Emergency COVID-19 Vaccines Deliver Without Animal Testing

The COVID-19 vaccine was ready just one year after the identification of the virus. In comparison, most vaccines are approved only after 10 to 15 years, in part due to lengthy animal studies. 

Overall, pharmaceutical companies support moving away from animal studies because of societal concerns about animal welfare. They also consider non-animal alternatives faster, cheaper, and better. Even so, regulators are hesitant to use them because they don’t want to lose public confidence in vaccine safety.

Using Pfizer/BioNTech’s vaccine (called “Comirnaty”) and the European Medicines Agency as a case study, this report uses document analysis of primary research related to vaccine development and the COVID-19 vaccine in particular, as well as interviews with Dutch and other European expert stakeholders, to identify how the emergency approval process reduced the role of animal studies when releasing Comirnaty. 

The study found that emergency protocols changed both the research requirements and the timeline of vaccine approval, which in turn affected the use of animal testing. It is optimistic that they can also work for non-emergency vaccines. Those changes include:

1. Rolling review: Data was analyzed as they became available instead of all together in one batch. Once the data was sufficient, the EMA granted the vaccine a conditional marketing authorization which depended on receiving quality, safety, and efficacy data as soon as they became available. This prevented excess animal testing. 

2. Re-use of data: Regulatory agencies accepted data used for earlier vaccines of the same type (in this case, mRNA vaccines). Medical scientists have a thorough understanding of how mRNA vaccines function, so they didn’t need to do as many new animal studies.

3. Non-animal alternatives: At all stages of the vaccine approval, there were possibilities for non-animal research. This was possible in part because new technology (such as “in silico” and “in vitro” techniques) allowed scientists to learn about the virus without living test subjects. Even when living subjects are necessary, animal tests are not essential for efficacy testing. Efficacy testing can safely use human trials.

4. Earlier human trials: Accelerated approval allowed human trials to start while animal studies were in progress. Human-specific data could replace animal data, especially for efficacy testing. Batch testing typically uses animal studies because the vaccine can be inconsistent at this stage, but COVID-19 vaccine tests used mostly human trials. Because the vaccine’s function was well understood, each batch was reliable enough to go straight to human trial.

These changes were made to speed up vaccine approval because of the COVID-19 emergency. Because animal testing is time-consuming, emergency protocol largely reduced animal use without sacrificing safety or efficacy. This study is useful for people and agencies who worry that using non-animal alternatives may be riskier than using animal studies.

Ultimately, we can improve vaccine timelines, human health, and animal welfare by amending the perception that non-animal alternatives are less safe and effective. Then, regulators may make the above aspects of emergency approval standard for more vaccines.