Booster for 12 and Up At A Glance:
- FDA approves booster for 12 years and up without advisory committee weighing in.
- CDC recommends booster ahead of advisory committee meeting.
- 3-dose standard regimen in trials for children because of failed immune response.
The last few months have been a whirlwind of vaccine recommendations, boosters, mandates, and questionable approvals. On Monday, the FDA authorized use of the Pfizer inoculation as a booster for 12-15-year-olds. The agency simultaneously shortened the time between the two-dose primary series and the booster from six months to five. All of this was done without the reconvening of the VRBPAC (Vaccine and Related Biological Products Advisory Committee). In September, the committee voted to restrict boosters for those 65 years and over and those at risk of severe illness. At the time, the committee cited lack of evidence in the risk/benefit of the booster in younger individuals. In September, committee member, Paul Offit, who is also the director of the Vaccine Education Center at Children’s Hospital of Philadelphia stated:
“We’re being asked to approve this as a three-dose vaccine for people 16 years of age and older, without any clear evidence if the third dose for a younger person when compared to an elderly person is of value.”
Signals of discord were evident within the FDA when Marion Gruber, director of the FDA’s Office of Vaccines Research and Reviews, and her deputy director, Phil Krause, announced they’d step down. The announcement came just after Joe Biden publicly announced the push for boosters for all Americans to be available mid-September before any committee meetings. Now approval for the boosters was granted without consulting the advisory board.
Dr. Marty Makary, chief of the Johns Hopkins Islet Transplant Center took aim on Twitter this past Saturday ahead of the announcement of the approval:
Dear President Biden,
FDA is bypassing it’s scientific advisors to authorize boosters for all kids 12-15 next week. This is unconscionable–undermines the integrity of the FDA’s standard process! Please require FDA to put this authoriz before the VRBPAC advisory comm for a vote!
He followed up with:
It is a slap in the face to science for @US_FDA to circumvent the standard convening of the expert advisory board… FDA is quietly doing this because their experts previously voted it down, voicing concerns about medical harms. @POTUS @DrWoodcockFDA
CDC Follows Up with Booster Recommendation
On Tuesday, January 4, the CDC announced:
Today, CDC is updating our recommendation for when many people can receive a booster shot, shortening the interval from 6 months to 5 months for people who received the Pfizer-BioNTech COVID-19 Vaccine. This means that people can now receive an mRNA booster shot 5 months after completing their Pfizer-BioNTech primary series. The booster interval recommendation for people who received the J&J vaccine (2 months) or the Moderna vaccine (6 months), has not changed.
Additionally, consistent with our prior recommendation for adults, CDC is recommending that moderately or severely immunocompromised 5–11-year-olds receive an additional primary dose of vaccine 28 days after their second shot. At this time, only the Pfizer-BioNTech COVID-19 vaccine is authorized and recommended for children aged 5-11.
CDC Director, Rochelle Walnesky, issued the statement:
If you or your children are eligible for a third dose or a booster, please go out and get one as soon as you can. Additionally, FDA took action this week to authorize boosters for 12-15 year olds – and I look forward to ACIP meeting on Wednesday to discuss this issue.
The ACIP (Advisory Committee on Immunization Practices) is set to meet on Wednesday, following the recommendation. Typically, the ACIP recommendation comes as an advisory statement before the CDC’s official recommendation.
Here Comes Omicron, Vaccinated, Booster, or Not
The FDA and CDC cite the increase in COVID cases during the omicron surge as a driving force for the vaccine boosters. Omicron has shown it’s no respecter of vaccine status.
In the December 17, 2021 Morbidity and Mortality Weekly Report, the case for the vaccinated and omicron seemed bleak:
Among these cases of COVID-19 attributed to the Omicron variant, 34 (79%) occurred in persons who completed the primary series of an FDA-authorized or approved COVID-19 vaccine ≥14 days before symptom onset or receipt of a positive SARS-CoV-2 test result, including 14 who had received an additional or booster dose; five of the 14 persons had received the additional dose <14 days before symptom onset. Six (14%) persons had a documented previous SARS-CoV-2 infection. The most commonly reported symptoms were cough, fatigue, and congestion or runny nose. One vaccinated patient was hospitalized for 2 days, and no deaths have been reported to date.
Just a few weeks ago, Pfizer announced it had been developing a new omicron specific vaccine.
The good news is that the omicron peak has seemed to already have passed in just over a month in South Africa with fewer severe cases.
Hold the Phone — Doc’s Thoughts:
Once again, the line “following the science” doesn’t seem to mean the same to everyone. These agencies and other policy makers claim to be following science, but when you actually read the data and the studies, you’ll see that the science doesn’t actually support what they are saying. For example, a statement from the FDA:
In making its decision, the FDA says it “determined that the protective health benefits of a single booster dose of the Pfizer-BioNTech COVID-19 Vaccine to provide continued protection against COVID-19 and the associated serious consequences that can occur including hospitalization and death, outweigh the potential risks in individuals 12 through 15 years of age.”
Yet, we see so few serious cases of COVID in kids, and there haven’t been any studies in the safety of the boosters! However, we see so many adverse events that have been overlooked. Cases of myocarditis, nervous system disorders, and other injuries among quite young, healthy people. Even Tony Fauci has admitted that it’s possible the shot could be making people sicker than helping. And somehow, we are still ignoring over 140 studies on natural immunity, which many of these kids already have! I’m not sure how many people actually still believe these agencies and “experts” are following science anymore.
When Pfizer submitted data for the 5-11-year-olds, they did it with a “bridging” study instead of actual data from real trials. A group of Canadian doctors with the help of an expert in the mRNA technology, posted a video explaining the trials in easy-to-understand detail.
On December 17, 2021, Pfizer indicated it wasn’t getting the immune response it had hoped for in children ages 2-5 years. Even though it appears, by the same criteria, 6-month-olds-24-month-olds were demonstrating the same response, deemed effective by the bridging study in older populations. The decision to add a third shot to the regimen for 2-5-year-olds was due to the lower immune response. However, it seems that is also being extended to the youngest population as well; even though the immune response was demonstrated. The press release from Pfizer BioNTech states:
While the study is ongoing and remains blinded, a pre-specified immunogenicity analysis was conducted on a subset of the study population one month following the second dose. Compared to the 16- to 25-year-old population in which high efficacy was demonstrated, non-inferiority was met for the 6- to 24-month-old population but not for the 2- to under 5-year-old population in this analysis. No safety concerns were identified and the 3 µg dose demonstrated a favorable safety profile in children 6 months to under 5 years of age.
The decision to evaluate a third dose of 3 µg for children 6 months to under 5 years of age reflects the companies’ commitment to carefully select the right dose to maximize the risk-benefit profile. If the three-dose study is successful, Pfizer and BioNTech expect to submit data to regulators to support an Emergency Use Authorization (EUA) for children 6 months to under 5 years of age in the first half of 2022.
All of this rush to grant EUA approval for the youngest children and boosters for even more ages comes just months after the first VRBPAC committee stated they didn’t believe the vaccine was needed for all children in the first place. In fact, watching the almost 9-hour long meeting reveals the concerns many people, even the voting members had. In the end they decided they had to vote for it to be approved, because as Dr. Eric Rubin stated:
“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.”
Dr. A Fuller also stated a similar sentiment:
“If we don’t make it available, we’ll never know what will happen with a larger group of people.”
All of these reactions were in regard to the initial two-dose series for children ages 5-11. Now we have boosters for ages 12 and up. Can you follow the path? What do you think is coming next? All of this when we have omicron circulating which many doctors and experts have suggested could be a natural immune booster and help with protection better than a vaccine ever could. Still, policy is being dictated by corporate scientists, not science and the FDA and CDC continue to withhold data from the public.
Support Your Child’s Immune Response
If you have any questions about your child’s immune response or yours, contact a Wellness Way clinic for more information. We can help assess your child’s risk for severe illness and guide you through a process of supporting them. In order to make an informed decision, you need to have all of the answers from risk-benefit of the shots to the risk-benefit of your child’s unique health condition. We do health differently, we don’t guess.