Developing safe and effective vaccines is a costly and expensive endeavor. One way to motivate vaccine manufacturers is to guarantee up front that governments will purchase large quantities of vaccine. From NEJM:
Equally important is offering companies protection against potentially substantial liability should Covid-19 vaccines cause real or perceived injuries to recipients. Manufacturers won’t agree to procurement contracts or ship vaccine without liability protection. According to an AstraZeneca executive, for example, in the company’s bilateral contracts, it has been granted protection against legal claims arising from the use of its vaccine products, since it “cannot take the risk” of liability. As early as 2006, the International Federation of Pharmaceutical Manufacturers and Associations, the global pharmaceutical-industry lobbying group, publicly demanded that manufacturers be granted protection from lawsuits associated with vaccine-related adverse events if they were going to participate in pandemic responses. In the United States, the Public Readiness and Emergency Preparedness Act provides manufacturers immunity from lawsuits related to injuries caused by vaccines, with narrow exceptions. People injured by Covid-19 vaccines must file claims with a fund administered by the Department of Health and Human Services.
For a vaccine that will most likely be distributed worldwide, there is an inevitable risk of serious adverse events, such as seizures and allergic reactions, even with a very safe product. Such events might not begin surfacing until a substantial number of people have been vaccinated. During the 2009 H1N1 influenza pandemic, the incidence of serious adverse events after immunization varied by country. In the United States, the Vaccine Adverse Event Reporting System received reports of such events at a rate of 2.45 per 100,000 doses. China’s equivalent surveillance system found that 1083 of the 8067 adverse events recorded (1.21 per 100,000 doses) were serious. Compensation costs also varied. One H1N1 vaccine that contained an adjuvant was associated with an increased risk of narcolepsy, which resulted in substantial compensation claims in Northern European countries.
So the vaccine manufacturers smartly offload the liability risk onto governments. The manufacturers don’t mind at all if fears of COVID-19 are overblown: they sell more vaccine in that environment. Looking at all comers, the risk of death or serious adverse effects from COVID-19 are under 0.5% for an individual. The full risks of an adverse effect from a vaccine may not be known for several years after release. This is why so many folks will be reluctant to take the vaccine. The risk:benefit ratio will vary with your age and co-morbidities. For instance, an obese 70-year-old with diabetes, heart failure, and emphysema may benefit from the vaccine very much more than a healthy 25-year-old.
Steve Parker, M.D.
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