• Skip to primary navigation
  • Skip to main content
  • Skip to primary sidebar
  • Skip to footer

MassDevice

The Medical Device Business Journal — Medical Device News & Articles | MassDevice

  • Latest News
    • Cardiovascular
    • Orthopedics
  • Wall Street Beat
    • Funding Roundup
    • Mergers & Acquisitions
  • Podcasts & Webinars
    • Podcasts
    • Webinars
  • Resources
    • About MassDevice
    • Newsletter Signup
    • Leadership in Medtech
    • Manufacturers & Suppliers Search
    • MedTech 100 Index
    • Videos
    • Whitepapers
  • DeviceTalks Tuesdays
  • Coronavirus: Live updates

VRBPAC

FDA signals careful approach in authorizing COVID-19 vaccines in young children

May 2, 2022 By Brian Buntz

FDA is planning a series of virtual meetings of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) throughout June. In the meetings, the advisory committee will discuss authorizing the COVID-19 vaccine from Novavax (Nasdaq:NVAX) and authorizing the use of the vaccines from Moderna (Nasdaq: MRNA) and Pfizer-BioNTech (NYSE:PFE; Nasdaq:BNTX) in children aged 6 months […]

Filed Under: Featured, Pharmaceutical Tagged With: BioNTech, COVID-19 vaccines, FDA, Moderna, Novavax, NVX‑CoV2373, Pfizer, Vaccines and Related Biological Products Advisory Committee, VRBPAC

FDA advisory panel to convene to consider second booster dose

March 21, 2022 By Brian Buntz

The Vaccines and Related Biological Products Advisory Committee (VRBPAC) is scheduled to meet on April 6 to discuss the potential use of COVID-19 vaccine booster does. Both Pfizer (NYSE:PFE) and Moderna (Nasdaq:MRNA) are seeking to amend the emergency use authorization of their respective vaccines to allow for an additional booster. Pfizer and its partner BioNTech SE (Nasdaq:BNTX) […]

Filed Under: Blog, Featured, Pharmaceutical Tagged With: BioNTech, COVID-19, COVID-19 boosters, FDA, Pfizer, Vaccines and Related Biological Products Advisory Committee, VRBPAC

FDA advisory panel recommends boosters only for older and high-risk individuals

September 17, 2021 By Brian Buntz

The Vaccines and Related Biological Products Advisory Committee (VRBPAC) unanimously supported emergency use authorization to administer the Pfizer-BioNTech Comirnaty vaccine as a booster to those 65 years of age and older individuals at high risk of developing severe COVID-19. The panel, however, resoundingly rejected a plan to administer the vaccine as a booster to individuals […]

Filed Under: Featured, Pharmaceutical Tagged With: BioNTech, coronavirus, COVID-19, COVID-19 vaccine, COVID-19 vaccine trial, COVID-19 vaccines, FDA, Pfizer, Vaccines and Related Biological Products Advisory Committee, VRBPAC

Why emergency authorization of COVID-19 therapies could pose regulatory questions

March 11, 2021 By Brian Buntz

Few of the COVID-19 therapies in use in the U.S. have won full FDA approval. The widespread use of emergency use authorization may accelerate the distribution of disease-modifying agents and vaccines to patients, but it also could cause regulatory complications. “I’m nervous about the prospect of there never being a COVID vaccine that meets the […]

Filed Under: Featured, Food & Drug Administration (FDA), Pharmaceutical, Regulatory/Compliance Tagged With: COVID-19, FDA, Johnson & Johnson, Moderna, Pfizer, Regulatory, VRBPAC

Primary Sidebar

DeviceTalks Weekly

May 27, 2022
Quick message - No DTW podcast, but plenty else to listen to over this weekend and next week.
See More >

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.
Need Medtech news in a minute?
We Deliver!

MassDevice Enewsletters get you caught up on all the mission critical news you need in med tech. Sign up today.

MDO ad

Footer

MASSDEVICE MEDICAL NETWORK

DeviceTalks
Drug Delivery Business News
Medical Design & Outsourcing
Medical Tubing + Extrusion
Drug Discovery & Development
Pharmaceutical Processing World
MedTech 100 Index
R&D World

Device Talks Webinars, Podcasts, & Discussions

Attend our Monthly Webinars
Listen to our Weekly Podcasts
Join our Device Talks Tuesdays Discussion

MASSDEVICE

Subscribe to MassDevice E-Newsletter
Advertise with us
About
Contact us
Add us on Facebook Follow us on Twitter Connect with us on LinkedIn Follow us on YouTube

Copyright © 2022 · WTWH Media LLC and its licensors. All rights reserved.
The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media.

Advertise | Privacy Policy | RSS