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Latest From BioNTech SE
AstraZeneca and Novavax have not filed EUAs for their vaccines, and they never might. The pathway remains viable in the short-term, but as BLAs are approved and supplies are no longer short, the window may close.
Emergency use authorization in 12-15 year-olds follows announcement of a June advisory committee meeting on pediatric data requirements, including the FDA’s criteria for younger children. Authorization for US adolescents has raised ethical questions about prioritizing this lower-risk group over hard-hit populations overseas.
Roche’s former chief medical officer has new career as board member to three companies, including COVID-19 vaccine pioneer Moderna, and is co-founder of a startup seeking to develop more affordable drugs. She helped pave the way for FDA’s breakthrough therapy designation and diversification of Genentech’s clinical trials.
German mRNA specialist choses Singapore as its first regional hub in Asia Pacific, where it also plans to build a manufacturing site to support the global supply of both vaccines and therapeutics and a regional “rapid response” capability for future pandemics.
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