AstraZeneca and Catalent defend Covid vaccine manufacturing process

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AstraZeneca and one of its major European suppliers have defended their Covid-19 vaccine production process after the European medicines regulator said it was investigating the possibility that there were manufacturing defects in batches specific.

The European Medicines Agency’s investigation follows reports of possible side effects, including blood clots, which have led at least 16 European countries to suspend or limit use of the vaccine. The EMA said it was unlikely that the reported adverse events were related to the vaccine or specific lots, but that a link could not yet be ruled out.

Emer Cooke, the head of the EMA, said on Tuesday the agency was investigating “the possibility or plausibility of any event related to specific batches” of the Oxford / AstraZeneca jab, as well as “any manufacturing differences”. . . this could lead to disparities between the lots ”.

AstraZeneca said each batch of its vaccine goes through “over 40 different quality control tests” between the lab and people’s arms.

“Each batch manufactured in our supply network must meet the same exacting production and quality standards,” the company said. “Regular quality control tests are carried out at every stage of production, to ensure that the production process is well controlled and that the results are always within the required levels. ”

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In Europe, where most of the reported blood clot events have been recorded, the Oxford / AstraZeneca vaccine is manufactured in a multi-step process.

The active ingredient or drug substance is supposed to be produced in factories including one in Belgium and one in the Netherlands. It is then shipped to so-called “fill and finish” facilities where the drug product is manufactured and bottled.

One of AstraZeneca’s filling and finishing facilities is the Anagni plant in Italy, run by the American company Catalent. This factory produced two of the batches that initially triggered the suspension of vaccinations in Austria and Italy, ABV 5300 and ABV 2856.

These lots are not used in the UK, according to UK health authorities, but they have been widely distributed across Europe.

Cooke said an initial investigation after Austria’s suspension of batch ABV 5300 did not reveal any “plausible” link between this batch of vaccine and the reported adverse events.

“As we are seeing more events reported across Europe, we are seeing more lots involved,” she said. “This is unlikely to be a lot specific event. . . but we cannot exclude it.

Mario Gargiulo, president of Catalent’s European biologics division, told the Financial Times that every batch that Anagni ships has met quality specifications and rigorous testing.

“All documentation and quality evaluations relating to these lots have been reviewed again by Catalent, AstraZeneca and Italian [drugs] regulator, AIFA, ”he said. Italian regulators will inspect the plant for a third time this week, officials said.

AstraZeneca’s drug facility in Seneffe, Belgium is led by Thermo Fisher Scientific, which declined to comment on the EMA probe. The Leiden drug plant in the Netherlands, run by Halix, has yet to supply vaccine ingredients to the EU as it awaits EMA approval. Oxford BioMedica in the UK, which is also licensed to supply a drug substance for AstraZeneca in the EU, also declined to comment.

Catalent also has manufacturing sites in the United States, where it fills vials for Johnson & Johnson and Moderna. Earlier this year, it had to resort to manual bottle checking for J&J due to a manufacturing issue, which delayed some deliveries.

Additional reporting by Guy Chazan in Berlin, Michael Peel and Sam Fleming in Brussels and Sarah Neville in London


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