Vaccines Europe, a pharmaceutical industry lobbying group, has issued a memo to its member companies saying it would seek liability protection from the European Union (EU) for corporations manufacturing COVID-19 vaccines. The memo, obtained by the Financial Times, expressed concern about the “inevitable risks” of rushing the development and global marketing of COVID-19 vaccines.1 2 3 According to the document:
The speed and scale of development and rollout do mean that it is impossible to generate the same amount of underlying evidence that normally would be available through extensive clinical trials and healthcare providers building experience.
Vaccines Europe added that for this reason it will advocate for a “comprehensive no-fault and non-adversarial compensation system, and an exemption from civil liability.” The memo acknowledged that some people will likely suffer “adverse events” after receiving COVID-19 vaccines and that, given the large number of people who will get the vaccines, this might lead to “numerous damage claims.”1 2 3
The precedent that such liability protection would set worries Yannis Natsis, a patient representative on the management board of the European Medicines Agency (EMA). “This kind of discussion around giving companies a free pass, this undermines patient safety and confidence in vaccines,” Natsis said.4
On Aug. 27, 2020, AstraZeneca signed a contract with the EU exempting the company from future liability claims in exchange for supplying EU countries with at least 300 million doses of a COVID-19 vaccine by mid-2021.3 The Brussels Times reported:
In its current form, the [AstraZeneca] deal allows the multinational drugmaker to pass the hot potato of product liability onto national governments, leaving them exposed to the financial consequences of any potential side-effect claims.3
During negotiations leading up to the contract, Ruud Dober, a senior executive with AstraZeneca, said, “This is a unique situation where we as a company simply cannot take the risk if in four years the vaccine is showing side effects. Dober added, “In the contracts we have in place, we are asking for indemnification. For most countries it is acceptable to take that risk on their shoulders because it is in their national interest.”5 6
AstraZeneca and the University of Oxford have been working to develop an experimental COVID-19 vaccine known as AZD1222 (formerly ChAdOx1 nCoV-19 or “chimpanzee adenovirus Oxford 1” novel coronavirus-19).7 On Aug. 15, 2002, the results of a Phase I/II human clinical trial for AZD1222 were published in The Lancet. The trial involved 1,077 healthy adults between the ages of 18 and 55 years old and data showed that AZD1222 caused side effects—both local and systemic reactions—in approximately 60 percent of the trial participants.8 9
Vaccines Europe, which is a division of the European Federation of Pharmaceutical Industries and Associations, represent numerous major pharmaceutical companies, including Abbott Laboratories, AstraZeneca, CureVac, GlaxoSmithKline, Janssen Pharmaceuticals, Merck Sharp & Dohme, Novavax, Pfizer, Sanofi, Seqirus and Takeda Pharmaceutical Company.2 10
1 Benzinga SD. AstraZeneca, Novavax, Pfizer, Others Lobby EU For Legal Protection Against COVID-19 Vaccine Liabilities: FT. Yahoo! Finance Aug. 26, 2020.
2 Mancini DP, Peel M. Covid-19 vaccine makers lobby EU for legal protection. Financial Times Aug. 26, 2020.
3 Newcomb L. As AstraZeneca Signs Deal With EU, Critics Warn Big Pharma Push for Covid Vaccine Liability Protections a ‘Dangerous Precedent’. Common Dreams Aug. 27, 2020.
4 Lerner S. Drug companies continue to shed liability for rushed coronavirus treatments. The Intercept Aug. 28, 2020.
5 Fisher BL, Parpia R. 2005 PREP Act and 1986 Act Shield Vaccine Manufacturers from Liability. The Vaccine Reaction Aug. 10, 2020.
6 Burger L, Aripaka P. AstraZeneca to be exempt from coronavirus vaccine liability claims in most countries. Reuters July 30, 2020.
7 Cáceres B, Fisher BL. Children Recruited in U.K. for COVID-19 Vaccine Trial. The Vaccine Reaction June 7, 2020.
8 Folegatti PM, et al. Safety and immunogenicity of the ChAdOx1 nCoV-19 vaccine against SARS-CoV-2: a preliminary report of a phase 1/2, single-blind, randomised controlled trial. The Lancet July 20, 2020; 396(10249): 467-478.
9 Herper M. Studies provide glimpse at efficacy of Covid-19 vaccines from Oxford-AstraZeneca and CanSino. STAT July 20, 2020.
10 Vaccine industry response to COVID-19. Vaccines Europe.