Efficacy and Safety of COVID-19 Vaccines in Older People

Roy L. Soiza; Chiara Scicluna; Emma C. Thomson


Age Ageing. 2021;50(2):279-283. 

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In summary, it is likely that a vaccine programme will be rolled out starting with older people with frailty despite scant evidence of efficacy or safety in this group. The rapidly evolving and devastating nature of the pandemic arguably justifies this approach and health officials will want to atone for mistakes made in the first wave, where a policy of discharging hospitalised care home residents with COVID-19 whilst still infectious led to outbreaks and cost lives.[14] The exclusion of older people, particularly those with frailty, from clinical trials of therapeutics that they may most benefit from has been recognised for decades.[15] Although the speed with which vaccines have been developed, tested and rolled out has been rightly widely lauded, it is a pity that some old habits have remained unchanged. The safety and efficacy of COVID-19 vaccines in the population that should most benefit from them may only become apparent after they have been given. No pharmacovigilance studies have been formally proposed or announced. Key information on safety and efficacy may therefore need to be acquired retrospectively through usual regulatory authority surveillance systems and epidemiological studies, although no design can substitute for the information that could have been acquired in more inclusive randomised controlled trials. Even the benefits of annual vaccination of older people against influenza are unquantified and disputed,[16] so the same may occur with COVID-19 vaccination programmes. Some may argue that the inclusion of older people with frailty or complex co-morbidity would slow down development of a working vaccine, as the risk of severe adverse events and pauses to trials increase. However, trials in these populations are possible and judicious application of pause rules and other safety criteria could mitigate against the risk of unnecessary and costly delays. Better engagement between teams working on vaccine trials and those with experience of running trials in older people with frailty is needed to help achieve a closer match between trial and key 'real world' populations.