Thank you. I was looking forward to your newsletter this morning for rational and easy to understand scientific forecast on Omicron. Chag Sameach. I'll have to look for that book for my grandkids.
My biggest question is: what exactly is the regulatory pathway for an updated vaccine, should one be required? Will the FDA want a full phase III trial again? Or just safety and immunogenicity data, as with the 5-11 trial? How large will the sample need to be?
Relatedly, what does this mean for kids' vaccines? Adolescents had to wait half a year after the first EUA, younger kids almost an entire year. Children under 5 still have nothing. It seems like it would be ill-advised from a public health perspective, as well as more than a little cruel, to make children and parents wait that long again.
Thank you. I was looking forward to your newsletter this morning for rational and easy to understand scientific forecast on Omicron. Chag Sameach. I'll have to look for that book for my grandkids.
My biggest question is: what exactly is the regulatory pathway for an updated vaccine, should one be required? Will the FDA want a full phase III trial again? Or just safety and immunogenicity data, as with the 5-11 trial? How large will the sample need to be?
Relatedly, what does this mean for kids' vaccines? Adolescents had to wait half a year after the first EUA, younger kids almost an entire year. Children under 5 still have nothing. It seems like it would be ill-advised from a public health perspective, as well as more than a little cruel, to make children and parents wait that long again.