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With Pfizer EUA For 5-11 And Moderna Delay For Adolescents, US FDA Walks Myocarditis Tightrope

 
• By Nielsen Hobbs

COVID vaccine safety concerns from international analyses will force sponsors and FDA to again confront the challenge of how to make bad news for one shot not turn into bad news for all.

Pfizer orange cap covid vaccine
PFIZER’S VERSION OF ITS COVID VACCINE FOR CHILDREN 5-11 FEATURES A LOWER DOSE AND AN ORANGE-COLORED CAP. • Source: Pfizer

The US Food and Drug Administration offered treats and probably a little bit of a scare to COVID vaccine sponsors on the Friday before Halloween when it gave Pfizer Inc. emergency use authorization for its COVID-19 vaccine in children 5-11 and then apparently told Moderna, Inc. that safety concerns would extend the review of its vaccine for use in 12- to 17-year-olds.

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More from Approvals

EU Biosimilar Filings, Opinions And Approvals

 
• By Neena Brizmohun

A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.

New EU Approvals

 
• By Neena Brizmohun

The Pink Sheet's list of EU centralized approvals of new active substances has been updated to include four new products, one of which is Tivdak, Pfizer/Genmab’s treatment for previously treated recurrent or metastatic cervical cancer.

Leqembi Launch Set For Germany & Austria After Winning EU Approval At Last

 
• By Neena Brizmohun

Eisai is working on securing reimbursement across the EU for Leqembi now that the Alzheimer’s disease treatment has secured marketing approval from the European Commission.

African Medicines Agency Set To Launch With New Leader In April

 
• By Anabel Costa-Ferreira

The African Medicines Agency is to appoint a director general and become operational at the end of this month.

More from Product Reviews

US FDA User Fee Collection Safe In Preliminary Trump 2026 Budget Plan

 
• By Cathy Kelly

The preliminary White House 2026 budget plan cuts agency funding, but not so sharply that user fees are excluded from collection.

New EU Approvals

 
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The Pink Sheet's list of EU centralized approvals of new active substances has been updated to include four new products, one of which is Tivdak, Pfizer/Genmab’s treatment for previously treated recurrent or metastatic cervical cancer.

US CDC Panel Recommends Some 50-59 Year-Olds For RSV Vaccination

 
• By Bridget Silverman

All RSV vaccines with US FDA approval for high-risk younger adult patients will be incorporated in US CDC’s Advisory Committee for Immunization Practices recommendations. Merck’s infant RSV antibody is on track for a June vote