Post by Nadica (She/Her) on Jun 15, 2024 1:30:49 GMT
Novavax Submits Application to U.S. FDA for Updated Protein-based 2024-2025 Formula COVID-19 Vaccine - Published June 14, 2024
- Novavax's updated JN.1 COVID-19 vaccine is active against current circulating strains, including KP.2 and KP.3
- Novavax's JN.1 COVID-19 vaccine would be the only protein-based option available in the U.S.
- Novavax's filing is aligned with FDA, EMA and WHO global recommendations on vaccine composition
- Novavax intends to have its vaccine in pre-filled syringes available in the U.S. for immediate release post-authorization and following recommendation by the U.S. CDC
GAITHERSBURG, Md., June 14, 2024/PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX), a global company advancing protein-based vaccines with its Matrix-M™ adjuvant, today announced that it has submitted an amendment to its Emergency Use Authorization to the U.S. Food and Drug Administration (FDA) for its updated JN.1 COVID-19 vaccine (NVX-CoV2705) for individuals aged 12 and older. The submission is in line with guidance from the U.S. FDA, European Medicines Agency (EMA) and the World Health Organization (WHO) to target the JN.1 lineage this fall.1-3
Novavax's JN.1 vaccine has demonstrated broad cross-neutralizing antibodies against multiple variant strains, including KP.2 and KP.3, indicating the potential to protect against forward drift variants. As discussed at the recent FDA Vaccines and Related Biological Products Advisory Committee meeting, there is a public health benefit to target JN.1, the parent strain of the most common currently circulating variants.
"Novavax is committed to having a protein-based COVID-19 option available at the start of the vaccination season, which is critical because research suggests that providing vaccine choice, along with healthcare provider recommendations, may help improve vaccination rates," said John C. Jacobs, President and Chief Executive Officer, Novavax.
Nonclinical data have demonstrated that Novavax's JN.1 vaccine induces broad neutralization responses to JN.1 lineage viruses including those containing the F456L and R346T mutations, and to "FLiRT" and "FLuQE" variants.2,4,5 Novavax's vaccine also produces conserved polyfunctional, Th1-biased CD4+ T cell responses to a range of JN.1 lineage variants.2 Novavax's updated JN.1 COVID-19 vaccine targets the "parent strain" of KP.2 and KP.3.2
Novavax intends to have doses in the U.S. for distribution by mid-July. Upon FDA authorization and U.S. Centers for Disease Control and Prevention (CDC) recommendation, Novavax is preparing to promptly deliver to U.S. customers. Novavax is also working with other regulatory authorities globally on authorization or approval of its JN.1 COVID-19 vaccine.