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Teen girl getting vaccine

FDA OKs updated COVID vaccine from Novavax

October 3, 2023

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The Food and Drug Administration (FDA) has authorized an updated COVID-19 vaccine from Novavax for people ages 12 years and older.

The protein-based vaccine provides an alternative to the mRNA COVID-19 vaccines from Moderna and Pfizer that received final approval in September. That approval by the Centers for Disease Control and Prevention (CDC) extends to Novavax. The CDC said it will update its interim clinical considerations to include Novavax as quickly as possible. Novavax expects doses would be available in the coming days. The updated vaccine contains the SARS-CoV-2 XBB.1.5 strain and is intended to match circulating virus strains better than the original formula.

“Today’s authorization provides an additional COVID-19 vaccine option that meets the FDA’s standards for safety, effectiveness and manufacturing quality needed to support emergency use authorization,” Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research, said in a press release. “As we head into the fall season and transition into 2024, we strongly encourage those who are eligible to consider receiving an updated COVID-19 vaccine to provide better protection against currently circulating variants.”

Under the authorization, people who are 12 years of age and older can get one dose of the updated Novavax vaccine if they previously were vaccinated with any COVID vaccine and have not already received a recently updated mRNA COVID-19 vaccine. Adolescents ages 12 years and older and adults who have not received any COVID-19 vaccine are eligible to receive two doses of Novavax vaccine. Clinicians should watch for more guidance as the CDC updates its interim clinical considerations.

Animal data presented to the CDC’s Advisory Committee on Immunization Practices last month showed an increased neutralizing response across several SARS-CoV-2 XBB pseudoviruses. While safety data have been limited by the low number of doses administered, the most common adverse events reported to the Vaccine Adverse Events Reporting System for the original formula include dizziness, fatigue and headache, according to the CDC.

Now that the updated Novavax vaccine has been authorized, the company’s original COVID-19 vaccine can no longer be used.



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