The Precautionary Principle and the Vaccine Rollout in Europe

In Europe, use of the AstraZeneca COVID-19 vaccine was halted due to the precautionary principle (PP). While France and the United Kingdom are taking the vaccine, Denmark, Norway, and Sweden continue to be suspended. Most countries in Europe had suspended distribution of the vaccine because of concerns that it may cause fatal blood clots. The suspension occurred as the third wave of the virus was spreading across Europe. There are ethical issues that must be confronted by AstraZeneca as well as concerns among regulatory authorities in many countries.

The problem comes in balancing risks and benefits along with the ethical issues associated with both preventing the COVID-19 virus and avoiding harm to some people. Almost all vaccines have the potential to have a negative effect on a few people, but most people accept the risks for the benefits of not getting sick. Vaccinations were halted due to the PP which states that, "if an action or policy has a suspected risk of causing harm to the public or to the environment, and there is no scientific consensus, the burden of proof falls on those taking the action." This also is in line with the Hippocratic oath that doctors take to "first do no harm." In other words, an ethical and legal approach to dealing with innovations when extensive scientific knowledge is not available. It is a principle that emphasizes caution, pausing and gathering more data before releasing a product, such as the AstraZeneca vaccine, before it has been proven to not cause serious harm. This policy is used by regulators in situations where they want to protect the public interest. AstraZeneca could have major liability if the vaccine caused harm to many people unless the government protected them from lawsuits. Unfortunately, all vaccines have risks and the PP does not take the accompanying benefits into consideration. In this case, the benefits could be the eradication of a pandemic that has resulted in the deaths of nearly 3 million people globally. In fact, the principle requires scientists to prove something that is nearly impossible. In this case, after 20 million people in the U.K. and E.U. received the vaccine, there were only 25 cases of potentially fatal blood clots. The number of blood clot cases was actually lower than expected in the general population. The ethical issue for public policy makers is balancing the use of extreme caution with continuing all prudent efforts to protect the health and well-being of a country.