Moderna MRNA announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has given a positive opinion recommending marketing authorization for its updated COVID-19 vaccine. The European Commission is expected to give its decision in some weeks’ time.
As directed by the FDA in June, Moderna’s updated vaccine is tailored to the XBB.1.5 sublineage for active immunization to prevent COVID-19 in individuals six months of age and older. The FDA had directed vaccine manufacturers to develop updated monovalent XBB.1.5 COVID-19 vaccines for autumn/winter 2023 vaccination campaigns. This is because, back then, XBB.1.5 was the dominant variant. Now, the dominant strains are BA.2.86 (also called Pirola) and EG.5.1 (also called Eris).
However. clinical data from studies on Moderna’s monovalent XBB.1.5 vaccine candidate has shown improved neutralizing antibody responses against multiple currently circulating Omicron-related sub-lineages, including Pirola, Eris as well as FL.1.5.1 (also called Fornax).
So far this year, shares of Moderna have declined 37.2% compared with the industry’s 13.7% fall.
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Last week the FDA approved/authorized the updated mRNA-based COVID-19 vaccines of Pfizer PFE/BioNTech BNTX and Moderna. These vaccines are approved for individuals 12 years of age and older and are authorized under emergency use for individuals 6 months through 11 years of age.
The U.S. Centers for Disease Control and Prevention (CDC) has also recommended for everyone 6 months and older to take the updated COVID shot. Pfizer and Moderna expect the vaccines to be launched in pharmacies, hospitals and clinics across the United States this week. Americans who have health insurance will get this COVID-19 vaccine for free as most plans will cover the new vaccine.
Novavax NVAX has also developed an updated protein-based non-mRNA COVID-19 vaccine to target XBB lineages. However, the FDA did not give a green signal to Novavax’s updated vaccine. Novavax issued a press release stating that it is ready to distribute its updated vaccine for the fall season once it receives FDA approval and CDC recommendation.
Zacks Rank
Moderna currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Moderna, Inc. Price and Consensus
Moderna, Inc. price-consensus-chart | Moderna, Inc. Quote
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