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Groups in Canada and Australia are urging public health officials to reconsider rolling out COVID-19 vaccines for young children, following the authorization earlier this month in both countries of Moderna’s COVID-19 vaccine for children ages 6 months to 5 years.

The Australian Vaccine-risks Network (AVN) on July 19 sent an open letter to Dr. Brendan Murphy, secretary of Australia’s Department of Health and Aged Care, voting members of the Australian Technical Advisory Group on Immunisation and members of parliament threatening to “move forward with preparations for seeking the intervention of the Federal Court of Australia” if officials don’t respond.

The Canadian COVID Care Alliance (CCCA) on July 14 published an open letter to Canadian health officials stating their members would “be happy to meet you to discuss findings documented in this letter in greater detail.”

Both letters emphasized three arguments against authorizing the mRNA shots in young children and babies:

  1. Children don’t need COVID-19 vaccination because they are at extremely low risk of COVID-19.
  2. In any case, the mRNA shots don’t work well.
  3. The potential harm from the mRNA shots outweighs the benefits for young children.

Both letters also referenced the June 30 open letter to U.K. health officials from more than 70 physicians and scientists warning against vaccinating younger children against COVID-19.

The U.K. letter, written in response to the U.S. Food and Drug Administration’s (FDA) Emergency Use Authorization (EUA) in mid-June of the Moderna and the Pfizer-BioNTech COVID-19 shots for children as young as 6 months, urged U.K. health officials to not “make the same mistake” the FDA made.

All three letters referenced Søren Brostrøm, director of the Danish Health and Medicines Authority, who in June said, “We did not get much out of having children vaccinated against coronavirus last year.”

Australia’s Therapeutic Goods Administration on July 18 provisionally approved a pediatric dose of Moderna’s Spikevax COVID-19 shot for children ages 6 months to 5 years old. Rollout of the vaccines is contingent on input from the Australian Technical Advisory Group on Immunisation.

A few days earlier, on July 14, Health Canada authorized the use of Spikevax for children 6 months to 5 years of age. According to the statement, “As a result of this authorization, approximately 1.7 million children are now eligible for vaccination against COVID-19.”

Risks ‘far outweigh’ benefits for children

The 11-page CCCA letter contains 117 references and six pages of figures and graphs to support the group’s argument that “the data shows that, in the Omicron era, when population-based immunity is widespread, the risks associated with COVID-19 mRNA vaccines far outweigh the benefits in children.”

The authors of the CCCA letter criticized the FDA, stating, “no gold standard, placebo-controlled disease endpoint trials, large enough [with at least 800,000 participants] to categorically establish the clinical safety and long-term efficacy of the Pfizer COVID-19 mRNA vaccinations in children 12- to 15-years-old, 5- to 11-years-old, 2- to 4-years-old, and 6-months-old to 23-months-old have been undertaken.”

Instead, the EUA for Pfizer was “based on the preliminary results of four very small immuno-bridging trials, enrolling fewer than 3,000 participants each.”

The CCCA letter presented data from the Canadian province of Ontario, which “reported a negative dose-response effect for the COVID-19 vaccinations [original emphasis].”

The letter continued:

“In other words, the proportion of cases of COVID-19 were highest among those who had been ‘boosted,’ lower among the ‘fully inoculated’ and least among the ‘not fully inoculated’ (which includes the ‘uninoculated’).”

The authors presented graphs from the Public Health Ontario website, noting a similar pattern was observed in the 12- to 17-year-olds and the 5- to 11-year-old age groups.

“Additionally, a greater proportion of ‘boosted’ Ontarians have died, revealing that the vaccinations may be associated with serious secondary effects.”

The CCCA letter concludes:

“We trust that our research has provided you with evidence needed to adjust Canadian health policy to protect our children from undue harm. We would be happy to meet you to discuss findings documented in this letter in greater detail.”

‘Huge gap’ in Pfizer’s vaccine trial documentation

According to the authors of the AVN letter, the Pfizer documentation presented to the FDA had huge gaps in the evidence provided.

For example, the letter stated:

“The protocol was changed mid-trial. The original two-dose schedule exhibited poor immunogenicity with efficacy far below the required standard. A third dose was added by which time many of the original placebo recipients had been vaccinated.”

The AVN letter argued the Moderna shot for young children fails to meet Australia’s regulatory requirements to be granted “provisional determination” (similar to EUA in the U.S.) under regulation 10L(1)(a) of the Therapeutic Goods Regulations.

To receive provisional determination, there must be “an indication of the medicine is the treatment, prevention or diagnosis of a life-threatening or seriously debilitating condition,” the letter stated.

The authors said Australia’s health department and TGA did not “show any data or science to support a conclusion that COVID-19, and particularly the Omicron variant now widespread across Australia, is ‘life-threatening’ to infants aged 6 months up through 4 years, nor indeed that infants 6 months up through 4 years suffer ‘seriously debilitating’ symptoms when infected with COVID-19.”

The authors also addressed the issue of manipulative strategies used to promote COVID-19 vaccination of children, and said pushing unnecessary and novel mRNA-based vaccines onto young children risks undermining parental confidence in routine immunization programs.