"The federal agency cited that as the reason it declined to review the application, which claimed there was a lack of adequate and well-controlled data. Moderna said the letter claimed that the FDA thought the biotech giant's flu vaccine does not reflect the best-available standard of care. The company has pushed back on the allegation, and CEO Stephane Bancel said the letter did not identify any safety or efficacy concerns with our product."
"If there are things that need scrutiny, a review process can address them. At the end of the review, they can identify the issues that need to be corrected. That gives the company an opportunity to make changes and adapt. When that guidance isn't provided, it makes it very difficult for someone submitting materials to know how to proceed, Bruce Y Lee, a professor of health policy and management at the CUNY Graduate School of Public Health and Health Policy, told Al Jazeera."
The FDA refused to review Moderna's application for approval of the mRNA-1010 flu vaccine, citing use of a marketed product as a comparator and a lack of adequate, well-controlled data and asserting the vaccine does not reflect the best-available standard of care. Moderna disputed the agency's rationale and indicated the letter did not identify safety or efficacy concerns with the product. Experts warn that absence of clear regulatory guidance complicates submissions and prevents identification and correction of issues through a formal review process. Moderna previously reported mRNA-1010 showed higher effectiveness than an approved comparator vaccine.
Read at www.aljazeera.com
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