By I. Edwards HealthDay Reporter<\/b>
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FRIDAY, April 4, 2025 (HealthDay News) — The U.S. Food and Drug Administration (FDA) has delayed the full approval of Novavax\u2019s COVID-19<\/a> vaccine.<\/p>\n The decision had been expected by April 1, but the agency now says it needs more information before moving forward.<\/p>\n The Novavax<\/a> shot is already available under emergency use. But full FDA approval would allow the vaccine to be used more widely and could offer more reassurance to people looking for options besides the existing mRNA vaccines, CNN <\/em>reported.<\/p>\n The delay dovetails with moves by Republican lawmakers in at least seven states to ban or limit mRNA vaccines. Some, according to KFF Health News<\/a>, are also pressing regulators to revoke federal approval for mRNA-based COVID shots, which President Donald Trump has touted as a key first-term achievement.<\/p>\n Novavax uses protein-based technology, a more traditional method than the mRNA vaccines from Pfizer<\/a> and Moderna<\/a>.<\/p>\n \u201cAs of Tuesday, April 1, we had responded to all of the FDA\u2019s information requests and we believe that our [Biologics License Application] is ready for approval,\u201d Novavax said in a statement, adding that its application \u201cincluded robust Phase 3 clinical trial data that showed our vaccine is safe and effective for the prevention of COVID-19.\u201d<\/p>\n \u201cWe are confident our well-tolerated vaccine represents an important alternative to mRNA COVID-19 vaccines for the U.S.,\u201d Novavax added.<\/p>\n The delay comes as the FDA is undergoing leadership changes. Dr. Scott Steele<\/a> was recently named acting director of the FDA\u2019s vaccine division after Dr. Peter Marks stepped down<\/a> last month.<\/p>\n U.S. Department of Health and Human Services (HHS) Secretary Robert F. Kennedy Jr.<\/a>, who has long opposed vaccines, has made false claims about the COVID shots and recently shared misleading information about the measles vaccine — which came amid a deadly measles outbreak.<\/p>\n An HHS spokesman told CNN<\/em>, \u201cthe FDA\u2019s independent review process for the Novavax vaccine, like all vaccines, is based solely on ensuring safety and efficacy, not political considerations. Any delays are a result of scientific review.\u201d<\/p>\n The FDA\u2019s press office was also placed on administrative leave this week as part of a government downsizing effort<\/a>.<\/p>\n More information<\/strong><\/p>\n Yale Medicine has more on the different COVID vaccines<\/a>.<\/p>\n