CDC on COVID Shot for Children At A Glance:
- CDC ACIP votes 14-0 to recommend COVID vaccine for children ages 5-11.
- New ingredient added to formulation.
- 37,000 public comments submitted from concerned citizens, doctors, and experts.
Yesterday, the CDC ACIP committee met to discuss recommendations for the COVID shot for children in the 5-11 age group. With a vote of 14-0, the committee voted to recommend the vaccine. According to the voting question, the vaccine would be approved for everyone over the age of five years, regardless of underlying conditions or whether they had recovered from a previous COVID infection. The supporting statement also indicated an unwavering support with the vote cast by each member.1
The many scientific inconsistencies
As with the Comirnaty approval in September and the FDA’s allowance for the EUA approved Pfizer-BioNTech vaccine to be used interchangeably, there are many red flags on this EUA recommendation.
We’ve been told numerous times that this is the same formulation as the adult and teen shot. However, in documentation provided to the FDA for EUA approval, a change in ingredients was noted.
To provide a vaccine with an improved stability profile, the Pfizer-BioNTech COVID-19 Vaccine for use in children 5-11 years of age uses tromethamine (Tris) buffer instead of the phosphate buffered saline (PBS) as used in the previous formulation and excludes sodium chloride and potassium chloride.2
During the discussion of “new and different formulations,” the only matters discussed were the dilution and volume of the injection as well as the smaller needles to be used. At the time of publication, we are still researching which version of the vaccine was used in the clinical trials and when the formulation changed.
Questionable New Ingredient
Tromethamine has several concerning side effects and is directed to be used with caution in children. According to the page specifically for Tromethamine on drugs.com:
WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:
- Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
- Signs of low blood sugar like dizziness, headache, feeling sleepy, feeling weak, shaking, a fast heartbeat, confusion, hunger, or sweating.
- Signs of high potassium levels like a heartbeat that does not feel normal; feeling confused; feeling weak, lightheaded, or dizzy; feeling like passing out; numbness or tingling; or shortness of breath.
- Trouble breathing, slow breathing, or shallow breathing.
- Shortness of breath, a big weight gain, or swelling in the arms or legs.
- This medicine may cause tissue damage if the drug leaks from the vein. Tell your nurse if you have any redness, burning, pain, swelling, blisters, skin sores, or leaking of fluid where the drug is going into your body.3
Other concerns were raised regarding dosing this shot with other childhood vaccines. The recommendation has been that while it hadn’t been tested with other vaccines given at the same time, as long as the injection site is separated by at least one inch, this practice would be approved. Especially since flu shot season is also in full swing, the committee wanted to be sure to approve this measure as well.
Parents and Public Comments
Only 30 minutes was slotted for public comment from concerned citizens and experts.4 Over 37,000 comments were submitted online.
Many concerned citizens spoke out with how trust has been “shattered” with the public health agencies like the FDA and CDC. The parents and doctors who’ve done their research pointed out the real data in terms of transmission, infection, and risk of serious illness do not support the data collected and reported.
Concerns regarding how the study was done, specifically through immunobridging, short follow-up times, the vaccination of the control group as soon as possible, and intentionally undersized groups unable to detect adverse events were raised, but not discussed. With only 2 weeks of follow-up for some participants and up to 2 months for others, people were concerned that vaccine-induced immunity was inferred while the natural immunity nearly 42 percent of the childhood population is believed to have was neglected. These commenters told the committee, “science does not support” the need for this vaccine and urged them to stand up and “be brave,” not to just vote “yes.”
The FDA “gold-standard” was called into question by experts as they reviewed the concerns raised by the FDA during their meeting last week. While these concerns went on record, the committee went on to vote 17-0 to approve the vaccine for use in youngsters, even as one voting member stated just before the vote:
“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 how we found out about rare complications of other vaccines.”
What’s Next?
Rochelle Walensky signed off on the recommendation for children ages 5-11 to start receiving the shot. Beginning Wednesday, 28 million children are now eligible to receive the vaccine.5,6 The side effects are said to be similar to those of adults and teens.
Hold the Phone — Doc’s Thoughts:
Eleven months ago, we didn’t have a vaccine approved for people in the highest risk population. Today we are starting to inject our most vulnerable population. Children who can’t speak up for themselves. Children who don’t have a great risk from COVID. Children who have been shown to recover quickly after often asymptomatic cases. Children, 42 percent of whom already have robust natural immunity.
Listening to the CDC’s ACIP meeting, it seems as if they didn’t listen to the concerns of the FDA. The members of the FDA’s VRBPAC last week discussed how they thought the vaccine should be available, but not necessarily all children would need it. But they felt that decision was left to the CDC ACIP meeting. Yesterday, ACIP glossed over that concern and raced ahead with an all or nothing vote. Well, we see how that went. It seems as though there was a lot of abdicating the responsibility of watching over the children in favor of pushing the vote through “to make it available for all.” Pushing would also be a logical assessment since several sessions were cut short on the question period due to timing. How were the voting members of the committee supposed to make an informed decision if they couldn’t ask questions?
Looking for Science to Follow
Interestingly, the CDC ACIP said that testing for natural antibodies wouldn’t be an option because there are no FDA approved tests. Yet, we are relying on the faulty, recalled, inaccurate, and not FDA approved PCR tests to tell us whether the child has COVID or not? That doesn’t seem to be following logic, much less science.
What about the fact these youngsters only had 2 months-2 weeks of follow-ups post vaccination? Or the idea that while there are several studies that show the spike protein travels to other areas of the body in as few as 15 minutes, the shot can be given at the same time as another childhood vaccine as long as the injection site is separated by one inch. One inch. Somehow for something that is able to flow through the body so fast, I don’t see how one inch is supposed to be considered a safety measure. And again, there were no tests to even attempt the one-inch separation. That means the first child to receive this in their pediatrician’s office or the local pharmacy will unknowingly be the trial participants.
Speaking of that traveling spike protein…why again are we using a formulation for a strain that is no longer around? Now that doesn’t seem to be following science either. What about the ever-changing variants? We’re going to be looking at a flu-shot situation here where every year it’s a new formulation. Unfortunately, this year they’re starting out with last year’s formulation.
Let’s look at what should be one of the first questions we should be asking. Does it stop transmission? According to the CDC, no. Who are we protecting? During the public comments time, one of the speakers nailed it. We shouldn’t be using children “as a shield” with a failed vaccine. This is unethical and despicable.
You want to know what else is despicable?
- They’re not talking about this new formulation with the questionable ingredients.
- They’re not considering children with any underlying conditions while the trials were only conducted on healthy kids.
- The science used was theoretical, not actual.
- The statement fed to us is the side effects for kids are “similar to those of adults and teens.” And yet the 837,593 reports to VAERS through October 22, 2021 didn’t seem to raise any red flags.
- When asked about what the message is for concerned parents regarding myo/pericarditis, the suggestion was to “amplify the appropriate message.” Meaning, talk about the “benefits” of the vaccine.
No Time for the Hard Questions and Comments
There was only 30 minutes for so many concerned citizens, doctors, and experts to speak through the public comment session. Yet, there was a solid 40 minutes of soft-ball questions and cheerleading immediately before the vote. The vote for a vaccine in which only 34% of parents were sure they were going to get for their child.
During that 40-minute session, one member was quick to make sure listeners knew their vote wasn’t linked to mandates. Although we’ve seen that story before. Especially with governors already promising mandates for school children. Oddly, there was also the mention of the trial for children as young as six months. The facilitator was quick to change the subject from that comment.
What’s Next?
Today, in the November 3rd ACIP meeting, the childhood vaccination schedule was discussed and what an update for 2022 should look like. I guess we’ll get to see that information coming out soon as well. Any guesses on which vaccine will likely be added to that schedule and avoid all legal consequences?
Parents, inform yourselves. Study. How serious of a risk is COVID for your children? What are their risk factors? I know that with no vaccine insert under EUA, that may be tricky. Maybe that should be a consideration. You have a choice. You need to stand up and be the voice for your children.
1CDC: ACIP meeting November 2-3, 2021 recording
2FDA: Vaccines and Related Biological Products Advisory Committee Meeting October 26, 2021
5CDC: CDC Recommends Pediatric COVID-19 Vaccine for Children 5 to 11 Years
6MSN: A Covid-19 vaccine is now available for 5-11-year-olds in the US
