The EU will assume responsibility for claims over a certain amount made against AstraZeneca (AZ) relating to potential side-effects from its Oxford University-partnered COVID-19 vaccine.
According to Reuters, AZ will only pay for legal costs up to a certain threshold, at which point the costs will be shouldered by European governments. It is uncertain exactly how the costs will be shared with individual European governments.
Although the European Commission (EC) declined to comment on the specifics of the deal, one EU official involved in talks said that the deal was made possible thanks to the low cost of AZ’s potential shot.
“If a company asks for a higher price we don’t give the same conditions,” the official told Reuters. The EU liability agreement would cover legal costs and potential compensation in the rare case of serious side-effects from AZ’s COVID-19 vaccine occurring.
Although it is unlikely that such an event will happen, the speed at which vaccines for the novel coronavirus – SARS-CoV-2 – are currently being developed increases the need for protection against unforeseen side-effects.
AZ reach an agreement with the EU in August to provide 400 million doses of its vaccine candidate, AZD1222. The deal is to be financed with the EC’s ‘Emergency Support Instrument’, which has funds dedicated to the creation of a portfolio of potential vaccines produced by different companies.
The EU has also signed a deal with Sanofi for access to its GlaxoSmithKline-partnered COVID-19 vaccine, although a similar liability clause has not been added to this agreement.
This could be due to the higher price sought by Sanofi for its vaccine, which is more expensive than AZ’s shot – Sanofi’s candidate’s price is €10 per dose, while AZ agreed a lower cost for its shot of €2.5 per dose.
In August, reports from European officials revealed that deals between vaccine developers and the EU were being hindered by strict liability rules that offer only partial protection against legal risks for potential candidates.
In the US, a number of deals have been reached with a slew of companies developing COVID-19 vaccines. The US system, however, puts the liability for any potential vaccine completely on the government, with the company avoiding any associated legal costs or compensation pay-outs.
The AZ/EU liability deal was negotiated before the Cambridge,UK-headquartered pharma company was forced to pause trials of its COVID-19 vaccine after a British participant developed neurological symptoms. Although the trials have resumed in Britain, they are still on hold in the US.