The agency is seeking more data on the vaccine, said the source, who declined to be named because they weren\u2019t authorized to speak publicly about the situation. The Wall Street Journal first reported that the FDA had missed its decision deadline. <\/p>\n
The move came as the FDA named Dr. Scott Steele acting director of the Center for Biologics Evaluation and Research, which oversees vaccine regulation, days after former director Dr. Peter Marks was forced out. In his resignation letter, Marks cited \u201cefforts being advanced by some on the adverse health effects of vaccination\u201d that he called \u201cconcerning.\u201d <\/p>\n
US Health and Human Services Secretary Robert F. Kennedy Jr., a longtime anti-vaccine advocate, has falsely called vaccines for Covid-19 \u201cthe deadliest vaccine ever made\u201d and more recently made misleading statements about the safety of the measles vaccine amid a deadly outbreak centered in West Texas. <\/p>\n
The Novavax vaccine, which uses more traditional protein-based technology than the newer mRNA vaccines from Pfizer\/BioNTech and Moderna, has been subject to emergency use authorization since 2022. But with FDA action, it would be the third vaccine against Covid-19 to receive full FDA approval. Full approval would make the vaccine available beyond an emergency declaration and could provide additional reassurance to people seeking the vaccine. <\/p>\n
The company said Wednesday that it hadn\u2019t received an official decision from the FDA but that April 1 was the date by which the agency had been set to issue the decision. <\/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, noting that the 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 US,\u201d Novavax said. <\/p>\n<\/p>\n
The agency is seeking more data on the vaccine, said the source, who declined to be named because they weren\u2019t authorized to speak publicly about the situation. The Wall Street Journal first reported that the FDA had missed its decision deadline. The move came as the FDA named Dr. Scott Steele acting director of the …<\/p>\n","protected":false},"author":1,"featured_media":2174,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"loftocean_post_primary_category":0,"loftocean_post_format_gallery":"","loftocean_post_format_gallery_ids":"","loftocean_post_format_gallery_urls":"","loftocean_post_format_video_id":0,"loftocean_post_format_video_url":"","loftocean_post_format_video_type":"","loftocean_post_format_video":"","loftocean_post_format_audio_type":"","loftocean_post_format_audio_url":"","loftocean_post_format_audio_id":0,"loftocean_post_format_audio":"","loftocean-featured-post":"","loftocean-like-count":0,"loftocean-view-count":454,"tinysalt_single_post_intro_label":"","tinysalt_single_post_intro_description":"","tinysalt_hide_post_featured_image":"","tinysalt_post_featured_media_position":"","tinysalt_single_site_header_source":"","tinysalt_single_custom_site_header":"0","tinysalt_single_custom_sticky_site_header":"0","tinysalt_single_custom_sticky_site_header_style":"sticky-scroll-up","tinysalt_single_site_footer_source":"","tinysalt_single_custom_site_footer":"0","footnotes":""},"categories":[35],"tags":[],"class_list":["post-2173","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-health-news"],"_links":{"self":[{"href":"https:\/\/retirednurseblog.com\/index.php\/wp-json\/wp\/v2\/posts\/2173","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/retirednurseblog.com\/index.php\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/retirednurseblog.com\/index.php\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/retirednurseblog.com\/index.php\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/retirednurseblog.com\/index.php\/wp-json\/wp\/v2\/comments?post=2173"}],"version-history":[{"count":0,"href":"https:\/\/retirednurseblog.com\/index.php\/wp-json\/wp\/v2\/posts\/2173\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/retirednurseblog.com\/index.php\/wp-json\/wp\/v2\/media\/2174"}],"wp:attachment":[{"href":"https:\/\/retirednurseblog.com\/index.php\/wp-json\/wp\/v2\/media?parent=2173"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/retirednurseblog.com\/index.php\/wp-json\/wp\/v2\/categories?post=2173"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/retirednurseblog.com\/index.php\/wp-json\/wp\/v2\/tags?post=2173"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}