The US Food and Drug Administration’s data expectations for combination COVID and flu vaccines are higher than those of its European counterparts, creating potential difficulties for sponsors, GSK plc’s Philip Dormitzer, the company’s senior VP and global head of vaccines research and development, said.
Key Takeaways
- EU standards for combo flu-COVID vaccines may be easier for new entrants than FDA’s.
- GSK considering challenge studies, post-licensure studies in EU to help obtain data for US approval of combo product
The US will likely require new COVID vaccine entrants to conduct efficacy studies for their combo product, while immunological studies should be acceptable in the EU
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