Centers for Disease Control and Prevention (CDC) Director Rochelle Walensky, M.D. approved the Pfizer COVID vaccine for children aged 5 to 11 years, CDC announced Tuesday.
Walensky signed off on the pediatric shots just hours after her agency’s advisory panel recommended them for these young children. The Food and Drug Administration (FDA) had already authorized the vaccine for them on Friday.
Eric Rubin, M.D., a member of the FDA independent advisory panel and editor-in-chief of New England Journal of Medicine, said Tuesday regarding emergency authorization of the Pfizer vaccine for young children, “We’re never gonna learn about how safe the vaccine is until we start giving it. That’s just the way it goes.”
“This is just really exciting news, that we now have vaccine recommendations for 28 million children between the ages of 5 to 11,” Walensky said Wednesday on CBS Mornings, adding:
We at the advisory committee reviewed a lot of data yesterday. We looked at the risks of disease, the risks of death, of hospitalizations of long COVID among children, and, importantly, we looked at how well these vaccines worked: 91 percent effective against infection, and then, of course, we reviewed the safety data. There were no severe events associated with the safety of this vaccine, and, in fact, we see the side effects of this vaccine are very similar to what we’ve seen in adults, the most common of which is a sore arm, which goes away in about a day or two. So, the overwhelming evidence for parents to really know and understand is that the benefits of this vaccine so much outweigh the risks of COVID itself.
“We have taken the time to get this right for our children,” Walensky claimed, encouraging parents who might be hesitant to have their children get the jabs.
Jane Orient, M.D., executive director of the Association of American Physicians and Surgeons (AAPS), however, said in a statement to Lumen-News, “In the time allotted, Dr Walensky could not possibly have done an independent review of the evidence presented, or even a fraction of the 140,000 public comments.”
“The government had ordered 68 million doses, evidently counting on her to be a rubber stamp,” Orient asserted.
During a press briefing Wednesday by the White House COVID-19 Response Team and Public Health Officials, Walensky also said “the risk to children of severe COVID remains too high and too devastating.”
But she also said that children “are at lower risk of becoming severely ill with COVID-19 compared to adults,” and then added, “We know that beyond the clinical impact of COVID, there have been detrimental social and mental health impacts from this pandemic.”
Walensky then immediately veered to the subject of school closures during the pandemic, presumably detailing these “social and mental health impacts.”
She continued that many of the school age children, the ones who are now eligible for the vaccine, have missed important events during the pandemic shutdowns, such as sports and after-school activities.
“We have watched as the education gaps that exist in this country have widened as this virus has disproportionately impacted racial and ethnic minority communities,” Walensky added as well.
She then connected these issues to the vaccines:
Pediatric vaccination has the power to help us achieve healthy, safe, and inclusive environments for our children.
Getting your child vaccinated can help protect them against COVID-19, as well as reduce disruptions in in-person learning and activities, helping us get back to school as we once knew it and hope it can be: a safe and enriching environment for all of our children.
But Walensky said similar things just months ago about adult vaccines.
In March, she announced, “Our data from the CDC today suggest that vaccinated people do not carry the virus.”
By August, however, the CDC director had already changed her message about the vaccines’ effectiveness.
“Our vaccines are working exceptionally well,” she asserted, “They continue to work well with delta with regard to severe illness and death, but what they can’t do anymore is prevent transmission.”
And, recently, Walensky has said the federal government’s definition of “fully vaccinated” could be subject to change since boosters are now available to many American adults.
“We may need to update our definition of fully vaccinated in the future,” she said at a press briefing a couple of weeks ago. “But right now, what I would say is, if you’re eligible for a booster, go ahead and get your booster.”
Will children age 5-11 need boosters as well, just months after they are considered “fully vaccinated?”
In a statement on the COVID vaccines for young children, AAPS included among its observations of the Pfizer vaccine testing:
- In the testing, only 1,518 children received the shots, and 750 received a placebo. This is far too few to see uncommon side effects, such as myocarditis/pericarditis, as Pfizer admits.
- Follow-up was for two months in one group and only 2.5 weeks in another. The Pfizer application states that long-term sequelae of post-vaccination myocarditis/pericarditis in participants 5 to 12 years of age will be studied after the vaccine is authorized for children.
- The children were not examined for mild, asymptomatic myocarditis, which might cause long-term damage, as by checking troponin levels or echocardiograms, or for blood clotting problems, as by checking platelet counts and D-dimers.
- The only FDA-approved product, BioNTech’s Comirnaty (not yet available in the U.S.) is required to do studies on myocarditis lasting 5 years.
Ashish Jha, M.D., dean of the Brown University School of Public Health, hailed the CDC’s vaccine advisory panel for approving the shots for young children.
“These are our nation’s leading physicians and scientists,” he tweeted Tuesday. “Most are also parents. The vote was unanimous because the evidence is so clear.”
As STAT News observed in May, Jha, “for the record,” is not “a virologist, immunologist, or vaccinologist.”
He has appeared, however, as a coronavirus expert on CNN and other networks. In November 2020, Jha, admitted to Sen. Ron Johnson (R), at a Senate committee hearing on the topic of early treatment of COVID, he has never even treated patients with the COVID infection.
Last week, Yale epidemiology professor Harvey Risch, M.D., Ph.D., told Fox News’ Life, Liberty & Levin host Mark Levin if he were making a decision about his own children, “I would homeschool them.”
Honestly, I would organize with other parents to take them out of the school and create homeschooling environments. There’s no choice. Your child’s life is on the line. It’s not a high risk, vaccination is not a high risk, that’s going to kill every child by doing so. However, it’s enough of a risk that, on the average, the benefit is higher for homeschooling than it is for vaccination and being in school. And that’s just the bottom line.
Robert F. Kennedy, Jr., chairman of Children’s Health Defense (CHD), and Meryl Nass, M.D., wrote last week to each member of the FDA’s advisory committee highlighting the most recent research showing children ‘have virtually zero risk of hospitalization and death from the COVID-19 virus,” a press release stated.
“Conversely, according to Pfizer’s own study trial data, the chance of death in children from the Pfizer vaccine is 107 times higher than death due to COVID,” said Brian Hooker, Ph.D., CHD Chief Science Officer.
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