The US Meals and Drug Administration (FDA) amended the emergency use authorization of the Novavax COVID-19 vaccine, adjuvanted to be used in people 12 years of age and older to incorporate the 2023-2024 components, making it the third COVID-19 vaccine accessible this fall.
People 12 years of age and older beforehand vaccinated with a COVID-19 vaccine (and who haven’t already been vaccinated with a not too long ago up to date mRNA COVID-19 vaccine) are eligible to obtain one dose, and unvaccinated people obtain two doses.
The up to date vaccine addresses presently circulating variants to supply higher safety towards severe penalties of COVID-19, together with hospitalization and loss of life. According to the totality of the proof and enter from the FDA’s professional advisors, the Novavax COVID-19 vaccine, adjuvanted, a monovalent vaccine, has been up to date to incorporate the spike protein from the SARS-CoV-2 omicron variant lineage XBB.1.5 (2023-2024 components).
Novavax’s vaccine is protein-based, making it the one non-mRNA XBB.1.5 vaccine accessible within the US.
This authorization follows the FDA’s current approvals and authorizations of up to date mRNA COVID-19 vaccines for 2023-2024 manufactured by ModernaTX Inc and Pfizer Inc.
“COVID-19 is as soon as once more on the rise with infections and hospitalizations growing, so it’s vital that people get vaccinated to guard themselves and their family members,” says John C Jacobs, president and CEO of Novavax, in a launch. “Novavax’s authorization at this time means individuals will now have the selection of a protein-based, non-mRNA choice to assist shield themselves towards COVID-19, which is now the fourth main reason for loss of life within the US. Within the coming days, people within the US can go to pharmacies, physicians’ places of work, clinics, and numerous authorities entities to obtain an up to date Novavax vaccine.”
The authorization was based mostly on non-clinical knowledge exhibiting that Novavax’s COVID-19 vaccine induced useful immune responses towards XBB.1.5, XBB.1.16, and XBB.2.3 variants. Extra non-clinical knowledge demonstrated that Novavax’s vaccine induced neutralizing antibody responses to newly rising subvariants BA.2.86, EG.5.1, FL.1.5.1, and XBB.1.16.6 in addition to sturdy CD4+ polyfunctional mobile (T-cell) responses towards EG.5.1 and XBB.1.16.6.
These knowledge point out Novavax’s vaccine can stimulate each arms of the immune system and should induce a broad response towards presently circulating variants.
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