Vinay Prasad, the Trump administration’s top vaccine regulator at the Food and Drug Administration, single-handedly decided to refuse to review Moderna’s mRNA flu vaccine, overruling agency scientists, according to reports from Stat News and The Wall Street Journal. Stat was first to report, based on unnamed FDA sources, that a team of career scientists at the agency was ready to review the vaccine and that David Kaslow, a top career official who reviews vaccines, even wrote a memo objecting to Prasad’s rejection. The memo reportedly included a detailed explanation of why the review should proceed. The Wall Street Journal confirmed the report with its own sources, who added that FDA scientists attended an hourlong meeting with Prasad in early January, in which they laid out their objections to Prasad’s plans to block the vaccine review. They reportedly told Prasad—a political appointee known for causing turmoil and espousing anti-vaccine rhetoric—that it was the wrong approach. Prasad’s objection was not based on any potential problem with Moderna’s experimental mRNA vaccine; rather, it was with the existing licensed vaccine Moderna used for a comparison in a Phase 3 clinical trial that enrolled nearly 41,000 adults aged 50 and older. The FDA reviewed Moderna’s trial plans on multiple occasions prior to the company’s submission, without objection. While Moderna acknowledged that FDA scientists had suggested using a different vaccine comparator for trial participants aged 65 years and older—who are eligible for a high-dose flu shot—they highlight that the agency concluded that Moderna’s plan was “acceptable.”
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