Why is the FDA pushing Pfizer on under-5 vaccinations?

AP Photo/Mark Lennihan, Pool

With approved vaccines (or at least those granted emergency approval) now being available to most Americans, the word “most” is under scrutiny this week. There still hasn’t been an approval granted – or even requested – for vaccines to be given to children under five years of age. This has been a matter of concern to at least some parents, even though children in that age group are among the least likely to experience any serious effects from COVID. It would appear that the Biden administration is growing impatient with the process because the Associated Press learned this week that the FDA is “urging” Pfizer to apply for emergency authorization for children ages six months to five years and to do so this week. This should raise questions for everyone because that’s pretty much the opposite of how this system is supposed to work.

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U.S. regulators are urging drugmaker Pfizer to apply for emergency authorization for a two-dose regimen of its COVID-19 vaccine for children 6 months to 5 years old while awaiting data on a three-dose course, aiming to clear the way for the shots as soon as late February, a person familiar with the matter told The Associated Press Monday.

The company’s application was expected to be submitted as soon as Tuesday.

Early Pfizer data has shown the vaccine — which is administered to younger kids at one-tenth the strength of the adult shot — is safe and produces an immune response. But last year Pfizer announced the two-dose shot proved to be less effective at preventing COVID-19 in kids ages 2-5, and regulators encouraged the company to add a third dose to the study on the belief that another dose would boost the vaccine’s effectiveness much like booster doses do in adults.

Pfizer has been conducting clinical trials on the youngest children for some time now. The doses are reportedly only one-tenth the strength of the adult dose and are given three weeks apart. They expect the third booster dose to be given to them as little as two months after the second dose. The concern the pharmaceutical company has is that the first two doses, while providing some level of immunity, don’t seem to be as effective against the Omicron variant. But the third dose appears to significantly boost immunity, at least among the small number of subjects who have received it.

Perhaps even more invasively on the part of the administration, the FDA is pushing Pfizer to seek emergency authorization of only the initial two doses. They would then come back and request authorization for the booster dose at a later date.

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None of that speaks to the main issue I wanted to ask about today. The AP report goes on to note that “speeding the authorization of pediatric vaccines against COVID-19 has been a priority for more than a year of the Biden administration.” While that may be understandable in terms of the politics involved, that’s not how this system is supposed to work.

Pfizer is the company developing the vaccine and they are the ones who are conducting the clinical trials. They should know when they feel comfortable enough with the results they’ve produced to submit them to the FDA for review. Then, if the medical experts (that’s the important part) at the FDA feel that the trial results are satisfactory, they can provide emergency approval for the process until all of the trials are complete.

The point is, the Biden administration’s desire to make approval of the vaccine a “priority” for political purposes is not supposed to be a consideration in this process in any way shape, or form. The AP article notes that approving vaccines for this age group would be important for “reopening and keeping open schools and daycare centers — and for freeing up parents occupied by childcare responsibilities to return to the workforce.”

Every word of that may be true and I’m sure many parents share those hopes and concerns. But none of those objectives have anything to do with medical science or keeping children safe. Those are political objectives that Biden’s people believe would help boost his tanking approval ratings. What happened to following the science? This administration is continuing to demonstrate that all of the preaching about “The Science” has been a smokescreen. If they believed in the functionality of the system they would wait for Pfizer to complete the work they feel is required during the trials and evaluate it appropriately. Having politicians pushing the FDA to start whispering in Pfizer’s ear is not the way this is supposed to work.

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Jazz Shaw 7:20 PM | March 18, 2024
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