FDA, CDC Approve New Child Covid Boosters Without Human Data

The FDA authorized the bivalent booster for adults in late August without human data. The only data was from a small study performed on mice. Yet, it was approved, nonetheless.

Approval from the Centers for Disease Control and Prevention (CDC) followed in lockstep, as they have for the last two years.

The new, updated bivalent booster targets the original version of SARS-CoV-2 as well as the currently circulating Omicron variants. The FDA points to their analysis of data from adults who received the Moderna bivalent vaccine and kids who received the old monovalent booster to guide their recent decision.

They also said they are approving the Pfizer bivalent vaccine for kids because it is made in a similar fashion to Moderna, despite no supporting data submitted by Pfizer.

The FDA authorized the bivalent booster for adults in late August without human data. The only available information at the time was from a small study performed on mice. Yet, it was approved, nonetheless.

Within a few days of the FDA okaying the bivalent booster in kids, Pfixzer released human data on the bivalent booster in adults, which show an increase in circulating antibodies seven days after the dose. Does it offer increased protection against severe disease? Unclear. How long do the antibodies stay elevated? Unclear.

To put this plainly, there are no data on the bivalent booster shot in kids.

Not to mention, to be eligible for the new bivalent booster, kids must first get two doses of the outdated vaccine that has little benefit against Omicron. Less than a third of children ages 5 to 11 have received two doses of the vaccine, according to CDC data.

The FDA is still recommending the initial two-dose series with the original vaccine before getting the bivalent booster. The short-lived, decreased effectiveness of the initial two-dose series against Omicron has been well documented, most recently in the New England Journal of Medicine, citing, “No effect against the omicron variant was noted” 20 weeks after the primary series.

They also noted that while the originally available booster dose increased protection against symptomatic disease for two to four weeks following injection, it quickly declined. Similar results were reported for the Omicron-specific monovalent booster that became available early summer. Comparable results will likely be seen with the bivalent booster in adults.

Kids remain the lowest risk for developing severe COVID-19. To recommend boosting them, a benefit must be clear.

Yet, the efficacy data are nonexistent.  

What about safety?

There are no safety data in kids and the bivalent booster.

They have also not assessed how kids would respond to repeated boosters if they already received one or have recovered from COVID-19.

Plus, the booster data the FDA referenced in their authorization studied the original booster given five months after the two-dose series in kids, not two months as they are now recommending with the bivalent booster.

They are not taking into account the growing number of cardiac inflammation cases in young, healthy people following the vaccines and boosters, most commonly after repeated doses. They are also not taking into account that the virus has weakened, thus causing less severe illness.

It is impossible to understand how the FDA could approve and CDC recommend a new booster for kids without any pediatric data evaluating the risk:benefit.

Americans need better data. Unfortunately, these seemingly innocuous recommendations from the CDC expanding the use of boosters leads to mandates that can ultimately harm children. Harm can be either direct from potential risks of the vaccine/booster or indirect through learning loss and discriminatory exclusion from activities.

And for what? There is no proven benefit at this time, less have they confirmed they are safe. That’s probably why the FDA and CDC bypassed their own expert advisory review committees before making this decision.

Dr. Rochelle Walensky, CDC director, has publicly apologized for the mishandling of the pandemic. The FDA lost two high-level executives because of approving boosters with insufficient data.

This is another missed opportunity to show parents they have kids’ best interest at task.

They told Americans to follow the science.

It is high time for the CDC and FDA to do the same.

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