Admin_Adham
The US FDA has approved two companies’ COVID vaccines that target the latest variant of the virus for adults aged at least 65 years and individuals at high risk for severe outcomes, according to manufacturers’ information.
Moderna received FDA approval of its supplemental Biologics License Application (sBLA) for updates to SPIKEVAX, now indicated for individuals aged 6 months through 64 years with at least one underlying condition that qualifies them as having high risk for severe COVID outcomes, as well as adults aged 65 years or older, according to a press release. Moderna’s new COVID vaccine mNEXSPIKE received approval for those aged 12-64 with at least one high-risk underlying condition and all individuals aged 65 years or older.
Pfizer received FDA approval of its sBLA for updates to its COVID vaccine COMIRNATY, now indicated for all adults aged 65 years or older and individuals aged 5-64 years with at least one underlying condition that puts them at increased risk for severe COVID outcomes, according to a press release.
Both manufacturers’ vaccines are designed to target the LP.8.1 sublineage of the COVID virus, on the basis of guidance from the FDA.
The Pfizer approval was based on clinical trial data showing safety and efficacy of the vaccine, including in children aged 5-11 years, and on preclinical data showing improved immune responses against multiple circulating sublineages of the COVID virus, according to the company.
The updated LP.8.1.-targeting COVID vaccines from Moderna have been approved by regulators in other parts of the world, including Canada, Europe, Japan, and Switzerland, and additional applications are under review, according to the company.
Both manufacturers said in their press releases that their products are ready for immediate shipping and should be available to clinicians within a few days.
