"Agency insiders told reporters that a team of career scientists was ready to review the vaccine and held an hour-long meeting with Prasad to present the reasons for moving forward with the review. David Kaslow, a top career official responsible for reviewing vaccines, also wrote a memo detailing why the review should proceed. Prasad rejected the vaccine application anyway. According to today's announcement, the FDA reversed that rejection"
"Andrew Nixon, spokesperson for the US Department of Health and Human Services, confirmed the reversal to Ars Technica. "Discussions with the company led to a revised regulatory approach and an amended application, which FDA accepted," Nixon said in a statement. "FDA will maintain its high standards during review and potential licensure stages as it does with all products." The FDA typically takes a levelheaded approach to working with companies, rarely making surprising decisions or rejecting applications outright."
Agency insiders reported that career scientists were ready to review Moderna's vaccine and met with Prasad; David Kaslow wrote a memo recommending the review, but Prasad rejected the application. The FDA later reversed that rejection after Moderna proposed splitting the application to seek full approval for people aged 50–64 and accelerated approval for people 65 and up, with accelerated approval requiring an additional confirmatory trial. HHS confirmed the revised regulatory approach and emphasized FDA standards. The initial rejection was tied to a control vaccine claim and coincides with anti-mRNA positions linked to Robert F. Kennedy Jr., including events alleging vaccine injury.
Read at Ars Technica
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