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.
CytoDyn’s COVID-19 candidate leronlimab joins BrainStorm’s ALS therapy in being taken to task as FDA has become more willing to publicly counter investigational drug data announcements it considers to be misleading.
Incorporation of the Ped-PRO-CTCAE instrument would help inform short-term tolerability and long-term effects of treatment, particularly newer immunotherapy agents, but there are logistical and operational challenges to overcome, advisory committee members said.