Thursday, October 14, 2021

White House Tells Governors to Get Ready to Vaccinate Young Kids, Even Though FDA Hasn’t Approved It. Pediatrician Says, Not so Fast.



In a private phone call Tuesday with the nation’s governors, the White House told states to prepare to vaccinate children as young as 5 by early November. A White House official said the call was made in anticipation of Pfizer’s COVID vaccine being cleared for Emergency Use Authorization (EUA) in the coming weeks for children ages 5 to 11.

According to NBC News, the Biden administration purchased 65 million pediatric doses of the Pfizer/BioNTech vaccine — enough to vaccinate an estimated 28 million children who would be eligible should the U.S. Food and Drug Administration (FDA) approve Pfizer’s request to vaccinate the younger age group.

In anticipation of a green light from the FDA, the administration began planning vaccination efforts with states, pharmacies and medical groups. The administration told providers in a planning document last week the vaccine for children will be delivered to thousands of sites within one week of FDA authorization.

The pediatric Pfizer vaccine will be distributed in 100-dose packs. Each dose is one-third of what is given to adults, and will be free through sites enrolled in a federal program that guarantees the shots are provided at no cost. Some states are planning to provide the vaccine through schools.

“We’ve secured plenty of supply, and we’ll be putting in place an allocation, ordering and distribution system similar to what we’ve used for the other vaccines,” said Biden’s White House COVID coordinator, Jeff Zients, on a phone call, obtained by ABC News, with governors.

“It is distressing to hear that the Biden administration has already purchased 65 million doses of pediatric COVID vaccines,” said Dr. Elizabeth Mumper, pediatric physician and CEO of the Rimland Center for Integrative Medicine. “Vaccinating children is not the way out of the pandemic.”

In an email to The Defender, Mumper said she hopes the White House will consider the following data:

Remember, Mumper said, COVID injections do not diminish transmission, the vaccinated can catch and spread COVID and with children we should first do no harm.

FDA to meet Oct. 26 on Pfizer vaccine for kids, experts question need, safety

Pfizer and BioNTech said this month they submitted a request for EUA for children ages 5 to 11 to receive a lower dose of its vaccine. The FDA’s advisory committee is scheduled to meet Oct. 26 to discuss the request.

Pfizer’s study on elementary-school-aged kids included volunteers from the U.S., Finland, Poland and Spain. Exact details on the effectiveness of the vaccines in clinical trials involving kids has not been publicly released, although Pfizer said the study showed the smaller dosage was “safe and effective.”

According to Alex Berenson, former New York Times reporter and author of 12 novels and two nonfiction books — and current author of the Substack publication “Unreported Truths” — Pfizer’s clinical data on its COVID vaccine for 5- to 11-year-olds showed no evidence of actual health benefit to the children who received it.

“In other words, what Pfizer demonstrated in its 2,300-patient child trial is that its mRNA doses can make your kids make spike proteins (and have side effects),” Berenson said.

“Per Pfizer’s Sept. 20 press release announcing the trial’s results, the trial didn’t show the vaccine reduced hospitalizations (which are basically non-existent in healthy children) or even mild cases,” Berenson said.

Nowhere in Pfizer’s press release did it say the vaccine did anything to make kids stay healthier, Berenson explained. “But it did reveal side effects generally comparable to those observed in participants 16 to 25 years of age,” he said. “In other words, (sometimes severe) headaches, fatigue and fever.”

“Clinically significant myocarditis?” Berenson asked. “Who knows? With barely 1,000 boys receiving the vaccine, even fairly common side effects could go unnoticed.”

Pfizer said in its press release clinical trial data for children was not intended to draw meaningful conclusions about the vaccine’s ability to prevent disease or hospitalizations.

“Instead, researchers looked at antibody levels, comparing them with levels in adults that had conferred high protection. Regulators are expected to compare those immune responses to vaccine efficacy data in the adult population,” the release states.

COVID not ‘extraordinary’ threat to kids

Reacting to the news, Matthew Yglesias, writer, editor and senior fellow at the Niskanen Center said, “Serious cases [of COVID] are so rare in children that it’s extremely hard to do a trial with sufficient statistical power to tell if you are preventing them.”

Whether parents will embrace the vaccines for their kids is still a question, and could depend on details released in coming weeks on the clinical trial, ABC News reported.

In a September poll, the Kaiser Family Foundation found only one-third of parents with kids ages 5-11 were willing to vaccinate their kids right away, while another third wanted to “wait and see.”

Overall, children are still considered significantly less likely than adults to experience negative outcomes from COVID. According to an estimate by the American Academy of Pediatrics and the Children’s Hospital Association, less than 2% of all child COVID cases resulted in hospitalization as of Oct. 7.

Among 45 states reporting mortality statistics from COVID, children were 0.00%-0.26% of all COVID deaths, with seven states reporting zero child deaths. ​In states reporting, only 0.00%-0.03% of all child COVID-19 cases resulted in death.

As The Defender reported Oct. 12, according to recent data in King County, Washington, which has some of the country’s most detailed COVID data, the risks for unvaccinated children look similar to the risks for vaccinated people in their 50s.

“COVID is a threat to children. But it’s not an extraordinary threat,” Dr. Alasdair Munro, a pediatric infectious-disease specialist at the University of Southampton, said in a tweet. “It’s very ordinary. In general, the risks from being infected are similar to the other respiratory viruses you probably don’t think much about.”

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