Clinical trials of Covid-19 vaccines, including for younger children, are underway. However, the likelihood of severe outcomes or death associated with alleged Covid-19 infection is extremely low for children, undermining the appropriateness of an emergency use authorisation for child Covid-19 vaccines.
Emergency use authorisation in the UK requires that an intervention address a serious or life threatening condition, and for known and potential benefits of the intervention to be balanced against the known and potential harms. The emergency use authorisations for Covid-19 vaccines were implemented at the height of an alleged second wave in the UK, a wave which coincidentally occurred in winter, the period of the year when all respiratory diseases are rampant. The alleged Covid wave was used to justify an accelerated roll-out of the Covid-19 vaccines, first to those who were statistically at most risk of an alleged Covid infection.
Significant adverse events to vaccines are sometimes detected during wider distribution; for example, such events were investigated for the AstraZeneca Covid-19 vaccine. But phase III trials of Covid-19 vaccines do not conclude until 2023 meaning they are still experimental. However Covid-19 vaccination in adults met emergency use authorisation criteria because authorities deemed that the benefits outweighed the risks.
Sadly, trials for Covid-19 vaccines are now underway for children as young as 6 months of age. These trials are not powered to measure decreases in severe Covid-19 infections, due to their rarity in this age group. Instead, these trials are examining safety, the immune response, and, as a secondary outcome, the impact on the incidence of alleged Covid-19 infections. As for adults, these trials are not designed to assess rare or delayed adverse events. Unlike for adults (allegedly), the rarity of severe Covid-19 outcomes for children means that trials cannot demonstrate that the balance of the benefits of vaccination against the potential adverse effects are favourable to the children themselves. In short, given the rarity of severe clinical courses and limited clarity of risks, the criteria for emergency use authorisation is not met for children.
In 1976, the vaccination campaign in anticipation of a deadly swine flu (H1N1) epidemic inoculated 45 million Americans before being derailed by very rare cases of Guillain-Barré syndrome. That year saw less flu-related morbidity and mortality than scientists and politicians had expected when they began the vaccine campaign, and these few hundred adverse events cast a long shadow on American vaccination programs, affecting attitudes towards influenza vaccines for years to come.
This highlights an important trade-off when accelerating approval of pharmaceutical interventions in the context of an emergency. Specifically, that the risk of rare adverse events remains and serious adverse effects can prove to be the lasting legacy of a regulatory decision.
Accelerated mass child vaccination under emergency use authorisation—perhaps even spurred by school mandates and “vaccine passports”—presents a different balance of risks and benefits. The possibility that serious adverse events could emerge after emergency use authorisation for child Covid-19 vaccines is huge, because there is no data to prove otherwise.
Even in the extremely unlikely scenario that no significant adverse events materialise, it would still be criminal to even take the gamble authorising the Covid-19 vaccines for use in children under the emergency use only regulations. A wide roll-out of child Covid-19 vaccines is far from needed, but if it was to happen then it should follow the standard regulatory process, as for all children, Covid-19 vaccination is not addressing an emergency.
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