The highly anticipated new COVID-19 vaccines, updated for the fall season, are set to be available by the end of September. This will be once both the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) give their approval for the revised shots. Currently, the most common form of the virus in circulation is the XBB variants, strains descended from the original Omicron variant.
Moderna, Pfizer, and Novavax, three leading vaccine manufacturers, are expected to offer the updated shots for this fall. These shots will be eligible for virtually all children and adults. The rollout of these vaccines will signify three major shifts in the U.S. response to the virus: the end of government-bought vaccine supplies, simplified eligibility criteria for getting shots, and a significant change in the vaccines’ recipe.
So, what’s different about these new COVID-19 vaccines? After a meeting of its outside vaccine advisers in June, the FDA announced that it would ask vaccine makers to use a single component in their recipes, specifically targeting the XBB.1.5 variant. This is a departure from the previous round of boosters, which utilized a “bivalent” composition blending two components.
Even though newer XBB descendants, like the rapidly spreading EG.5 strain, have emerged, experts maintain that these variants are closely related. Therefore, the updated vaccine formula should still provide protection. Dr. Eric Rubin, one of the FDA’s vaccine advisers, stated, “There doesn’t seem to be any particular advantage to a bivalent vaccine. XBB is the current lineage, and there is good cross-protection, no matter what antigen is chosen, according to the data that we’ve been shown.”
While the new vaccines are expected to be ready by late September, widespread availability might not occur until October. Two steps are required before the vaccines can enter the commercial market in the U.S.: FDA approval and updated recommendations from the CDC.
The FDA is expected to grant approval or emergency authorization to all three new COVID-19 vaccines within the next two months. Both Pfizer and Moderna have already submitted their applications to the FDA. Pfizer’s CEO, Albert Bourla, anticipates FDA approval by the end of August. Novavax is still in the process of completing its submission for emergency use authorization.
Although the FDA is not likely to hold another meeting regarding the new shots, the CDC plans to convene its Advisory Committee on Immunization Practices to issue updated recommendations. This is essential to secure liability protections for vaccinators, insurance coverage, and access to the new vaccines.
This timeline suggests that the new COVID-19 vaccines may not be widely available until October, as indicated by CDC Director Dr. Mandy Cohen. This is later than the earlier prediction by Dr. Peter Marks, the FDA’s top vaccines official, who estimated availability in September.
Regarding eligibility for the new COVID-19 vaccines, federal officials have been working to simplify the criteria, similar to the annual influenza shot. Teens and adults would have the option to choose any of the three updated vaccines. For children as young as 2 years old, draft CDC vaccine recommendations propose a single new shot from either Pfizer or Moderna to stay up to date. Children as young as 6 months might still be advised to receive two or three doses.
In conclusion, the upcoming new COVID-19 vaccines hold great promise for combating the virus. They are designed to target the XBB variants and are expected to be available by the end of September. These vaccines will offer protection against the most common strains in circulation. However, full availability may not occur until October, pending FDA approval and CDC recommendations. The eligibility criteria for receiving the vaccines will be simplified, allowing for easier access for all age groups.
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