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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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.
Benefits of independence from exogenous insulin outweighed the risks from long-term immunosuppression necessary with the allogeneic pancreatic islet cellular therapy, majority of panelists said, but they urged the FDA to limit the indication to a very small subpopulation of patients.
Agency wants to use pandemic-interrupted clinical trials to gauge how decentralized approaches impacted study integrity and to inform prospective use of such designs post-COVID.