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AstraZeneca’s chief has defended the company’s shock admission that the EU’s first coronavirus vaccine deliveries will fall far short of expectations, claiming the number that will be delivered is “not so bad” and his company only committed to meet demand to its “best effort.”
In setting out the company’s position, Pascal Soriot, the chief executive of the Anglo-Swedish firm, told Italy’s la Repubblica newspaper in an interview published Tuesday that the EU’s deliveries were in large part delayed because the bloc was late signing a contract for the vaccine — three months behind the U.K. — and therefore EU manufacturing facilities were playing catch-up in ironing out glitches.
He also denied allegations that the company had been selling its vaccines beyond the EU to make a quick buck. Soriot said the company was not making a profit on the vaccine anywhere, with prices ranging between $3 and $4 a dose globally, dependent upon local supply chain costs.
Some European leaders had reacted with outrage to Friday’s news that AstraZeneca’s scheduled COVID-19 vaccine supplies to the EU would be significantly cut. European Health Commissioner Stella Kyriakides said Monday it was “not acceptable,” while Italy and Latvia said they want to sue the company.
Amid suspicions the pharma giant was selling jabs that ought to have been contracted to the EU elsewhere for a higher price, Kyriakides announced new export rules that would require companies to notify Brussels of any vaccines they intend to sell outside of the bloc. The Commission also wants to know exact manufacturing yields at each facility and where these doses are destined.
Soriot said the EU will receive 3 million doses once the vaccine is approved by the European Medicines Agency, and 17 million total by February. He downplayed the shortfall in orders, saying stress was causing EU leaders to react badly.
“Governments are under pressure,” Soriot said. “Everybody is getting kind of a bit, you know, aggravated or emotional.”
He said AstraZeneca will be making 100 million doses globally a month from February, noting “Europe is getting 17 percent of the global production … for a population that is 5 percent of the world population.”
The issues lie with difficulties in manufacturing high yields of the active ingredient, or drug substance, which are made at sites in the Netherlands and Belgium, he said. Once the active ingredient is ready, it’s shipped to Italy and Germany where it is diluted and put into vials — and there are “zero problems” with the latter process, Soriot said.
Water-tight contract
Reports of legal action against the company — potentially from Italy, as well as calls for a European-level lawsuit — for not meeting its contracted deliveries, didn’t appear to faze Soriot, with the CEO insisting he was confident in the wording of the company’s agreement.
The EU “contract is very clear: Our commitment is, I am quoting, ‘our best effort,’” he said. It was drawn up this way because AstraZeneca and its partner Oxford University had already signed a deal with the U.K. government for 100 million doses, and was committed to delivering them, while the EU deal for 400 million doses was signed three months later, with the bloc wanting them to be shipped concurrently.
“We said, ‘OK, we’re going to do our best, we’re going to try, but we cannot commit contractually because we are three months behind U.K.,’” he said, adding the company knew it was a “super stretch goal.”
At a news conference Tuesday, the European Commission’s chief spokesman, Eric Mamer, noted that AstraZeneca was fulfilling orders to other customers — a clear reference to the U.K., where the vaccine has been deployed for several weeks — and said the EU saw no reason why it should not receive its expected supply once the vaccine is formally approved, as is expected later this week.
“We see that doses are being delivered elsewhere and we know that we have signed an agreement with AstraZeneca in August, that member states placed their orders, I believe around October, and that we are now at the end of January,” he said. “Therefore, we believe that the doses should be basically available to be delivered if and when the conditional marketing authorization is recommended by the European Medicines Agency.”
But Soriot pointed out that the British agreement stipulates that supply coming out of the U.K. would go to the U.K. first. The EU agreement allows use of the U.K. manufacturing sites, “but only later,” Soriot said, once Britain reaches a “sufficient number of vaccinations.”
EU’s ‘really bad luck’
The British deal, facilitated by Oxford University’s early talks with the U.K. government, allowed manufacturing to be expanded and fine-tuned early in the U.K., overcoming hurdles in scaling up a complex biological process, Soriot said, before the vaccine was approved.
The later deal with the EU meant all these processes were three months behind. The company had to train partners across Europe on how to manufacture the vaccine, and “some people are new to this process … They don’t know how to make the vaccine and they’re not as efficient as others,” he said.
For this reason, the most-efficient U.K. facility yields three times the vaccine doses compared with the less-efficient factories elsewhere, and facilities with the lowest yields are those supplying the EU, according to Soriot.
“Unfortunately, it’s really bad luck,” he said. “There’s nothing mysterious about it.”
In response to the remarks by Soriot, the European Commission’s Mamer reiterated the EU’s insistence that AstraZeneca fulfill its contractual obligations and better explain why it would not be able to deliver the promised quantities of vaccine. Earlier on Tuesday, at the Commission’s daily news conference, Mamer said he had been unable to answer reporters’ many questions about what had gone wrong because AstraZeneca had not provided sufficient explanation for the expected production shortfall.
EU officials have said previously that the bloc’s purchase agreements with the company were not tied to any particular production facility and that they sought out agreements with companies with a demonstrated capacity for the large-scale manufacturing required to make vast quantities of vaccine.
“When we signed the agreement, it was on the basis that these companies had production capacity, and we expected that there is flexibility,” Mamer said Tuesday night. “We are looking forward to continue the conversation during the steering board meeting tomorrow evening.”
Meanwhile, the U.K.’s approach to delay the second jab until 12 weeks to enable more people to get the first was “absolutely the right way to go, at least for our vaccine,” Soriot said. “You get a better efficiency if you get the second dose later than earlier.” Denmark and the Netherlands are now also delaying second doses by six weeks.
Soriot denied that AstraZeneca was selling vaccines outside of the EU to make more money, underlining that the company was contractually obliged with Oxford University to make no profit. “We’re certainly not taking vaccines away from the Europeans to sell it somewhere else at the profit,” he said. “It would not make sense.”
And Soriot said he was baffled as to why German media reported the vaccine has just 8 percent efficacy in over 65s. “It’s incorrect,” he said, adding: “Lots of very smart people” working for regulators in countries that have approved the vaccine accepted its efficacy in people 18 years old and above.
This article is part of POLITICO’s premium policy service: Pro Health Care. From drug pricing, EMA, vaccines, pharma and more, our specialized journalists keep you on top of the topics driving the health care policy agenda. Email [email protected] for a complimentary trial.
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