Thread by @JGPharmD

I disagree with the implication that that the panelists would jump right in with those points. And truthfully, if he felt they should have prevented approval, he should have voted that way. 1/

https://twitter.com/emilyakopp/status/1453136997309198345

1- What would longer follow-up have achieved? Since the vast majority of vaccine adverse effects occur quickly in the first month after vaccination, it isn't a safety issue. Those children are still enrolled and we'll learn more from them. Waiting 6+ mos would delay vaccines. 2/

2- Yes, children have less severe infection than adults. They also die from COVID. As mentioned during #VRBPAC , 30% of the kids who have died from COVID had no medical issues. And if you think this should be restricted to high-risk kids (I don't), ACIP will consider. 3/

3- Infection-acquired immunity clearly decreases later infection, though less consistency than vaccine-induced immunity. This doesn't mean the vaccine should not be available. If CDC wishes to weigh in on if that should be a factor, then it can. IMO 1x doses should be studied. 4/

4- 40% of children 5-11 having prior COVID means that 60% of children didn't have prior COVID. Some of those children will die from COVID. 5/

5- Agree that 3-week dosing intervals are likely suboptimal, but they work. We can tell that because vaccines prevented COVID in the children in the studies. If waning becomes an issue, that can be addressed later. Is the lesson 'don't vaccinate bc you may have to do so again'?..

... during the pandemic?? That seems crazy to me. By necessity we are learning as we go. 6-7/

6- There is no way to know what will happen with future waning. There is should also be no expectation that the lower dose in children will lead to a lack of cellular immunity. We also had no idea what would happen 4-6 months after vaccination in adults with these new vaccines 8/

7- "I don't expect protection from infection to last more than a few months, negatively impacting public perception of vaccines" is based on nothing. 9/

Notice that only one of these points deal with the actual charge of #VRBPAC- to assess the data presented and decide if the vaccine reaches a threshold for an EUA. The Pfizer vaccine was shown to be safe and effective in kids 5-11. As a parent and ID pharmacist, I am thrilled /10

Yes, I was pretty fired up during that meeting. /10