Robert M. Kaplan and Diana Zuckerman, Ph.D., Monterey Herald: April 26, 2021
Last week, the University of California and the California State University system proposed mandating COVID-19 vaccines for faculty, staff, and students beginning in the fall. Only those with medical conditions aggravated by vaccination or those with legitimate religious objections would be excused. The policy is consequential: Public university students, faculty and staff include nearly 1,000,000 Californians. But is the mandate feasible? And, should the California universities dive headfirst into what promises to be a complicated controversy?
With waning competition for shots, public health officials now worry about vaccine hesitancy. Lower vaccination rates give more opportunities for variants to develop and could make the pandemic last longer. We all benefit when more people are vaccinated. Yet, national polls by Stanford and YouGov show that about 20% of Americans will refuse to be vaccinated, and one in three estimate their likelihood of getting vaccinated is below 50%. Only 20% strongly agree that vaccines should be mandated and 45% report that vaccinations should be strictly voluntary.
Requiring vaccinations may be legal. Since 1905, courts have consistently upheld vaccination mandates, but with some exemptions. Although 50 states and Washington D.C. can require vaccines for primary schools, all states allow medical exemptions. Further, 45 states permit religious exemptions and 15 recognize philosophical objections. Only 16 states allow post-secondary institutions to require vaccinations for influenza or hepatitis B.
Despite these precedents, the UC/CSU proposal could be derailed because current CDC policy only allows mandates for vaccines approved by the Food and Drug Administration. Technically, no COVID vaccine is currently approved. Instead, the three vaccines have been authorized under a different vetting mechanism called Emergency Use Authorization. Unlike FDA approval, EUA is a temporary agreement that allows medical products to be used in emergency situations based on FDA’s determination that the benefits “may” outweigh the risks. That requires a less rigorous standard of evidence than FDA approval. Before the pandemic, EUAs were only used to speed emergency treatments to a relatively small number of people threatened by Ebola, Zika, and anthrax.
To be fair, each of the three authorized (but unapproved) COVID vaccines underwent rigorous testing in large studies. However, the FDA had announced that full approval of these vaccines would require following study participants for “at least one to two years.” For the EUA’s, FDA permitted just two months of follow-up and stated that while two months was the minimum to determine safety, it wasn’t sufficient to determine how long the vaccines would be effective.
With the EUAs in hand and bolstered by promising early results and extremely high demand for vaccines, companies had no incentive to continue the trials. Despite advice by scientists to continue studies with the inclusion of a control group, all three companies provided the vaccine to participants who had received a placebo. The ethical reasons for this are obvious; however, the consequence is that a rigorous evaluation of the long-term benefits and side effects is no longer possible in the absence of a placebo control group.
What do we know about safety? 137 million Americans have had at least one dose of the vaccine. Although at least half have experienced bothersome reactions, very few have reported serious side effects that resulted in permanent damage or death. The FDA and CDC have two systems to track real-world reactions. V-SAFE is an app that regularly asks vaccinated individuals to report any health problems. Unfortunately, very few individuals use it. The other system, the Vaccine Adverse Event Reporting System (VAERS) is designed for health care providers to report bad reactions to vaccines. As with V-SAFE, reporting is not enforced and therefore reactions are under-reported. The current systems are limited because they were not designed to accurately determine how many people experience adverse events.
UC/CSU should be commended for proposing a bold strategy to address a serious problem. A mandate to vaccinate university communities could turn the campuses into COVID safe zones. However, it is likely to encounter serious legal challenges if none of the vaccines are FDA approved before the mandate is implemented. Instead of waiting for the FDA to deny approval for insufficient evidence, the UC and CSU systems could use their exceptional creativity and research capability to produce better evidence that would inform the FDA about the long-term scientific safety and effectiveness of the vaccines.
Robert M. Kaplan is a faculty member at Stanford University’s Clinical Excellence Research Center and a former Associate Director of the National Institutes of Health. Diana M. Zuckerman is the President of the Washington DC-based National Center for Health Research. She is an expert on the safety and effectiveness of medical products. You can view the original article here.