Is 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 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.” — 's Gruber.
The deliberation of the vaccine experts at the FDA Advisory meeting yesterday: concerns over adequate safety data, emergency authorization (EUA) and more
FDA shows signs of cold feet over emergency authorization of Covid-19 vaccines via
Super impt 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 via
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. #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 via
Watch this space: FDA shows signs of cold feet over emergency authorization of Covid-19 vaccines. Story via
Yesterday, the FDA showed signs of cold feet over emergency authorization of Covid-19 vaccines, writes.
FDA shows signs of cold feet over emergency authorization of #Covid19 vaccines via
FDA shows signs of cold feet over emergency authorization of Covid-19 vaccines via
Really critical issues raised by 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'