Why is Pfizer pushing an untested vaccine on children?

It has to do with efficacy – and corporate profits.

The face of Pfizer – Pfizer board member (and former FDA commissioner) Scott Gottlieb, MD – was on CBS Face the Nation today estimating the upcoming availability of the Pfizer vaccine for kids aged 5-11.

Face The Nation @FaceTheNation

NEW: Request for Emergency Use of Pfizer’s COVID vaccine submitted to FDA for use in kids 5-11 Former FDA commissioner @ScottGottliebMD told @margbrennan it's "still possible" vaccines will be available for kids by Halloween, pending a review of data

His key quote:

“The FDA has said the review is going to be a matter of weeks, not months. . . that could give you a vaccine by Halloween.”

Perhaps more concerning is the fact that Gottlieb is confident Pfizer will get FDA approval. This concern is based on the questionable safety and effectiveness of the Pfizer vaccine for kids aged 5-11, as well as questions over whether there is a need for an emergency use authorization for that segment of the American population.

Are the vaccines safe and effective for children?

Pfizer tested the vaccine on a small sample of “2,268 participants 5 to <12 years of age.” Pfizer concluded that the results demonstrated “strong immune response in this cohort of children one month after the second dose.”

Pay attention to that last part: “one month after the second dose.”

Is that it – is Pfizer pushing this vaccine on children after just one month of efficacy data? (The benefit of the emergency use authorization - studies can be limited.)

By now it’s clear this is Pfizer’s pattern: they say the vaccine’s “duration of protection” is “unknown” while data demonstrates its effectiveness wanes over time.

Compare the Comirnaty Fact Sheet to the latest reporting on the Pfizer vaccine:

One would rightfully assume that the effectiveness of the vaccine will wane in children as it has done in other populations. One would also be correct to assume this is the rationale for Pfizer to submit its current (one month) data to the FDA, hoping for approval from its friends in government before its study group shows the vaccine has diminishing returns.

All that has to do with effectiveness. Now we get to the question of safety.

This has always been a pandemic of the oldest among us.

 According to CDC data, children aged 5-14 years-old have accounted for only 161 COVID-19 deaths since the start of the pandemic. In comparison, this same group has experienced 194 pneumonia deaths. To put these numbers into perspective, the CDC cites over 530,000 COVID-19 deaths for the ages 65 years and up.  As New York Magazine observed, “The Kids Were Safe from COVID the Whole Time.”

Those numbers are important when we start to look at the necessity of a vaccine for kids. As with all vaccines, there is a cost-benefit analysis that must be made: do the benefits of the vaccine outweigh the cost? (This is something the FDA and CDC have drilled to the American public – that the benefits of the vaccines outweigh the costs.) Looking at the data, a 17 year-old teenager might properly disregard the vaccine while a 75 year-old might seriously consider it. This is expected.

Considerations of costs and benefits get us to the safety of the vaccine for kids aged 5-12. Pfizer proudly announces the vaccine’s side effects for 5-12 year olds is “generally comparable to those observed in participants 16 to 25 years of age.”

That’s not good.

If you’ve been paying attention, you know why those numbers (ages 16-25) matter. It’s because young people – especially young men – in that age range have an increased risk of developing heart problems after the second Pfizer dose. The younger they are, the greater the risk:

“Boys between 16 and 19 years of age had the highest incidence of myocarditis after the second dose . . . The risk of heart problems in boys of that age was about nine times higher than in unvaccinated boys of the same age.”

Other countries have recognized the risks. Sweden and Denmark, for example, have paused the Moderna vaccine for younger age groups.

Finally, we observe that children are not experiencing a COVID-19 emergency (which would be defined as hospitalizations or deaths from COVID-19, not the infection itself). They are back at school without vaccines – and in many jurisdictions, with no masks – and they’re fine.

If that’s true, then why is Pfizer pushing the vaccine on young children from 6 months to 12 years?

I think you know the answer.