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

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Today, the U.S. Food and Drug Administration granted emergency use authorization (EUA) for an updated version of the Novavax COVID-19 vaccine that more closely targets currently circulating variants to provide better protection against serious consequences of COVID-19, including hospitalization and death. The updated vaccine is authorized for use in individuals 12 years of age and older. It includes a monovalent (single) component that corresponds to the Omicron variant JN.1 strain of SARS-CoV-2.

“The COVID-19 vaccines have had a tremendous positive impact on public health and vaccination continues to be the most effective method for COVID-19 prevention,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. “COVID-19 continues to be a very real risk for many people, and we encourage individuals to consider getting an updated COVID-19 vaccine when eligible. 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.”

This authorization follows the FDA’s recent approvals and authorizations of updated mRNA COVID-19 vaccines for 2024-2025 manufactured by ModernaTX Inc. and Pfizer Inc.

What You Need to Know
  • Individuals 12 years of age and older who have never been vaccinated with any COVID-19 vaccine are eligible to receive two doses of this updated vaccine, 3 weeks apart.
  • Individuals who have been vaccinated only with one dose of any Novavax COVID-19 vaccine are eligible to receive one dose of the updated Novavax COVID-19 vaccine at least 3 weeks after the previous dose.
  • Those who have been vaccinated with a prior formula of a COVID-19 vaccine from another manufacturer or with two or more doses of a prior formula of the Novavax COVID-19 vaccine are eligible to receive a single dose of the updated Novavax COVID-19 vaccine at least 2 months after the last dose of a COVID-19 vaccine.

 

Coronavirus vaccines, once free, are now pricey for uninsured people​


As updated coronavirus vaccines hit U.S. pharmacy shelves, adults without health insurance are discovering the shots are no longer free, instead costing up to $200.

The federal Bridge Access Program covering the cost of coronavirus vaccines for uninsured and underinsured people ran out of funding. Now, Americans with low incomes are weighing whether they can afford to shore up immunity against an unpredictable virus that is no longer a public health emergency but continues to cause long-term complications and hospitalizations and kill tens of thousands of people a year.

The program’s elimination marks the latest tear in a safety net that once ensured people could protect themselves against the coronavirus regardless of their financial situation. Health experts worry that the paltry 22 percent rate of adults staying up-to-date on vaccines will erode further. And they fear that the roughly 25 million people without health insurance in the nation will be especially vulnerable to covid because they tend to be in poorer health and avoid medical care when sick.

Nicole Savant, a 33-year-old part-time paralegal and dog walker, lost her Medicaid benefits last year when her income rose. She wants the latest shot because she knows people who died of covid before the vaccines became available and because she faces a higher risk of severe disease being overweight.

 
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