Animal Testing Perspective

Ever since Edward Jenner inoculated an eight-year-old boy against smallpox using the pus from a milkmaid’s cowpox blister, animals have been central to vaccination.

That was 1796. More than 200 years later smallpox has been eradicated and deaths caused by infectious diseases like diphtheria, tetanus and polio have been slashed. The benefits for humans have been immense but this progress has come at the cost of literally millions of animals.

We can now be vaccinated against dozens of lethal illnesses but each of these has been developed thanks to animal research and testing. What’s more, guaranteeing the safety and quality of vaccines currently involves testing every batch of vaccines produced on animals.

The upshot is that vaccine quality control accounts for between 10% and 15% of the 100 million or more animals used in laboratories every year. Obviously, this is a very large number so the appetite for alternatives is high.

As well as reducing the number of animals required in line with the 3Rs, finding new ways to make sure vaccines work and are safe could save money and time. Vaccines have relatively short shelf-lives so getting them to doctors and patients without undue delay is essential. The trick is to find non-animal tests without compromising on safety.

At the recent EPAA conference in Brussels, Coenraad Hendriksen of the Netherlands Vaccines Institute, outlined a radical solution which could dramatically change the way vaccines are quality tested. At present, each individual batch of vaccine – produced by manufacturers is tested on animals.

In his presentation, he explained the potential of the ‘consistency approach’ to quality control. In essence, this means moving away from testing every batch. Instead, scientists would test a few batches of vaccine on animals and then apply non-animal tests to batches made with the same starting material.

The aim would simply be to test that the subsequent batches were ‘consistent’ with the original batches which were tested on animals. Some animals would still be needed at the start of the process but the impact of moving to this method could be huge.

So why hasn’t it already been done? Well, partly the answer is normal human inertia: we’ve done it this way for ages and change is never easy. Another reason is that regulators would need to accept this ‘consistency’ testing instead of the current animal-intensive methods. That’s why, as Susanna Louhimies of the European Commission’s environment directorate said at the EPAA event, it’s essential that industry and global regulators work together on this.

Work on the consistency approach is already well under way through the EPAA, although there is still much to be done and Hendriksen acknowledged that a “paradigm shift” would be required if this new approach is to become the norm.

Still, if it means using fewer animals while still producing high-quality vaccines it will be worth the effort.