A New Charge for Public Health: Prevention of SARS-CoV-2 Vaccine Politicization

Posted on May 29, 2020 by jphmpdirect

by Toby D. Terwilliger, MD

As several promising SARS-CoV-2 vaccines enter into Phase II and III clinical trials, it is incumbent on physicians and public health officials to keep the public informed regarding the requisite process of vaccine development. It is eminently imaginable that we may find ourselves in a situation where certain politicians pressure the FDA, pharmaceutical companies, and physicians into sanctioning an incompletely tested vaccine for political expediency. And the media frenzy and public misgivings that follow will be nearly impossible to navigate unless physicians and public health officials lay the groundwork now with a proactive messaging campaign. We saw a similar phenomenon with hydroxychloroquine. But with a vaccine, the stakes will be exponentially higher. We cannot allow civic unrest spawned from misguided politicians to get in the way of scientific modus operandi, lest we recreate the tragedies of past vaccines-gone-wrong.

In 1954, at the height of the Salk-Sabin race for a polio vaccine, a pharmaceutical company called Cutter Laboratories produced 120,000 doses of contaminated polio vaccine. Due to pressure from the industry, politicians, and the public, the NIH Laboratory of Biologics Control (now the Center for Biologics Evaluation and Research [CBER] of the FDA) rushed the inspection of the vaccine lots and missed a contamination with live virus, resulting in 40,000 children being infected with polio. In one of the largest pharmaceutical disasters of all time, 188 people were paralyzed by vaccine-strain polio and 10 died¹.

Eleven years later, researchers at the NIH administered 219 doses of vaccine against respiratory syncytial virus (RSV) to infants and children. Instead of providing protection against RSV, the vaccine resulted in an increase in RSV infections and a 16-fold higher rate of hospitalizations, due to an immunologic phenomenon known as “enhancement².” Two infants died as a result.

Fortunately, adverse events like these are the exception rather than the rule when it comes to vaccine development. But we can and must learn from them. We must maintain a unified, clear message to the public that conducting systematic, robust clinical trials is paramount to ensuring the safety of widely circulated vaccines. If we do not and a SARS-CoV-2 vaccine is widely distributed before it is thoroughly tested, the consequences could be severe.

Let’s say that a SARS-CoV-2 vaccine has an adverse event that is relatively uncommon (~1 in 1000). A Phase II trial (usually <1,000 patients) is unlikely to pick up such an event, while a Phase III trial (10,000s – 100,000s patients) has much greater power to do so. If the vaccine were administered on a broad scale (say 100 million people) before Phase III trials were completed, 100,000 people could suffer this “uncommon” event. If this event is death, then that would mean 100,000 people could be killed by the vaccine. This is why clinical trials exist, to prevent this kind of suffering.

With the timing of Phase II/III trials coinciding with the run-up to the November elections, there will be immense temptation for politicians to push the FDA to issue an Emergency Use Authorization (EUA) for political gain. Who can blame them? We all desperately want a solution to this pandemic. An EUA for a vaccine in and of itself is not necessarily dangerous; conversely, it is highly likely that vaccines will be issued on an emergency basis on a small scale to communities with large outbreaks before they are formally approved by the FDA. But we must ensure that such EUAs are produced from rigorous scientific inquiry, restricted to the highest risk communities, and not influenced by political pressure.

We cannot wait until a presidential tweet or an armed protest forces us into action. By investing in a strong public health campaign now, we can prevent public uncertainty and a dangerous backlash against the medical community in the fall.

References:

Juskewitch JE, Tapia CJ, Windebank AJ. Lessons from the Salk polio vaccine: methods for and risks of rapid translation. Clin Transl Sci. 2010;3(4):182‐185. doi:10.1111/j.1752-8062.2010.00205.x
Acosta PL, Caballero MT, Polack FP. Brief History and Characterization of Enhanced Respiratory Syncytial Virus Disease. Clin Vaccine Immunol. 2015;23(3):189–95. Epub 2015/12/18. doi: 10.1128/CVI.00609-15. PubMed PMID: 26677198; PubMed Central PMCID: PMCPMC4783420.
“Vaccine Testing and Approval Process.” Centers for Disease Control and Prevention, Centers for Disease Control and Prevention, 1 May 2014, http://www.cdc.gov/vaccines/basics/test-approve.html.