RT’s Three Key Takeaways:
- Up to date Safety: The FDA has licensed an up to date model of the Novavax COVID-19 vaccine that targets the Omicron JN.1 pressure.
- Eligibility and Dosing: The up to date vaccine is accessible for people aged 12 and older, with particular dosing schedules primarily based on prior vaccination standing, together with choices for individuals who have by no means been vaccinated or those that have beforehand obtained a COVID-19 vaccine.
- Regulatory Approval: The FDA’s emergency use authorization for the up to date Novavax vaccine follows current approvals and authorizations of up to date mRNA COVID-19 vaccines by Moderna and Pfizer.
The US Meals and Drug Administration (FDA) granted emergency use authorization (EUA) for an up to date model of the Novavax COVID-19 vaccine that extra intently targets at present circulating variants to supply higher safety towards severe penalties of COVID-19, together with hospitalization and dying.
The up to date vaccine is allowed to be used in people 12 years of age and older. It features a monovalent element that corresponds to the Omicron variant JN.1 pressure of SARS-CoV-2.
“The COVID-19 vaccines have had an incredible constructive affect on public well being, and vaccination continues to be the best technique for COVID-19 prevention,” says Peter Marks, MD, PhD, director of the FDA’s Heart for Biologics Analysis and Analysis, in a launch. “COVID-19 continues to be a really actual threat for many individuals, and we encourage people to contemplate getting an up to date COVID-19 vaccine when eligible.”
What to know:
- People 12 years of age and older who’ve by no means been vaccinated with any COVID-19 vaccine are eligible to obtain two doses of this up to date vaccine, three weeks aside.
- People who’ve been vaccinated solely with one dose of any Novavax COVID-19 vaccine are eligible to obtain one dose of the up to date Novavax COVID-19 vaccine not less than three weeks after the earlier dose.
- Those that have been vaccinated with a previous components of a COVID-19 vaccine from one other producer or with two or extra doses of a previous components of the Novavax COVID-19 vaccine are eligible to obtain a single dose of the up to date Novavax COVID-19 vaccine not less than 2 months after the final dose of a COVID-19 vaccine.
The FDA assessed manufacturing and nonclinical information to help the change to the 2024-2025 components. The up to date vaccine is manufactured utilizing an identical course of as earlier formulation of this vaccine.
The FDA has decided that the up to date Novavax COVID-19 vaccine has met the statutory standards for issuance of an EUA, together with that the identified and potential advantages of the vaccine outweigh its identified and potential dangers in people 12 years of age and older.
The FDA granted the emergency use authorization of the Novavax COVID-19 vaccine to Novavax Inc of Gaithersburg, Maryland.
This authorization follows the FDA’s current approvals and authorizations of up to date mRNA COVID-19 vaccines for 2024-2025 manufactured by Moderna and Pfizer.
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