FDA approves two COVID-19 vaccines for 2023-2024

12 September 2023

fda_food_and_drug_administration_large-1

The US Food and Drug Administration (FDA) has now approved the supplemental Biologics License Application (Comirnaty 2023-2024 Formulation) from US pharma major Pfizer (NYSE: PFE) and partner BioNTech (Nasdaq: BNTX).

The authorization is for individuals 12 years and older and emergency use authorization has been granted for individuals six months through 11 years of age for the companies’ Omicron XBB.1.5-adapted monovalent COVID-19 vaccine.

This season’s vaccine is indicated as a single dose for most individuals five years of age and older. Children under the age of five may be eligible to receive additional doses of this season’s vaccine if they have not already completed a three-dose series with previous formulations of a COVID-19 vaccine.

This article is accessible to registered users, to continue reading please register for free. A free trial will give you access to exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space for a week. If you are already a registered user please login. If your trial has come to an end, you can subscribe here.

Try before you buy

Free

7 day trial access

Take a Free Trial

All the news that moves the needle in pharma and biotech
Exclusive features, podcasts, interviews, data analyses and commentary from our global network of life sciences reporters.
Receive The Pharma Letter daily news bulletin, free forever.

Become a subscriber

£820

Or £77 per month

Subscribe Now

Unfettered access to industry-leading news, commentary and analysis in pharma and biotech.
Updates from clinical trials, conferences, M&A, licensing, financing, regulation, patents & legal, executive appointments, commercial strategy and financial results.
Daily roundup of key events in pharma and biotech.
Monthly in-depth briefings on Boardroom appointments and M&A news.
Choose from a cost-effective annual package or a flexible monthly subscription

The Pharma Letter is an extremely useful and valuable Life Sciences service that brings together a daily update on performance people and products. It’s part of the key information for keeping me informed

Chairman, Sanofi Aventis UK