A. Pfizer didn’t report in their press release any cases of myocarditis, so I assume they didn’t see any. Even in adult studies, there weren’t a lot of cases in studies with 30,000 to 40,000 people. They had to wait until millions of people were vaccinated to relay that signal.
Side effects you’re more likely to see in 5- to 11-year-olds are the same list you see in older children and adults: fever, chills, fatigue and a sore arm. But it sounds like these may be even less likely in the younger kids. These are relatively minor problems.
Q. If Pfizer requests emergency use authorization by the end of September, when might the FDA okay the vaccine’s use and how fast could doses be available?
A. The FDA already has a fair amount of knowledge about what’s happening in these trials but doesn’t have a complete submission from Pfizer at this point. The leadership at the FDA has said once data is made available they will review it quickly.
I’d anticipate that before the end of September to mid-October they’d have a meeting and the FDA and its advisory committee would be able to review data and decide to expand the authorization to younger kids. Then, it would be reviewed by the CDC and its Advisory Committee on Immunization Practices. That’s the advisory panel of experts that recommends who gets the vaccine, contraindications and a schedule.
Everyone’s current prediction is the end of October we’ll have the vaccine available. But we don’t have anything set in stone yet.
Q. This will be two shots, three weeks apart, so how will that work with flu shots and even make-up routine childhood vaccinations?
A. The CDC will be part of this recommendation, but normally we recommend kids get vaccines on schedule, which means they can get more than one at the same time.
The reason we say this is when people try to space them out or not give them at the scheduled time, it leads to missed opportunities to get kids up to date. Life gets in the way, and people don’t come back for vaccines that you encouraged them not to get. It causes logistical problems because kids have to take off school again and parents have to take off work again.
It’s likely we’ll hear a recommendation from the CDC that it’s safe to get flu and COVID vaccines at the same time.