After initially refusing to review a candidate mRNA vaccine developed by Moderna Inc for influenza, the US Food and Drug Administration has reversed itself and agreed to consider the product for a marketing authorisation. The decision was announced by Moderna on 18 February and follows a meeting between the agency and the company during which a compromise was reached.
A vaccine developed by GSK Plc and approved for the prevention of lower respiratory tract disease caused by the respiratory syncytial virus (RSV) appears to have a wider benefit, according to a retrospective study of patients who have received the drug. The study results were presented at a conference in Italy on 17 February. The vaccine, Arexvy, protects against respiratory syncytial virus which causes infections in the lungs and respiratory tract. The virus is common but the effects are most serious for young children and older adults.
Moderna Inc has asked for a meeting with the US Food and Drug Administration to query the agency’s decision to refuse to review its candidate mRNA vaccine for influenza. Effective 16 February, the agency hadn’t disclosed whether or not it would consider a follow-up discussion known as a Type-A meeting. This follows an event in early February when the director of the FDA’s biologics evaluation and research division at the agency, Vinayak Prasad, issued a refusal-to-file letter to Moderna overruling the advice of career staff at the agency.
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