Dearth Of Seasonal Flu Adds Uncertainty To Vaccine Strain Selection For Next Season
Low influenza activity in the face of COVID-19 mitigation measures has made it more difficult to predict which strains may become predominant, but US FDA advisory committee unanimously endorses WHO recommendations for influenza A and B strains to be included in US trivalent and quadrivalent vaccines.
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US position remains that boosters are not needed yet, but CBER Director Peter Marks says regulators are discussing how to harmonize applications for booster shots.
Nagoya Protocol Complicates Seasonal Flu Vaccine Manufacturing And Could Slow Future Pandemic Responses
Industry experts contrast the multilateral response to COVID-19, which included rapid disclosure of the SARS-CoV-2 genetic sequence, with delays and complexities in accessing seasonal influenza viruses and other pathogens originating in countries that have adopted the Nagoya Protocol and implemented access and benefit-sharing legislation.
Discrete packaging for authorized dose in 6-11 year-olds is not yet available, so vaccination providers have to use product from a vial labeled for ‘booster doses only’ in adults. ACIP members unanimously endorse use of the mRNA vaccine in individuals ages 6-17 years but urge manufacturers to move away from relying on color to differentiate formulations.