Novavax Inc. today announced, 'We are working productively with the U.S. Food and Drug Administration (FDA) as they complete their review, including providing additional information as needed, and the FDA has committed to moving swiftly on regulatory authorization.'
'We expect to have authorization in time for peak vaccination season.'
Novavax filed for U.S. Emergency Use Authorization of our 2024-2025 formula protein-based COVID-19 vaccine (NVX-CoV2705) in June 2024.
In the United States, Novavax's products have been and will be available after FDA authorization in thousands of locations nationwide, including pharmacies.
For example, Walgreens recently confirmed their pharmacists are available to help patients navigate the latest vaccination guidance, including the timing of vaccinations, given the uneven geographical spreading of the coronavirus.
Additionally, numerous countries have authorized Novavax's COVID-19 vaccines over the past few years.
Novavax wrote on August 22, 2024, 'Our 2024-2025 formula COVID-19 vaccine targets JN.1, the "parent strain” of currently circulating variants and should provide acceptable coverage and cross-reactivity against JN.1 lineage viruses, including KP.2.3, KP.3, KP.3.1.1 and LB.1.1.'
'Upon authorization, Novavax’s vaccine will be the only protein-based option available in the U.S. for individuals aged 12 and older to prevent COVID-19.'
On August 8, 2024, Novavax reported it achieved total revenue of $415 million in the second quarter of 2024 and ended the period with $1.1 billion in Cash.