XBB.1.5 strain of Covid
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The U.S. Food and Drug Administration (FDA) has released a recommendation for Covid vaccine manufacturers to develop single-strain shots for the fall that specifically target the omicron subvariant XBB.1.5. This strain is currently the dominant variant of the virus nationwide.
In their official release, the FDA stated, “Based on the totality of the evidence, we advise manufacturers to develop vaccines with a monovalent XBB 1.5 composition.” This recommendation applies to pharmaceutical companies such as Pfizer, Moderna, and Novavax.
A monovalent vaccine is designed to provide protection against a specific variant of Covid.
XBB.1.5 is descended from the omicron variant, which caused a spike in Covid cases in the U.S. early last year. It is also one of the most immune-evasive strains identified to date.
In early June, XBB.1.5 accounted for almost 40% of all Covid cases in the U.S., according to data from the Centers for Disease Control and Prevention (CDC). While this proportion is gradually decreasing, cases of related variants like XBB.1.16 and XBB.2.3 are on the rise.
The FDA’s decision aligns with the recommendation made by an advisory panel to the agency. The panel unanimously voted in favor of monovalent vaccines targeting a member of the XBB family, with XBB.1.5 being the preferred option.
This decision is also positive news for Pfizer, Moderna, and Novavax. These companies have already been developing updated versions of their shots specifically targeting XBB.1.5. Preliminary data presented by each company indicates that their vaccines elicit strong immune responses against all XBB variants.
In response to the FDA’s announcement, a spokesperson from Novavax stated, “Novavax is encouraged by today’s FDA announcement, and the company’s XBB 1.5 COVID vaccine candidate is being manufactured at commercial scale with the intent to be in the market for the fall vaccination campaign.”
Pfizer has announced that it will be able to deliver a monovalent vaccine targeting XBB.1.5 by July. However, Moderna and Novavax have not provided specific timelines for delivery.
Dr. Peter Marks, head of the FDA’s vaccine division, suggested that the updated vaccines could potentially be available to the public around September.
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