The story reports on an animal trial of a cytomegalovirus (CMV) vaccine in pregnant guinea pigs. The story does not mention that CMV is species-specific, so results from a guinea pig trial are not directly applicable to humans. CMV infection in newborns is an under-appreciated problem and the story did provide some useful information to readers. However, the story provided no quantitative evidence from the study and failed to put the research into the context of other CMV vaccine research, some of which may be further along.
A story on such animal research must remind readers that the vaccine has not yet undergone even safety testing in humans. There is only one brief line that the researcher "hopes to begin testing the vaccine on people later this year." But as the editorial accompanying the journal article makes clear, there are several vaccines well along in development other than the one described. A university news release mentioned twice (once as early as the second paragraph) that human trials had not yet begun. This story mentioned plans for human testing only once – 11 paragraphs deep.
The story does not discuss the expected cost of any CMV vaccine or who should receive it – except for the final line from the researcher projecting that "the best strategy for eradicating CMV some day would be universal immunization of young children." What would that cost? Would women of childbrearing age get it? All adults? If it's not too soon to report on such animal research, it's not too soon to start asking such questions.
The story cites the lead author of the study and a researcher/policy maker from the National Institute of Child Health and Human Development, the organization that funded the study – both of whom have an interest in announcing positive results. The story should have offered the perspective of someone not affiliated with the study, especially since there are other vaccines under development. The accompanying editorial in the journal in which this study was published provided balance. Even that editorial writer could have added needed perspective to the story.
Two aspects of health care costs were ignored in this story. There is no discussion of the expected cost of a CMV vaccine. (This is significant, as the researcher is quoted saying the "best strategy for eradicating CMV would be universl immunization of young children.") And the story does not discuss the potential cost savings of a vaccine that was safe and effective in humans – in terms of post-partum care and on-going pediatric care for children born with CMV-related disabilities.
The story provides no quantitative evidence from the study cited. The new vaccine group (there were actually two vaccines studied) was improved, but the CMV infection rate was about 50%. One would expect that a story on a human vaccine trial would quantify benefits, so one should certainly expect that a far more preliminary stage of animal testing should give an idea of how big a potential benefit was seen.
The story does not mention the potential harms of a vaccine. Granted, they may be unknown at this time as human testing has not begun, but the fact that human trials of safety (much less efficacy) have not yet begun should have been emphasized along with the species-specific nature of such research.
The story does not mention the study design or provide any quantitative data from the study. CMV infection has species-specific outcomes. Pup death is a consequence in guinea pigs whereas deafness is the manifestation in humans. The trial demonstrated an improvement in the pup survival as noted in the article. However, the transmission rate in the study population was not statistically different from the controls. So transmission from mother to fetus still occurred at the same rate. The story was apparently based on the journal article cited, but the accompanying editorial in that journal put the vaccine trial into perspective, yet it was not cited in the story. That editorial refers to some CMV vaccine research in early human trials – beyond the stage of this work.
The story cites the lead author of the study and a researcher/policy maker from the National Institute of Child Health and Human Development, the organization that funded the study – both of whom have an interest in announcing positive results. The story should have offered the perspective of someone not affiliated with the study, especially since there are other vaccines under development. The accompanying editorial in the journal in which this study was published provided balance to the article. Even that editorial writer could have added needed perspective to the story.
The story could have made more clear what is stated so clearly in an editorial accompanying the research article in the journal cited: "no means of preventing congenital CMV infection or its cognitive, motor, or sensory sequelae is available or even on the visible horizon." Nonethless, we'll give the story the benefit of the doubt on this criterion.
The story reports on an animal trial of a CMV vaccine in guinea pigs. A story on such animal research must remind readers that the vaccine has yet to even undergo safety testing in humans. There is only one brief line that "he hopes to begin testing the vaccine on people later this year." Nonethless, we'll give the story the benefit of the doubt on this criterion.
The story – in 9 words – made passing reference to the fact that this is "one of the first experimental vaccines against the virus." But we learn nothing more about how this research compares with the other trials. Nonetheless, we'll give the story the benefit of the doubt on this criterion.
Although the University of Minnesota sent out a news release on this research dated February 21, and this story was published on February 22, we have no direct evidence that the story relied solely or largely on a news release.
Systematic, Criteria-Driven
The tale of two “negative” studies. Or, how spin is applied to make research findings look more impressive. A must read. https://johnmandrola.substack.com/p/the-tale-of-two-negative-studies
The @nytimes chose to interview one of the editors of the @AnnalsofIM (publisher of this paper) who "gushed with extraordinary glee: It’s huge! There are very few things that reduce your mortality by 30%."
Turns out coffee is not one of those few things despite all that glee. https://twitter.com/garyschwitzer/status/1533202075928215558
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