DETROIT – Pfizer says the COVID-19 vaccine works in kids ages 5 to 11.
However, scientists and experts from the CDC, FDA and its advisory panel have yet to see the data or process it.
Dr. Oveta Fuller, a virologist from the University of Michigan, one of 18 very important voices on the FDA advisory panel, explains what she’ll be looking for when the actual data gets released.
“Children are not little adults. They’re not like, hey, let’s give less. Children are developing so we need to be sure that there are no developmental issues,” said Dr. Fuller.
Perhaps never before in the history of modern medicine has there been so much scrutiny for a pharmaceutical on its road to FDA approval, but it’s an important school-house-rock caliber process that is very specific and detailed.
The science behind the vaccine must be evidence based. So for the question of children it comes down to the numbers.
How many children got the vaccine? How many got this much of a vaccine verses that much of the vaccine?
In other words what was the exact dosing and the results of that dosing and how does that compare to the placebo group?
These FDA advisory board members need to have the data, know how the data was collected and what the data shows and for children five to eleven there is even more of an onus to get it right.
“We’re not so worried about effectiveness because we know the vaccine is effective, but we want to be sure that the dosage and the duration and those things are correct for children,” said Dr. Fuller.
And it’s the same process that led to the eventual FDA approval of the M-RNA vaccines in August, but the no-vote to recommend the boosters from its advisory panel Friday at least not yet.
“Sometimes with other vaccines the longer the period between the vaccination, the better the boost and greater the bump. There’s just a lot for me of not complete information with what we need to see in terms of what will give us the best bang for the buck,” said Dr. Fuller.
Michigan reported 7,185 new cases of COVID-19 and 35 virus-related deaths Monday -- an average of 2,395 cases over the past three days.
Monday’s update brings the total number of confirmed COVID cases in Michigan to 995,910, including 20,700 deaths. These numbers are up from 988,725 cases and 20,665 deaths, as of Friday.
The deaths announced Monday include nine identified during a Vital Records review.