Flexible approaches used to accelerate COVID-19 vaccines deserve wider uptake.
Within ten months of scientists identifying SARS-CoV-2, the European Commission and the US Food and Drug Administration (FDA) had authorized vaccines for emergency use, thus beginning immunization programmes that are saving many lives. Regulatory approval for vaccines usually takes ten years. Much of the speed was achieved by prioritizing COVID-19 programmes; another innovation was allowing human studies to begin before all standard animal tests had been concluded.
The critical need and clamour for COVID-19 vaccines necessitated an abridged regime of animal testing of the candidate vaccines, instead relying more heavily on lab-based tests and other techniques (3D cell cultures, organoids, bioprinted tissues, computer models). Regulators approved this because of the urgency. This Nature piece discusses the argument for continuing the abridged animal testing for future pharmacological agents. It is time regulators updated their expectations in light of the advances in testing technology and the limitations of using animal models to predict what will happen with humans.
I’m a veterinary physician who specializes in systematic reviews and integrating multiple lines of evidence. Over 15 months, a team and I interviewed regulators, industry scientists and other experts, and examined more than 150 regulatory filings concerning human testing and emergency approval for COVID-19 vaccines, to see how regulatory scientists considered ways to maintain human safety while breaking with tradition (see go.nature.com/3vxw1za).
This mindset should now be applied more broadly. Introducing alternatives to animal testing could, in my view, produce better medical products and reduce the cost and time to bring them to market.