Thread by @DiseaseEcology

Why do we exclude groups from vaccine trials (pregnant, lactating women, people w/ anaphylactic reactions) & then allow vaccination of them based on trials? Isn't this recipe for possibly very bad outcomes? Urgent remedy needed.
Thread
nytimes.com/2020/12/11/hea…

Pfizer/BioNtech vaccine was just granted EUA from FDA. EUA does not exclude any groups, except children under 16.
fda.gov/media/144412/d…
CDC met today & also recommended vaccination w/out clear exclusions for groups excluded (e.g. pregnant women).
cnbc.com/2020/12/12/cdc…

But who was excluded from phase 3 trial? Many groups!
Pregnant/breastfeeding women
History of anaphylaxis
Immunocompromised
Those being treated w/ corticosteriods
etc.

I understand that we are trying to get vaccine ready as soon as possible, but trials will include what FDA requires & I don't understand why FDA would allow design that excludes key groups.

This concern is shared by many excluded groups who are then forced to request that those groups aren't excluded from vaccination. This is very problematic.
h/t @nataliexdean
acog.org/-/media/projec…

It could lead to severe side effects being seen for the 1st time during vaccine rollout, as we saw in UK
(nytimes.com/2020/12/11/hea…), & this is damaging for public confidence. An urgent effort to remedy this is needed.

Also, I'm guessing it must have been revised, but trial exclusion criteria (clinicaltrials.gov/ct2/show/NCT04…) include previous diagnosis w/ COVID-19. But FDA doc & NEJM paper clearly show people w/ previous infection included.
fda.gov/media/144245/d…

Can someone explain this mismatch b/w trial & protocol? COVID-19 seems to be exclusion criteria for actual trial (not just primary endpoint), but clearly trial included many w/ previous exposure & COVID-19. Thanks!