Pfizer Children’s Vaccine At A Glance:
- The FDA, not Pfizer initiated the process for EUA approval of vaccines for children under 5.
- Trials show failed attempt to stimulate hoped-for immune response.
- VRBPAC will meet with data on 2/3 of vaccine doses; final data to come months later.
On Tuesday, Pfizer announced it would submit the data and apply for EAU for its 3-microgram, 2-dose series for children aged 6-months4-years. This age group represents two different categories in the trials: 2-4 years and 6 months-24 months.
The FDA requested the submission and application instead of Pfizer initiating the EUA process. The FDA has called a previously unscheduled meeting for February 15, 2022 of the Vaccines and Related Biological Products Advisory Committee (VRBPAC) to discuss the request for EUA. This, along with other uncommon practices regarding this rolling submission application, raises a few questions.
If at First the Vaccine Fails, Dose Again
In the approval of the first pediatric segment, ages 12-15, and subsequently the 5-11-year-olds immunobridging studies were used, rather than analyzing the actual number of cases reduced by the shots. In blood serum analysis, the neutralizing antibodies that were deemed effective in older cohorts, ages 18 and over, were compared to the response in the younger cohorts. If they were comparable, the vaccines were deemed “effective.”
In December, Pfizer announced the 3-microgram, 2-dose regimen did not produce satisfactory results for the 2-5 year old population, while it did in the 6 month-24 month cohort. Because the 3-microgram dose held a better safety profile, it was decided to remain at this level, but to add a third dose to the regimen, eight weeks following the second dose, for all groups 6-months-5-years of age; even for the 6-month-24-month cohort that showed a favorable antibody response to the 2-dose series.
The data on this third shot is not expected until March.
What is Pfizer Submitting to the FDA for EUA?
With only data from a failed trial available for 2-5-year-olds available, what was submitted to the FDA?
The process is being considered a “rolling submission” of data. At this point the EUA would cover a 2-dose regimen, even without the supporting data for efficacy in the 2-5-year range. As data becomes available in the coming months, Pfizer will submit for further analysis in hopes a third dose will be added to the series for all age cohorts in this request.
Even with the preliminary data to be coming yet the first half of this year, the study is slated to go until May of 2026.
Not All in Support of this Approach
Many are questioning whether this is a good approach. Merck’s former executive director of medical affairs for vaccines, John Grabenstein stated:
“I cannot think of any example ever where the FDA reached a regulatory decision without knowing the data from the end of the trial. I just can’t believe that they would authorize getting started without knowing what the third dose would do.”
Is This EUA Wanted or Needed?
In order for the EUA to be granted, an emergency need has to be established. Many argue that children just don’t have the same negative reactions to COVID that adults–specifically older, less healthy adults have. The rate of cases may be increasing, but those cases remain mostly mild and asymptomatic among children.
Only 31% of parents in this age group are considering getting their children vaccinated right away. Nearly as many, 26% say they definitely will not be getting their child vaccinated while a large majority is in the wait-and-see or only-if-required groups. The question remains: who wants this vaccine, and why is it being rushed through the approval process to the point the FDA initiates the process versus the company that produces it?
Hold the Phone — Doc’s Thoughts:
There is an odd push for this vaccine. If we would slow down and think about it, it’s quite obvious. The push is said to be because of the increased number of cases with omicron. Yet omicron is burning out in most places and those vaccinated aren’t showing benefit. Oddly, Pfizer is also rushing ahead with an omicron specific vaccine.
Let’s talk about that whole idea of the 2-dose failure. What makes us think a third dose will help? What happens if we are just exposing our children to more vaccines that are causing more harm than good? Dr. Paul Thomas has shown how the increase in childhood vaccines has multiplied chronic illness in his patients. Watch this episode of A Different Perspective to hear from a pediatrician who has first hand seen thousands of children in his practice and respects the wishes of parents in how they choose to vaccinate their children or not.
Timing in Question
There are several factors that raise questions with the timing of this situation and process. The FDA has recently said that it would take nearly 55 years and then upped the ante to 75 years to review the data for public release. Yet, they reviewed it in 108 days in order to approve it for EUA. The data is only first being submitted for this EUA now for two different cohorts, one of which we know has failed. They will have less than two weeks to review that data to meet the February 15th deadline for the VRBPAC meeting, after which there will likely be a vote. I wonder if we’ll hear another heinous quote like this one from the meeting for the 5-11-year-olds by committee member, Dr. Eric Rubin:
“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 are they defining as “effective”? With this bridging study with the third dose show any benefit? Recently, studies have shown that there is no benefit to this vaccine among variants like omicron, in fact, it raises the risk of becoming infected with COVID! So, if this rolling submission is to add data as it becomes available, how much data will be required in the end? Will we see if there is truly any benefit, or if it is simply a short-lived antibody spike that wanes quickly?
Even hopeful, pro-vaccine advocates are raising questions. Infectious disease epidemiologist with UTHealth School of Public Health in Dallas, Katelyn Jetelina is asking questions too:
Chief among them: “Did they move the goalposts?” She noted that researchers could change what they are examining in the trial — looking at T cell responses or cases and hospitalizations, for instance, instead of neutralizing antibodies.
If regulators are looking at real-world numbers on cases and hospitalizations among the vaccinated and unvaccinated children, she asked, “Do they have enough data?” The clinical trial wasn’t designed to examine these questions, she noted, and there might not be enough participants in the trial to understand the vaccines’ efficacy in those settings.
So the question remains, what data are they analyzing, and how are they going to present it to meet their goal? With Pfizer having paid out some of the largest medical fraud lawsuits ever, these are valid questions to be addressed.
The Ugly “Benefit” of Approving Vaccines for Children
In 1986 vaccine manufacturers were placed in a special category of the marketplace in which they couldn’t be held liable for any injury caused to children from their products. This legal shield is put into place for all age ranges once a vaccine is added to the childhood schedule.
One other question I’d bring up to consider. Which age range, in all of life, receives the most vaccines? Childhood, primarily before the age of five. These new, experimental, mRNA vaccines have never been tested alongside other vaccines; in fact, no vaccine has. Even the WHO admits it hasn’t done those studies. What are the risks involved in administering this shot alongside other childhood vaccines that have already been proven to increase risks of illness and injury? We don’t know. And we won’t know for several years.
Remember, you have the right to informed consent and whether to vaccinate your children. It is up to you to educate yourself on that responsibility and freedom for your child’s safety.
If your goal is to protect your child and boost their immune response, the first thing to do is to test where they are, and how to best support their unique health needs. If we focus more on the host than on the germ, we will have better results. Contact a Wellness Way clinic near you to learn how to support your immune system as well as your child’s.