White House Plans for Vaccinating Children At A Glance:
- White House rushes ahead to reveal plans to vaccinate children ages 5-11.
- FDA scheduled to review data October 26. May lead to EUA approval.
- CDC to meet November 2-3 to discuss possible recommendations following EUA approval.
- Data submitted is for a bridging study, not actual cases reduced.
The White House has announced its plans to prepare for the vaccination of 28 million children. The plan is to go into effect as soon as the FDA and CDC give their approvals and recommendations.
Just two weeks ago, Pfizer submitted data and requested EUA approval for its COVID-19 vaccine for children ages 5-11. The vaccine is one-third as potent as the adult version for ages 12 and over and follows the same 2-dose regimen three weeks apart. This formula was created for the initial variant of the SARS-CoV-2 virus.
Amidst the confusing endorsement of boosters before approvals and recommendations were granted, the White House indicated this was just preparation. Their goal is to have the vaccines in over 25,000 pediatrician’s offices and other public clinics within a week of approval. FEMA will assist in instituting school and community-based clinics that will be funded and supported.1
Near the end of July, the FDA called for both Pfizer and Moderna to expand their studies to include 3,000 children each. The data that is reported on reflects 2,268 participants. At the time of publishing, the results of the remaining 732 children have not been found. If the study did immediately enroll more children at that time, those children wouldn’t have been considered fully vaccinated until just two to three weeks before data was submitted for review.
The study for efficacy did not reflect actual cases of COVID that was reduced by vaccination as there weren’t enough cases in either the control or test group to consider. Instead, a “bridging” study was done. The researchers relied on blood serum tests to indicate the antibody levels found in older cohorts and determined that since they were similar, the shot had been effective. Some question the difference between a child’s immune system and an adult’s; children are not mini-adults. Can these tests be sufficient in determining safety and efficacy?
Next Steps to Consider Before White House Plan
The FDA’s VRBAC committee is scheduled to meet October 26 to discuss its approval. The website is open to submit a public comment for the committee’s consideration. Once the FDA gives its stamp of approval, the CDC’s ACIP committee will determine its recommendations as to how and when the vaccines are used. The CDC is scheduled to meet November 2-3.
The Biden administration is wasting no time and, it appears, anticipating EUA approval and CDC recommendations:
Within hours of formal approval, which is expected after the Food and Drug Administration signs off and a Centers for Disease Control and Prevention advisory panel meets on Nov. 2-3, millions of doses will begin going out to providers across the country, along with the smaller needles needed for injecting young children.
Within days of that, the vaccine will be ready to go into arms on a wide scale.1
The White House indicated 15 million doses would be prepared and ready to ship the first week.
Around the World
Vaccinating young kids has not been done on a large scale around the world. Israel is also awaiting FDA approval for this new age group.
Cuba will begin vaccinating children as young as 2 against the coronavirus this week, making it the only country so far to immunize children that young.
Chile has begun vaccinating children 6 and older. China and the United Arab Emirates are now vaccinating children as young as 3.2
With the concerns of Nordic countries with Moderna’s mRA vaccines, we will see how they move forward with vaccinating children. Singapore3, Malaysia4, and Denmark5 have decided it is time to abandon the need for strict COVID protocols and learn how to live with COVID in the endemic phase.
Hold the Phone — Doc’s Thoughts:
We knew this would be coming. The legal shield that covers a vaccine goes into effect as soon as it hits the childhood vaccination schedule. Then, whether it’s child or adult, there is no legal consequences for the vaccine manufacturer directly (in this case, Pfizer).
There are several things for parents to consider, and that all doctors should as well. Think about this: remember when we talked about kids being asymptomatic carriers of coronavirus or SARS-CoV-2? That would indicate those kids were now carrying antibodies and T-cells and B-cells that would provide natural immunity. Why would those kids need to be vaccinated? They wouldn’t. How many people who’ve had chicken pox or measles run in for their vaccine for the same disease? None! It’s not necessary, and at times could be dangerous! Pfizer, Moderna, and J&J haven’t released the information about what happens to a person’s immune response or if they are at an increased risk for adverse reactions if they’ve recovered and then get vaccinated. Yet, they’re gearing up to vaccinate as many kids as possible as fast as they can. This isn’t following any science at all!
Where are the other 738 kids that were required by the FDA to be a part of the study? Why isn’t there a report on them? How could this be considered long-term data considering the timing of the study expansion and the time Pfizer turned in its data? I think these questions need to be answered.
These studies are so short. They aren’t scheduled for completion for another year or two according to the clinical trials pages. Let’s consider the bridging study. Children are not simply mini adults. Their immune response is quite different. They are growing, adapting to things they come into contact with daily. We can’t apply the same serum antibody level as a response as effective or safe. Again, no science followed. Just some fancy number work that would make any accountant look questionable. Considering 15 million doses are ready to go within hours of approval, it sounds like it might be considered a done deal before the questionable data has been reviewed. That’s a large investment in a lot of product that hasn’t been approved yet and won’t be for weeks.
Just two weeks ago, we shared a story of a family whose two youngsters were accidently vaccinated with adult doses of the COVID vaccines when they went in for the annual flu shots. The youngsters are now facing heart issues. What about the confirmed cases of young people with myocarditis, numerous neurological concerns, Guillain-Barre, heart attacks, and other concerns all over the world? What about the experts who’ve spoken out and petitioned the FDA to slow down their approval? Even the WHO has weighed in on vaccinating children and stated it isn’t necessary.
Parents, take note. There is a lot written into a school’s policies you may not be aware of. For instance, Governor Newsom has already mandated that children in schools will be vaccinated as soon as the shot has full approval.6 In California, age 12 is considered old enough to consent.7 With all of the coercion we’ve seen for adults, think about what it will be like for teens and kids! California State Superintendent, Tony Thurmond, has mentioned he knows lawmakers are working to reduce that age of consent.8 Be aware, check your school’s policies, and be prepared to get vocal or act if you need to protect your child.
All for a population with a 0.00%-0.03% chance of death from COVID according to the American Academy of Pediatrics.9 Supporting their innate immune system and helping them to develop a robust adaptive immunity is key to children’s health. That doesn’t include using a vaccine for a variant that isn’t dominant or of much concern anymore!
Parents, know the risk/benefit of the vaccine and COVID. Study and educate yourself. Likely this vaccine won’t have a product insert available until it becomes fully approved. Your information will be limited until then, but you must do all you can so that you can make an informed decision. Informed consent is crucial to a free nation. It’s crucial to the health and wellbeing of yourself and your children.
1AP News: White House details plans to vaccinate 28M children age 5-11
2New York Times: Cuba will begin giving shots to children as young as 2.
3WSJ: From Pandemic to Endemic, Singapore Creates Model for Living With Covid-19
4CNBC: Malaysia will start treating Covid as ‘endemic’ around end-October, trade minister says
5Science.org: Will the pandemic fade into an ordinary disease like the flu? The world is watching Denmark for clues
6Office of Governor Gavin Newsom: California Becomes First State in Nation to Announce COVID-19 Vaccine Requirements for Schools
7Vaxteen: As a minor in California, can you consent to vaccines?
8ABC 10: California State Superintendent: Lawmakers discussing reducing age of consent for vaccination
9American Academy of Pediatrics: Children and COVID-19: State-Level Data Report