European Commission Raids AstraZeneca’s Belgian Vaccine Plant

 The European Commission’s (EC) fight with AstraZeneca heated up Wednesday when it sent Belgium regulators to the manufacturer’s COVID-19 vaccine production site near Brussels. Regulators removed samples and records from the plant, which are being examined by experts from Belgium, the Netherlands, Italy and Spain. A report, and a possible second visit, is expected within days.

The raid was triggered by production problems at the facility run by AstraZeneca’s partner, Novasep, a European leader in the production of viral vectors. Those problems resulted in AstraZeneca reducing the doses it can supply to the European Union (EU) this quarter by 60% (down from 56.2 million doses to only 31 million) and also called the number of doses anticipated for Q2 2021 into question.

In a letter to AstraZeneca, EC Commissioner Stella Kyriakides seemed to suggest that doses may have been diverted from EU member states to other nations. As she said, “The European Union wants to know exactly which doses have been produced by AstraZeneca and where exactly so far, and if or to whom they have been delivered. The answers of the company have not been satisfactory so far.”

The inspection of AstraZeneca’s Seneffe production site, south of Brussels, was conducted to ensure “that the delivery delay is indeed due to a production problem on the Belgian site,” according to a spokesperson for the Belgium health ministry, speaking to The Guardian.

Assurances by the World Health Organization’s Special Envoy on COVID-19, Dr. David Nabarro, that shortfalls result from efforts to improve the quality of production and they are just a part of reality, weren’t sufficient for the EC.

On Thursday, in another salve aimed at the company, Germany’s Federal Ministry of Health advised that AstraZeneca’s vaccine not be used for people older than 65, Reuters reported. AstraZeneca refuted those claims, but South Korea also is assessing the vaccine’s efficacy among the elderly. So far, the vaccine’s efficacy data for elderly populations remains limited.

The European Medicines Agency (EMA) meets Friday, January 29^th, to vote on approving the AstraZeneca vaccine. While side-stepping AstraZeneca’s debacle with the EC, EMA Executive Director Emer Cooke said the company still was providing data early in the week and that emergency use authorization was up to the EU member states rather than her agency, Ireland’s national public radio, RTE, reported.

Speaking at the World Economic Forum held virtually this week (rather than at its usual Davos, Switzerland venue), EC President Ursula von der Leyen pledged to form a “vaccine export transparency mechanism” to monitor vaccine exports from Europe. As she pointed out, "Europe invested billions to help develop the world's first Covid-19 vaccines to create a truly global common good. Now, the companies must deliver. They must honor their obligations. Europe means business.”

That determination was expressed by Kyriakides, too, noting, “all companies producing vaccines against COVID-19 in the EU will have to provide early notification whenever they want to export vaccines to third countries.”

Humanitarian shipments were excluded.

This includes doses leaving the EU for the U.K.

The day of the raid in Belgium, Kyriakides suggested that the AstraZeneca vaccines that were made in the U.K. should be distributed within the EU. Although the U.K. signed a contract three months before the EU, Kyriakides maintained that “first-come, first served works in a butcher’s shop, but not in contracts and not in our advanced purchase agreements.”

Causing the U.K. to rely upon vaccine produced on its shores could delay the time to reach herd immunity (defined as 75% vaccination) by two months, according to the analytics firm Airfinity and reported by MSN.

Thursday, U.K. Cabinet Office minister Michael Gove agreed to help the EU with its shortage, but only if it had spare vials. “But the really important thing is to make sure our own vaccination program proceeds precisely as planned,” he said in The Guardian newspaper.

There’s no denying that Europe is suffering. Hospitals in Paris and two other regions (Burgundy and Hauts-de-France) plan to suspend COVID-19 vaccinations next week because of vaccine shortfalls. Germany says its shortages will continue into April. Portugal says it will have only half its expected doses by March.

None-the-less, AstraZeneca pointed out that its supply chains were established to meet the needs of specific contracts. Consequently, any production problem in one region affects only that region.

With manufacturing issues slowing production, EC officials are threatening to make AstraZeneca’s contract public, the British newspaper The Telegraph reported. If that happens, the public will learn that AstraZeneca, unlike other large vaccine manufacturers, is making the vaccine available at cost.

Since Tuesday, AstraZeneca’s share prices have fallen 5.5% and its reputation risks being tarnished. In light of this and an ongoing row with the EC, some speculate the company may revisit its at-cost pricing decision.

https://www.biospace.com/article/european-commission-raids-astra-zeneca-s-belgian-vaccine-plant/