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Only two placebo controlled trials in this population have ever been conducted, and neither was designed to detect any difference in hospital admissions or deaths. Moreover, dramatic increases in use of influenza vaccines has not been associated with a decline in mortality. Not enrolling enough elderly people or minorities. A vaccine that has been proved to reduce the risk of symptomatic disease by a certain proportion should, you might think, reduce serious outcomes such as hospital admissions and deaths in equal proportion. Peter Marks, an FDA official with responsibility over vaccine approvals, recently stated as much about influenza vaccination, which “only prevents flu in about half the people who get it. And yet that’s very important because that means that it leads to half as many deaths related to influenza each year.” But when vaccines are not equally effective in all populations the theory breaks down. If frail elderly people, who are understood to die in disproportionate numbers from both influenza and covid-19, are not enrolled into vaccine trials in sufficient numbers to determine whether case numbers are reduced in this group, there can be little basis for assuming any benefit in terms of hospital admissions or mortality. Whatever reduction in cases is seen in the overall study population (most of which may be among healthy adults), this benefit may not apply to the frail elderly subpopulation, and few lives may be saved. This is hard to evaluate in the current trials because there are large gaps in the types of people being enrolled in the phase III trials. Despite recruiting tens of thousands, only two trials are enrolling children less than 18 years old. All exclude immunocompromised people and pregnant or breastfeeding women, and though the trials are enrolling elderly people, few or perhaps none of the studies would seem to be designed to conclusively answer whether there is a benefit in this population, despite their obvious vulnerability to covid-19. “Adults over 65 will be an important subgroup that we will be looking at,” Moderna’s Zaks told The BMJ. “That said . . . any given study is powered for its primary endpoint—in our case covid-19 disease irrespective of age.” Al Sommer, dean emeritus of the Johns Hopkins School of Public Health, told The BMJ, “If they have not powered for evidence of benefit in the elderly, I would find that a significant, unfortunate shortcoming.” He emphasised the need for “innovative follow-up studies that will enable us to better determine the direct level of protection immunisation has on the young and, separately, the elderly, in addition to those at the highest risk of severe disease and hospitalisation.” One view is that trial data should be there for all target populations. “If we don’t have adequate data in the greater than 65 year old group, then the greater than 65 year old person shouldn’t get this vaccine, which would be a shame because they’re the ones who are most likely to die from this infection,” said vaccinologist Paul Offit. “We have to generate those data,” he said. “I can’t see how anybody—the Data and Safety Monitoring Board or the FDA Vaccine Advisory Committee, or FDA decision-makers—would ever allow a vaccine to be recommended for that group without having adequate data.” “I feel the same way about minorities,” Offit added. “You can’t convince minority populations to get this vaccine unless they are represented in these trials. Otherwise, they’re going to feel like they’re guinea pigs, and understandably so.”