Mystery of Italian town's 29 million Covid-19 vaccination shots strains EU-AstraZeneca ties

Catalent's facility has been buzzing with vaccine activity for months.
Catalent's facility has been buzzing with vaccine activity for months.PHOTO: EPA-EFE

ROME (BLOOMBERG) - For the Italian town of Anagni, it came as a shock that the sprawling pharmaceutical plant just beyond its vineyards held 29 million doses of AstraZeneca's Covid-19 vaccine.

"It's not easy to know that so many doses are stocked so close to us," Ms Daniele Natalia, the town's mayor, said in an interview in the mediaeval centre of Anagni, which centuries before becoming a drug-making hub was a papal summer retreat.

When news of the find - following a raid - broke last Wednesday (March 24), the world's eyes were riveted on the town an hour's drive south of Rome as it struggled with the sudden discovery.

That evening, the provincial police fired off an alert to agents of an Italian intelligence unit known as the DIGOS, which handles organised crime, terrorism, and kidnapping.

Word of the presence of the coveted shots "could arouse reactions of an impromptu or violent nature from a varied audience", the alert, seen by Bloomberg News, read.

It called for increased patrols at the site, a liquid Fort Knox with vaccines carrying an official price tag of US$116 million to US$145 million (S$156 million to S$195 million).

The 29 million shots and the puzzle they present have catapulted Anagni into the heart of the European Union's fight with AstraZeneca, which the bloc says has failed to deliver on its contracts.

The EU triggered the inspection amid fears that the doses might be spirited away to Britain, following apparent discrepancies between numbers from the company and those the European Commission had for the plant.

AstraZeneca's response that they are destined for the EU and for developing countries has done little to dispel the bloc's impression that the company was not being upfront.

'Been deceived'

"European citizens have the sensation of having been deceived by some pharmaceutical companies," Italian Prime Minister Mario Draghi told fellow EU leaders at a virtual summit last Thursday, without explicitly naming AstraZeneca.

Since learning that there was a mountain of vaccines a short commute from his office, Mr Draghi has been on a warpath, at least by the reserved standards of the former European Central Bank president.

Last Friday, he revisited the issue at a press conference in Rome.

"The impression is that some companies - I won't name any names - sold things two or three times," he said, raising his left eyebrow and allowing a grin to curl up the right corner of his mouth. While coy about naming names, Mr Draghi, 73, also said he has signed up to get his AstraZeneca shot in the coming week.

European leaders are still trying to figure out if the Anagni supply means they are being deprived of doses or whether they simply do not understand the drug-maker's complex supply chain.

AstraZeneca's latest promise is for 30 million shots to be delivered to the EU this quarter, about 25 per cent of its original commitment.

For its part, AstraZeneca says ther is no mystery in Anagni.

"It is incorrect to describe this as a stockpile," the Anglo-Swedish company said last Wednesday, adding that the bottling process is complex and that filled vials must undergo quality control.

Countering a report in La Stampa newspaper that characterised the doses as "hidden", and possibly being readied for export to Britain, AstraZeneca said 16 million of the doses are for Europe and another 13 million for Covax, the programme to supply developing countries.

The phone call

Still, the paranoia revealed by the case is a microcosm of the crisis of trust that has defined AstraZeneca's relations with governments as it muddles through regulatory approvals and supply shortfalls.

It also shows how badly vaccine nationalism and a deadly, economy-crushing pandemic mix.

By Mr Draghi's account, the Anagni episode started on the evening of March 20.

"I received a phone call from the president of the EU Commission about some lots that did not appear in the Commission's accounts and that would have been stored at the Anagni plant," he told the Italian Parliament the day the news broke. "An inspection was suggested."

Mr Draghi said he then called his health minister, who has at his disposal a specialised food and drugs unit of the Carabinieri military police.

The officers immediately went to the vaccine-bottling plant, and by the next morning, after working all night, they had identified the lots, Mr Draghi said.

Some doses have since been shipped to AstraZeneca's distribution facility in Belgium, "but in the meantime the surveillance continues for the remaining lots", he said.

450 million doses

While questions remain about squaring the 29 million shots with the EU's accounts, it should have come as no surprise that the Anagni plant had tens of millions of doses.

The facility is run by Catalent Inc, a Somerset, New Jersey-based company that has a contract to fill tiny glass vials with as many as 450 million doses of the AstraZeneca vaccine, in a deal announced last June.

During a visit inside the plant last July, Bloomberg Businessweek reported that the fill-and-finish line can crank out 24,000 vials per hour.

With each vial holding 10 doses, that meant the plant was on track to bottle 50 million doses a month, Catalent's president of European biologics, Mr Mario Gargiulo, said at the time.

Catalent's 28,000 sq m facility has been buzzing with vaccine activity for months.

Its workers add final ingredients to AstraZeneca's vaccine mix, pump it into the filling line of sterilised bottles, move the cargo into an inspection machine that scrutinises each vial with nine cameras from different angles, and then rack the vials into boxes that are ready for transport.

Hidden abundance

Having doses on site, especially in bulk form, does not mean they're remotely ready for shipping.

It can take 1½ months for a vial to complete the process from the start of filling to its release from the factory to the market, Mr Gargiulo said in July.

That might explain why the Catalent executive seemed puzzled last Wednesday when asked by telephone about "hidden" doses discovered at his plant.

The doses present in Anagni include bulk "drug substance", some in the bottling process, and those already in vials for quality control and awaiting shipping, he said.

The total dose count on site varies daily, and may have been 29 million on the day of the inspection, and "one day could be 19 million", he said.

Meanwhile, for the residents of Anagni - who like other Europeans are awaiting inoculations to restart their lives - the shots are a bittersweet discovery of hidden abundance in their backyard.

What's more, many million more doses of vaccine will be piling up there soon.

Three days before the inspection, Catalent announced that it had expanded its deal with another vaccine-maker, Johnson & Johnson, for fill, finish, packaging and inspection of its one-shot Covid-19 vaccine - right there in Anagni.

For all that, what still remains a mystery is why European officials and AstraZeneca were not on the same page on the Anagni doses. And that may continue to keep their relations strained.