{"id":41761,"date":"2025-05-02T05:55:59","date_gmt":"2025-05-02T10:55:59","guid":{"rendered":"https:\/\/ustower.net\/?p=41761"},"modified":"2025-05-02T05:57:48","modified_gmt":"2025-05-02T10:57:48","slug":"updated-covid-vaccines-for-the-fall-may-be-in-jeopardy-under-kennedys-new-rules","status":"publish","type":"post","link":"https:\/\/ustower.net\/?p=41761","title":{"rendered":"Updated Covid vaccines for the fall may be in jeopardy under Kennedy’s new rules"},"content":{"rendered":"\n

The anticipated rollout of updated Covid vaccines<\/a> this fall might be at risk after a change by Health and Human Services Secretary Robert F. Kennedy Jr. in how vaccines are tested, experts say.<\/p>\n\n\n\n

Under the change by Kennedy, according to an HHS spokesperson, all new vaccines will need to go through placebo-controlled clinical trials \u2014 where some people get the actual shot and others get something inactive, like a saline shot \u2014 to compare the results.<\/p>\n\n\n\n

Running trials that include a placebo group is already routine for most new vaccines.<\/p>\n\n\n\n

The original Covid vaccines, from Pfizer and Moderna, approved in late 2020, went through placebo-controlled trials. But as the virus\u2002<\/a>continued to mutate<\/a>\u2002<\/a>and the vaccines needed to be updated to match the circulating strain, drugmakers moved to a flu vaccine-like model \u2014 using smaller studies to test how well the updated shots triggered an immune response<\/a> against the variant in question.<\/p>\n\n\n\n

Like the annual flu shot, the updated Covid vaccines weren\u2019t treated as entirely new products, since they still used the same formula, with just a tweak to what strain the vaccine would be targeting. The mRNA Covid vaccines were designed so that this change would be particularly easy to make<\/a>, in the event the shots needed to be quickly updated.<\/p>\n\n\n\n

Quickly, in this case, turns out to be several months. In order to have enough Covid doses ready to go for the fall, vaccine-makers are told what strain to target in the spring.<\/p>\n\n\n\n

The Food and Drug Administration\u2019s vaccine advisory committee is expected to meet in May or June to make a recommendation on which strains should be included in the next round of shots. A person familiar with the matter, who was not authorized to speak publicly, said the FDA had planned to schedule a meeting for May 22. An HHS spokesperson declined to comment on the meeting date.<\/p>\n\n\n\n

If the FDA deems Pfizer\u2019s and Moderna\u2019s updated vaccines \u201cnew\u201d products, requiring fresh trials, it\u2019s extremely unlikely the doses would be ready for the fall, experts said.<\/p>\n\n\n\n

Dr. Paul Offit, the director of the Vaccine Education Center at Children\u2019s Hospital of Philadelphia and a member of the FDA’s vaccine advisory committee, said the change would almost certainly delay the rollout of the updated shots from Pfizer and Moderna by \u201cmonths,\u201d as it would take time for the drugmakers to design the new trials and enroll participants.<\/p>\n\n\n\n

That would only be the start \u2014 the drugmakers would then have to run the actual trial, which would take several months on its own, at minimum, and analyze the results.<\/p>\n\n\n\n

Even the Covid vaccines \u2014 which were hailed as \u201cthe most successful government science program\u201d because of how quickly they were developed, according to Dr. Alex Greninger, a professor of laboratory medicine and pathology at UW Medicine in Seattle \u2014 still took at least about six months to run their Phase 3 trials.<\/p>\n\n\n\n

The HHS spokesperson didn\u2019t directly respond to a question about whether the Pfizer and Moderna vaccines would require new clinical trials.<\/p>\n\n\n\n

However, the spokesperson said in a statement that \u201cFDA Commissioner Dr. Marty Makary has indicated that significant updates to existing vaccines \u2014 such as those addressing seasonal strain changes or antigenic drift \u2014 may be considered \u2018new products\u2019 requiring additional clinical evaluation.\u201d<\/p>\n\n\n\n

\u201cAs we\u2019ve said before, trials from four years ago conducted in people without natural immunity no longer suffice,\u201d the spokesperson said. \u201cA four-year-old trial is also not a blank check for new vaccines each year without clinical trial data,\u201d they said, adding that the flu shot would be exempt from the new rule, because it \u201chas been tried and tested for more than 80 years.\u201d<\/p>\n\n\n\n

The FDA has already delayed the approval of Novavax\u2019s updated Covid vaccine<\/a>, requiring the company to carry out a new clinical trial because the strain included in the shot differs from what was originally authorized.<\/p>\n\n\n\n

Vaccine experts panned the new requirements.<\/p>\n\n\n\n

It\u2019s \u201cunethical,\u201d Offit said, noting that it\u2019s generally frowned upon in the scientific community to give someone a placebo when an approved product already exists that can protect them.<\/p>\n\n\n\n

Dr. Stanley Plotkin, a pediatrician who played a key role in developing the rubella vaccine, said the move would make \u201cno sense.\u201d<\/p>\n\n\n\n

\u201cWhat would be reasonable is to compare the old vaccine with the new vaccine to see whether the new vaccine gives better immunologic responses,\u201d Plotkin said. \u201cWe have vaccines against Covid, where we have pretty concrete ideas as to what works and what doesn\u2019t work. We know they\u2019re not perfect, but we have vaccines we know work.\u201d<\/p>\n\n\n\n

Spokespeople for Pfizer and Moderna did not immediately respond to requests for comment.<\/p>\n\n\n\n

Former government officials have said HHS, under Kennedy, was moving to slow-walk vaccine approvals<\/a>, including by imposing new regulatory hurdles on drugmakers, such as changing the requirements for approval or seeking additional clinical trial data. <\/p>\n\n\n\n

Vaccine experts also fear the rule change is part of a broader effort by Kennedy to sow distrust in vaccines and limit public access to them.<\/p>\n\n\n\n

\u201cThe goal is to make vaccines more onerous to make, more onerous to test by bringing up these sort of false safety concerns or false efficacy concerns,\u201d Offit said.<\/p>\n\n\n\n

Dr. Sean O\u2019Leary, chair of the American Academy of Pediatrics Committee on Infectious Diseases, said the change is unlikely to affect brand-new vaccines. But it could have major implications for vaccines that may require updates besides Covid \u2014 like those for RSV \u2014 since placebo trials are costly and take significantly more time to conduct.<\/p>\n\n\n\n

\u201cIt\u2019s really not feasible, and would lead to lots of hospitalizations and deaths,\u201d O\u2019Leary said.<\/p>\n\n\n\n

Plotkin added that vaccines being developed for infections that are incurable, like HIV, may also be at risk.<\/p>\n\n\n\n

\u201cSuppose you wanted to develop a new HIV vaccine?\u201d he asked. \u201cWould you do a placebo-controlled trial in that situation? I mean exposing children to a disease which is very serious without offering them anything.\u201d<\/p>\n\n\n\n

Nbcnews<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"

The anticipated rollout of updated Covid vaccines this fall might be at risk after a change by Health and Human Services Secretary Robert F. Kennedy Jr. in how vaccines are tested, experts say. Under the change by Kennedy, according to an HHS spokesperson, all new vaccines will need to go through placebo-controlled clinical trials \u2014 where some […]<\/p>\n","protected":false},"author":7,"featured_media":41762,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[5784],"tags":[29856,3600,1765,1814,1429],"class_list":["post-41761","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-health","tag-autumn","tag-covid-19-vaccine","tag-kennedy","tag-risk","tag-vaccine"],"_links":{"self":[{"href":"https:\/\/ustower.net\/index.php?rest_route=\/wp\/v2\/posts\/41761","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/ustower.net\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/ustower.net\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/ustower.net\/index.php?rest_route=\/wp\/v2\/users\/7"}],"replies":[{"embeddable":true,"href":"https:\/\/ustower.net\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=41761"}],"version-history":[{"count":1,"href":"https:\/\/ustower.net\/index.php?rest_route=\/wp\/v2\/posts\/41761\/revisions"}],"predecessor-version":[{"id":41763,"href":"https:\/\/ustower.net\/index.php?rest_route=\/wp\/v2\/posts\/41761\/revisions\/41763"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/ustower.net\/index.php?rest_route=\/wp\/v2\/media\/41762"}],"wp:attachment":[{"href":"https:\/\/ustower.net\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=41761"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/ustower.net\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=41761"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/ustower.net\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=41761"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}