4:13 PM, Feb 27, 2020


FDA advisory panel to discuss two COVID vaccines for young kids on Wednesday

Posted at 3:30 PM, Jun 13, 2022

(WXYZ) — The only age group not yet eligible for COVID-19 vaccines may soon have two to choose from.

This Wednesday, the FDA’s Advisory Panel is set to discuss both Pfizer and Moderna's COVID-19 vaccines for children under 5.

The FDA posted its analysis of both companies’ vaccines, and both were found to be safe and effective.

This is great news. As you know, I’m a parent and my youngest son is one of the 18 million American children who are not yet eligible to be vaccinated. But it looks like that’s about to change. According to the FDA’s documents, both Pfizer and Moderna's COVID-19 vaccines appear to be safe and effective.

Moderna’s trial involved more than 6,000 children between the ages of 6 months and 5 years. Their dosing regimen consists of two shots, each 25-micrograms given 28 days apart. That’s roughly one-quarter the strength of an adult dose. The clinical trial found Moderna’s vaccine produced a similar immune response to adults aged 18 to 25. And there were no known cases of myocarditis, which is inflammation of the heart, that’s been seen in older age groups.

As for Pfizer’s data, its clinical trial involved just over 1,400 children. The dosing regimen initially consisted of 2 shots, 3-micrograms each which is about one-tenth the strength of an adult dose. But that didn’t produce a good enough immune response so a third shot was added. That appeared to do the trick as the trial found Pfizer’s vaccine efficiency to be 80.4%.

Moderna’s vaccine for kids under 5 was found to be about 40 to 50% effective at preventing symptomatic COVID-19. Whereas Pfizer’s that I just mentioned is 80.4%. But here’s the catch…the trial protocol is set at 21 symptomatic cases. That’s what’s needed to determine vaccine efficacy. And Pfizer only has 10 cases. Eight were in the placebo group and two were in the vaccine group. So this means the efficacy rate could change as more cases are factored in.

Now, at the meeting this Wednesday, the FDA’s independent panel of experts will discuss and vote on whether or not they feel the FDA should authorize both these vaccines, or one of them, or neither of them.

However, if the FDA does give its stamp of approval, the CDC would also have to give the green light before our youngest group of children can start getting vaccinated against COVID-19. I know many parents who have been waiting a long time for this, and if all goes well, we could have vaccines rolling out as soon as next week for our littlest ones.

Additional Coronavirus information and resources:

View a global coronavirus tracker with data from Johns Hopkins University.

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