{"id":11874,"date":"2025-04-30T18:00:00","date_gmt":"2025-04-30T22:00:00","guid":{"rendered":"https:\/\/cov19longhaulfoundation.org\/?p=11874"},"modified":"2025-04-30T09:04:58","modified_gmt":"2025-04-30T13:04:58","slug":"fda-scrutiny-of-novavax-covid-19-vaccine-sparks-uncertainty-about-other-shots-2","status":"publish","type":"post","link":"https:\/\/cov19longhaulfoundation.org\/?p=11874","title":{"rendered":"FDA scrutiny of Novavax COVID-19 vaccine sparks uncertainty about other shots"},"content":{"rendered":"\n

By\u00a0\u00a0LAURAN NEERGAARD\u00a0and\u00a0MATTHEW PERRONE<\/p>\n\n\n\n

WASHINGTON (AP) \u2014 The Trump administration\u2019s effort to impose<\/a> new requirements on Novavax\u2019s COVID-19 vaccine<\/a> \u2014 the nation\u2019s only traditional protein-based option<\/a> for the coronavirus \u2014 is sowing uncertainty about updates to other vaccines, too.<\/p>\n\n\n\n

Novavax said Monday that the Food and Drug Administration was asking the company to run a new clinical trial of its vaccine<\/a> after the agency grants full approval. The company said it had responded and that it believed its shot remains \u201capprovable.\u201d<\/p>\n\n\n\n

But a weekend post<\/a> on social media by FDA Commissioner Marty Makary<\/a> suggested the prospect of needing a new trial before the shots\u2019 yearly strain update \u2014 something unlikely to be possible before fall. That\u2019s raised questions about whether other vaccines<\/a> will be caught in the turmoil.<\/p>\n\n\n\n

\u201cI don\u2019t think because there\u2019s a strain change that this is a new product,\u201d said Dr. Jesse Goodman of Georgetown University, a former FDA vaccine chief. If that\u2019s the new policy, \u201cyou\u2019d always be doing clinical trials and you\u2019d never have a vaccine that was up to date.\u201d<\/p>\n\n\n\n

The unusual move at FDA come shortly after the agency\u2019s\u00a0longtime vaccine chief<\/a>\u00a0was forced out\u00a0over disagreements<\/a>\u00a0with Makary\u2019s boss, Health Secretary\u00a0Robert F. Kennedy Jr<\/a><\/a><\/a><\/p>\n\n\n\n

Kennedy won Senate confirmation to his job, in part, by promising not to change the nation\u2019s vaccine schedule. Since taking office, he\u2019s promised to \u201cinvestigate\u201d children\u2019s shots<\/a>, canceled meetings of expert vaccine advisers<\/a> and directed officials to look again for connections between vaccines and autism, a link long-ago debunked<\/a>.<\/p>\n\n\n\n

The Novavax vaccine, which originally showed effectiveness in a nearly 30,000-person clinical trial, is still being sold under emergency use authorization in the U.S. The nation\u2019s other two options, mRNA vaccines made by Pfizer and Moderna, have earned full FDA approval for certain age groups.<\/p>\n\n\n\n

Because the coronavirus continually mutates, manufacturers follow instructions<\/a> from FDA to make one change each year to their recipe \u2014 which strain to target \u2014 just like flu vaccines.<\/p>\n\n\n\n

The FDA was on track to grant Novavax full approval by its April 1 target date, according to two people with direct knowledge of the situation who spoke on condition of anonymity to discuss confidential agency matters. But Trump appointees directed FDA scientists to pause their decision, according to one of the people. Since that highly unusual move, Novavax and the agency have been discussing additional requirements for approval.<\/p>\n\n\n\n

In his weekend tweet, FDA\u2019s Makary referred to the Novavax vaccine as \u201ca new product,\u201d presumably because it had been updated to match last year\u2019s common coronavirus strain.<\/p>\n\n\n\n

\u201cNew products require new clinical studies,\u201d Makary added.<\/p>\n\n\n\n

An administration spokesman didn\u2019t respond to specific questions about Pfizer and Moderna but suggested all COVID-19 vaccines could face stricter requirements.<\/p>\n\n\n\n

\u201cIt\u2019s now been years since COVID has presented the threat it once did, and the urgency to rush approval of boosters without normal oversight no longer exists,\u201d said Andrew Nixon, a Health and Human Services spokesman, in a statement.<\/p>\n\n\n\n

The FDA had been treating the annual COVID-19 strain updates exactly as it\u2019s done for decades with flu vaccines \u2014 not as new products, but existing ones that are merely adjusted to protect against the latest strains, said Dr. Paul Offit, a vaccine expert at Children\u2019s Hospital of Philadelphia.<\/p>\n\n\n\n

Offit said the companies still must perform tests in small numbers of people that show these updated vaccines produce levels of virus-fighting antibodies known to be protective, and they\u2019re closely monitored for safety.<\/p>\n\n\n\n

Nixon, the HHS spokesman, suggested the policy might not apply to the flu shot, \u201cwhich has been tried and tested for more than 80 years.\u201d<\/p>\n\n\n\n

Under federal law, the FDA is required to follow established procedures when issuing requirements to drugmakers for approval. If the agency skips certain steps or imposes additional requirements for political reasons, experts say, it could be sued by drugmakers \u2014 or even patients, such as those who prefer the Novavax vaccine over its competitors because of an allergy or some other reason.<\/p>\n\n\n\n

In addition to large clinical trials conducted before all three COVID-19 vaccines were cleared for use, there\u2019s data on real-world use, said former Health Secretary Xavier Becerra, who oversaw COVID-19 vaccine policy during the Biden administration.<\/p>\n\n\n\n

\u201cAt the point where I had left, we had put some 700 million COVID vaccines into the arms of Americans,\u201d he said. \u201cThat\u2019s a pretty good size clinical trial.\u201d<\/p>\n","protected":false},"excerpt":{"rendered":"

By\u00a0\u00a0LAURAN NEERGAARD\u00a0and\u00a0MATTHEW PERRONE WASHINGTON (AP) \u2014 The Trump administration\u2019s effort to impose new requirements on Novavax\u2019s COVID-19 vaccine \u2014 the nation\u2019s only traditional protein-based option for the coronavirus \u2014 is sowing uncertainty about updates to other […]<\/p>\n","protected":false},"author":2,"featured_media":11876,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[761,900,445,592,607,608],"tags":[],"class_list":["post-11874","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-concerns","category-novavax","category-policies-politics","category-treatments","category-vaccine-news","category-vaccine-safety"],"_links":{"self":[{"href":"https:\/\/cov19longhaulfoundation.org\/index.php?rest_route=\/wp\/v2\/posts\/11874","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/cov19longhaulfoundation.org\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/cov19longhaulfoundation.org\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/cov19longhaulfoundation.org\/index.php?rest_route=\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/cov19longhaulfoundation.org\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=11874"}],"version-history":[{"count":1,"href":"https:\/\/cov19longhaulfoundation.org\/index.php?rest_route=\/wp\/v2\/posts\/11874\/revisions"}],"predecessor-version":[{"id":11875,"href":"https:\/\/cov19longhaulfoundation.org\/index.php?rest_route=\/wp\/v2\/posts\/11874\/revisions\/11875"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/cov19longhaulfoundation.org\/index.php?rest_route=\/wp\/v2\/media\/11876"}],"wp:attachment":[{"href":"https:\/\/cov19longhaulfoundation.org\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=11874"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/cov19longhaulfoundation.org\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=11874"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/cov19longhaulfoundation.org\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=11874"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}