COVID-19 – Should we be vaccinating 12 to 15 year olds?

By Maryanne Demasi, PhD

Governments around the world have implemented aggressive campaigns to promote COVID-19 vaccines, promising that a ‘jab in every arm’ will expedite our path to freedom.

Initially, elderly people in care homes and those most vulnerable in our society were prioritised for vaccination. But, now as the highly transmissible Delta variant rips through the population, many say that we must start vaccinating the children to stop the spread. 

Early studies suggested that kids were largely spared from the effects of the original strain, with much lower incidences of SARS-CoV-2 infection, but recent outbreaks of the Delta strain in some Australian schools have led to school shutdowns, with threats of an overwhelmed hospital system.

On 31 March 2021, Pfizer announced in a press release, its “positive topline results” from a vaccine trial involving young people. Pfizer CEO and Chairman, Albert Bourla, pleaded for “urgency to expand the authorization of our vaccine to use in younger populations”. 

Much of the mainstream media, including popular commentators uncritically endorsed the move, despite the lack of published data in peer-reviewed journals. It was not long after, that major drug regulators in the US, UK, Canada and more recently Australia, granted ‘emergency use authorisation’ or ‘provisional approval’ for the use of the COVID-19 vaccines in 12- to 15-year olds.

This has divided expert opinion and created division and derision among academics. While trial data suggests that the benefits of the COVID-19 vaccines in older adults and high-risk individuals outweigh the harms, the net benefit of vaccinating children, remains debatable. 

Vaccinating children will hasten the path to herd immunity, but many are now asking whether it’s the duty of children to protect the elderly.  Should we burden them with the potential harms of the vaccine, when the risk of severe illness & death from COVID-19 for kids, is minuscule? 

Reports of children dying of COVID-19

On 14 July 2021, the US Centre for Disease Control (CDC) reported 335 deaths in children under 18 with a COVID-19 diagnosis on their record. Prof Marty Makary at Johns Hopkins School of Medicine was quick to point out that the CDC did not distinguish whether COVID-19 was the cause of death, or if it involved a pre-existing condition.

Prof Makary team performed an analysis of 48,000 kids under 18 years diagnosed with COVID-19, and found that there was a mortality rate of zero among children without a pre-existing medical condition such as leukaemia.

Similarly, a UK study reported that deaths were “incredibly rare” among children and teenagers, (25 reported between March 2020 - February 2021), and that those with complex neuro-disabilities were at the highest risk of death.

This has implications for deciding whether to roll out mass vaccination of healthy children, if the disease is generally asymptomatic or mild, and the harms of the vaccine are largely unknown.

The ‘expert committees’ decide

In the US, the CDC’s Advisory Committee on Immunization Practices decided that the benefits of two-dose vaccination outweigh the harms for all kids 12 to 15, despite significant concern over reports of myocarditis and pericarditis following the Pfizer vaccine, predominately in young males.

In Canada, the National Advisory Committee on Immunization (NACI) also recommended a complete series of the Pfizer-BioNTech COVID-19 vaccine should be offered to 12- to 15-year-olds with a “discussion about very rare reports of myocarditis and/or pericarditis”.

In the UK, on the other hand, the Joint Committee on Vaccines and Immunization (JCVI), expressed more caution. 

“The health benefits in this population are small, and the benefits to the wider population are highly uncertain. At this time, JCVI is of the view that the health benefits of universal vaccination in children and young people below the age of 18 years do not outweigh the potential risks.”

It did, however, make an exception for the most vulnerable in that age group.

“JCVI advises that children and young people aged 12 years and over with specific underlying health conditions that put them at risk of serious COVID-19, should be offered COVID-19 vaccination.”

In Australia, the Federal government’s advice from its independent advisory committee, the Australian Technical Advisory Group on Immunisation (ATAGI), was to prioritise vulnerable 12- to 15yr olds for the Pfizer’s vaccine (Comirnaty). 

Specifically, children aged 12-15 with medical conditions (including asthma, diabetes, obesity, cardiac and circulatory congenital anomalies, neuro developmental disorders, epilepsy, immuno-compromised and trisomy 21), aboriginal and Torres Strait Islander children and those in remote communities. 

ATAGI will make recommendations for use in all other children in the 12–15 years age group within the coming months, following the review of emerging information overseas.

Why the conflicting advice? 

Conflicting advice from public health authorities can cause anxiety and further fuel vaccine hesitancy. If everyone is looking at the same data, why are experts coming to different conclusions? 

In this case, it depends on where a committee puts emphasis on all the moving parts – the vaccine efficacy, the risk of contracting the disease, the known harms of the vaccine and the unknown long-term harms that are yet to be determined. 

The unknown, long-term harms of a new vaccine may be enough to sway a panel to exercise more caution. The COVID-19 vaccines have only received “emergency” or “provisional” approval based on an assessment of the “available data” from interim results, as the Phase 3 trials are still ongoing. 

What happened in the vaccine trial with kids?

Recently, results published in the New England Journal of Medicine showed that the Pfizer-BioNTech vaccine had 100% efficacy in children and adolescents aged 12-15 years without prior evidence of COVID-19 infection. Specifically, in close to 1000 children who received placebo, 16 “tested positive” for COVID-19, compared to none in the vaccinated group.

However, reduced “positive COVID-19 cases” needs to be weighed up against any serious harm caused by the vaccine. 

The Australian Product information (PI) pamphlet, also known as the consumer’s packaging insert, shows the most frequent adverse events (AEs) were injection site pain (> 90%), fatigue and headache (> 70%), myalgia and chills (> 40%), arthralgia and pyrexia (> 20%). 

However, more serious AEs included acute peripheral facial paralysis (or palsy). Four occurred in the vaccine group compared to zero in the placebo group. 

While Pfizer claimed in its press release that the vaccine was “well tolerated” in kids, there was a 3.5-fold increased risk of suffering a serious adverse events (AEs) in the vaccinated group, compared to placebo (suppl table 2).

Ongoing surveillance of harms

Since there is only two months of follow up trial data underpinning the vaccine’s approval in kids, there has been ongoing monitoring of AEs – known as ‘post-marketing surveillance’. 

Not all AEs can be attributed to the vaccine, i.e. it cannot establish causality, but the system can alert drug regulators to important signals. For example, authorities now know that the Pfizer vaccine is associated with myocarditis, pericarditis and anaphylaxis, which have been spontaneously reported. 

In the US, the Vaccine Adverse Event Reporting System (VAERS) had received 1226 preliminary reports of myocarditis and pericarditis after about 300 million doses of the Pfizer and Moderna vaccines up to 11 June, prompting the US drug regulator (FDA) to add a warning about the harm to information sheets for the mRNA covid vaccines.

The BMJ reported: “confirmed cases have mostly been seen in male adolescents and young adults and occur more often after the second dose than the first. CDC data showed that after 3,625,574 second doses administered to men aged 18-24 there were 233 reports of myocarditis or pericarditis, when 2 to 25 would have been expected. After 5,237,262 doses administered to women in this age group 27 cases were seen, against an expected 2 to 18.”

These post marketing surveillance systems, however, are problematic because they significantly under-represent harms. It is estimated that 90-95% of AEs are not reported to drug regulators. It is only a voluntary system, the process is complex, time consuming and there is low awareness among consumers that these systems exist. 

Ethical considerations

Given the uncertainty of the net benefit, there is a rigorous debate about the ethics of vaccinating children for the benefit of the elderly. Experts are warning against using children as a means to achieve herd immunity among adults. 

“Children are not a tool to be used,” said infectious diseases paediatrician Prof Robert Booy, to the SMH. “Before saying, ‘let’s ask children to save the elderly people,’ which is not necessarily a bad thing, what’s in it for the children?”

In the BMJ’s Journal of Medical Ethics, Professors from Oxford University argued that given the current state of knowledge about COVID-19 immunity and vaccines, it would be wrong to pose the costs and risks of vaccines on children for three reasons. 

“First, they are unlikely to benefit from COVID-19 vaccination directly. Second, the collective benefit would likely be very limited. Third, we have already imposed very large costs on children during this pandemic through indiscriminate restrictions, using them as mere means to others’ ends.”, they wrote. 

The debate continues to rage. There will be those who insist that we need to vaccinate the kids to “protect granny”, but at what cost? Young people have already shouldered a huge social burden to protect the vulnerable. 

In the end, the significant challenge will be to strike a fair balance between the interests of the less vulnerable (to protect their freedoms) and the most vulnerable (to protect them from COVID-19).