Exclusive: AstraZeneca gets partial immunity in low-cost vaccine deal with EU

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BRUSSELS (Reuters) – European governments will pay claims above an agreed limit against AstraZeneca for side effects from its potential COVID-19 vaccine, on terms different from a deal with Sanofi, said a EU official to Reuters.

The deals reflect different strategies by two of the world’s leading drugmakers to protect themselves as a debate rages on the responsibilities for vaccines to end the pandemic.

AstraZeneca AZN.L has secured European Union backing in a confidential deal that reflects the lower price sought by the UK drugmaker, the official said.

“If a company asks for a higher price, we don’t give the same terms,” ​​said the manager, who was involved in the negotiations but declined to be identified because the contracts are confidential.

Unexpected side effects after regulatory approval of a drug are rare, but the speed at which a COVID-19 vaccine is pursued increases the risk of unforeseen conditions.

The deal with AstraZeneca, which shifts some of the risks of a vaccine rollout to taxpayers, was reached in August and its liability clauses have not been released before.

As part of the deal, AstraZeneca would only pay legal fees up to a certain threshold, the official said, declining to specify how the costs would be shared with individual European governments or the cap.

The financial shield would cover both legal fees and potential compensation, which is rarer but potentially much higher if something goes wrong.

In exchange for the higher price paid for its vaccine, French drug maker Sanofi SASY.PA, which works with GlaxoSmithKline as a partner, has not obtained any liability waiver.

Spokesmen for AstraZeneca, Sanofi and the European Commission declined to comment on details of the deals.

Asked about AstraZeneca’s relatively low price, a spokesperson reiterated the company’s commitment to share the vaccine widely and not profit from it during the pandemic.

FILE PHOTO: The logo of pharmaceutical company AstraZeneca is displayed on a ground display at the New York Stock Exchange (NYSE) in New York City, United States, April 8, 2019. REUTERS / Brendan McDermid / File Photo

As part of the AstraZeneca deal, EU countries agreed to pay 2.5 euros ($ 2.92) per dose, while Sanofi negotiated a price of around 10 euros, the official said.

SIDE EFFECTS

As part of the supply agreements, the only two sealed to date by Brussels, the EU has also paid a non-refundable deposit of 336 million euros to AstraZeneca to secure 400 million doses, proportionally less than the 324 million euros that it paid to Sanofi. 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 seeking compensation although the company remains responsible for its vaccine.

The deal with AstraZeneca was negotiated before suspending late-stage trials of its vaccine candidate this month after a British volunteer developed neurological symptoms. Testing resumed in Britain but not in the United States.

EU governments would only share the costs of compensation if any unexpected side effects appeared after the AstraZeneca vaccine was approved.

Liability has been a key stumbling block in talks with other COVID-19 vaccine makers, EU officials said, as companies fear risking higher legal costs than they typically are. faced when vaccines are developed in much longer trials.

A spokesperson for the European Commission said that the advance purchase agreements “provide for member states to compensate the manufacturer for certain liabilities incurred under specific and strict conditions”, but that “the responsibility still lies with the companies”.

This means that it would be the company’s responsibility to defend its shot in court.

Drugmakers have called on EU regulators to put in place a Europe-wide compensation system, while patient organizations are calling for an EU-wide fund funded by pharmaceutical companies that would offset the effects unexpected secondary.

The EU legal regime is among the least favorable to drugmakers on compensation claims, although plaintiffs have rarely been successful as the law requires them to prove the link between a disease and a vaccine that may l to have provoked.

The United States has granted immunity from liability for COVID-19 vaccines that receive regulatory approval.

Meanwhile, Russia has said it will take part of the legal responsibility if there is a problem with the vaccine developed by the Gamaleya Institute in Moscow.

Reporting by Francesco Guarascio @fraguarascio; Additional reporting by Ludwig Burger in Frankfurt, Matthias Blamont in Paris and Tom Hals in New York; Edited by Josephine Mason and Alexander Smith

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