Is @US_FDA getting cold feet about emergency use authorizations as a tool to rapidly deploy #Covid19 vaccines? It seemed pretty clear from yesterday's VRBPAC meeting the agency may be thinking about other routes to use.
Excellent article by @HelenBranswell on Covid vaccines. Certain groups, e.g. staff of nursing homes, may be able to receive it sooner on expanded access basis. Reality check: a vaccine won't end the pandemic and a vaccination program will be very complex.
“We are concerned [a #Covid19 vaccine EUA] would interfere with longterm assessment of safety & efficacy in ongoing trials & potentially even jeopardize product approval. & not only the first vaccine, but maybe even follow-on vaccines.” — @US_FDA's Gruber.
Super impt @HelenBranswell story on how the first authorization of a #COVID19 vaccine could throw other trials into disarray and limit data collection. It's something the FDA's worried about too
statnews.com/2020/10/23/fda… via @statnews
There are serious signs the FDA is getting cold feet over the notion of issuing emergency use authorizations to allow for the widespread early deployment of Covid-19 vaccines. buff.ly/3mjRmeu
#FDA #Covid_19 #vaccines
These are imp questions & we need a global discussion on how we want to proceed with #COVID19 vaccine clinical trials. Stopping them too early means lack of longer term data on efficacy, safety, esp in subgroups @CEPIvaccines@GaviSeth@WHOstatnews.com/2020/10/23/fda… via @statnews
Really critical issues raised by @HelenBranswell about the early data from #Covid_19
Vaccine trials 💉👇🏻
Good to hear FDA 'urging vaccine manufacturers to keep their trials blinded as long as possible, to collect as much data as they can'