The race to find a cure for SARS-CoV-2, the virus that causes COVID-19, is heating up around the world as countries battle to see which one can produce a winner first. While Russia announced it has a vaccine that it expects to be approved this month that it plans to administer in a mass vaccination campaign in October, the Chinese military has already approved a “specially needed drug” in June for limited military use. It normally takes ten-plus years to develop a vaccine that is safe and effective, but the stakes to be first are high, particularly, it would seem, between the US, Russia, and China. Trump has repeatedly promised his administration would have a drug by the end of the year, but more recently, he has said he’s optimistic that a vaccine will be available even sooner, perhaps sometime around the US election in November. If Operation Warp Speed, his $10 billion vaccine initiative, is successful, he stands to gain politically.

Heidi Larson, Director of the Vaccine Confidence Project at the London School of Hygiene and Tropical Medicine, recently told Reuters, “[F]ast is good for politicians. But from the public perspective, the general sentiment is: ‘too fast can’t be safe’.”

And that is precisely what has some scientists concerned that federal regulators may be put under extreme political pressure to approve a drug that isn’t safe or effective. Others worry that even if a vaccine is carefully vetted, it may not be long-lasting or effective in ending the pandemic. A recent article in the New York Times that breaks down the vaccine testing process summarizes the status of drugs currently in development, and while it’s clear that in some cases steps are being combined (Phase I and II trials), we must ensure that none are skipped and that no rules are bent.

At a recent Congressional hearing, top US infectious disease expert Dr. Anthony Fauci offered some assurance that the US is not likely to use a vaccine developed in Russia or China, where regulations are less transparent than in the US. “I do hope that the Chinese and the Russians are actually testing the vaccine before they are administering the vaccine to anyone,” he said. “We are going very quickly. I do not believe that there will be vaccines, so far ahead of us, that we will have to depend on other countries to get us vaccines.”

In 2019, the World Health Organization identified vaccine hesitancy as one of the top ten global health threats, which makes public mistrust another concern for public health officials. A recent Gallup poll indicates that 35% of Americans wouldn’t get a free, FDA-approved COVID-19 vaccination if it were available today. As urgent as it is to develop a vaccine, it’s important to remember that any vaccines that don’t live up to their promises may actually further erode public confidence.

At the same time, we would be wise to remember the history of recent vaccination mishaps. The 1942 hepatitis B epidemic in the US Army during the first year of World War II is an historical reminder that policy decisions made by health experts can go awry. Yellow fever never occurred in either Axis or Allied troops during the subsequent war years, but tropical disease experts argued for the use of the vaccine, resulting in tens of thousands of cases of HBV infection. Although the resultant epidemic has faded from contemporary thought, major new policy decisions should be aware of Robert Burns’ timeless admonition about the best-laid plans of mice and men. Read: The Yellow Fever Vaccine Misadventure of 1942 by Dr. John Marr in the Journal of Public Health Management and Practice.

“Along with chlorination, pasteurization and sanitation,” Dr. Marr said in an email, “immunization has been one of the most successful tools in the history of public health — but some were serious failures. The 1955 Cutter polio vaccine mishap caused polio; in the mid-1960s an attenuated measles led to the atypical measles syndrome; the 1976 swine flu initiative may have been responsible for an epidemic of Guillain-Barré syndrome; in 2017 a Philippine dengue fever vaccine induced hemorrhagic dengue syndrome in recipients when they contracted a natural dengue virus; in 2001 a Lyme disease vaccine was withdrawn because of serious side reactions. Untoward and unexpected sequelae of immunizations have a long undistinguished history but a little known adverse vaccine-associated epidemic in 1942 was the largest in our country’s history.”

A new JAMA Viewpoint by Shah, Marks, and Hahn provides some reassurance that the FDA is aware of these concerns and has issued guidance, summarized below, to help ensure the safety and efficacy of any new COVID-19 vaccine that will be used widely in the US. 

• Clear recommendations around efficacy thresholds — “[T]he primary efficacy endpoint point estimate for a placebo-controlled efficacy trial should be at least 50%, and the statistical success criterion should be that the lower bound of the appropriately alpha-adjusted confidence interval (CI) around the primary efficacy endpoint point estimate is >30%.”
• Population diversity in clinical trials to ensure a comprehensive assessment of product safety and effectiveness to properly inform decision making, which includes disproportionately affected populations such as racial and ethnic minorities, older adults, and individuals with medical comorbidities.
• Safety considerations prior to the initiation of most large-scale COVID-19 vaccine trials, including postmarket surveillance such as the FDA’s Vaccine Adverse Event Reporting System and the Sentinel Initiative, coupled with existing federal collaborations on vaccine safety to ensure that infrastructure is in place for pharmacovigilance, especially for certain subpopulations.

Vaccines have made the world safer and healthier. Immunizations are critically important to the elimination (or near elimination) of infectious diseases such as smallpox and polio and help to reduce seasonal flu and other viruses. Still, it’s imperative that we heed the lessons of past vaccine misadventures as we work quickly and carefully to develop a new vaccine for COVID-19 that the public can trust.

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