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|October 26, 2021
FDA VRBPAC Meeting Today to Discuss the Pfizer-BioNTech COVID-19 Vaccine in 5 to 11 Year Olds
Author(s)John Parkinson
The committee is meeting today to review the data presented to them, and will vote to either recommend or not an Emergency Use Authorization in this pediatric population.
Advertisement
The Food and Drug Administration (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) panel is meeting today to discuss whether or not to recommend an Emergency Use Authorization (EUA) for the Pfizer-BioNTech vaccine in the 5 to 11 year old pediatric population.
The meeting will include a presentation by Pfizer who will be discussing data on their COVID-19 vaccine series in this age group.
The Centers for Disease Control and Prevention (CDC) will be presenting on the epidemiology of COVID-19 in children, followed by the known safety signals of vaccines in adolescents and young adults.
The FDA will review the Pfizer-BioNTech vaccine submission and present post-authorization evaluation and a benefit-risk analysis.
There will be a public comment portion of the meeting and a question and answer session for the committee in the afternoon.
After this, the committee will take a vote on whether or not to recommend the EUA. Check back later today when the committee votes.
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.
The antiviral did not produce greater symptom improvement than placebo in patients with the condition in the RECOVER-VITAL trial.
The FDA has approved formulations for the 2026-2027 vaccines including Pfizer-BioNTech's Comirnaty XFG, Novavax's commercial partners Sanofi and Takeda have secured approvals for its Nuvaxovid, and Moderna's Spikevax and mNEXSPIKE vaccines, all with protections against the currently circulating variant.
The FDA has approved Pfizer-BioNTech's 2026-2027 Comirnaty XFG formula, an updated COVID-19 vaccine targeting the XFG variant, for adults 65 and older and for individuals ages five through 64 with at least one high-risk underlying condition.
Venky Soundararajan, PhD, co-founder and chief scientific officer of nference, explains what the semaglutide-COVID-19/influenza data can and can't tell clinicians about mechanism, bias, and the evidence bar before it should shape prescribing.
A retrospective cohort study of more than 29 million patients found adults with prior semaglutide use had significantly lower 30-day mortality, hospitalization, and acute kidney injury after COVID-19 or influenza infection compared with a metformin comparator group.
In this week's top infectious disease stories, a Pennsylvania teen became the state's fourth measles death in weeks, the CDC reported a 17% summer surge in rabies exposure calls, new research revisited whether cefepime raises mortality risk, a multihospital review examined ceftriaxone's safety after state alerts, and examining Legionella pneumonia diagnostics.
Advertisement
Advertisement