by I. Edwards
The U.S. Meals and Drug Administration (FDA) has granted full approval to Novavax’s COVID-19 vaccine, however just for sure individuals.
The vaccine is now accredited for adults aged 65 and older, or for individuals ages 12 to 64 who’ve no less than one well being situation that places them at increased danger of significant sickness from COVID-19, The Related Press reported.
Novavax’s shot is the one protein-based COVID vaccine out there within the U.S. Till now, it had solely been allowed for emergency use in individuals 12 and up.
In contrast to the mRNA vaccines from Pfizer and Moderna, that are accredited for anybody 12 and older and approved for teenagers as younger as 6 months, Novavax shall be restricted to particular teams.
The FDA didn’t clarify why it added these restrictions to Friday’s approval, in keeping with AP.
Nonetheless, the transfer aligns with the views of U.S. Well being Secretary Robert F. Kennedy Jr. and others within the Trump administration, who’ve expressed skepticism towards vaccination up to now.
In an announcement, Novavax CEO John Jacobs stated, “Market research and U.S. CDC statistics indicate that older individuals and those with underlying conditions are the populations most likely to seek out COVID-19 vaccination seasonally. This significant milestone demonstrates our commitment to these populations and is a significant step towards the availability of our protein-based vaccine option.”
Novavax had anticipated full approval for broader use by April 1, after the FDA reviewed information from a 30,000-person medical trial exhibiting the vaccine was secure and efficient. However as an alternative of a broad approval, the FDA requested the corporate to conduct extra analysis.
That features a research on whether or not the vaccine is linked to any heart-related situations, and one other on whether or not wholesome individuals aged 50 to 64 profit from taking a COVID vaccine.
Advisers to the U.S. Facilities for Illness Management and Prevention (CDC) are set to vote on who must be inspired to get yearly COVID photographs, AP stated. The Novavax choice might sign that federal officers have already determined what plan of action they plan to take.
Extra data:
The U.S. Facilities for Illness Management and Prevention has extra on COVID vaccine steering.
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FDA provides full approval to Novavax COVID shot for high-risk teams (2025, Could 19)
retrieved 19 Could 2025
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