European Commission warns AstraZeneca on Covid-19 vaccine delay

Executive says company expects all deliveries to occur as agreed after it warns of delays

AstraZeneca CEO Pascal Soriot has described the development of Covid-19 vaccines as a "huge undertaking" that could only have happened with the collaboration of governments and vaccine developers. Video: Reuters

 

The European Commission has warned AstraZeneca that it expects all vaccine deliveries to continue according to an agreed delivery schedule after the pharmaceutical company announced delays.

The scale of the reduction in deliveries to the European Union is from 80 million doses by the end of March to 31 million, according to a senior EU official, meaning Ireland’s allocation along with all other member states would be 60 per cent lower than thought.

The EU’s executive body wrote a letter to the company on Monday and commission president Ursula von der Leyen spoke to its chief executive, Pascal Soriot, by phone and “made very clear what it is that we expect from the company, based on the advance purchasing agreement”, a spokesman said.

Under the EU’s joint-procurement programme, AstraZeneca received a three-digit-million-euro sum to pre-book production capacity and the advance manufacture of doses of the vaccine, to be distributed as soon as approval was granted.

“The answers of the company have not been satisfactory so far,” health commissioner Stella Kyriakides said after a meeting with the company.

“We want our contract to be fully fulfilled . . . The European Union will take any action required to protect its citizens and rights.”

AstraZeneca applied for approval for its vaccine earlier this month from the European Medicines Agency (EMA), which is due to discuss the application on Friday.

AstraZeneca on Monday evening described German media reports saying its Covid-19 vaccine was shown to have a very low efficacy in the elderly as "completely incorrect".

German daily papers Handelsblatt and Bild said in separate reports on Monday the vaccine had an efficacy of 8 per cent or less than 10 per cent, respectively, in those over 65 and the German government did not expect the European regulator to approve the product for that age group.

Transparency register

The EU is pressing the company to find “creative” ways of making up the doses, and for a transparency register to monitor exports of vaccines out of the EU to third countries.

“We, as the EU, must be able to know whether and what vaccines are being exported from the EU,” German health minister Jens Spahn said. “Only that way can we understand whether our EU contracts with the producers are being served fairly. An obligation to get approval for vaccine exports on the EU level makes sense.”

Ireland’s High-Level Task Force on Covid-19 Vaccination was due to meet on Monday to discuss the delay to the delivery of the AstraZeneca vaccine to EU countries.

Ireland had expected to receive 600,000 doses of the AstraZeneca vaccine in the first quarter of the year. A 60 per cent reduction would scale that number back to 240,000.

Health Service Executive (HSE) chief executive Paul Reid said previous commitments made by AstraZeneca for February deliveries still stand, and the HSE will begin the process of vaccinating people over the age of 70 through general practitioners and pharmacies.

However, it is unclear how many of the over-70s cohort will be vaccinated with the supply.

With discussions about future vaccine deliveries due to get under way in Ireland, there have been calls for greater transparency about who has had the Covid-19 vaccine and how many frontline workers have yet to be vaccinated.

Minister for Health Stephen Donnelly said on Monday that 143, 000 vaccinations had been carried out by Sunday.

The vaccine made by the British-Swedish multinational is already in use in Britain, and has been granted emergency approval in countries including India and Mexico. It is due to be reviewed by the EMA on Friday.

Contract

“AstraZeneca has been contractually obligated to produce since as early as October and they are apparently delivering to other parts of the world, including the UK, without delay,” said German MEP Peter Liese, who is health spokesman for the largest group in the European Parliament.

“The flimsy justification that there are difficulties in the EU supply chain but not elsewhere does not hold water, as it is of course no problem to get the vaccine from the UK to the continent,” he added.

“The company cannot be interested in permanently damaging its reputation in the world’s largest single market. Many in the company seem to be embarrassed by the matter. That’s why I expect a change in the delivery plans for the EU in the next few hours, and an accelerated one at that.”

“Our focus . . . is to make sure that the company actually delivers the doses as swiftly as possible because we have a health emergency to deal with and that is what we are focused on at the moment,” a commission spokesman said.

‘Me first’ behaviour

Addressing an online World Economic Forum event, Mr Soriot said the global response to Covid-19 had been marred by “me-first” behaviour.

“The first phase of Covid is full of good examples but it’s also full of places where we see international collaboration hasn’t been the best. It could have been a 4th of July, Independence Day kind of moment, but it unfortunately wasn’t because there was a bit of ‘me first’ behaviour,” said Mr Soriot.

“We should remember that what we are trying to do collectively here has never been done in the history of the world. Develop a vaccine, or several vaccines, in a year, and then scale up to billions of doses when we know today [that] the biggest manufacturer has only got a capacity of a billion doses per year across all their vaccines,” he said. “It’s a huge undertaking.”

Moderna

Meanwhile, Merck – one of the top two vaccine makers worldwide – on Monday pulled the plug entirely on its Covid vaccine programme after underwhelming early trial results.

And Moderna said it plans to start clinical trials of an altered booster version of its Covid-19 vaccine aimed at the South African variant of the disease after tests showed its authorised vaccine may produce a diminished antibody response to the variant.

It will also test an additional booster shot of its authorised vaccine in trials to see if it boosts antibody reaction against the South Africa variant.

The current Moderna vaccine regimen is for two shots four weeks apart. The company said in a press release that it was being cautious and that the two-dose regimen of the vaccine was still expected to be protective against the South African and other variants detected to date.

The company said the vaccine did not see any adverse impact from the UK variant – which has been shown to be more transmissible – in the tests. – Additional reporting: Reuters

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