Why is there such a big push to vaccine every child around the world? Is it because the underlying premise in the war against COVID-19 is that the eradication of SARS-CoV-2 will only happen via mass vaccination—that the children along with the “unvaccinated” represent the last “reservoirs” of the pathogen—SARS-CoV-2? Addressing that question was Bill Gates himself, one of the biggest mass vaccine proponents, recently challenging the premise that the current crop of vaccines on the market can stop transmission. If this is the case, then the only reason to vaccinate young children would be to protect them against serious infection leading to hospitalization. But then the risk-benefit profile must strongly lean in favor of vaccination—that is the risks of side effects and adverse events must be materially trumped by the risks of SARS-CoV-2 severe infection in children aged 5 to 11 years of age. Recently in India’s Sunday Guardian Live, a couple Indian physician-researchers shared their optimistic opinions as to the safety of the COVID-19 vaccines as used in children. Experts ranged from Dr. Rajeev Kaul, Professor and microbiologist from University of Delhi to Dr. Debayan Mallik, head of the Rural Health Training Center, Jagannath Gupta Institute of Medical Sciences as well as Hospital Calcutta shared their upbeat opinions on the COVID-19 vaccines for the young. But are their answers any better than experts we tracked recently in America?
Study Data Seems Positive. But…
The experts in India appear to base most of their opinion on the clinical trials coming out of India. Even though these studies haven’t yet tracked long term outcomes, nonetheless that is what they have to go with. For example, Dr. Kaul shared “Bharat Biotech has recently submitted data to Central Drugs Standard Control Organization (CDSCO) regarding Covaxin trial in children of 2 years age and above. This data shows positive recommendations indicating that Covaxin is safe in children. Both Pfizer and Moderna have also declared that their vaccine is safe in children aged 6 to 11. These trials have shown that fatigue, headache, fever and pain at the site of injection were common side effects of the vaccine in children, as has been the case in adults. Therefore, it can be concluded that the safety profile of these vaccines in children is favourable.”
Moreover, Dr. Mallik shared the same optimistic view for the same underlying reasons—that the pharmaceutical company’s clinical trials shared positive results with an acceptable safety risk declaring “The vaccines are safe to be used on children.”
Mallik also slipped “Whether there will be any serious aftereffects in vaccinated children, however rare they may be, it can only be determined after data from large scale trials will be analysed,”
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Critique of this POV
Note that the Indian microbiologist and key opinion leader qualifies his state by declaring that the pharmaceutical companies of Pfizer and Moderna made a declaration that the vaccine is safe in children aged 5 to 11. But as TrialSite has chronicled recently the FDA failed to review the Pfizer data prior to the the last Oct 26 VRBPAC meeting. This means that the regulators just assumed that everything that the pharmaceutical company declared was accurate, was in fact, accurate.
And despite the fact that the FDA delayed emergency use for Moderna for the aged 5 to 11 cohort—due to concerns of myocarditis—the Indian physician declared that the vaccine should be good because Moderna said so.
TrialSite reminds all that all of the Scandinavian nations have either temporarily or permanently halted the use of the Moderna vaccine called mRNA-1273 on young people due to safety concerns.
Children are society’s most vulnerable, and any mass vaccination program must ensure all risks are commonly understood.
TrialSite raised concerns for children aged 5 to 11 based on the October 26 FDA VBRPAC and subsequent CDC ACIP meetings including:
Vaccines were produced with unprecedented speed. This isn’t a bad thing in and of itself—in fact, it is good for the progress of medicines development, but we shouldn’t be in a rush to inoculate an entire young generation until there is more safety data and an improved risk profile. For example, the amount of safety that accumulated for other vaccines required for school should be comparable to the current ones. It’s also worth noting that most of the vaccines approved for child vaccine-preventable illnesses are for diseases that target children with more severe symptoms. COVID remains significantly deadlier in the elderly.
The risk-benefit analysis isn’t what the CDC claims. Children have a very low serious illness and death rate. Nearly all of the children that have been severely ill or have died, which is a very small amount to begin with, have had underlying comorbidities. See slide #19. The FDA analysis led to the conclusion that the vaccine represented a 6.6x benefit. However, after a review by expert David Wiseman, the risk-benefit ratio becomes negative 1.8, meaning the risk is higher than the benefit. This is because of several factors, including waning effectiveness to non-myocarditis serious adverse events.
We should be focused on specific risk cohorts among the young, and not focus on a one-size-fits-all vaccination approach. This includes no mandates for such young children, until we have at least years of hard data.
The FDA acknowledged that they didn’t thoroughly review the data at the VRBPAC meeting on October 26. See slides #18-19. Critical questions remain.
On hesitancy about safety, Dr. Eric Rubin declared that we are “never going to learn how safe this vaccine is unless we start giving it.” Note PolitiFact provides content for review but the point is that there is no long-term data in a very vulnerable and low-risk group. Shouldn’t we be as careful as possible with our children and ensure more data is available?
Whistleblowers reveal stark data quality problems with the Pfizer-BioNTech study as reported in the BMJ. Even when Pfizer was made aware of quality issues with one managing research company, they handed them four more vaccine contracts, including one for vaccines in children.
Disclosures that some of the manufacturing inputs changed should be associated with revalidation of production systems and outputs. Specifically, Pfizer changed the children’s formula to produce the product. This is a deviation from the study protocol. Under any normal conditions this change would need to be validated.
Call to Action: Why would all of these doctors go on record making claims of safety when sophisticated nations such as Norway, Sweden, Denmark, Iceland and Finland are stopping the use of at least one of the mRNA-based vaccines by young people? Why aren’t these doctors raising a more holistic perspective?