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An FDA advisory committee voted Wednesday to recommend both the Pfizer-BioNTech and Moderna COVID-19 vaccines for children as young as six months old.
While a handful of companies have dominated the COVID-19 vaccine market in the U.S. and Europe, a number of biotechs are continuing to develop vaccines to use as booster shots.
It was an extraordinarily busy week for clinical trial news and updates due to several prominent international conferences. Here’s a look at some of the highlights.
The FDA plans to review changes to Novavax’s manufacturing process before it authorizes its vaccine.
On Tuesday, the FDA’s Vaccines and Related Biological Products Advisory Committee voted 21-0 with one abstention to recommend authorization of Novavax’s COVID-19 vaccine.
The early data demonstrated a favorable safety profile and encouraging indications of clinical activity. BNT122 is being developed in multiple solid tumor indications.
The FDA has expressed worries over four cases of heart inflammation, or myocarditis, that were observed in pivotal clinical trials of Novavax’s COVID-19 vaccine.
June is starting off with a number of important dates for the FDA, including an advisory committee meeting to discuss COVID-19 vaccines in children as young as six months.
Children under the age of five could be eligible to receive Pfizer-BioNTech’s vaccine against COVID-19 as soon as late June.
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