Taking Responsibility for Vaccine Side Effects – Legal versus Moral Obligations for Vaccine Manufacturers

Klaus Leisinger is the President of the Global Values Alliance, the former personal advisor to UN General Secretary Kofi Annan on corporate responsibility and a business ethics expert with four decades of experience. 

The ethical challenges related to vaccines are now so manifold that an entire discipline was created: vaccine or vaccination ethics. The most obvious problems that are generally discussed are access to vaccines for those with limited spending power and the moral obligation to get vaccinated to achieve herd immunity. This blog focuses on a more recent ethics challenge: should COVID-19 vaccine developers and manufacturers take financial responsibility for vaccine side effects even without a legal requirement?

The case of Germany

In June 2023, the German firm BioNTech faced a lawsuit litigating for damages due to alleged side effects of the BioNTech/Pfizer COVID-19 vaccine. In February 2024, the lawsuit was rejected by the relevant court in Frankfurt.However, even if future lawsuits were successful, vaccine developers and manufacturers would not have to pay compensation. A release of liability was negotiated between the vaccine suppliers and the vaccine buyers, including the German government. This means that anyone vaccinated against the coronavirus with a vaccine approved in Germany is entitled to care and support from the state for proven health damage caused by the vaccination. Those affected do not lose their entitlement even if they have been adequately informed of potential risks and have consented to the vaccine.

There are moral reasons for states to support vaccination. The rationale is that those who are vaccinated not only protect themselves but also protect others from infection. 

As part of vaccine ethics, one might also ask, shouldn’t those companies who made large profits with COVID-19 vaccines be called upon to supply funding for medical treatment, as well as to provide pensions and compensation for those who suffer from severe side-effects regardless of the legal situation? One could also say that the profits of vaccine companies should not be privatised while the costs of alleviating the suffering of those affected by vaccine damage are left solely to the state.

So how does ethics come into play?

In business ethics terms, the distinction between legality and legitimacy is crucial. When analysing the social responsibility of companies in terms of ethics, we need to differentiate between what companies mustshould and can do.

The must dimension includes actions conducted in accordance with the legal, technical, economic and sociopolitical status quo. In other words, whatever a company does must conform with all laws and regulations in its respective countries of operation. From this perspective, profits achieved legally are largely unproblematic in ethical terms – unless such legally compliant actions cause damage to people and nature. Damage that could be avoided by assuming additional responsibility and taking appropriate action.This brings us to the should dimension of responsibility: if damage to people and nature can be avoided based on one’s knowledge and one’s voluntary additional efforts, then it becomes a moral obligation. In this context, ability equals ethical duty. Efforts to fulfil societal should expectations are desirable for the common good. Anyone who violates what is normatively right, for example, by failing to use up-to-date environmentally friendly technology, failing to ensure fair working conditions, or failing to conduct human rights due diligence, makes themselves morally vulnerable.

Last but not least, there is a can dimension of corporate responsibility which has a high socio-ethical value and is therefore the most desirable. Examples of voluntary additional services in the can dimension often include granting access to knowledge, expertise and networks existing within the company. These additional voluntary actions, however, are even less legally enforceable than the standard should ones. Whether a company is committed to this dimension usually depends on the philosophy of responsibility it practices and the values of its senior management. Potential public praise might be desirable for branding and marketing purposes but the basic motivation ought to be the will to achieve something concrete for a good cause and for its own sake. 

How does this apply to COVID-19 vaccines?

This brings us back to the above-mentioned problem of assistance for people suffering from severe COVID-19 vaccination side effects, which are not legally mandatory but are socially and ethically desirable.

Applying the ethical minimum (i.e. applicable legal regulations) is one possible corporate policy. However, not everything which should be legally prescribed is legally prescribed. Voluntary additional assistance in the should and can dimensions would not only help to alleviate human suffering but constitute an investment in the reputation of vaccine manufacturers in particular and the pharmaceutical industry in general. In addition to high levels of regulation, voluntary additional initiatives in the should and can dimensions would be in the self-interest of this economic sector and could even prevent additional regulation in future.

For example, the following initiatives would currently be both desirable and possible:

  • supporting the COVAX initiative, which aims to ensure equal and fair access to COVID vaccines worldwide;
  • applying differential pricing and significantly below market rates for vulnerable patient groups;
  • providing donations and logistical help to improve access to vaccines for people in the world’s poorest countries.

With regard to supporting people suffering from serious side effects, vaccine manufacturers could set up an independently managed fund to which all companies contribute, for example, a certain percentage of the profits generated from COVID-19 vaccinations. The collected funds could then supplement state benefits in certain cases.

However, corporate should and can initiatives would not only provide concrete relief for suffering people but also offer an important contribution to societal acceptance of complex scientific research and its sponsors by:

  • showing through concrete action that vaccine manufacturers do not retreat to legal minimums when it comes to the fate of sick people in emergency situations; 
  • building relationships of trust with strategically important stakeholders in order to find a common denominator and co-created solutions.

These voluntary initiatives would not only directly improve the conditions of suffering people; they would also ease the regulatory burden, thereby allowing the whole sector to function more efficiently and paving the way for further innovative and beneficial research.