FDA Approves Updated Novavax COVID-19 Vaccine

The U.S. Food and Drug Administration (FDA) has authorized an updated version of the Novavax COVID-19 vaccine, tailored to provide better protection against currently circulating variants.

People 12 years and older who were previously vaccinated with a COVID-19 vaccine and have not recently received an updated mRNA COVID-19 vaccine are eligible for one dose. Meanwhile, unvaccinated individuals can receive two doses of the updated Novavax vaccine.

"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," said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research, in a statement.

Novavax COVID-19 vaccine has been amended to include the spike protein from the SARS-CoV-2 omicron variant lineage XBB.1.5, providing better protection against serious consequences of COVID-19, such as hospitalization and death.

The authorization follows recent FDA approvals for updated mRNA vaccines for 2023 to 2024 manufactured by ModernaTX Inc. and Pfizer Inc. These vaccines are recommended for individuals six months and older.

While COVID-19 vaccines were provided by the government free of charge at the beginning of the pandemic, they now must be paid for by a person’s private or government insurance plans.

Who should get vaccinated?

The Centers for Disease Control and Prevention (CDC) recommends everyone five years and older get one updated COVID-19 vaccine, whereas children aged six months to four years may need more than one dose of updated COVID-19 vaccine.

People who are moderately or severely immunocompromised may get additional doses of the updated COVID-19 vaccine.

Those who recently had COVID-19 may consider delaying the dose by three months, according to the CDC. Not getting vaccinated after COVID-19 recovery increases the risk of reinfection.

Children and adults may get a COVID-19 vaccine and other vaccines, including a flu vaccine, at the same appointment.

Nearly half (47%) of American adults are planning to get the new COVID-19 vaccine, according to a recent survey by KFF COVID-19 Vaccine Monitor.

However, most parents say they will not get their child the updated vaccine, including 61% of parents of teenagers aged 12 to 17 and 64% of parents of children ages five to 11. The majority of parents (66%) of children between six months and four years old said they "probably" or "definitely" won’t vaccinate their child with the new COVID-19 vaccine.