Astra Zeneca is discussing what to do with its vaccine business – World

Dober also says Astra Zeneca will meet its commitments to produce hundreds of millions of doses of the coronavirus vaccine.

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He then added that “a small group of people reporting to me and Me (Pangalos, head of research) is considering whether this is a sustainable business.”

“We need to have a discussion with senior management and then with the AstraZeneca board. We are exploring various options, but it is too early at this stage to complete this process,” Dober said.

According to him, there is hope that in the next few weeks the legal dispute with the European Union over the delayed and unfulfilled deliveries of the Astra Zeneca vaccine will be resolved. The European Commission has filed two lawsuits and has virtually severed ties with the company, refusing to buy more of its vaccine for now.

The product has the most orders in the world (nearly 170 countries have approved Vaxzevria) and Astra Zeneca is still hoping to apply for approval in the United States – perhaps as early as September – although the procedure is relatively long. “The short answer is that this is an important vaccine and we believe it can play a role in the future,” CEO Pascal Sorio told reporters. Pangalos told me at the same event that the US FDA regulator wanted information terribly and it had yet to be provided.

In another exclusive report today, Reuters reported that Canada and Mexico had imported millions of doses of Vaxzevria and offered them to those who wished to be vaccinated, but without inspecting the facilities where they were produced.

It is again the Emergent BioSolutions plant in Baltimore, with a total of 4 million doses exported to US neighbors in late March with permission from President Joe Biden’s administration.

It now turns out that regulators in Canada and Mexico have referred to the certification of the plant by the European Medicines Agency (EMA) as a site complying with “good manufacturing practices”. But the EMA told Reuters that the certification was done remotely and covered part of the company that did not actually produce AstraZeneca vaccines.

Three weeks later, the FDA halted work in Baltimore after finding that batches of the Johnson & Johnson vaccine produced there contained material from the Astra Zeneca vaccines.

There have been no reports of casualties from the doses already sent, and regulators say they have not actually been delivered yet. The company still does not work today and tens of millions of doses of vaccines of the two companies are in a regulatory dispute, although there are no reports of a problem with the Astra Zeneca vaccine, and the company explains that more than 40 tests have been performed with its product. for compliance with safety, cleanliness and quality standards.

However, the case once again raises the question of how complex the system of certification of pharmaceutical sites has become, including by regulators and agencies from a completely different country and even continent.

Details coming later at www.dnevnik.bg.

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