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Released May 03, 2021 | GALWAY, IRELAND
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Written by Martin Lynch, European News Editor for Industrial Info (Galway, Ireland)--The European Union (EU) has confirmed increased manufacturing capacity for COVID-19 vaccines at sites in Belgium and Spain as it seeks to overcome notable shortages in vaccine delivery.
The European Medicines Agency (EMA) has approved an increase in batch size and associated process scale-up at Pfizer's vaccine manufacturing site in Puurs, Belgium. It said that the decision is "expected to have a significant impact on the supply of Comirnaty, the COVID-19 vaccine developed by BioNTech/Pfizer, for Europe.
Visiting the plant, EU President Ursula von der Leyen said: "This manufacturing site was the first to produce an mRNA vaccine at large scale in Europe. I saw the Lipid Nano Particle Skid earlier--that was impressive to see that, when we were visiting the site. And I was told that this is a machine that plays the crucial role in the production of mRNA vaccines. The first one ever was built right here in Puurs, in that lab, last summer. A groundbreaking innovation. And this pioneering technology could be the backbone of our future vaccine portfolio. Indeed, mRNA vaccines will be central to the EU's preparedness plan for fighting COVID-19 and other viruses."
She added: "With the enormous efforts of BioNTech-Pfizer and the acceleration of their vaccine deliveries, I am now confident that we will have sufficient doses to vaccinate 70% of the adult population in the European Union already in July. And this pioneering technology we see here will help us with that. We are working with BioNTech-Pfizer on a new contract. This contract will foresee the delivery of 1.8 billion doses for the years 2021 to 2023. We will conclude it in the next days."
The EMA also green-lit a new filling line at Moderna's finished product manufacturing site for the EU in Rovi, Spain. The new line will enable an increase in finished product fill activities, to synchronize with the active substance scale-up process at the active substance manufacturing site (Lonza, Visp) approved last month.
In related news, the European Commission confirmed that it is taking legal action against AstraZeneca over its failure to meet its vaccine obligations. The company has failed to meet its delivery targets ever since it received approval for its vaccine in February and has been the subject of a number of warnings from the EU. For additional information, see February 1, 2021, article - Europe Warns AstraZeneca On Low COVID-19 Vaccine Deliveries.
"The commission has started last Friday a legal action against the company AstraZeneca on the basis of breaches of the advanced purchase agreement," explained EU spokesman Stefan De Keersmaecker. "Some terms of the contract have not been respected and the company has not been in a position to come up with a reliable strategy to ensure the timely delivery of doses. What matters to us in this case is that we want to make sure that there's a speedy delivery of a sufficient number of doses that European citizens are entitled to, and which have been promised on the basis of the contract."
AstraZeneca stated that it regretted the action and will defend its position. "Following an unprecedented year of scientific discovery, very complex negotiations, and manufacturing challenges, our company is about to deliver almost 50 million doses to European countries by the end of April, in line with our forecast. We believe any litigation is without merit. Vaccines are difficult to manufacture, as evidenced by the supply challenges several companies are facing in Europe and around the world. We are making progress addressing the technical challenges and our output is improving, but the production cycle of a vaccine is very long which means these improvements take time to result in increased finished vaccine doses."
Industrial Info Resources (IIR), with global headquarters in Sugar Land, Texas, six offices in North America and 12 international offices, is the leading provider of global market intelligence specializing in the industrial process, heavy manufacturing and energy markets. Industrial Info's quality-assurance philosophy, the Living Forward Reporting Principle, provides up-to-the-minute intelligence on what's happening now, while constantly keeping track of future opportunities. Follow IIR on: Facebook - Twitter - LinkedIn.
The European Medicines Agency (EMA) has approved an increase in batch size and associated process scale-up at Pfizer's vaccine manufacturing site in Puurs, Belgium. It said that the decision is "expected to have a significant impact on the supply of Comirnaty, the COVID-19 vaccine developed by BioNTech/Pfizer, for Europe.
Visiting the plant, EU President Ursula von der Leyen said: "This manufacturing site was the first to produce an mRNA vaccine at large scale in Europe. I saw the Lipid Nano Particle Skid earlier--that was impressive to see that, when we were visiting the site. And I was told that this is a machine that plays the crucial role in the production of mRNA vaccines. The first one ever was built right here in Puurs, in that lab, last summer. A groundbreaking innovation. And this pioneering technology could be the backbone of our future vaccine portfolio. Indeed, mRNA vaccines will be central to the EU's preparedness plan for fighting COVID-19 and other viruses."
She added: "With the enormous efforts of BioNTech-Pfizer and the acceleration of their vaccine deliveries, I am now confident that we will have sufficient doses to vaccinate 70% of the adult population in the European Union already in July. And this pioneering technology we see here will help us with that. We are working with BioNTech-Pfizer on a new contract. This contract will foresee the delivery of 1.8 billion doses for the years 2021 to 2023. We will conclude it in the next days."
The EMA also green-lit a new filling line at Moderna's finished product manufacturing site for the EU in Rovi, Spain. The new line will enable an increase in finished product fill activities, to synchronize with the active substance scale-up process at the active substance manufacturing site (Lonza, Visp) approved last month.
In related news, the European Commission confirmed that it is taking legal action against AstraZeneca over its failure to meet its vaccine obligations. The company has failed to meet its delivery targets ever since it received approval for its vaccine in February and has been the subject of a number of warnings from the EU. For additional information, see February 1, 2021, article - Europe Warns AstraZeneca On Low COVID-19 Vaccine Deliveries.
"The commission has started last Friday a legal action against the company AstraZeneca on the basis of breaches of the advanced purchase agreement," explained EU spokesman Stefan De Keersmaecker. "Some terms of the contract have not been respected and the company has not been in a position to come up with a reliable strategy to ensure the timely delivery of doses. What matters to us in this case is that we want to make sure that there's a speedy delivery of a sufficient number of doses that European citizens are entitled to, and which have been promised on the basis of the contract."
AstraZeneca stated that it regretted the action and will defend its position. "Following an unprecedented year of scientific discovery, very complex negotiations, and manufacturing challenges, our company is about to deliver almost 50 million doses to European countries by the end of April, in line with our forecast. We believe any litigation is without merit. Vaccines are difficult to manufacture, as evidenced by the supply challenges several companies are facing in Europe and around the world. We are making progress addressing the technical challenges and our output is improving, but the production cycle of a vaccine is very long which means these improvements take time to result in increased finished vaccine doses."
Industrial Info Resources (IIR), with global headquarters in Sugar Land, Texas, six offices in North America and 12 international offices, is the leading provider of global market intelligence specializing in the industrial process, heavy manufacturing and energy markets. Industrial Info's quality-assurance philosophy, the Living Forward Reporting Principle, provides up-to-the-minute intelligence on what's happening now, while constantly keeping track of future opportunities. Follow IIR on: Facebook - Twitter - LinkedIn.
