FDA approved updated 2026-2027 COVID-19 vaccines from Pfizer-BioNTech, Moderna, and Novavax's partners, all reformulated to target the XFG variant, giving clinicians several options ahead of the fall respiratory virus season.
|Articles|September 28, 2021
Pfizer-BioNTech Submits Pediatric COVID-19 Vaccine Data to FDA
Author(s)Kevin Kunzmann
The companies will be seeking emergency authorization for a lighter-dose mRNA vaccine for children aged 5 to <12 years old.
Advertisement
Pfizer-BioNTech has submitted data to the US Food and Drug Administration (FDA) supporting the companies’ bid for authorized use of their
The developers of 2-dose mRNA vaccine BNT162b2 announced Tuesday morning that phase 2/3 trial data, featuring 2200-plus pediatric participants and data supporting the vaccine’s benefit and safety in children, has been submitted to the FDA as part of their pending Emergency Use Authorization (EUA) submission for this patient population. The formal submission is planned for coming weeks.
Investigators observed a pair of 10mcg doses of BNT162b2 in 2268 pediatric trial participants for its safety, tolerability, and immunogenicity. According to Pfizer, their phase 2/3 findings are comparable to those observed in an assessment of BNT162b2 in adults and adolescents aged 16-25 years old.
The companies are also anticipating to provide “topline” immunogenicity and safety readouts from 2 different age cohorts of the trial in the fourth quarter of 2021: children aged 2 to <5 years old, plus children 6 months to <2 years old. Phase 3 data from Pfizer-BioNTech’s international pediatric trial program will be submitted for publication in a peer-reviewed publication in the near future.
Advertisement
Related to this article
The Vaccine Integrity Project, in collaboration with the American Medical Association, conducted a vaccine and immunization effectiveness and safety review for RSV, Influenza, and COVID-19 for the 2026-2027 season. JAMA published the review, and here is an overview of the data going into this year's seasonal respiratory virus season.
A new study in infants challenges the long-standing belief about the pathogen’s effects in the youngest pediatric population. Senior author Joseph Zackular, PhD, provides insights around his work including how it reshapes gut development and offers potential intervention strategies to shield neonates.
The 18-year old resident of the state suffered from acute disseminated encephalomyelitis. Pennsylvania numbers are surging with some of the highest state totals of measles cases in the country.
The death was reported in Jefferson County where the coroner released a statement announcing it was in an unvaccinated woman.
Editor in chief Jason Gallagher, PharmD, FCCP, FIDP, FIDSA, BCPS, discusses the proposed OMB rule restricting federal grants for international research collaboration, and how it threatens infectious disease medicine's inherently borderless surveillance networks, publication access, and knowledge-sharing systems.
The antiviral did not produce greater symptom improvement than placebo in patients with the condition in the RECOVER-VITAL trial.
GSK will advance its investigational mRNA seasonal flu vaccine candidate, which targets both hemagglutinin and neuraminidase, into a phase 3 trial in September 2026 after the shot outperformed licensed flu vaccines in a phase 2 study.
Advertisement
Advertisement
Trending on Contagion Live
1
CDC Tracking 4 Active Foodborne Outbreaks
2
Measles Update: September 25, 2026
3
On World Rabies Day, When to Seek Treatment, Clinical Considerations for Post Exposure Prophylaxis
4
Enivronmental Stewardship: The Role of Antimicrobials in Climate Change
5