULTS: Overall, 2260 adolescents 12 to 15 years of age received injections; 1131 received BNT162b2, and 1129 received placebo. As has been found in other age groups, BNT162b2 had a favorable safety and side-effect profile, with mainly transient mild-to-moderate reactogenicity (predominantly injection-site pain [in 79 to 86% of participants], fatigue [in 60 to 66%], and headache [in 55 to 65%]); there were no vaccine-related serious adverse events and few overall severe adverse events. The geometric mean ratio of SARS-CoV-2 50% neutralizing titers after dose 2 in 12-to-15-year-old participants relative to 16-to-25-year-old participants was 1.76 (95% confidence interval [CI], 1.47 to 2.10), which met the noninferiority criterion of a lower boundary of the two-sided 95% confidence interval greater than 0.67 and indicated a greater response in the 12-to-15-year-old cohort. Among participants without evidence of previous SARS-CoV-2 infection, no Covid-19 cases with an onset of 7 or more days after dose 2 were noted among BNT162b2 recipients, and 16 cases occurred among placebo recipients. The observed vaccine efficacy was 100% (95% CI, 75.3 to 100). CONCLUSIONS: The BNT162b2 vaccine in 12-to-15-year-old recipients had a favorable safety profile, produced a greater immune response than in young adults, and was highly effective against Covid-19. (Funded by BioNTech and Pfizer; C4591001 ClinicalTrials.gov number, NCT04368728.).

AI snapshot

Written from the paper’s full text.

TL;DR

In an ongoing multinational, placebo-controlled, observer-blinded trial, two 30 μg doses of BNT162b2 given 21 days apart to 12-to-15-year-olds had a favorable safety profile, produced a greater neutralizing antibody response than in 16-to-25-year-olds, and showed 100% observed efficacy against Covid-19 from 7 days after dose 2. These findings supported expansion of emergency use authorization to adolescents 12 years of age or older.

Key findings

  • Among 2260 adolescents who received injections (1131 BNT162b2, 1129 placebo), reactogenicity was mainly transient and mild-to-moderate: injection-site pain in 79 to 86%, fatigue in 60 to 66%, and headache in 55 to 65%; there were no vaccine-related serious adverse events and few overall severe adverse events. Fever ≥38°C after dose 2 occurred in 20% of 12-to-15-year-old BNT162b2 recipients vs. 17% of 16-to-25-year-old recipients.
  • The geometric mean ratio of SARS-CoV-2 50% neutralizing titers after dose 2 in 12-to-15-year-olds relative to 16-to-25-year-olds was 1.76 (95% CI, 1.47 to 2.10), meeting the noninferiority criterion of a lower 95% CI boundary >0.67 and indicating a greater response in the younger cohort. Among all participants, neutralizing geometric mean titers 1 month after dose 2 were 1283.0 in 12-to-15-year-olds and 730.8 in 16-to-25-year-olds; GMFRs were 118.3 and 71.2, respectively.
  • Among 1983 participants without evidence of previous SARS-CoV-2 infection, no Covid-19 cases with onset ≥7 days after dose 2 occurred among BNT162b2 recipients vs. 16 cases among placebo recipients, for observed vaccine efficacy of 100% (95% CI, 75.3 to 100). In all 2229 participants who could be evaluated regardless of previous infection, efficacy was 100% (95% CI, 78.1 to 100), with 0 vs. 18 cases.
  • After dose 1 and before dose 2, there were 3 Covid-19 cases among BNT162b2 recipients vs. 12 among placebo recipients (vaccine efficacy, 75%; 95% CI, 7.6 to 95.5). No cases of severe Covid-19 were observed in this age cohort.

Methods

  • This was a phase 3 part of an ongoing phase 1–2–3 randomized, placebo-controlled, observer-blinded trial in healthy persons 12 years of age or older; this report covers 12-to-15-year-old participants enrolled at 29 U.S. sites, randomized 1:1 to receive two intramuscular injections of 30 μg BNT162b2 or saline placebo 21 days apart, with data collected through March 13, 2021.
  • Safety assessed local and systemic reactogenicity recorded in an electronic diary for 7 days after each dose, unsolicited adverse events through 1 month after dose 2, and serious adverse events through 6 months after dose 2. Immunogenicity was assessed before vaccination and 1 month after dose 2 using SARS-CoV-2 serum neutralization and RBD- or S1-binding IgG assays; noninferiority was assessed by the geometric mean ratio of 50% neutralizing titers in 12-to-15-year-olds vs. 16-to-25-year-olds.
  • Efficacy against confirmed Covid-19 with onset ≥7 days after dose 2 was summarized descriptively in the 12-to-15-year-old cohort; vaccine efficacy was defined as 100×(1−IRR), with two-sided Clopper–Pearson 95% confidence intervals.

Limitations

  • The paper states that the efficacy analysis was prespecified as descriptive because an accurate sample size could not be calculated before trial start given uncertainties about SARS-CoV-2 incidence; therefore, the primary basis for establishing efficacy in 12-to-15-year-olds was a neutralizing antibody response noninferior to that in 16-to-25-year-olds, for whom efficacy had been shown.
  • The paper states that safety data included follow-up through 1 month after dose 2 for some participants, and longer-term safety and duration of efficacy and antibody responses in children were not yet available; racial and ethnic diversity was lower among 12-to-15-year-old participants than among those 16 years or older; all 12-to-15-year-old participants were enrolled at U.S. sites while 16-to-25-year-old participants were recruited globally; a testing laboratory supply limitation resulted in fewer participants than anticipated in immunogenicity analyses; concomitant vaccination was not formally examined; and the results do not determine whether BNT162b2 prevents asymptomatic infection or transmission.
  • Evident from the text: 1308 participants (58%) had at least 2 months of follow-up after their second vaccine dose, and the efficacy analysis was based on a limited number of Covid-19 cases in this cohort, with no severe Covid-19 cases observed.

Model-written summary. Check it against the paper before relying on it.

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Crossref · 10.1056/nejmoa2107456

Cites

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Claims the paper makes

0 of 29 cited sources checked · 0 supported · 0 flagged

  • Findingown data

    Among all participants regardless of serologic evidence of previous SARS-CoV-2 infection, the serum-neutralizing geometric mean titer 1 month after BNT162b2 dose 2 was 1283.0 in the 12-to-15-year-old cohort and 730.8 in the 16-to-25-year-old cohort.

    “Among all participants regardless of serologic evidence of previous SARS-CoV-2 infection, the serum-neutralizing geometric mean titer 1 month after BNT162b2 dose 2 was 1283.0 in the 12-to-15-year-old cohort and 730.8 in the 16-to-25-year-old cohort (Fig. S2).”
    Quote in the paperSubstantial claim
  • Findingown data

    Fever (oral body temperature ≥38°C) occurred after dose 2 of BNT162b2 in 20% of 12-to-15-year-old recipients and 17% of 16-to-25-year-old recipients.

    “Fever (oral body temperature, ≥38°C) occurred after dose 2 of BNT162b2 in 20% of 12-to-15-year-old recipients and in 17% of 16-to-25-year-old recipients.”
    Quote in the paperNot a substantial claim
  • Findingown data

    The corresponding GMFRs among placebo recipients were 1.4 and 1.1.

    “The corresponding GMFRs among placebo recipients were 1.4 and 1.1.”
    Quote in the paperNot a substantial claim
  • Findingown data

    In both age cohorts, injection-site pain was the most common local reaction.

    “In both age cohorts, injection-site pain was the most common local reaction.”
    Quote in the paperNot a substantial claim
  • Findingnone given

    In general, systemic events were reported more often after BNT162b2 dose 2 than after dose 1.

    “In general, systemic events were reported more often after BNT162b2 dose 2 than after dose 1.”
    Quote in the paperNot a substantial claim
  • May combine two claims. 22
  • Classified as probably not a substantial claim. 9

  • May combine two claims.

    Findingown data

    Among 16-to-25-year-old BNT162b2 recipients, 11% reported any adverse event and 6% had vaccine-related adverse events.

    “Among 16-to-25-year-old BNT162b2 recipients, 11% reported any adverse event and 6% had vaccine-related adverse events.”
    Quote in the paperSubstantial claim

  • May combine two claims.

    Findingown data

    Appendicitis was reported in 2 participants: 1 BNT162b2 recipient in the 16-to-25-year-old cohort and 1 placebo recipient in the 12-to-15-year-old cohort.

    “Appendicitis was reported in 2 participants: 1 BNT162b2 recipient in the 16-to-25-year-old cohort and 1 placebo recipient in the 12-to-15-year-old cohort.”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Findingown data

    Local and systemic events were generally mild to moderate in severity, reported at similar frequencies in both age cohorts, and typically resolved within 1 or 2 days.

    “Local and systemic events were generally mild to moderate in severity, reported at similar frequencies in both age cohorts, and typically resolved within 1 or 2 days.”
    Quote in the paperSubstantial claim

  • May combine two claims.

    Findingown data

    The geometric mean ratio of BNT162b2 neutralizing geometric mean titer in 12-to-15-year-old participants to that in 16-to-25-year-old participants 1 month after dose 2 was 1.76 (95% CI, 1.47 to 2.10), which met the noninferiority criterion of a lower boundary of the two-sided 95% CI >0.67.

    “The geometric mean ratio of the BNT162b2 neutralizing geometric mean titer in 12-to-15-year-old participants to that in 16-to-25-year-old participants 1 month after dose 2 was 1.76 (95% confidence interval [CI], 1.47 to 2.10) (Table 2), which met the noninferiority criterion (i.e., a lower boundary of the two-sided 95% confidence interval of >0.67).”
    Quote in the paperSubstantial claim

  • May combine two claims.

    Findingown data

    No thromboses or hypersensitivity adverse events or vaccine-related anaphylaxis was seen.

    “No thromboses or hypersensitivity adverse events or vaccine-related anaphylaxis was seen.”
    Quote in the paperSubstantial claim

  • May combine two claims.

    Findingown data

    Lymphadenopathy was reported in 9 of 1131 BNT162b2 recipients (0.8%) and 2 of 1129 placebo recipients (0.2%) who were 12 to 15 years of age, as compared with 1 of 536 BNT162b2 recipients (0.2%) and no placebo recipients who were 16 to 25 years of age.

    “Lymphadenopathy was reported in 9 of 1131 BNT162b2 recipients (0.8%) and in 2 of 1129 placebo recipients (0.2%) who were 12 to 15 years of age, as compared with in 1 of 536 BNT162b2 recipients (0.2%) and in no placebo recipients who were 16 to 25 years of age.”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Findingown data

    After dose 1 and before dose 2, there were 3 Covid-19 cases among BNT162b2 recipients and 12 cases among placebo recipients, corresponding to vaccine efficacy of 75% (95% CI, 7.6 to 95.5).

    “After dose 1 and before dose 2, there were 3 Covid-19 cases noted (within 11 days after dose 1) among BNT162b2 recipients, as compared with 12 cases among placebo recipients (vaccine efficacy, 75%; 95% CI, 7.6 to 95.5) (Table S3).”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Findingown data

    Among BNT162b2 recipients, severe adverse events were reported in 0.6% of those 12 to 15 years of age and 1.7% of those 16 to 25 years of age.

    “Among BNT162b2 recipients, severe adverse events were reported in 0.6% of those who were 12 to 15 years of age and in 1.7% of those who were 16 to 25 years of age.”
    Quote in the paperSubstantial claim

  • May combine two claims.

    Findingown data

    Among 12-to-15-year-old participants, adverse events from dose 1 through 1 month after dose 2 were reported by 6% of BNT162b2 and placebo recipients; related adverse events were reported by 3% of BNT162b2 recipients and 2% of placebo recipients.

    “Among 12-to-15-year-old participants, adverse events occurring from dose 1 through 1 month after dose 2 were reported by 6% of BNT162b2 and placebo recipients; slightly more BNT162b2 recipients than placebo recipients reported related adverse events (3% vs. 2%) (Table S2).”
    Quote in the paperSubstantial claim

  • May combine two claims.

    Findingown data

    Among 1983 participants in the 12-to-15-year-old cohort who could be evaluated and did not have evidence of previous SARS-CoV-2 infection, no Covid-19 cases with onset 7 or more days after dose 2 were observed among BNT162b2 recipients and 16 cases were observed among placebo recipients, corresponding to an observed vaccine efficacy of 100% (95% CI, 75.3 to 100).

    “Among the 1983 participants in the 12-to-15-year-old cohort who could be evaluated and did not have evidence of previous SARS-CoV-2 infection, no cases of Covid-19 with an onset of 7 or more days after dose 2 were observed among BNT162b2 recipients and 16 cases were observed among placebo recipients, which corresponded to an observed vaccine efficacy of 100% (95% CI, 75.3 to 100) (Table 3).”
    Quote in the paperSubstantial claim

  • May combine two claims.

    Findingown data

    Few participants in any cohort (≤0.4% through 1 month after dose 2) had serious adverse events, and none were considered by the investigators to have been vaccine-related.

    “Few participants in any cohort (≤0.4% through 1 month after dose 2) had serious adverse events, and none were considered by the investigators to have been vaccine-related.”
    Quote in the paperSubstantial claim

  • May combine two claims.

    Findingown data

    Severe injection-site pain after any BNT162b2 dose was reported in 1.5% of 12-to-15-year-old participants and 3.4% of 16-to-25-year-old participants; no severe pain was reported after placebo.

    “Severe injection-site pain after any BNT162b2 dose was reported in 1.5% of 12-to-15-year-old participants and in 3.4% of 16-to-25-year-old participants; no severe pain was reported after placebo administration.”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Findingown data

    In all 2229 participants in the 12-to-15-year-old cohort who could be evaluated, regardless of previous SARS-CoV-2 infection, vaccine efficacy from 7 days after dose 2 was 100% (95% CI, 78.1 to 100), with no Covid-19 cases among BNT162b2 recipients and 18 cases among placebo recipients.

    “Similarly, in the group that included all 2229 participants in the 12-to-15-year-old cohort who could be evaluated, regardless of whether they had evidence of previous SARS-CoV-2 infection, vaccine efficacy from 7 days after dose 2 was 100% (95% CI, 78.1 to 100), with no Covid-19 cases observed among BNT162b2 recipients and 18 cases observed among placebo recipients.”
    Quote in the paperSubstantial claim

  • May combine two claims.

    Study design and conductown data

    The trial was a randomized, placebo-controlled, observer-blinded, phase 3 trial.

    “We conducted a randomized, placebo-controlled, observer-blinded, phase 3 trial as part of a phase 1–2–3 trial assessing BNT162b2 safety, immunogenicity, and efficacy in healthy persons 12 years of age or older.”
    Quote in the paperSubstantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Study design and conductnone given

    All 12-to-15-year-old participants in this trial were enrolled at U.S. sites, whereas the 16-to-25-year-old participants were recruited globally.

    “All 12-to-15-year-old participants in this trial were enrolled at U.S. sites, whereas the 16-to-25-year-old participants were recruited globally.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductown data

    The study did not formally examine concomitant vaccination with BNT162b2 and other vaccines received during adolescence.

    “Although some participants received other vaccinations during the trial period, we did not formally examine concomitant vaccination with BNT162b2 and other vaccines received during adolescence.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductown data

    Randomization was conducted with an interactive Web-based response system.

    “Randomization was conducted with the use of an interactive Web-based response system.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductown data

    A testing laboratory supply limitation resulted in fewer participants than anticipated for the immunogenicity analyses.

    “A testing laboratory supply limitation of the qualified viral lot used for assay validation and clinical testing resulted in the trial having fewer participants than anticipated for the immunogenicity analyses.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductown data

    In the immunogenicity subset, all participants in both age cohorts were from the United States.

    “In the immunogenicity subset, however, all participants in both age cohorts were from the United States.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductown data

    This report includes safety data through 1 month of follow-up after dose 2 for some participants.

    “This report includes safety data through 1 month of follow-up after dose 2 for some participants.”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Interpretationown data

    The lower boundary of the two-sided 95% confidence interval for the geometric mean ratio was greater than 1, indicating a greater response in adolescents than in young adults.

    “The lower boundary of the two-sided 95% confidence interval for the geometric mean ratio was greater than 1, indicating a greater response in adolescents than in young adults.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductown data

    More than 97% of BNT162b2 recipients received dose 2.

    “More than 97% of the BNT162b2 recipients received dose 2.”
    Quote in the paperNot a substantial claim

  • Classified as probably not a substantial claim.

    Study design and conductreasoning

    The efficacy analysis for the 12-to-15-year-old cohort was planned as a descriptive analysis because the number of cases in age subgroups was unknown.

    “The efficacy analysis for the 12-to-15-year-old cohort was planned as a descriptive analysis because the number of cases that would occur in the age subgroups was unknown.”
    Quote in the paperSubstantial claim

  • Classified as probably not a substantial claim.

    Study design and conductown data

    A sample of 225 BNT162b2 recipients who could be evaluated (or 280 overall) in each age cohort was estimated to provide 90.8% power for declaring noninferiority, defined as a lower limit of the 95% confidence interval for the geometric mean ratio of >0.67.

    “A sample of 225 BNT162b2 recipients who could be evaluated (or 280 BNT162b2 recipients overall) in each age cohort was estimated to provide 90.8% power for declaring noninferiority (defined as a lower limit of the 95% confidence interval for the geometric mean ratio of >0.67).”
    Quote in the paperSubstantial claim

  • May combine two claims.

    Interpretationcitation

    Vaccination of adolescents is likely to confer the direct benefit of preventing disease along with indirect benefits, including community protection.

    “Vaccination of adolescents is likely to confer the direct benefit of preventing disease along with indirect benefits, including community protection.24”
    Quote in the paperSubstantial claim0 of 1 sources checked
    • cites [24] Kao CM, Orenstein WA, Anderson EJ. The importance of advancing severe acute respiratory syndrome coronavirus 2 vaccines in children. Clin Infect Dis 2021; 72: 515- 518. 33527122 PMC7314192 source

      Not checked in the free run.

  • May combine two claims.

    Premisecitation

    In healthy adults, two 30-μg doses of BNT162b2 elicited high neutralizing titers and robust antigen-specific CD4+ and CD8+ T-cell responses against SARS-CoV-2.

    “In healthy adults, two 30-μg doses of BNT162b2 elicited high neutralizing titers and robust, antigen-specific CD4+ and CD8+ T-cell responses against SARS-CoV-2.3,4”
    Quote in the paperNot a substantial claim0 of 2 sources checked
    • cites [3] Walsh EE, Frenck RW Jr, Falsey AR, et al. Safety and immunogenicity of two RNA-based Covid-19 vaccine candidates. N Engl J Med 2020; 383: 2439- 2450. 33053279 PMC7583697 source

      Not checked in the free run.

    • cites [4] Sahin U, Muik A, Vogler I, et al. BNT162b2 induces SARS-CoV-2-neutralising antibodies and T cells in humans. December 11, 2020 (https://www.medrxiv.org/content/10.1101/2020.12.09.20245175v1). preprint. source

      Not checked in the free run.

  • May combine two claims.

    Interpretationcitation

    Vaccine efficacy in the 16+ age cohort is consistent among racial and ethnic subgroups, and a similar pattern is likely in the younger cohort.

    “Although racial and ethnic diversity was lower among the 12-to-15-year-old participants than among those who were 16 years of age or older, vaccine efficacy in the latter age cohort is consistent among racial and ethnic subgroups,5 and a similar pattern is likely in the younger cohort.”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites [5] Polack FP, Thomas SJ, Kitchin N, et al. Safety and efficacy of the BNT162b2 mRNA Covid-19 vaccine. N Engl J Med 2020; 383: 2603- 2615. 33301246 PMC7745181 source

      Not checked in the free run.

  • May combine two claims.

    Interpretationcitation

    Vaccination of adolescents will allow them to reintegrate into society and resume in-person learning safely.

    “Vaccination of adolescents will allow them to reintegrate into society and resume in-person learning safely, which are especially important outcomes given the severe mental health effects of the Covid-19 pandemic on this group.18,22,26”
    Quote in the paperSubstantial claim0 of 3 sources checked
    • cites [18] Townsend E. Debate: the impact of school closures and lockdown on mental health in young people. Child Adolesc Ment Health 2020; 25: 265- 266. 33049100 PMC7675670 source

      Not checked in the free run.

    • cites [22] Cooper DM, Afghani B, Byington CL, et al. SARS-CoV-2 vaccine testing and trials in the pediatric population: biologic, ethical, research, and implementation challenges. Pediatr Res 2021 February 24 (Epub ahead of print). 33627824 PMC7903864 source

      Not checked in the free run.

    • cites [26] Jones EAK, Mitra AK, Bhuiyan AR. Impact of COVID-19 on mental health in adolescents: a systematic review. Int J Environ Res Public Health 2021; 18: 2470- 2470. 33802278 PMC7967607 source

      Not checked in the free run.

  • May combine two claims.

    Interpretationreasoning

    Given the observed immunogenicity and efficacy, it is likely that vaccination will also prevent asymptomatic infection in children, thereby broadening community protection.

    “Given the observed immunogenicity and efficacy, it is likely that vaccination will also prevent asymptomatic infection in children, thereby broadening community protection.”
    Quote in the paperSubstantial claim

  • May combine two claims.

    Premisecitation

    Although children and adolescents generally have milder Covid-19 than adults, severe illness can occur in this population, especially in those with underlying medical conditions.

    “Although children and adolescents generally have milder Covid-19 than adults, severe illness can occur in this population, especially in those with underlying medical conditions.11”
    Quote in the paperSubstantial claim0 of 1 sources checked
    • cites [11] Tsabouri S, Makis A, Kosmeri C, Siomou E. Risk factors for severity in children with coronavirus disease 2019: a comprehensive literature review. Pediatr Clin North Am 2021; 68: 321- 338. 33228941 PMC7392074 source

      Not checked in the free run.

30 of 30

  • The paper relies on this without support.

    Noninferiority of the neutralizing antibody response to BNT162b2 in 12-to-15-year-old participants compared with 16-to-25-year-old participants predicts noninferior vaccine efficacy in the 12-to-15-year-old population.

    “Noninferiority of immunogenicity in 12-to-15-year-old adolescents, as shown in our trial, was initially planned as the primary assessment of vaccine effectiveness through “immunobridging,” an approach in which the effectiveness of a vaccine is inferred from immunogenicity data.”
1 of 1

Claims other papers make about this one

Each is checked against this paper’s own text: does it say what the citing paper says it does?

  • BNT162b2 showed 95% protection against symptomatic COVID-19 in participants 16 years or older and 100% efficacy in participants 12 to 15 years of age.

    “95% protection against symptomatic COVID-19 in participants 16 years or older8 and 100% efficacy in participants 12 to 15 years of age80”

    From COVID-19 mRNA vaccines: Platforms and current developments (2022) · cites this paper as [80]

  • In 12- to 15-year-olds, two 30 μg doses of BNT162b2 showed a favorable safety profile and resulted in 100% vaccine efficacy.

    “In 12- to 15-year-olds, two 30 μg doses of BNT162b2 showed a favorable safety profile and resulted in 100% vaccine efficacy.80”

    From COVID-19 mRNA vaccines: Platforms and current developments (2022) · cites this paper as [80]

  • BNT162b2 was 95 to 100% efficacious in preventing Covid-19 illness from 7 days to approximately 2 months after the second dose.

    “and was 95 to 100% efficacious in preventing Covid-19 illness from 7 days to approximately 2 months after the second dose.3,4”

    From Evaluation of the BNT162b2 Covid-19 Vaccine in Children 5 to 11 Years of Age (2022) · cites this paper as [4]

  • Results of an ongoing phase 1-2-3 clinical study in healthy persons 12 years of age or older support the safety, immunogenicity, and efficacy of a two-dose series of 30-μg BNT162b2 injections administered 21 days apart.

    “Results of an ongoing phase 1–2–3 clinical study in healthy persons 12 years of age or older support the safety, immunogenicity, and efficacy of a two-dose series of 30-μg BNT162b2 injections administered 21 days apart.3-5”

    From Evaluation of the BNT162b2 Covid-19 Vaccine in Children 5 to 11 Years of Age (2022) · cites this paper as [4]

  • BNT162b2 was more immunogenic among 12-to-15-year-olds than among young adults.

    “was more immunogenic among 12-to-15-year-olds than among young adults”

    From Evaluation of the BNT162b2 Covid-19 Vaccine in Children 5 to 11 Years of Age (2022) · cites this paper as [4]

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Authors
Frenck, R. W., Klein, N. P., Kitchin, N., Gurtman, A., Absalon, J., Lockhart, S., Perez, J. L., Walter, E. B., Senders, S., Bailey, R., Swanson, K. A., Ma, H., Xu, X., Koury, K., Kalina, W. V., Cooper, D., Jennings, T., Brandon, D. M., Thomas, S. J., Türeci, Ö., Tresnan, D. B., Mather, S., Dormitzer, P. R., Şahin, U., Jansen, K. U., & Gruber, W. C.
Affiliations
Kaiser Permanente (US)
Corresponding author
Gurtman, Alejandra
ORCID
Venue
New England Journal of Medicine
Publisher
Massachusetts Medical Society
Published
2021-07-15
Volume
385
Issue
3
Pages
239-250
ISSN
  • 0028-4793 (ISSN-L)
  • 1533-4406
DOI
10.1056/nejmoa2107456
PMC
PMC8174030
OpenAlex
W3164720238
Semantic Scholar
060a25a1ec6ab0bacf403dfd6c0d8a109fc01e1b
Cited by
889
References
20
Citations by year
2026: 20 · 2025: 58 · 2024: 84 · 2023: 177 · 2022: 382 · 2021: 166 · 2013: 1
FWCI
64.06
Type
journal article
Language
en
Open access
Licence
www.nejmgroup.org/legal/terms-of-use.htm (vor)
Locations
  • New England Journal of Medicine (publishedVersion)
  • PubMed Central (publishedVersion)
  • PubMed (publishedVersion)
Funders
Pfizer Inc.
Topics
  • Health Sciences › Medicine › Infectious Diseases › SARS-CoV-2 and COVID-19 Research
  • Health Sciences › Medicine › Infectious Diseases › COVID-19 Clinical Research Studies
  • Social Sciences › Health › Vaccine Coverage and Hesitancy
Keywords
BNT162b2, COVID-19 vaccines, adolescents, vaccine safety, immunogenicity, neutralizing antibodies, non-inferiority, vaccine efficacy, reactogenicity, SARS-CoV-2, COVID-19 prevention, mRNA vaccines, injection site pain
MeSH terms
Immunogenicity, Vaccine, COVID-19, COVID-19 Vaccines, BNT162 Vaccine, Adolescent, Adult, Age Factors, Antibodies, Viral, Child, Female, Humans, Immunoglobulin G, Injections, Intramuscular, Male, Pain, Treatment Outcome, Young Adult, Antibodies, Neutralizing

About these checks

Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.

Claims read by deepseek-v4.1-flash under definition version 3 (extract-v3) on 2026-10-10.

Classified by jev-1.13-20260917 (gold-guideline-v0.2) on 2026-10-10.

Statistics and arithmetic are recomputed, not judged.

Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.

What counts as a claim ›How we measure confidence ›How we check this ›

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