• Moderna’s messenger RNA influenza vaccine succeeded in two pivotal clinical trials, but the Food and Drug Administration isrefusing to even reviewthe application seeking regulatory approval, telling the company that the comparator in the studies - an FDA-approved vaccine - is insufficient. • The FDA’s refuse-to-file letter did not identify any safety or efficacy concerns for the vaccine, mRNA-1010, Moderna said after Tuesday’s market close. • The agency told the company that the vaccine lacked an adequate and well-controlled study and the comparator does not reflect standard of care. • Refuse-to-file letters inform a company that an application lacks information for the agency to conduct a review. • While the issue may be resolved by submitting additional data, it can also mean the agency wants a company to conduct another clinical trial. • Refuse-to-file letters are considered confidential communication between the FDA and a company, and are not typically made public.
Article Summaries:
- Moderna’s messenger RNA influenza vaccine succeeded in two pivotal clinical trials, but the Food and Drug Administration is refusing to even review the application seeking regulatory approval, telling the company that the comparator in the studies - an FDA-approved vaccine - is insufficient. The FDA’s refuse-to-file letter did not identify any safety or efficacy concerns for the vaccine, mRNA-1010, Moderna said after Tuesday’s market close. The agency told the company that the vaccine lacked an adequate and well-controlled study and the comparator does not reflect standard of care. Refuse-to-f
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