The Precautionary Principle
The FDA's refusal to review Moderna's mRNA influenza vaccine application, marked by increased and more stringent scrutiny, illustrates the precautionary principle. This approach prioritizes the avoidance of potential risks, especially in public health, even if it means slowing down or rejecting innovative solutions. The decision to overrule career scientists suggests a leaning towards heightened caution over pure scientific consensus, reflecting a trend of greater vigilance in vaccine approvals amidst public concerns.
The Long Shadow of Caution
The recent news that the FDA declined to review Moderna's mRNA flu vaccine application, a decision reportedly overriding career scientists, might seem like a mere bureaucratic hiccup. Yet, underneath this administrative refusal lies a profound philosophical commitment, one that has shaped human endeavor for centuries: the Precautionary Principle. It’s a concept that whispers, and sometimes shouts, better safe than sorry, even when "sorry" is a nebulous, unproven risk.
At its heart, the Precautionary Principle suggests that when an action or policy has a suspected risk of causing harm to the public or the environment, in the absence of scientific consensus that the action or policy is not harmful, the burden of proof that it is not harmful falls on those proposing it. It’s a shift from innocent until proven guilty to guilty until proven innocent in the realm of potential harm. Its roots can be traced to 1970s Germany, with the Vorsorgeprinzip, meaning "fore-caring" or "foresight principle," initially applied to environmental protection.
Why does this idea resonate so deeply, recurring across disparate fields from environmental policy to financial regulation, and now, vaccine approval? Perhaps it's an ingrained human aversion to unknown unknowns, especially those with the potential for catastrophic or irreversible consequences. We are, by nature, pattern-seekers and risk-avoiders, and the specter of a future regret can be a powerful brake on present action.
Consider the tragedy of Thalidomide in the late 1950s and early 60s. This sedative was initially approved in many countries with insufficient testing, leading to thousands of babies born with severe birth defects. The ensuing global outcry, and the subsequent strengthening of drug approval processes, particularly in the US where Frances Oldham Kelsey famously resisted its approval, serves as a stark reminder of the cost of lacking precaution. It instilled a deep-seated vigilance within regulatory bodies, a collective memory that still influences decision-making today.
The FDA's heightened scrutiny of mRNA vaccines, even for a familiar foe like influenza, reflects a world still reeling from a pandemic and wary of rapid innovation. Vinay Prasad's reported decision to overrule career scientists points to a deliberate shift, a choice to err on the side of caution, even if it means slowing the march of medical progress. It’s a reflection of public concerns, amplified by the speed of COVID-19 vaccine development, and a regulatory body responding to perceived needs for greater assurance.
This raises a fundamental tension: In a world demanding both safety and speed, how do we calibrate the delicate balance between the promise of innovation and the imperative of precaution? When does an abundance of caution become a barrier to progress, and when is it a necessary safeguard against unforeseen catastrophe?