SHARES
COVID-19 vaccine – the whole world is waiting in anticipation!
It’s almost a year since the start of a pandemic bringing the world to its knees. Each time we’ve seen marked improvements, then whoosh…. a surge again. Evident relapses occur in many countries at the relaxation of restrictions or letting down of our guard.
Happily, the scientific community draws closer and closer to completing their clinical trials for their COVID-19 vaccine. Although, you will find it surprising, most of the clinical trials did not include all members of the population!
COVID-19 Vaccine Clinical Trials
Globally, the percentage for population of 65 years and older, is currently 9%. It is set to rise further to 16 per cent by 2050. In COVID 19 cases, people over the age of 65 make up 80 percent of COVID-19 deaths. Yet a new study shows that they are less likely to be part of important clinical trials involving vaccines.
The study from September 2020 JAMA (Journal of the American Medical Association) revealed that most COVID-19 vaccine trials have not included older people to the extent that younger have. Researchers investigating the COVID-19 studies looked at 847 COVID-19 clinical trials and all 18 vaccine trials on ClinicalTrials.gov, the largest clinical trial database. They discovered that in studies between October 2019 and June 2020, over 50 percent of both COVID-19 clinical and vaccine trials excluded people over 65.
Why exclude older adults?
Generally the intent in the design and trial of vaccines, is for both children and adults to ultimately benefit from the end product, unlike regular medications. In regular medications, usually considerations are for a certain subset of the population. In contrast, vaccines cover a much broader audience with differing health profiles and age groups.
Exclusions in this case aren’t all that unusual as it is important to safeguard the health of the study volunteers. Naturally some individuals who have severe or unstable risk factors should not be in the clinical trials. For example, some studies have an age-basis cutoff, while others have indirect exclusion criteria. Others require participants to have a smartphone or other access to technology.
Nevertheless, the motivation of getting FDA approval more expediently, may push companies to study only the healthiest people. Because comparatively, older people often experience more side effects from vaccines versus the younger, healthier group. So, these complications and side effects can sometimes delay the approval process.
Other exclusions
Keeping people with common health conditions like diabetes out of the study population means only the healthiest individuals are in the study. Excluding this group isn’t necessarily a true representation of the general population.
Moreover there seems to be also a hesitancy to include the more vulnerable such as older adults, children, and pregnant people. Traditionally, vaccines are tested in adults first before being expanded to children.
Notably though, children don’t appear to be especially at risk for severe COVID-19 symptoms. Many who have contracted the virus were either asymptomatic or had mild symptoms. Thus their symptoms are rarely life threatening or complex.
Conclusion
On the whole, in my opinion, all eligible segments of populations need to be part of the COVID-19 vaccine studies. If trials exclude the older group, there would be limitations in assessing the efficacy, safety and correct dosage particularly for a group that needs the vaccine most.
Some argue you need only vaccinate the younger population to achieve herd immunity (67% level of immunity). Therefore vaccination of older adults is not necessary, however, this may not be true. For instance, think about settings where it would make sense to vaccinate this group of adults eg in nursing homes.
A widely available vaccine would be an important measure against COVID-19. But a successful vaccine must ensure the safety of the broader population.
For now, we can only play our part by being vigilant and responsible – social distancing, mask wearing and meticulous hand washing. All have to act in concert, only then can the public help slow the spread of COVID-19, until safe and effective vaccines are widely available. We are safe only when everybody else is.
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by Yashwini Ravindranath
Born & raised in Malaysia, Yashwini earned her M.D. studying in Moscow's Russian National Research Medical University. With an affiliation towards research, all things coffee and the startup ecosystem, she now contributes articles to GetDocSays View all articles by Yashwini Ravindranath.
