Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

No Non-Inferiority, No Problem: FDA Advisory Committee Endorses Prevnar 13

This article was originally published in The Pink Sheet Daily

Executive Summary

Panel votes 10-1 to recommend next-generation pneumococcal vaccine for prevention of invasive disease, but says claim for further protection against otitis media should await post-market study data.

You may also be interested in...



13 Going On 50: Pfizer Seeks Adult Indication For Prevnar

Advisory committee might closely scrutinize the requested indication for the 13-valent pneumococcal conjugate vaccine for adults age 50 and up; it is now indicated for children under six years old.

13 Going On 50: Pfizer Seeks Adult Indication For Prevnar

Advisory committee might closely scrutinize the requested indication for the 13-valent pneumococcal conjugate vaccine for adults age 50 and up; it is now indicated for children under six years old.

Prevnar 13's Added Strains, Extra Studies Help Insulate Pfizer's U.S. Position

By picking up serotype 19A, Pfizer's next-generation pneumococcal disease vaccine Prevnar 13 is armed to protect against the most prevalent strain of Streptococcus pneumoniae left in the U.S

Related Content

Topics

UsernamePublicRestriction

Register

PS068769

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel