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Updated non-mRNA COVID vaccine receives FDA approval for enhanced variant protection

COVID-19 vaccine COVID-19 vaccine
COVID-19 vaccine COVID-19 vaccine

What's new?

The updated non-mRNA COVID-19 vaccine offers targeted protection against Omicron variants for individuals 12+ with enhanced safety and efficacy.

According to a press release by the U.S. FDA on 30 August 2024, the newly updated non-mRNA COVID-19 vaccine designed to better protect against severe outcomes such as hospitalization and death has been granted emergency use authorization (EUA). This updated version is specifically tailored to target the Omicron variant JN.1, tackling currently circulating strains. Approved for individuals aged 12 and older, the vaccine offers a monovalent formulation and a vital option for COVID-19 prevention.

Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, highlighted the vaccine's role in ongoing COVID-19 prevention efforts, saying, "COVID-19 remains a significant risk, and today's authorization introduces another vaccine option that meets our laborious standards for safety and effectiveness."

Important Eligibility Updates:

  • New to COVID-19 Vaccination: Individuals aged 12 and older who haven't been vaccinated can receive two doses, spaced three weeks apart.
  • Previously Vaccinated with Non-mRNA Vaccine: Those who’ve received one dose of a non-mRNA COVID-19 vaccine are entitled to a single dose of the updated version, administered at least 3 weeks after their earlier shot.
  • Other Vaccinated Individuals: Those who’ve completed two or more doses of any previous COVID-19 vaccine formula can receive a single dose of the updated non-mRNA vaccine, at least 2 months after their last dose.

The FDA’s approval follows an extensive assessment of manufacturing and clinical data, confirming the vaccine's safety profile. Side effects are expected to mirror those seen in previous vaccine versions, and the now-authorized formulation will replace the older 2023-2024 adjuvanted formula, which is no longer authorized for use.

Source:

FDA News Release

Article:

FDA Authorizes Updated Novavax COVID-19 Vaccine to Better Protect Against Currently Circulating Variants

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