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AstraZeneca is scrambling to find more manufacturers to produce its coronavirus vaccine in Europe after the drugmaker’s bet on a limited number of sites fell short.
By the end of January, only one continental plant — located in Seneffe in Belgium — was authorized to manufacture the drug substance for the vaccine coveted by governments across Europe, alongside two sites in the U.K. and U.S.
After announcing the company would be unable to deliver nearly two-thirds of the 100 million doses it promised the EU by the end of March, AstraZeneca CEO Pascal Soriot initially pointed the finger at the Belgian plant, now owned by U.S. company Thermo Fisher Scientific.
But Thermo Fisher this week said it had done what it was obliged to under its contract with the drugmaker. “We have complied with all the contractual requirements we have with AstraZeneca,” Cedric Volanti, Thermo Fisher’s vice president for EU told a press conference Wednesday.
Now, the British-Swedish drugmaker is signing deals to increase the supply for the EU, including one with Germany’s IDT Biologika to start manufacturing the drug substance for the EU.
A successful strategy “has to have multiple sites,” one EU official said. “It appears now the U.K. is holding onto their plants, [and AstraZeneca was] relying solely on Thermo Fisher Scientific to manufacture for everybody — it’s impossible.”
The official, who wished to remain anonymous, said that while the plant’s production was running thousands of doses behind, inspections had revealed no serious issues that would leave it millions of doses off target. The Belgian factory was “a bit behind schedule” but it was “never their intention to cover the whole of the EU drug substance manufacturing — it’s unfeasible,” the official said.
While AstraZeneca has other producers within Europe, only three were approved by the European Medicines Agency to manufacture the substance for the vaccines, according to the conditional marketing authorization application dated January 29.
Alongside the plant owned by Thermo Fisher Scientific (listed by its original name Henogen), those are Oxford Biomedica in the U.K. and Catalent in the U.S. Another plant from AstraZeneca subsidiary MedImmune in the Netherlands is listed to carry out the batch release, or quality checks, of the vaccines.
A company can later amend its application to include more plants, however. Soriot told a press conference in January that the “bottleneck” for the company was “on the drug substance side and manufacturing the vaccine itself,” rather than at the later manufacturing stage, called fill-finish.
The CEO acknowledged the company would not be able to increase capacity “in the near term, because drugs substance takes … a relatively long time” to produce.
AstraZeneca declined to comment on whether it had failed to adequately plan to deliver the volumes of doses promised to the EU.
Territorial dispute
In January, when AstraZeneca announced the 60 percent cut in vaccine supply to the EU, Commission officials lambasted the company for exporting its EU-marked doses to the U.K. and then refusing to use any from the British supply chain to meet the shortfall on the Continent.
After a fight with the Commission over the delivery shortages, AstraZeneca announced it would be able to supply 40 million doses to the EU by the end of March. Some of those doses are coming from the U.S. site, located in Maryland.
When the Belgian plant — previously owned by Novasep — began producing the drug substance for AstraZeneca’s vaccine in 2020, its dose production volumes were roughly 4 million doses per month, according to the EU official. That rose to 8 million a month in January following an expansion.
The University of Oxford, which developed the shot together with AstraZeneca, contracted a plant in the Netherlands owned by company Halix as early as April to produce the drug substance.
This plant was only intended to be used for the U.K. supply chain, the official and a second person with knowledge of the U.K.’s contract with AstraZeneca confirmed. Both officials also said it was unclear whether the Dutch plant had yet produced any doses.
Dutch manufacturer Halix did not respond to requests for comment.
Similarly, IDT Biologika, based in Dessau, Germany, which handles fill-finish, has only ever done this work for the U.K. vaccine supply, a spokesperson confirmed. The company has not produced any vaccine for the EU, but it will now make drug substance and, in the future, do fill-finish for the EU under the new deal announced this week.
A different producer based in Italy owned by global manufacturing company Catalent is contracted to do the fill-finish for the EU doses. AstraZeneca also inked a deal in January with Madrid-based Insud Pharma to add fill-finish capacity for the EU.
The company is reportedly in talks with a Chinese company called Wuxi to produce more vaccine drug substance for the EU as well as a Russian group called R-Pharm. AstraZeneca declined to confirm this.
No breathing room
Manufacturing viral vector vaccines is incredibly complex with great room for disappointments, even if no machines break or there’s a bad batch, according to scientists.
Adam John Ritchie, a senior project manager at Oxford University’s Jenner Institute who was involved in setting up manufacturing for the AstraZeneca vaccine in the U.K., has said manufacturers need to start by growing a large amount of cells before the vaccine is purified. Actual yield can vary greatly.
“Projections on available doses tend to rely on best case scenarios,” he wrote in a Twitter thread. “If each site gets maximum yield from each run, you get all those doses.”
“Maybe a good yield is a million doses per run (in reality, it depends on how big your cell culture is). But maybe the first few runs only yield 250 thousand doses,” he said. “It costs the same — it takes the same number of staff, same equipment etc regardless of how good the yield is. It also takes the same time.”
The EU has at all stages been a step behind the U.K., not only on vaccine deliveries but also on the earlier steps to secure contracts and approvals.
The person with knowledge of the U.K.’s contract with AstraZeneca said the U.K. was ultimately more successful in ramping up manufacturing because the British government was more actively involved in the details of the manufacturing process. The European Commission, by comparison, was a “passive customer.”
Health Commissioner Stella Kyriakides has claimed it wasn’t a queue at the butcher shop, “but the EU has treated it like that, like they can just place an order for the sausages and they’ll come,” the person said. “That’s not what the U.K. has done. They helped the butcher buy a machine, helped it with staff, helped it with farming the pigs, helped it develop the recipe.”
Of the EU’s strategy, they said: “It’s incredibly naive: These are the hardest manufacturing challenges the world has ever faced.”
Eline Schaart contributed reporting.
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