• About
  • Masthead
  • License Content
  • Advertise
  • Submit Press Release
  • RSS/Email List
  • Write for us
  • Contact us
2 Minute Medicine
No Result
View All Result

No products in the cart.

SUBSCRIBE
  • Specialties
    • Cardiology
    • Chronic Disease
    • Dermatology
    • Emergency
    • Endocrinology
    • Gastroenterology
    • Imaging and Intervention
    • Infectious Disease
    • Nephrology
    • Neurology
    • Obstetrics
    • Oncology
    • Ophthalmology
    • Pediatrics
    • Preclinical
    • Psychiatry
    • Public Health
    • Pulmonology
    • Rheumatology
    • Surgery
  • Wellness
  • Classics™
    • 2MM+ Online Access
    • Paperback and Ebook
  • Rewinds
  • Visual
  • Partners
    • License Content
    • Submit Press Release
    • Advertise with Us
  • AccountLog-in/out
    • Subscribe
    • Sign-in
    • My account
2 Minute Medicine
  • Specialties
    • Cardiology
    • Chronic Disease
    • Dermatology
    • Emergency
    • Endocrinology
    • Gastroenterology
    • Imaging and Intervention
    • Infectious Disease
    • Nephrology
    • Neurology
    • Obstetrics
    • Oncology
    • Ophthalmology
    • Pediatrics
    • Preclinical
    • Psychiatry
    • Public Health
    • Pulmonology
    • Rheumatology
    • Surgery
  • Wellness
  • Classics™
    • 2MM+ Online Access
    • Paperback and Ebook
  • Rewinds
  • Visual
  • Partners
    • License Content
    • Submit Press Release
    • Advertise with Us
  • AccountLog-in/out
    • Subscribe
    • Sign-in
    • My account
SUBSCRIBE
2 Minute Medicine
Subscribe
Home All Specialties Chronic Disease

mRNA Covid-19 vaccine safe and efficacious in 5-to-11-year-old children

byNhat Hung (Benjamin) LamandHarsh Shah
January 19, 2022
in Chronic Disease, Infectious Disease, Pediatrics, Public Health
Reading Time: 3 mins read
0
Share on FacebookShare on Twitter

1. BNT162b2 mRNA Covid-19 vaccine was efficacious in preventing symptomatic Covid-19 in children 5 to 11 years of age.

2. The BNT162b2 vaccine had a favorable safety profile with no serious adverse events reported.

Evidence Rating Level: 1 (Excellent)

Study Rundown: The BNT162B2 vaccine, containing lipid nanoparticles carrying mRNA which encodes the SARS-CoV-2 viral spike glycoprotein, has received authorization for adults and older children. With rising case numbers among school-age children, an appreciable risk of severe illness and complications, and the emergence of highly transmissible variants, the need for safe and effective Covid-19 vaccines remains high in this age group. This article reported results from a phase 1 dose-identifying study and an ongoing phase 2-3 safety and efficacy trial, investigating the BNT162b2 vaccine given to healthy children 5 to 11 years old. During the open-label phase 1, 3 groups received 2 vaccine doses 21 days apart at 10-, 20-, or 30-µg per dose, respectively. Based on safety and immunogenicity findings, 10-µg was selected for the randomized placebo-controlled phase 2-3. During this phase, it was found that BNT162b2 yielded non-inferior immunogenicity to the 16-to-25-year-olds, provided 90.7% efficacy against SARS-CoV-2 infection, and was not associated with severe adverse effects. While the follow-up period was limited, long-term monitoring will continue and these results provided robust support for vaccinating 5-to-11-year-old children with two 10-µg doses of BNT162b2.

Click here to read the study in NEJM

Relevant Reading: Safety, Immunogenicity, and Efficacy of the BNT162b2 Covid-19 Vaccine in Adolescents

In-Depth [randomized controlled trial]: This study reported results from an open-label dose level-identifying Phase 1 trial and a double-blind randomized placebo-controlled Phase 2-3 trial. These trials investigated the administration of the BNT162b2 mRNA vaccine against Covid-19 in participants 6 months to 11 years of age. The results reported were from the 5-to-11-year-old subgroup. 2 doses of BNT162b2 were administered 21 days apart. Children were included if they had no or stable pre-existing conditions. Children were excluded if they had an immunocompromising condition, were on immunosuppressive therapies, or had a history of a multisystem inflammatory syndrome in children (MIS-C). In phase 1, children were also excluded if they had previous clinical or virologic Covid-19 diagnoses. In phase 1, 48 children 5 to 11 years old received the vaccine at 10, 20, or 30 µg per dose (16 per dose level). In phase 2-3, 2268 children were randomly assigned at 2:1 ratio to receive the BNT162b2 vaccine (10 µg dose) (1517 children) or placebo (751 children). Safety was assessed via reactogenic events, as well as serious adverse events, including myocarditis. Immunogenicity was measured from blood samples via SARS-CoV-2 neutralization titers, and noninferiority was determined relative to titers obtained from the 16-to-25-year-old participants. Efficacy was evaluated against confirmed Covid-19 with onset at least 7 days after the second dose. During phase 1, higher dose levels (20- or 30-µg) were associated with more fever and severe adverse events while the 10-µg dose yielded comparable immunogenicity to higher dose levels. Hence, 10 µg was selected for Phase 2-3. During phase 2-3, local reaction and systemic events, such as fatigue, headache, chills, and muscle pains, were more common in BNT162b2 than placebo, especially following the second dose. Fever and antipyretics use was also more common following the second dose than the first. No serious adverse events were reported to be linked to the vaccine or placebo. No deaths, myocarditis, pericarditis, or anaphylaxis were reported. Regarding immunogenicity, the geometric mean ratio of SARS-CoV-2 neutralizing titers from 10 µg of BNT162b2 in 5-to-11-year-olds versus that from 30 µg in 16-to-25-year-olds 1 month after the second dose was 1.04 (95% confidence interval [CI], 0.93 to 1.18), meeting the pre-specified immunobridging non-inferiority criterion. Among children without evidence of previous SARS-CoV-2 infection, 3 Covid-19 cases were reported among BNT162b2 recipients while 16 were reported in the placebo group, resulting in the efficacy of 90.7% (95% CI, 67.7 to 98.3). No additional cases were reported in children with evidence of the previous infection. No severe Covid-19 or MIS-C was reported. While this study only reported the short-term results (median follow-up of 2.3 months), longer-term monitoring of safety and efficacy is underway. These results support a vaccination schedule consisting of two 10-µg doses of BNT162b2 for children 5 to 11 years of age against Covid-19.

RELATED REPORTS

Awake prone positioning does not seem to offer benefit in reducing endotracheal intubation for COVID-19-induced acute respiratory failure: COVI-PRONE trial

Vaccination boosted immunity acquired from previous SARS-CoV-2 infection

Single-dose Ad26.COV2.S vaccine provides moderate protection against Covid-19 related outcomes

Image: PD

©2022 2 Minute Medicine, Inc. All rights reserved. No works may be reproduced without expressed written consent from 2 Minute Medicine, Inc. Inquire about licensing here. No article should be construed as medical advice and is not intended as such by the authors or by 2 Minute Medicine, Inc.

Tags: bnt162b2COVID in childrencovid vaccineCOVID-19covid-19 infectionSARS-CoV-2
Previous Post

Women with mild autonomous cortisol secretion are at greater risk for cardiometabolic disease

Next Post

#VisualAbstract: Nedaplatin-based concurrent chemoradiotherapy is noninferior to cisplatin for stage II-IVB nasopharyngeal carcinoma

RelatedReports

Novel coronavirus identified from patients with pneumonia in Wuhan, China
Emergency

Awake prone positioning does not seem to offer benefit in reducing endotracheal intubation for COVID-19-induced acute respiratory failure: COVI-PRONE trial

May 16, 2022
Decreased expression of nasal ACE2 may be correlated with lower prevalence of COVID-19 in children
Chronic Disease

Vaccination boosted immunity acquired from previous SARS-CoV-2 infection

May 13, 2022
Novel coronavirus identified from patients with pneumonia in Wuhan, China
Chronic Disease

Single-dose Ad26.COV2.S vaccine provides moderate protection against Covid-19 related outcomes

May 13, 2022
Decreased expression of nasal ACE2 may be correlated with lower prevalence of COVID-19 in children
Chronic Disease

BNT162b2 safe and efficacious in children 5 to 11 years of age

May 13, 2022
Next Post
#VisualAbstract: Gonadotrophin-releasing hormone analogs reduces rates of premature ovarian insufficiency  in premenopausal women with breast cancer

#VisualAbstract: Nedaplatin-based concurrent chemoradiotherapy is noninferior to cisplatin for stage II-IVB nasopharyngeal carcinoma

Decreased expression of nasal ACE2 may be correlated with lower prevalence of COVID-19 in children

Rate of adverse events in placebo arms of COVID-19 vaccine trials

2 Minute Medicine Rewind October 14, 2019

Patients with image-confirmed cerebral infarct have superior benefit from clopidogrel-aspirin therapy in preventing recurrent stroke

License Our Award-Winning Physician-Written Medical News and Visual Abstracts

2 Minute Medicine is the leading authoritative medical news licensing service, and the only with reports written by practicing doctors.

LICENSE CONTENT

Get 2MM+ Premium Access

No ads & unlimited access to all current reports, over 9000 searchable archived reports, visual abstracts, Weekly Rewinds, and the online edition of The Classics Series™ textbook.

Subscription Options
2 Minute Medicine

2 Minute Medicine® is an award winning, physician-run, expert medical media company. Our content is curated, written and edited by practicing health professionals who have clinical and scientific expertise in their field of reporting. Our editorial management team is comprised of highly-trained MD physicians. Join numerous brands, companies, and hospitals who trust our licensed content.

Recent Reports

  • #VisualAbstract: Severe actinic keratosis and need for additional treatment are markers for an increased risk of cutaneous squamous cell carcinoma
  • Virtual yoga and meditation intervention may be associated with increased health-related quality of life
  • Wellness Check: Mental Health
License Content
Terms of Use | Disclaimer
Cookie Policy
Privacy Statement (EU)
Disclaimer

© 2021 2 Minute Medicine, Inc. - Physician-written medical news.

  • Specialties
    • Cardiology
    • Chronic Disease
    • Dermatology
    • Emergency
    • Endocrinology
    • Gastroenterology
    • Imaging and Intervention
    • Infectious Disease
    • Nephrology
    • Neurology
    • Obstetrics
    • Oncology
    • Ophthalmology
    • Pediatrics
    • Preclinical
    • Psychiatry
    • Public Health
    • Pulmonology
    • Rheumatology
    • Surgery
  • Wellness
  • Classics™
    • 2MM+ Online Access
    • Paperback and Ebook
  • Rewinds
  • Visual
  • Partners
    • License Content
    • Submit Press Release
    • Advertise with Us
  • Account
    • Subscribe
    • Sign-in
    • My account

© 2021 2 Minute Medicine, Inc. - Physician-written medical news.