Former government health officials fear the Trump administration is moving to slow-walk vaccine approvals, 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
The Food and Drug Administration confirmed Monday it was requiring drugmaker Novavax to run another clinical trial as part of the approval process for its Covid vaccine, which has been available under emergency use authorization since 2022<\/a>. Dr. Marty Makary, the FDA\u2019s commissioner, said the company is asking the agency to approve \u201ca new product\u201d based on old data. <\/p>\n\n\n\n Novavax\u2019s shot uses traditional protein-based vaccine technology and is the only alternative to the mRNA shots from Pfizer and Moderna. The drugmaker\u2019s application to the FDA was based on a 30,000-person randomized clinical trial conducted in 2021 in the U.S. and Mexico. <\/p>\n\n\n\n The agency missed an April 1 deadline decision, prompting concerns\u2002<\/a>among investors <\/strong>that it wouldn\u2019t be approved. <\/p>\n\n\n\n On Saturday, Makary\u2002suggested in a post on X\u2002<\/a>that Novavax was seeking approval for a \u201cnew\u201d vaccine because the strain used in its trial has since been updated to target a more recent Covid variant called JN.1. <\/p>\n\n\n\n \u201cUnder this administration, we are prioritizing the Gold Standard of Science–not what saves pharma companies \u2018tens of millions of dollars,\u2019\u201d Makary said. <\/p>\n\n\n\n Novavax declined to comment on Makary\u2019s remark. In a release issued Monday, Novavax said<\/a> it responded to an earlier FDA request to commit to providing more data on the vaccine if approved \u2014 a standard practice. <\/p>\n\n\n\n Dr. Paul Offit, the director of the Vaccine Education Center at Children\u2019s Hospital of Philadelphia, criticized the administration\u2019s move, pointing out that the seasonal flu vaccines are updated each year with new strains without the need for new clinical trials. The mRNA Covid vaccines have been similarly updated each year to target the most current strain. <\/p>\n\n\n\n \u201cI mean, how exactly does he propose they do this?\u201d said Offit, who also serves on an independent vaccine advisory committee for the FDA. \u201cIt just worries me that it\u2019s part of an overall general strategy to weaken vaccine efforts.\u201d <\/p>\n\n\n\n The FDA directs all media inquiries to the Department of Health and Human Services. In a written statement, an HHS spokesperson said the Biden administration waived clinical trial requirements for new Covid vaccines \u201cusing the COVID pandemic as an eternal justification for blanket approvals.\u201d <\/p>\n\n\n\n Under Makary, the spokesperson said, trials from four years ago \u201cno longer suffice.\u201d <\/p>\n\n\n\n \u201cWith Novavax seeking authorization for a new formulation targeting the JN.1 variant, the public deserves clear answers about its efficacy and if its benefits outweigh the risks,\u201d the spokesperson said. <\/p>\n\n\n\n The Wall Street Journal first reported<\/a> the FDA\u2019s request for a new clinical trial. <\/p>\n\n\n\n Novavax\u2019s shot isn\u2019t the only Covid vaccine that officials say may be at risk. <\/p>\n\n\n\n Dr. Tracy Beth H\u00f8eg, who was announced as a special adviser to Makary earlier this month, has called for more scrutiny of vaccines, telling FDA staff and high-ranking officials in a meeting outlining priorities that the agency would be doing fewer vaccine approvals going forward, according to three former government officials familiar with the matter, who spoke on the condition of anonymity for fear of retribution. <\/p>\n\n\n\n H\u00f8eg, a sports medicine physician, rose to prominence during the pandemic as a vocal critic of the Covid vaccines, particularly for children. <\/p>\n\n\n\n Her appointment added another anti-Covid-vaccine voice to the Trump administration. In 2021, HHS secretary Robert F. Kennedy Jr. described the Covid vaccine as the \u201cdeadliest vaccine ever made.\u201d In 2023, Makary and H\u00f8eg co-wrote an\u2002<\/a>editorial for the New York Post criticizing the Biden administration\u2019s recommendation of the Covid shot in children. <\/p>\n\n\n\n It\u2019s unclear what role \u2014 if any \u2014 H\u00f8eg played in the FDA imposing an additional requirement for Novavax\u2019s Covid vaccine approval. H\u00f8eg did not respond to multiple requests for comment. <\/p>\n\n\n\n There are also concerns about several upcoming FDA deadlines related to Pfizer\u2019s mRNA Covid vaccine, including <\/strong>a decision for the full approval for the shot in children under 11, according to two of the former officials. The vaccine currently has an emergency use authorization for ages 11 and under. <\/strong> <\/p>\n\n\n\n The mRNA vaccines are a particular target among anti-vaccine activists. The vaccines from Pfizer and Moderna are the first-ever approved using mRNA technology, which has led some to claim they pose a unique threat. Florida Surgeon General Joseph Ladapo has railed against mRNA vaccines, alleging they could possibly alter a person\u2019s DNA. Several states<\/a> have introduced legislation that would ban mRNA vaccines. The CDC says the mRNA Covid vaccines are safe<\/a> and do not alter DNA; the technology had been studied for decades before its first approval in the U.S. in late 2020. <\/p>\n\n\n\nOther vaccine approvals possibly at risk <\/strong> <\/strong><\/strong><\/h2>\n\n\n\n