FDA Making COVID Vax Decision Based on a Study of 10

< Please Share This

by Dr. Joseph Mercola


  • Pfizer announced preliminary data from Phase 2/3 trials in children 6 months to under 5 years would be submitted to the FDA for emergency use authorization; the data are based on 1,678 children and 10 who got sick, which Pfizer claims is an 80.3% effectiveness rate
  • Even vaccine advocate Dr. Paul Offit is dismayed at the number from which Pfizer is drawing conclusions. Just days before, New York announced the vaccine efficacy in children 5 to 11 years fell to 12% within two months after vaccination
  • Despite 48,833 records in VAERS of adverse events in children under 18 from the vaccine, Pfizer says the shot for 6 months to under 5 years old has “a safety profile similar to placebo”
  • Moderna announced their submission to the FDA for children younger than 5 years has a 37% to 51% effectiveness, which is close to the effectiveness of the flu vaccine
  • Data from the CDC show that as the months roll by, more Americans are not taking or completing the shots to meet CDC criteria to be fully vaccinated. The push to vaccinate children may likely be related to the pharmaceutical industry’s goal to mandate the vaccine under full legal immunity from damages

May 23, 2022, Pfizer-BioNTech1 announced preliminary results from their Phase 2/3 trial evaluating a three-dose vaccine schedule for children 6 months to under 5 years of age would be submitted to the FDA for emergency use authorization (EUA).

Many in mainstream media are hailing this development as important to children’s health, writing, “many parents of these very young children have been really anxious to get their kids vaccinated”2 and “Parents hoping to get their youngest children vaccinated against COVID-19 got some encouraging news Monday.”3

Yet, despite the continued push by mainstream media to encourage parents to vaccinate the very young, the Vaccine Monitor Survey from KFF4 found only 18% of parents with children under age 5 are planning to get their child vaccinated immediately.

Parents Expressing Concern for Children’s Safety

KFF reports that a larger number — 38% — are planning to wait to see the side effects the vaccine may have in younger children before making a decision and 27% have indicated they will definitely not have their child injected. Importantly, the survey also found that “Just over half of parents of children in this age range say they do not have enough information about the vaccines’ safety and effectiveness for children under age 5.”5

While information about vaccine injuries from the COVID-19 jab has been difficult to find on mainstream media, it is apparent from these numbers that many parents are concerned about their children’s safety and want more information before they’re willing to risk their health.

A paper published December 15, 2021, in JAMA6 referenced the previous survey by KFF,7 which found 27% of parents of children 5 to 11 years old were interested in giving their children the jab, which is a 9% drop from the survey in 2022. The paper8 sought to smooth the waters with parents who were hesitant to vaccinate their children by attributing fear to misinformation and a misunderstanding of what “EUA” means.

It is interesting to note that the author of the paper has received research grants from Pfizer and Moderna, and also serves on the advisory boards for Johnson & Johnson, Pfizer, and Merck.

The JAMA paper states the KFF survey found the primary reason parents were concerned were reasonably the “long-term and serious adverse effects, including future fertility issues.”9 According to the author, these concerns were addressed and disproven based on just one year’s worth of data.

Pfizer’s 80.3% Effectiveness Is Based on 10 Children

Pfizer’s announcement that they were seeking an EUA from the FDA for children 6 months to under 5 years is “based on 10 symptomatic COVID-19 cases identified from seven days after the third dose and accrued as of April 29, 2022.”10

While the study included 1,678 children who received three doses of the formulation, the stated 80.3% efficacy in children is based on just 10 cases. The number is so low that even outspoken vaccine advocate Dr. Paul Offit — co-inventor of a rotavirus vaccine11 — expressed dismay at the number, saying:12

“I mean, 10 children — you’re talking about 10 children. It’s a small number, so it’s really hard to comment or this as something more general since you don’t know because the numbers are so small.”

Pfizer announced these results after delaying the EUA application process to gather more data.13 Initially, children in the study did not produce a significant immune response after two doses, so the company delayed the request until they could give the children a third dose.

The trial reportedly was evaluating “the safety, tolerability and immunogenicity of three doses of the Pfizer-BioNTech COVID-19 Vaccine.”14 Curiously, Pfizer’s claim of 80.3% effectiveness in children comes on the heels of a New York state Department of Health study that showed vaccine efficacy in children ages 5 to 11 years old fell to 12% in two months after vaccination.15

In other words, 7 out of 8 kids who were vaccinated had no benefit from the vaccine two months after receiving the jab. The data taken from 365,502 children showed a striking difference between children ages 11 and 12. The effectiveness against infection in 12 year olds was 67%, but in 11-year-old children, it dropped to 11%.16

The data from the U.S. were consistent with a report from Britain17 that showed effectiveness against symptomatic infection dropped 22.6% after two months in adolescents aged 16 to 17 years.

Interestingly, the Pfizer press release published May 23, 2022, mentioned the word “safety” 22 times while discussing the COVID-19 vaccine for children, and wrote the shot was “well-tolerated among 1,678 children under 5 years of age with a safety profile similar to placebo.”18 The vaccine being used on the younger children is one-tenth the strength given to adults.19

Yet, the Vaccine Adverse Event Reporting System (VAERS)20 recorded 1,878 adverse events in children aged 5 and 10,029 in children aged 6 to 11 from data published as of May 13, 2022.

According to the American Academy of Pediatrics,21 as of May 2022, 35% of 5- to 11-year-olds received one dose and only 28% received both doses of the vaccine. If you extrapolate the adverse event numbers using 35% of the pediatric population that received at least one dose, there would have been 34,020 adverse events if 100% of children in the U.S. aged 5 to 11 years had been given the shot.

It seems highly unlikely that 11,907 adverse events in children 5 to 11 reported to VAERS after at least one injection would have resulted in only “mild or moderate”22 events in children aged 6 months to under 5 years, or that the shot could have “a safety profile similar to placebo.”

articles.mercola.com < continue reading & to watch video