FDA authorizes Novavax’s up to date COVID-19 vaccine concentrating on JN.1
The U.S. Meals and Drug Administration on Friday granted emergency use authorization for an up to date model of Novavax’s COVID shot.
The up to date vaccine is allowed to be used in people 12 years of age and older and can goal the JN.1 pressure of the virus.
“As we speak’s authorization offers an extra COVID-19 vaccine choice,” stated Peter Marks, director of the FDA’s Heart for Biologics Analysis and Analysis.
Doses are on monitor to be out there as early as the top of subsequent week, the corporate stated in an emailed response.
The up to date vaccine targets the ‘father or mother pressure’ of at present circulating variants, and has proven strong cross-reactivity in opposition to JN.1 lineage viruses, together with KP.2.3, KP.3, KP.3.1.1 and LB.1, stated CEO John Jacobs.
Earlier this month, the well being regulator accepted up to date COVID-19 vaccines made by Pfizer and Moderna concentrating on the KP.2 variant.
JN.1 was the dominant pressure in america earlier this 12 months. Whereas it’s not as prevalent, it’s estimated to account for 0.2% of instances over a two-week interval ended Aug. 31, the Facilities for Illness Management and Prevention’s information confirmed.
The KP.2 subvariant, however, is estimated to account for 3.1%, with KP.3.1.1 now turning into dominant at 42.2%.
In June, the well being regulator requested COVID vaccine makers to goal the KP.2 pressure for 2024-25 COVID-19 vaccines.
Novavax’s conventional protein-based shot affords an alternate vaccine expertise to those who are based mostly on messenger RNA – Moderna’s Spikevax and Comirnaty, which is collectively developed by Pfizer and BioNTech.
COVID-19-related hospitalizations and deaths have elevated over the previous three months in america. Demand for the pictures, nonetheless, has fallen sharply for the reason that peak of the pandemic.
Novavax expects total demand for COVID vaccines in america to stay much like final 12 months, however anticipates its personal efficiency to be higher, it stated earlier this month.
Reporting by Sriparna Roy in Bengaluru; Enhancing by Maju Samuel