Time for an Ethics Refresh?

Imagine it is the year 2025. The Covid-19 pandemic is now a few years behind us with the whole world having been vaccinated successfully. Life is returning to normal, even as global travel has not quite returned to pre-2020 levels.

And then imagine that in January of 2025 news emerges of a novel coronavirus outbreak in Uganda. Within weeks it becomes clear that the new virus, previously not found in humans, is spreading rapidly, and may have a case fatality rate that is higher than that of Covid-19. The world starts bracing for a new pandemic.

Meanwhile, scientists announce that they have, using the widely available viral sequence, created an mRNA vaccine that they believe will be safe in humans, and efficacious.  We can have phase 1 and phase 2 safety trials completed by May. A large-scale, phase 3 effectiveness trial, enrolling tens of thousands of volunteers, will deliver results by December 2025.

Having developed an efficacious and safe mRNA vaccine to deal with Covid-19 in 2020, should we be moving ahead with mass vaccine administration ahead of having completed a phase 3 trial in 2025? We could save hundreds of thousands of lives, and spare the economy another year of shut-down even as, of course, we incur some risk. Clearly the answer today in most western democracies, at the moment, would be no. It has been a foundational tenet of vaccine implementation that we want to ascertain mass safety and effectiveness before we distribute to the wider population.

But in 2020 Russia and China took a different approach. The two countries developed, respectively, the Sputnik-V and Sinovac vaccines, and proceeded with mass vaccination, likely reaching millions of people, well before the end of the vaccines’ phase 3 trials. The vaccines have had variable efficacy, although the former has efficacy and safety now confirmed to be comparable to the vaccines adopted in the west. The Russian and Chinese efforts to vaccinate their populations before the completion of their Covid-19 phase 3 trials were largely met by skepticism (and worries about coercion) in the western press and academic conversations.

Our ethical norms about when we should deploy biological solutions to novel viral assaults have changed before. During the AIDS epidemic, in no small part thanks to ACT UP activism, our system of regulatory approval, what we considered to be ethical, was shaken up, rethought. We established pathways for much faster delivery of life-saving drugs that were being held up by our pre-AIDS standards.

Is it time for new, post-Covid-19 ethical standards for how we approve and deploy vaccines?

Perhaps. In some ways we are too close to the heat of the moment to evaluate this clearly. But it seems to us that there is much to learn from this vaccine rollout, and that it is reasonable to ask: how many lives could we have saved, how much faster could we have restarted our economy, had we started mass vaccination as China did in July instead of December 2020, with informed consent laying out what we still did not know?   The time to think carefully about our ethics will be before, not during, the next pandemic.

 

Warmly,
Michael Stein & Sandro Galea

As we re-emerge from the pandemic, 2021 stands to be a turning point year for public health. In The Turning Point’s weekly essays, we reflect on what we learned during 2020, and what we are learning during 2021, that can guide us to the creation of a better, healthier world.

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