Does this mean the vaccine is approved?
Yes, were probably within days of an EUA, but still probably months away from a full approval.
An EUA is like a temporary approval.
It means the vaccine is allowed to be administered in the context of a public health emergency.
As time goes on, the EUA might be rescinded or revised.
What happens next?
In other words, its coming.
The vaccine maker and federal and state governments have already been working with hospitals and providers to distribute vaccines.
As soon as they get the word, theyre ready to start giving out the shots.
Who will get the first shots?
This decision is made on a few levels.
First, the CDC has a committee called ACIP that writes vaccine recommendations.
They have already indicated that they expecthealth care workers and nursing home residents to be first in line.
This committee will meet today and then again this weekend once the EUA is issued.
(You cantune in to listen to those meetings here, if youd like.)
What questions still remain?
There are so many.
Basically, everything in the study looks pretty good.
We just dont know very much about anything that wasnotin the study.
Some of the big questions:
Will this vaccine prevent asymptomatic infections?
Stopping asymptomatic transmission is crucial for developing herd immunity.
The vaccine would then protect individuals, but not the community.
The coronavirus would still run rampant, but it would find vaccinated people harder to kill.
Will this vaccine be safe for children?
The study started out with only adult subjects, and then added 16 and 17-year-olds.
They did okay, but there were only about 150 of them in a study population of around 40,000.
But that whole process could take months to years.
Is this vaccine safe to take during a pregnancy?
Its a delicate risk/benefit balance.
Theyll have the results of those soon.
Whats up with those severe allergic reactions in the UK?
We dont know yet.
We also dont know about any group that was underrepresented in the trials.
Regulators seemed dismayed about that, but were in a world of unknowns and tradeoffs.
