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This month, the Australian federal government updated its website to state that Moderna’s Spikevax is “no longer available” for children under 12.
It comes only three months after AstraZeneca’s COVID-19 vaccine was discontinued in Australia. (The original Comirnaty [Pfizer] vaccines remain available for use for children under 12 in Australia.)
The updated website was inconspicuous; there was no press release, no media coverage, and no “dear doctor” letters.
So, what triggered the move?
A pediatric formulation of Moderna’s mRNA vaccine was provisionally approved for children aged 6 years and older in February 2022 and for children aged 6 months to 5 years in July 2022.
But this only compounded earlier concerns about the safety of mRNA vaccines. The trials were small and there were no long-term safety data.
Myocarditis had been linked to the mRNA vaccines in young males — particularly from Moderna — with some postulating it was due to the higher concentrations of mRNA in Moderna’s formulation.
It even prompted some governments, including Australia’s Technical Advisory Group on Immunization, or ATAGI, to recommend extending the dosing interval from 4 weeks to 8 weeks, hoping to reduce the risk of myocarditis.
European countries like Denmark, Sweden, Germany, France and Norway, took it one step further and decided to suspend the use of Moderna’s vaccine in young people because of safety concerns.
But is that why the Australian government says it’s “no longer being manufactured” and therefore, “no longer available for use” in children under 12?
I asked direct questions to the Australian Therapeutic Goods Administration (TGA) about the safety data of Moderna’s Spikevax vaccine. However, after weeks of enquires, I could not get a straight answer on the rate of serious adverse events (SAEs).
For example, initially, they quoted a very high SAE rate of “1 in 200” in clinical trial participants aged 6 months and <2 years — a rate that would far exceed the harms of COVID-19 infection — but then insisted it was “very rare.”
When I sought clarity from the TGA, it began a string of emails back and forth, in which I would receive indirect responses to my direct questions about the rate of SAEs and its causal inference.
According to Moderna’s Spikevax Fact Sheet (approved by the FDA), the clinical trial involving children aged 6 months to <2 years found SAEs were reported by 0.9% (n=15) of kids in the vaccine group versus 0.2% (n=1) in the placebo group.
But no mention was made of the nearly 5-fold increase (0.7% absolute difference) in SAEs between the vaccine and placebo group.
If the 0.7% absolute difference seen in the randomized trial reflects a real and accurate measure of the difference between groups, this would translate into a 1 in 147 rate of SAEs. (1 in 147 rate of SAEs based on calculation 1/(15/1761 [vaccine] – 1/589 [placebo)].)
Later in the document, however, it seems a value judgment was made (either by the regulator or Moderna) that only 1 of the 15 vaccinated children who reported an SAE, had an SAE that was actually caused by the vaccine.
It stated:
“In participants 6 months through 23 months of age who received the vaccine, a 1-year-old female experienced serious adverse events of a Grade 3 fever 6 hours after Dose 1 and a febrile convulsion 1 day after Dose 1. These events were considered related to vaccination.”
So, it is still not clear why the vaccine is no longer available and is no longer being manufactured for this age group.
Moderna is busy finishing its large-scale mRNA research and manufacturing facility in Melbourne, Victoria, which is expected to make 100 million mRNA doses each year, beginning in 2024.
Perhaps it was a business decision to stop manufacturing the vaccine for children under 12 because the uptake in that cohort has been so low.
Moderna did not respond to repeated inquiries.
Either way, the secrecy behind the safety data of COVID-19 vaccines in general, is only fuelling speculation and increasing distrust in vaccination more broadly.
Originally published on Maryanne Demasi’s Substack page.
