OpenSAFELY: Effectiveness of COVID-19 vaccination in children and adolescents (2024)

Abstract

Background Children and adolescents in England were offered BNT162b2 as part of the national COVID-19 vaccine roll out from September 2021. We assessed the safety and effectiveness of first and second dose BNT162b2 COVID-19 vaccination in children and adolescents in England.

Methods With the approval of NHS England, we conducted an observational study in the OpenSAFELY-TPP database, including a) adolescents aged 12-15 years, and b) children aged 5-11 years and comparing individuals receiving i) first vaccination with unvaccinated controls and ii) second vaccination to single-vaccinated controls. We matched vaccinated individuals with controls on age, sex, region, and other important characteristics. Outcomes were positive SARS-CoV-2 test (adolescents only); COVID-19 A&E attendance; COVID-19 hospitalisation; COVID-19 critical care admission; COVID-19 death, with non-COVID-19 death and fractures as negative control outcomes and A&E attendance, unplanned hospitalisation, pericarditis, and myocarditis as safety outcomes.

Results Amongst 820,926 previously unvaccinated adolescents, the incidence rate ratio (IRR) for positive SARS-CoV-2 test comparing vaccination with no vaccination was 0.74 (95% CI 0.72-0.75), although the 20-week risks were similar. The IRRs were 0.60 (0.37-0.97) for COVID-19 A&E attendance, 0.58 (0.38-0.89) for COVID-19 hospitalisation, 0.99 (0.93-1.06) for fractures, 0.89 (0.87-0.91) for A&E attendances and 0.88 (0.81-0.95) for unplanned hospitalisation. Amongst 441,858 adolescents who had received first vaccination IRRs comparing second dose with first dose only were 0.67 (0.65-0.69) for positive SARS-CoV-2 test, 1.00 (0.20-4.96) for COVID-19 A&E attendance, 0.60 (0.26-1.37) for COVID-19 hospitalisation, 0.94 (0.84-1.05) for fractures, 0.93 (0.89-0.98) for A&E attendance and 0.99 (0.86-1.13) for unplanned hospitalisation. Amongst 283,422 previously unvaccinated children and 132,462 children who had received a first vaccine dose, COVID-19-related outcomes were too rare to allow IRRs to be estimated precisely. A&E attendance and unplanned hospitalisation were slightly higher after first vaccination (IRRs versus no vaccination 1.05 (1.01-1.10) and 1.10 (0.95-1.26) respectively) but slightly lower after second vaccination (IRRs versus first dose 0.95 (0.86-1.05) and 0.78 (0.56-1.08) respectively). There were no COVID-19-related deaths in any group. Fewer than seven (exact number redacted) COVID-19-related critical care admissions occurred in the adolescent first dose vs unvaccinated cohort. Among both adolescents and children, myocarditis and pericarditis were documented only in the vaccinated groups, with rates of 27 and 10 cases/million after first and second doses respectively.

Conclusion BNT162b2 vaccination in adolescents reduced COVID-19 A&E attendance and hospitalisation, although these outcomes were rare. Protection against positive SARS-CoV-2 tests was transient.

Competing Interest Statement

BG has received research funding from the Laura and John Arnold Foundation, the NHS National Institute for Health Research (NIHR), the NIHR School of Primary Care Research, NHS England, the NIHR Oxford Biomedical Research Centre, the Mohn-Westlake Foundation, NIHR Applied Research Collaboration Oxford and Thames Valley, the Wellcome Trust, the Good Thinking Foundation, Health Data Research UK, the Health Foundation, the World Health Organisation, UKRI MRC, Asthma UK, the British Lung Foundation, and the Longitudinal Health and Wellbeing strand of the National Core Studies programme; he is a Non-Executive Director at NHS Digital; he also receives personal income from speaking and writing for lay audiences on the misuse of science. BMK is also employed by NHS England working on medicines policy and clinical lead for primary care medicines data. IJD has received unrestricted research grants and holds shares in GlaxoSmithKline (GSK).

Funding Statement

The OpenSAFELY Platform is supported by grants from the Wellcome Trust (222097/Z/20/Z); MRC (MR/V015757/1, MC_PC-20059, MR/W016729/1); NIHR (NIHR135559, COV-LT2-0073), and Health Data Research UK (HDRUK2021.000, 2021.0157). In addition, this research used data assets made available as part of the Data and Connectivity National Core Study, led by Health Data Research UK in partnership with the Office for National Statistics and funded by UK Research and Innovation (grant ref MC_PC_20058). BG has also received funding from: the Bennett Foundation, the Wellcome Trust, NIHR Oxford Biomedical Research Centre, NIHR Applied Research Collaboration Oxford and Thames Valley, the Mohn-Westlake Foundation; all Bennett Institute staff are supported by BG's grants on this work. The views expressed are those of the authors and not necessarily those of the NIHR, NHS England, UK Health Security Agency (UKHSA) or the Department of Health and Social Care.

Funders had no role in the study design, collection, analysis, and interpretation of data; in the writing of the report; and in the decision to submit the article for publication.

Author Declarations

I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.

Yes

The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

This study was approved by the Health Research Authority (REC reference 20/LO/0651) and by the London School of Hygeine and Tropical Medicine Ethics Board (reference 21863).

I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.

Yes

I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).

Yes

I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable.

Yes

Data Availability

All data were linked, stored and analysed securely using the OpenSAFELY platform, https://www.opensafely.org/, as part of the NHS England OpenSAFELY COVID-19 service. Data include pseudonymised data such as coded diagnoses, medications and physiological parameters. No free text data was included. All code is shared openly for review and re-use under MIT open license [https://github.com/opensafely/vaccine-effectiveness-in-kids]. Detailed pseudonymised patient data is potentially re-identifiable and therefore not shared. Primary care records managed by the GP software provider, TPP were linked to ONS death data and the Index of Multiple Deprivation through OpenSAFELY.

OpenSAFELY: Effectiveness of COVID-19 vaccination in children and adolescents (2024)

FAQs

What is the success rate of the COVID vaccine for children? ›

Among 1,305 children given the vaccine, there were three cases of COVID-19 . Among 663 children given the placebo, there were 16 cases of COVID-19 . The results suggest that the vaccine is about 91% effective in preventing COVID-19 in this age group.

How effective is the COVID vaccine among adolescents? ›

During the peak of pediatric COVID-19 hospitalizations (December 19, 2021–March 19, 2022), VE was 55% (95% CI = 38–67) against COVID-19–related hospitalizations when the last dose was received a median of 129 days before hospitalization (IQR = 47–198 days) and 79% (95% CI = 59–89) against critical COVID-19–related ...

How safe are COVID-19 vaccines in children? ›

COVID-19 vaccination for children is safe.

While adverse reactions are rare, the benefits of COVID-19 vaccination outweigh the known risks of COVID-19 and possible severe complications.

What is the efficacy of the COVID vaccine age group? ›

Effect of interest, by age, yVaccine effectiveness (95% credible interval)
Partially vaccinated*Fully vaccinated†
30–59 y68.7 (53.5–86.4)93.8 (90.3–98.2)
60–69 y83.9 (68.1–93.0)99.2 (97.4–99.9)
70–79y70.6 (55.9–82.8)99.3 (98.6–99.7)
9 more rows

What are the results of the COVID vaccine study? ›

In clinical trials, three vaccines had higher (>90%) efficacy against COVID-19 infection [Pfizer-BioNTech (~95%), Moderna (~94%) and Sputnik V (~92%)] than the vaccines by Oxford-AstraZeneca (~70%) and Janssen (54-72%), against moderate and severe forms of COVID-19 infection10.

How long does the COVID vaccine last? ›

How long does the COVID vaccine last? Studies suggest COVID vaccines are most effective in the first few months following your shot. That's why when health experts recommend boosters or updated doses, they're usually given three to four months after your last COVID shot.

What are the negative effects of the COVID vaccine on children? ›

Potential COVID-19 vaccine side effects in children include:
  • Pain, swelling and redness where the shot was given.
  • Tiredness.
  • Headache.
  • Muscle pain.
  • Chills.
  • Fever.
  • Nausea.

How effective is the COVID vaccine? ›

CDC data show that vaccination offered significant protection. People who received the updated COVID-19 vaccine were 54% less likely to get COVID-19 during the four-month period from mid-September to January. The vaccine provided similar levels of protection against XBB lineage variants and the JN. 1 variant.

What if I refuse to vaccinate my child? ›

According to small study, some states have ruled that refusal to vaccinate constitutes child neglect. If doctors, in their sincere medical judgment, believe a child's health would be put at risk by vaccinations, then a medical exemption will be granted.

What is the efficacy of the vaccine at preventing COVID? ›

Moderna's initial Phase 3 clinical data in December 2020 was similar to Pfizer-BioNTech's—both vaccines showed about 95% efficacy for prevention of COVID.

What age is the CDC recommending Covid shots? ›

CDC recommends the 2023–2024 updated COVID-19 vaccines—Pfizer-BioNTech, Moderna, or Novavax—to protect against serious illness from COVID-19. Everyone aged 5 years and older ‡ should get 1 dose of an updated COVID-19 vaccine to protect against serious illness from COVID-19.

How effective is the Pfizer vaccine in older adults? ›

While clinical trial data on Pfizer-BioNTech and Moderna vaccines demonstrated 94% vaccine effectiveness in the elderly, the results in this study showed that vaccine effectiveness in real-world settings is marginally lower against infection (40%–89%), hospitalization (92%), ICU admission and intubation (98%–85%), and ...

How effective is the flu vaccine? ›

CDC vaccine effectiveness studies measure two outcomes: laboratory confirmed flu illness that results in a doctor's visit or laboratory-confirmed flu that results in hospitalization. For these outcomes, a VE point estimate of 60% means that on average the flu vaccine reduces a person's risk of a flu outcome by 60%.

How do vaccines work? ›

When a person gets a vaccine, the immune system responds to the antigen as if it were exposed to the actual germ (it makes antibodies and remembers how to defeat it). Then, if the body gets exposed to the actual germ, the immune system can recognize it right away and quickly fight it off to prevent disease.

What are the side effects of the Covishield vaccine? ›

Get medical attention immediately if from a few days following vaccination you get any of the following symptoms:
  • experience a severe or persistent headache, blurred vision, confusion or seizures (fits)
  • develop shortness of breath, chest pain, leg swelling, leg pain or persistent abdominal pain.

What is the Global vaccine Data Network? ›

The Global Vaccine Data Network is a consortium of research sites ready to conduct globally coordinated epidemiologic studies of the safety of vaccines, including COVID-19 vaccines, as they are introduced.

Top Articles
Latest Posts
Recommended Articles
Article information

Author: Jamar Nader

Last Updated:

Views: 5789

Rating: 4.4 / 5 (75 voted)

Reviews: 90% of readers found this page helpful

Author information

Name: Jamar Nader

Birthday: 1995-02-28

Address: Apt. 536 6162 Reichel Greens, Port Zackaryside, CT 22682-9804

Phone: +9958384818317

Job: IT Representative

Hobby: Scrapbooking, Hiking, Hunting, Kite flying, Blacksmithing, Video gaming, Foraging

Introduction: My name is Jamar Nader, I am a fine, shiny, colorful, bright, nice, perfect, curious person who loves writing and wants to share my knowledge and understanding with you.