Over the last eight to nine weeks, the Delta wave of the COVID-19 pandemic has caused a surge of infections, hospitalizations and deaths in America. With as many as 150,000 new infections, 100,000 in hospitals and close to 2,000 deaths from COVID-19 each day the pandemic is not under control. More than 90 percent of cases, hospitalizations and deaths from COVID-19 are now occurring among unvaccinated individuals. Clearly, vaccines are our best tool to limit the impact of COVID-19, and thus finding a way to vaccinate the nearly 80 million eligible Americans who remain unvaccinated is a national priority. Key to doing so is vaccinating the unvaccinated.
On Sept. 9, President Biden announced a six-pronged national strategy as a path to ending the pandemic. Since the first mRNA vaccine was granted Emergency Use Authorization (EUA) by the Food and Drug Administration (FDA) last Dec. 11 the U.S. has administered over 456 million doses of COVID-19 vaccines. As a result, 53.8 percent of the total population is fully vaccinated. Unfortunately, this is not sufficient. Sadly we have one of the lowest vaccination rates among the world’s wealthiest democracies. In addition, the percent of the population vaccinated varies from state to state from 69.77 percent in Vermont to 40.05 percent in West Virginia.
Hoping to vaccinate the roughly 80 million Americans who are still not vaccinated, Biden is requiring vaccinations for healthcare workers, federal employees and employers with 100 or more employees. His plan faces an uncertain reception among some Americans. The approximately 80 million eligible Americans still unvaccinated are not a homogenous group. They include those who have stated they will definitely not take the vaccine, who want to “wait and see,” and a small group that say they will get vaccinated if the vaccine were mandated. Those firmly opposed to getting the vaccine are overwhelmingly non-Hispanic white adults. They are much more likely to be insured and are more likely to identify as Republican. This explains why, in response to Biden’s announcement, several GOP governors immediately voiced their opposition calling it an “unconstitutional overreach” by the administration.
So, are vaccine mandates unconstitutional?. No, in 1902, facing a smallpox outbreak in Cambridge, Mass. board of health ordered that city residents who were 21 and older be vaccinated. When a local pastor was fined $5 for violating the mandate, he appealed his case all the way to the Supreme Court. In Jacobson v. Massachusetts, the Supreme Court upheld the local board mandate. Today, as a result, States can legally mandate children to be vaccinated for daycare and school entry. This is critical to maintain high vaccination coverage and lower the risk of vaccine-preventable diseases. However, mandating the COVID-19 vaccine faces additional challenges.
First, only the Pfizer-BioNTech vaccine has received full FDA approval, which means that the Moderna and Janssen/Johnson & Johnson vaccines are still under an Emergency Use Authorization (EUA). Can a vaccine that is under an EUA be mandated? Recently the Justice Department released an opinion stating that federal law does not prohibit businesses from requiring vaccines if the vaccines are being administered under an EUA.
Undoubtedly, there will be workers who file for medical and/or religious exemptions to vaccination. Legitimate medical exemptions are very uncommon. In fact, only a history of a severe allergic reaction (anaphylaxis) to one of the components of the vaccine is accepted by the FDA as a reason not to be vaccinated. Allergic reactions to the vaccine are extremely uncommon with a rate of 2 to 5 per million doses and thus medical exemptions are unlikely to be granted to most who request them.
Religious objections are the most likely way in which workers decline to be vaccinated. Under the federal Civil Rights Act of 1964, employers are required to provide reasonable accommodations for employees who have “sincerely held” religious beliefs that conflict with work requirements. In the case of the COVID-9 vaccines, major religious denominations have been unanimous in their support of vaccination with Pope Francis calling on all Catholics to be vaccinated as an “act of love.” The review of doctrine from major religions suggests that religious exemptions for vaccination are simply and insincerely using religion to avoid vaccination. Nevertheless, many who object to vaccination are citing personal religious beliefs as their major reason. Legal challenges to vaccine mandates citing religious objections to vaccination will likely end up in the Supreme Court.
So far, courts have upheld vaccine mandates. The first case was brought against Methodist Hospital in Houston where a federal court in Texas declared the mandate legal. The only case that has reached the high court is that of a group of students against Indiana University where Supreme Court Justice Amy Coney Barrett denied the request for an emergency relief from a ruling issued in favor of the mandate by the U.S. 7th Circuit Court of Appeal. Finally, 10 states have already enacted laws that prohibit vaccine mandates. This is likely to result in a court challenge of state versus federal rights.
In summary, vaccine mandates are critical if we are to end the pandemic but their impact will not be soon enough to make a difference. It is important that courts and legislation fully understand that to undermine them is to continue to allow COVID-19 to flourish. Additional measures could be helpful as well, for example mandating vaccination as a requirement for travel, as the European Union has already done and providing guidance and funding for proof of vaccination systems that are better than a piece of cardstock. For that reason, it is important that other measures in the president’s plan get implanted quickly including more masking and better access to testing.
Carlos del Rio, M.D., FIDSA, is vice president of the Infectious Diseases Society of America. He is a professor of medicine at Emory University School of Medicine and of global health and epidemiology at Emory’s Rollins School of Public Health, principal investigator and co-director of the Emory Center for AIDS Research, and co-principal investigator of the Emory-CDC HIV Clinical Trials Unit and Emory Vaccine and Treatment Evaluation Unit. He is also the international secretary of the National Academy of Medicine and the Chair of the PEPFAR Scientific Advisory Board. Follow him on Twitter: @CarlosdelRio7