Editor’s Note: Although cases of post-vaccination myocarditis have been identified, the risk of post-COVID-19 infection myocarditis is higher than the risk of post-vaccination myocarditis, according to Chief Campus Health Officer Madeline Wilson. 

On Oct. 27, 2022 the University administration announced that the COVID-19 bivalent booster would be required for all students, but not faculty or staff, by the spring semester. The news took me by surprise. Unlike Yale’s previous COVID-19 vaccine mandates, the bivalent booster requirement preceded any evidence supporting its clinical benefit. Moreover, while the benefits of boosting were unknown, the potential harms, including the elevated risk of myocarditis in young men, were clear. The University should rescind their bivalent booster requirement and provide a transparent and logical explanation of how mandate decisions are made. 

The COVID-19 pandemic severely disrupted student life in the spring of 2020. That same fall, news that Pfizer and Moderna had successfully developed effective vaccines offered hope that the public health emergency might soon end and university life could return to normal. Persuaded by the clear clinical evidence, many Yale students, myself included, eagerly received their shots. When Yale mandated the vaccine in the summer of 2021, I had no qualms. Evidence from randomized control trials demonstrated that the vaccines were the best way for students to protect themselves from severe COVID-19.

In late 2021, after breakthrough cases began to emerge and it became clear that these vaccines would not block transmission, Yale mandated an additional booster dose. Experts realized that these vaccines would not provide lasting, sterilizing immunity, but the decision to mandate boosters was supported by data from a randomized control trial which demonstrated that a third dose could prevent severe disease. Yale’s previous mandates gave students the impression that the University would require additional vaccines only after they were proven to provide an absolute benefit to students’ health.

Unfortunately, the bivalent booster mandate did not meet this standard. There is no evidence that young people receive a meaningful clinical benefit (reduction in severe disease or hospitalization) from the bivalent booster. Indeed, noting “uncertainty in the evidence of advantages and disadvantages” for the bivalent booster, Canada’s National Advisory Committee on Immunization does not recommend this booster for otherwise healthy young people. Likewise, Paul Offit, member of the FDA’s Vaccines and Related Biological Products Advisory Committee and one of the country’s top vaccine experts, has similarly questioned the logic of continually boosting young, healthy people given that the primary series continues to protect this population from severe disease.

In the months since Yale’s bivalent booster requirement was announced, the administration has attempted to retroactively cite a rationale for their decision. A recent email directs readers to a FAQ page to support the efficacy of the new bivalent vaccine. The page references two observational case-control studies published by the CDC in December (two months after Yale’s mandate was announced). Neither study provides sufficient evidence to support that the updated booster provides additional protection to a young student population that has received at least three previous doses and many of whom contracted COVID-19 last semester.

Randomized control trials are the gold standard for determining benefits associated with medical interventions, and it is not unreasonable for the university to wait for such evidence before enacting mandates, especially in non-emergency settings. Better yet, Yale and its professors should use their powerful and expert voices to demand Pfizer conduct these trials.

In absence of evidence suggesting a meaningful clinical benefit, a vaccine mandate might be justified in an attempt to limit disease transmission on campus. However, there is no data to suggest that the bivalent booster will prevent community spread. Past experience has revealed that while the COVID-19 vaccines provide long-lasting protection against severe disease, any protection against infection or transmission is temporary. Therefore, the university must answer why potential short-lived protection from mild infection outweighs the risk of myocarditis and other vaccine-associated adverse events. Is a mild infection in January worse than a mild infection delayed until March? 

Finally, while a meaningful clinical benefit or community benefit should be the absolute minimum prerequisite for a mandated medical intervention, it is not sufficient. The university must balance any potential benefits against the risks of adverse events and the moral harms of medical mandates. The administration ought to publicly present their case that the benefit of a bivalent booster outweighs these harms. 

As one of the country’s preeminent institutions of higher learning, Yale should lead by example and demand sound science before making intrusive and potentially harmful policy decisions. The administration should repeal their bivalent booster requirement and admit that they acted irresponsibly and in haste by mandating students accept a new vaccine with known harms and unproven benefits.

MATHIAS SKADOW is an Immunobiology PhD candidate in the Graduate School of Arts and Sciences. Contact him at mathias.skadow@yale.edu.