At A Glance:
- Pfizer press release states vaccine elicits same immune response as older cohorts.
- Study 2/3 complete 8 weeks after FDA asks for participant numbers to be increased to 3,000.
- No COVID case numbers released from the study; not enough cases to determine efficacy.
Pfizer’s vaccine is in the news again this morning. Today the vaccine manufacturer released a press release stating:
the vaccine was safe, well tolerated and showed robust neutralizing antibody responses.1
Pfizer and BioNTech plan to submit data to the FDA and other regulatory agencies as soon as possible for review and consideration for EUA approval.1
Pfizer Study Details
The data is from Phase 2/3 of the study and suggests the vaccines show the same level of immune response as the 16- to 25-year-old cohort and used a dose one-third the strength. This comparison of response is called a “bridging” study as it compares to what was considered effective for the older cohort’s response. According to the press release on Pfizer’s website:
The data summarized from this Phase 2/3 study, which is enrolling children 6 months to 11 years of age, was for 2,268participants who were 5 to 11 years of age and received a 10 µg dose level in a two-dose regimen. In the trial, the SARS-CoV-2–neutralizing antibody geometric mean titer (GMT) was 1,197.6 (95% confidence interval [CI, 1106.1, 1296.6]), demonstrating strong immune response in this cohort of children one month after the second dose. This compares well (was non-inferior) to the GMT of 1146.5 (95% CI: 1045.5, 1257.2) from participants ages 16 to 25 years old, used as the control group for this analysis and who were administered a two-dose regimen of 30 µg. Further, the COVID-19 vaccine was well tolerated, with side effects generally comparable to those observed in participants 16 to 25 years of age.1
Using this bridging study, we don’t yet have numbers or data to suggest what the efficacy is in reducing actual cases.
A Pfizer spokesperson said the companies may later disclose vaccine efficacy from the trial but there had not been enough cases of COVID-19 yet among the participants to make that determination.2
The clinical trial page indicates the data measured titers seven days after the second dose.3 The trial enrolled children whether or not they had been infected with COVID in the past.4 Pfizer plans to submit their data for peer review following the completion of the three-phase study which will include boosters.4 No results have been posted on the study site, since the study is ongoing until September 2023.3
FDA Requested Pfizer to Expand Study for Youngsters
At the end of July, just eight weeks ago, the FDA had requested the number of participants for both Moderna and Pfizer’s trials be increased to 3,000 for this age group.5,6 According to the CDC, most people aren’t considered fully vaccinated until about week six to eight, typically two weeks after the second dose.7
The study wasn’t designed with enough participants to recognize some of the side effects seen in the 12 and up age groups, such as myocarditis and pericarditis. This is typically seen sometime after the second dose and mostly in young men.8
Pfizer’s Gruber said once the vaccine is authorized for younger children, they’ll be carefully monitored for rare risks just like everyone else.8
International Childhood Vaccinations
Other countries have begun to vaccinate much younger children already. Cuba launched their campaign to vaccinate children ages two through ten last Thursday. As one of the first countries to begin vaccinating children so young, the communist country had just started vaccinating 11–18-year-olds within recent weeks. Many school age children will receive their doses at schools. Cuba is using a vaccine developed in their own country.9
In China, two vaccines have received emergency approval for children as young as three, however they have only been used in those ages 12-17. According to the Ministry of Education, 91 percent of adolescents aged 12-17 have been vaccinated.
Jin Dongyan, a virologist from the University of Hong Kong, stated:
Despite the lack of clear data on how well the Chinese-made vaccines prevent transmission, the jabs would “at least” reduce it, Jin said.10
Considering the zero-tolerance policy and lockdowns, Jin said the authorities still lacked confidence about the protection levels of the vaccine, especially against the Delta variant.10
Pfizer has been testing its vaccine on children two years and older. The company has indicated data on children two to five years could arrive soon after September. Information for the six-month to two-year-old group could come in October or November.11
On Sunday, Scott Gottlieb, former head of the FDA, was questioned in regard to requirements for school aged children:
“I think you’re going to see more local school districts and governors make those recommendations,” he said. “Eventually [Advisory Committee on Immunization Practices] is going to make a recommendation about whether this should be included in the childhood immunization schedule. My guess is they’re waiting for more of the vaccines to be fully licensed to make that kind of a recommendation. But I would expect this eventually to be required as part of the childhood immunization schedule.”11
According to the Pfizer press release:
There is no information on the use of the vaccine with other vaccines.4
Hold the Phone — Doc’s Thoughts:
Let’s back this up for a minute. They are applying for EUA for the vaccine in this new age bracket. According to the FDA, products need to meet these specific requirements to be EUA approved:
- Serious or life-threatening disease or condition
- Evidence of effectiveness
- Risk-benefit analysis
- No alternatives12
How many of these requirements does this vaccine meet for children in this age bracket? Exactly 0. The only childhood deaths with COVID include serious comorbidities. The effectiveness was measured as a comparison to titers to another age group. They haven’t released the numbers of cases and the efficacy. Risk-benefit? What is the risk of COVID for these kids? Slim to none. What is the risk of the vaccine? Unknown to significant. Similar to the teens and young adults. Have you checked out VAERS? Have you seen the numbers that are skyrocketing? No alternatives. I’ll hit on that one in a minute.
Analyzing the Study
Let’s look at their study criteria. We have no real numbers here as to how many cases of COVID were detected in either the vaccinated or placebo group. There weren’t enough to compare…because this isn’t serious for kids! They enrolled kids who may or may not have recovered from COVID. How many of those kiddos had natural immunity? That could be convenient to the numbers. They were so careless in their criteria that they may be actually analyzing natural immunity. This isn’t science, and certainly isn’t worth following!
I’m also curious as to what happened to the other 732 kids the FDA requested to be enrolled to get to a study of 3,000. If they were enrolled and vaccinated right away, they would just have been considered fully vaccinated and titer-checked within days of the press release. The timing, size, and procedures of this study are very concerning to say the least.
Did you notice that Pfizer indicated that there isn’t any information on how this vaccine interacts with other vaccines given at the same time? How does the childhood vaccination schedule work? As many as possible at a time. How many parents are going to know this and be vigilant in ensuring this schedule isn’t tampered with?
Speaking of the childhood vaccination schedule, once it is included on that schedule, all legal liability is gone. There’s a rush here for a reason. Not a single study is complete. Not one. The clinical trials aren’t completed until late 2022–2024. Once this vaccine makes it on the childhood schedule, Pfizer has 0 legal liability. What other industry can get away with this?
Let’s go back to that last bullet point for EUA. No alternatives. What about a healthy immune response? What about supporting your child’s body through nourishing whole foods, low stress, exercise, sunshine, fresh air, and nutritional supplements when needed? People aren’t ill for a lack of drugs. They’re ill for lack of attention, information, and discipline to what their bodies need.