Politicizing public health: the powder keg of rushing COVID-19 vaccines

ABSTRACT

Vaccine hesitancy is on the rise, as more individuals are delaying or refusing vaccines. This rise in hesitancy has been primarily driven by vaccine safety concerns, even though the vaccine development process is regulated by a robust and rigorous scientific system. Recent data suggest that many individuals would be unwilling to take a COVID-19 vaccine, once one is available. The Trump administration’s Operation Warp Speed aims to deliver a vaccine in the near future, even though no American or European COVID-19 vaccine has yet completed Phase 3 trials. The administration has used the emergency use authorization mechanism to fast track therapeutic products through the Food and Drug Administration and has not ruled out using the mechanism to fast track a COVID-19 vaccine. Perceived political pressure to push a COVID-19 vaccine will have a multitude of negative consequences. Not only will it lead to sub-optimal levels of vaccine acceptance toward a COVID-19 vaccine, it will reverse progress made in controlling vaccine preventable disease for years to come.

KEYWORDS:

• COVID-19 vaccines
• vaccine safety
• vaccine acceptance
• vaccine approval
• vaccine hesitancy

Despite a remarkable history of successful disease control through the use of safe and effective vaccines – driven, critically, by high rates of acceptance –, global vaccine hesitancy and anti-vaccination sentiment have been steadily growing since the late 1990s. Increasing numbers of people are delaying or outright refusing vaccination for themselves and their children. This trend has coincided with growing concerns about vaccine safety,¹ despite a robust regulatory process to ensure that licensed vaccines are both safe and effective. These concerns are now being further amplified during the current COVID-19 pandemic and its accompanying uncertainty.

The Trump administration’s Operation Warp Speed aims to deliver at least 300 million doses of safe and effective COVID-19 vaccines, equating to just under half of the American population potentially immunized under a two-dose regimen. During the recent GOP convention, President Trump pledged that Operation Warp Speed would successfully deliver a COVID-19 vaccine before the end of the year, if not sooner. Despite these promises, as of early November, no American or European vaccine against COVID-19 has yet completed Phase 3 trials, a crucial step in vaccine development that assures the vaccine has been proven both safe and efficacious before it advances in the regulatory process.

As vaccine scientists, we are alarmed. We are concerned that political pressure could lead to premature and potentially dangerous approvals – in the absence of complete clinical trial data – under the emergency use authorization (EUA) mechanism. This mechanism has been used by the U.S. Food and Drug Administration (FDA) to allow rapid access to therapeutics. There is precedent of the FDA using EUA in the COVID-19 context: EUAs were issued for convalescent plasma and hydroxychloroquine,² based on limited data and apparent political pressure. However, the use of an EUA to fast-track a COVID-19 vaccine to be delivered to healthy individuals in the absence of adequate safety data, particularly to meet political rather than regulatory requirements, is reckless. It was reported that, as of October, the FDA intends to take an appropriately tough line on the evidence required to support EUA of COVID-19 vaccines. However, the Trump administration continues to suggest that a vaccine will be ready imminently, raising concerns that the FDA will succumb to pressure from the White House to grant an EUA for COVID-19 vaccines.

We are not opposed to the use of an EUA. On the contrary, EUAs have been essential in public health emergencies,³ including a vaccine during the 2014 Ebola outbreak. To appropriately grant an EUA, it is essential that nonpartisan scientific experts and agencies carefully assess the balance of risks and benefits – weighing the health, economic, and social risks of unmitigated disease spread (in the absence of a safe, effective vaccine) with those of a vaccine developed through an abbreviated clinical trial and approval process.

The potential fallout from using an EUA for political gain is multifaceted. Many Americans already have concerns about potential COVID-19 vaccines. Epidemiologists estimate that approximately 70% of the population will need immunity, either through vaccination or natural infection, to turn the tide on the pandemic. In May 2020, approximately 67% of people in the United States indicated that they intended to receive a COVID-19 vaccine.⁴ By September, that had shifted substantially: a USA Today/Suffolk poll found that two-thirds of US voters indicated that they will not get a COVID-19 vaccine as soon as it is available, and one in four indicated that they intended to never get one. This lack of confidence suggests we will likely struggle to reach the critical 70% immunity threshold through vaccination.

Prior to the pandemic, public health agencies were struggling to combat organized efforts, largely spread through social media, to undermine vaccine confidence. The tsunami of COVID-19 misinformation shows no signs of abating.⁵ Coupled with falling vaccination rates against several infectious diseases, the World Health Organization declared vaccine hesitancy as one of 10 major global health threats in 2019. Any COVID-19 vaccine will face additional hurdles to acceptance, including the lack of a long-term safety record. The perception of a rushed vaccine development process will likely feed into vaccine safety concerns. Furthermore, if found to be ineffective or, worse, harmful, fast-tracking a COVID-19 vaccine to meet political timelines could produce such tremendous damage to vaccine acceptance that it could disrupt vaccination programs for generations and derail decades of progress against serious infectious diseases.

Innovative approaches focused on understanding vaccine safety and efficacy are essential to achieving shorter vaccine development timelines. This is acutely true in the current pandemic. Such innovative approaches should, for example, utilize enhanced surveillance to rapidly assess data on adverse events that could possibly be associated with vaccination; we have already seen this in action, as clinical trials for two COVD-19 vaccine candidates were appropriately paused following suspected adverse events to allow for full investigation. Decision-making related to trial protocols must be transparent and overseen by impartial, independent advisory boards.⁶

We are at a critical juncture. There is an urgent need to produce COVID-19 vaccines that are both safe and effective, yet the administration’s rush to produce a vaccine for political gain has undermined the country’s public health agencies. Over the last seven months, public health has repeatedly taken a backseat to political priorities.

While we are concerned about how undercutting the scientific process could affect vaccine acceptance, the broad-reaching effects on science generally are even more alarming. We must preserve the scientific process, including safeguarding the rigorous clinical trial requirements that have assured that vaccines reaching the public are both safe and effective. A COVID-19 vaccine must be free from political pressure. We are already facing a crisis – living in a fact-resistant world that distrusts and doubts science⁷ – and putting a COVID-19 vaccine on the market with incomplete clinical trial data that can be perceived as politically motivated will only erode public health efforts further, with the potential for lasting effects for years to come.

Disclosure of potential conflicts of interest

The authors confirm that there are no known conflicts of interest associated with this publication.