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European authorities will pay claims over an agreed limit against AstraZeneca over side-effects from its potential COVID-19 vaccine, under different terms to a deal struck with Sanofi, an EU official told Reuters.
The deals reflect different approaches by two of the world’s best drugmakers for protecting themselves as a debate rages about liabilities for vaccines aimed at ending the pandemic.
AstraZeneca has secured the European Union’s backing in a confidential agreement which reflects the lower price sought by the British drugmaker, the official said.
“If a business asks for a higher cost we do not give exactly the very same conditions,” said the official, who had been involved in the talks but declined to be identified as the contracts are confidential.
Unexpected side-effects after a drug has regulatory approval are rare, but the rate at which a COVID-19 vaccine is being chased increases the risks of unforeseen problems.
The deal with AstraZeneca, which shifts some of the dangers involved with the roll-out of a vaccine to taxpayers, has been struck in August and its accountability clauses have not previously been reported.
Under the deal, AstraZeneca would pay legal costs up to a certain threshold, the official said, declining to elaborate on how the costs would be shared with individual European governments or the cap.
The fiscal shield would cover both legal costs and potential compensation, which is rarer but potentially a much larger outlay in the event of something going wrong.
When asked about AstraZeneca’s relatively low price, a spokesman reiterated the corporation’s pledge to share the vaccine broadly and not to make a profit from it during the pandemic.
Underneath the AstraZeneca deal, EU countries have agreed to pay 2.5 euros ($2.92) per dose, while Sanofi has negotiated a price at around 10 euros, the official said.
SIDE-EFFECTS
As part of the distribution prices, the only two sealed so far by Brussels, the EU has also made a non-refundable downpayment of 336 million euros to AstraZeneca to procure 400 million doses, proportionately lower compared to 324 million euros it paid to Sanofi to secure 300 million doses.
The EU official told Reuters that the contract with AstraZeneca included a narrow definition of side-effects that could limit the possibility of claiming compensation even though the company remains liable for its vaccine.
The deal with AstraZeneca was negotiated before it stopped late-stage trials of its vaccine candidate this month following a British volunteer developed neurological symptoms. Trials have resumed in Britain but not in the United States.
EU governments would share compensation costs only if unexpected side-effects emerged following the AstraZeneca vaccine was approved.
Liability has been a key stumbling block in talks with other COVID-19 vaccine makers, EU officials have said, as employers fear they risk larger legal costs than they usually face when vaccines are developed in much longer trials.
A European Commission spokesman said advance buy deals”provide for member nations to indemnify the manufacturer for particular liabilities incurred under strict and specific conditions”, but”liability still remains with the firms”.
This means it would be the company’s responsibility to defend its shot from the courts.
Drugmakers have called on EU regulators to prepare a Europe-wide compensation scheme, while patients’ organisations are calling for an EU-wide fund financed by pharmaceutical companies that would compensate for unexpected side-effects.
The EU legal regime is among the least effective to drugmakers on compensation claims, although plaintiffs have rarely managed to acquire as the law requires them to show the connection between an illness and a vaccine that may have caused it.
The United States has granted immunity from liability for COVID-19 vaccines that get regulatory approval.
