Now, the jabs are approved for seniors and people with at least one underlying condition, putting them at a high risk of severe infection ahead of the upcoming respiratory viral season.
Moderna said the FDA greenlit its updated Spikevax vaccine, which offers protection against the LP.8.1 variant of the virus. Pfizer’s updated Comirnaty shot, which also provides protection against the variant, was approved by the agency, the company said in a statement.
Pfizer’s jab was approved for adults 65 and older, as well as people between ages 5 and 64 who have at least one underlying health risk that puts them at greater risk of developing severe outcomes from the virus.
These approvals coincided with Health and Human Services Secretary (HHS) Robert F. Kennedy Jr. Announcing that the FDA was rescinding the emergency use authorizations (EUA) for COVID-19 vaccines, removing another potential avenue through which health individuals may have been able to access the shots.
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Under the EUA, children and adults could access COVID-19 vaccines regardless of their health status.
- The EUAs were granted to the COVID-19 vaccines prior to them receiving full approval from the FDA.
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EUAs are granted to medical products by the FDA when no approved, alternative product is available and the agency has determined that the potential benefits outweigh potential risks.
Despite these narrowed approvals and pathways to access, it remains unclear whether all individuals will be able to get COVID-19 vaccines this upcoming respiratory viral season.
In his announcement Wednesday, Kennedy said, “These vaccines are available for all patients who choose them after consulting with their doctors.”
