Discussion on Vaccine Recommendations and Safety

Is there any comment on using this vaccine at the same time with other

adjuvanted vaccines?

We have no data to, um, make, um, a recommendation one

way or the other.

So, um, just so you-- just to sort of put this in context of

other

vaccines, um, while s- preclinical studies

were not done using these

vaccines simultaneously, our general approach to immunizations is

that, um, they should be given, they can be given at the same time

in different, um, limbs.

Dr. Hunter?

Are adjuvanted, multiple adjuvanted vaccines,

uh, used in Europe or other markets?

Dr. Ward, do you wanna comment?

Not to, not to my knowledge.

Okay. Um, I think unless there's any further

discussion, we

will take a vote on this, uh, recommendation.

I wanna remind everyone to please, um, check your, um, voting

car-- whatever, machine thing and, um, I don't know what it

is. Voting is open.

Thank you very much. Uh, so the voting is completed,

um, and it is unanimous to support this

recommendation. Uh, thank you, all.

Does anybody have any comments they wish to make a-about their vote?

So just a, a, a slight reservation.

I think this is a huge advance and a step forward.

I, I am concerned about that signal, that myocardial infarction signal.

I am concerned about the use of this new adjuvant and, and certainly

urge us to continue to look at, uh, uh, the post-marketing data

carefully.

Thank you.

Dr. Hunter.

Just a question about that. Would we-- How soon would we be getting that

po-post-marketing data update here?

There's two kinds of data. Um, the Vaccine Safety Datalink

data will require people to be using the vaccine to develop

substantive database. And Dr. Sun, do you wanna

comment on the post-marketing

data that FDA is requiring?

I think for the myocardial infarction study,

we're con- we're, um, uh,

seeing that the date for or likely for completion is May twenty,

May thirty-one, twenty-twenty. There will also be, uh, studies

looking at, um, autoimmune diseases as well as herpes

zoster

and, and, uh, there will be a pregnancy registry as

well.

So that should, that should, that's all included in the post-marketing

surveillance.

Thank you.