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Last month, a dreadful study was published in the reputable journal NPJ Vaccines, titled “Risk assessment of retinal vascular occlusion after COVID-19 vaccination.” Using a database comprising over 6 million patient data, the study uncovered a 2.19-fold increased risk of retinal vascular occlusion after getting the mRNA vaccine compared to no vaccination.
Retinal vascular occlusion (RVO) is the second leading cause of visual loss. It happens when blood vessels behind the eye get blocked due to vascular inflammation, damaged vascular walls, or blood clots. Risk factors for RVO include diabetes, hypertension, obesity, and cardiovascular diseases.
Given that Covid vaccines have been infamously linked to vascular issues, could this study be another blow to the safety reputation of Covid vaccines? The answer is not clear-cut. It depends on how you interpret the study. But contrary to the claims of anti-vaccine alarmists, this study doesn’t mean people are going blind from the mRNA vaccine everywhere.
What the study did and found
A group of scientists, Li et al., from Taiwan and the U.S. capitalized on the TriNetX network database, which holds medical records of >90 million people in the U.S. After excluding those who (i) were <18 years, (ii) had a history of RVO six months prior, (iii) were prescribed certain medications four weeks prior, and (iv) had a history of Covid, only 745,041 vaccinated and 3,874,458 unvaccinated individuals remained.
Li et al. then matched 739,066 vaccinated to unvaccinated individuals at a 1:1 ratio, ensuring similar age, sex, and other baseline characteristics between groups. This ensures that any outcome examined is a result of vaccination, rather than confounding variables like age or sex.
Their study uncovered two key results:
- Overall, the vaccinated group had a 3.54-times and 2.19-times higher risk of RVO than the unvaccinated group at 12 weeks and 2 years of follow-up, respectively. This association was unaffected by age, sex, or race and remained significant for all subtypes of RVO (Figure 1).
- Subgroup analyses showed that RVO risk increased significantly and similarly after the 1st and 2nd doses of Pfizer’s or Moderna’s mRNA vaccines at 2 years of follow-up. But RVO risk was not significantly associated with Johnson & Johnson’s DNA vaccine.
But this study found no difference in RVO risk among recipients of the Covid mRNA (1st dose), influenza, and Tdap (tetanus, diphtheria, pertussis) vaccines. This suggests that the 1st mRNA vaccine dose posed no harm, contrary to the findings of Li et al., despite using the same database. The reasons for such discrepancies aren’t clear and weren’t discussed.
Looking at the effect sizes, Li et al.’s study produced powerful numbers with more than 2-fold changes in risk. But if you look at the absolute numbers, only 782 out of 739,066 (0.106%) vaccinated and 209 out of 739,066 (0.028%) unvaccinated people developed RVO at two weeks (Figure 1). This gives an excess of 573 RVO cases (0.077%). In other words, 1,300 people have to get the vaccine for 1 excess case of RVO to occur.
If we use Dorney et al.’s study instead, 45 out of 1.18 million (0.004%) people who got the 1st mRNA vaccine dose developed RVO. This rate is not significantly different from other vaccines. Then, 93 out of 1.18 million (0.008%) people who got the 2nd mRNA vaccine dose developed RVO, contributing to an excess of 48 RVO cases (0.004%). This means that 25,000 people have to get the vaccine for 1 excess case of RVO to occur.
If we take the average RVO incidence from Li et al.’s and Dorney et al.’s studies, it means 1 excess case of RVO will occur for every 13,150 vaccinated people — not a huge risk.
To close
The risk or rate of RVO following the mRNA vaccine has to be interpreted in light of the vaccine’s benefits and be compared to the risk of RVO from Covid itself. Covid vaccines confer important benefits, most notably in cutting the risk of severe Covid and its health consequences, such as long Covid and cardiovascular and neurological complications.
RVO is also one of the numerous complications of Covid. A 2023 study, also published in JAMA Ophthalmology, reported a 1.5-fold increased risk of RVO following Covid. Though this risk appears lower than that of the vaccine — based on the results of Li et al. and Dorney et al. — it’s tricky to compare studies of different sample sizes and methodologies.
Unfortunately, neither Li et al. nor Dorney et al. analyzed RVO risk in Covid-infected vs. -uninfected groups. This is a major limitation that prevents us from grasping the actual significance of their studies.
All in all, new emerging data has discovered yet another risk of mRNA vaccine, i.e., RVO (retinal vascular occlusion). But because such data stems from one database only, i.e., TriNetX, it’s still too early to make a definitive conclusion, more so given that no solid mechanistic basis exists and that unmeasured confounding can’t be ruled out.
Even if the association between mRNA vaccines and RVO truly exists, the effect size is not huge, and it’s unlikely to outweigh the benefits of vaccination, especially in populations at risk of severe Covid.
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