Released February 01, 2021 | GALWAY, IRELAND
en
Written by Martin Lynch, European News Editor for Industrial Info (Galway, Ireland)--The European Commission has warned COVID-19 vaccine maker AstraZeneca that it expects it to deliver the vaccine as promised after the company admitted that it is experiencing serious delays.
The delivery shortfall to the European Union (EU) will see the initial amount fall from 80 million doses by the end of March to 31 million--roughly 60% less than agreed-- according to senior EU officials. In August, the EC signed a preliminary deal with AstraZeneca for the purchase of 300 million doses of its vaccine, with an option to purchase 100 million more, on behalf of EU Member States. The news of production problems comes in the same week as the European Medicines Agency (EMA) is expected to grant the vaccine an emergency licence for use in the EU's 27 Member countries.
EU Health Commissioner Stella Kyriakides, explained: You know that AstraZeneca's vaccine is currently in the final stages of the approval...and if all requirements are met the EMA could recommend market authorisation by the end of this week. But there is a problem on the supply side. AstraZeneca surprisingly informed the Commission and the European Union Member States that it intends to supply considerably fewer doses in the coming weeks than agreed and announced. This new schedule is not acceptable to the European Union. The European Union has pre-financed the development of the vaccine and the production and wants to see the return. 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 European Union will take any action required to protect its citizens and rights."
Speaking to Italian newspaper La Repubblica, AstraZeneca chief executive officer, Pascal Soriot, said: "Of course, we are all very disappointed. We would like to produce more. I think we will deliver up to Europe in the month of February a reasonable quantity actually, very similar to what others have delivered on a monthly basis. But of course, it's less than expected and also because our vaccine is easy to use people expected more so we could scale up. Our team is working 24/7 to fix the issues of production of the vaccine itself. You have two steps in the production of a vaccine: one is you produce the vaccine itself. We call it a drug substance, the vaccine. Then, when we are finished with it, we move this into different plants where we put the vaccine into vials and we call that the drug product, the final product. For Europe the drugs substance is essentially produced in two plants, one in the Netherlands, one in Belgium. The drug product is actually produced in Italy and Germany. So from a drug product viewpoint, we have full capacity. We have zero problems. The current problems have to do with manufacturing the drug substance".
As of last September, AstraZeneca had also agreed to the supply of 300 million shots of the same vaccine to the U.S. for $1.2 billion and up to 30 million doses to the U.K. for $86.5 million. Other deals are in place with India and Mexico. In related news, pharma company Merck & Co. has pulled the plug on its COVID-19 vaccine development, citing inferior immune responses. The company had two candidates under development: V591, which it got as part of its purchase of the Austrian vaccine company Themis Bioscience, and V590, which it was working on with nonprofit research group IAVI.
The company stated: "This decision follows Merck's review of findings from Phase 1 clinical studies for the vaccines. In these studies, both V590 and V591 were generally well tolerated, but the immune responses were inferior to those seen following natural infection and those reported for other SARS-CoV-2/COVID-19 vaccines."
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. Our European headquarters are located in Galway, Ireland. Follow IIR Europe on: Facebook - Twitter - LinkedIn For more information on our European coverage send inquiries to info@industrialinfo.eu or visit us online at Industrial Info Europe.
The delivery shortfall to the European Union (EU) will see the initial amount fall from 80 million doses by the end of March to 31 million--roughly 60% less than agreed-- according to senior EU officials. In August, the EC signed a preliminary deal with AstraZeneca for the purchase of 300 million doses of its vaccine, with an option to purchase 100 million more, on behalf of EU Member States. The news of production problems comes in the same week as the European Medicines Agency (EMA) is expected to grant the vaccine an emergency licence for use in the EU's 27 Member countries.
EU Health Commissioner Stella Kyriakides, explained: You know that AstraZeneca's vaccine is currently in the final stages of the approval...and if all requirements are met the EMA could recommend market authorisation by the end of this week. But there is a problem on the supply side. AstraZeneca surprisingly informed the Commission and the European Union Member States that it intends to supply considerably fewer doses in the coming weeks than agreed and announced. This new schedule is not acceptable to the European Union. The European Union has pre-financed the development of the vaccine and the production and wants to see the return. 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 European Union will take any action required to protect its citizens and rights."
Speaking to Italian newspaper La Repubblica, AstraZeneca chief executive officer, Pascal Soriot, said: "Of course, we are all very disappointed. We would like to produce more. I think we will deliver up to Europe in the month of February a reasonable quantity actually, very similar to what others have delivered on a monthly basis. But of course, it's less than expected and also because our vaccine is easy to use people expected more so we could scale up. Our team is working 24/7 to fix the issues of production of the vaccine itself. You have two steps in the production of a vaccine: one is you produce the vaccine itself. We call it a drug substance, the vaccine. Then, when we are finished with it, we move this into different plants where we put the vaccine into vials and we call that the drug product, the final product. For Europe the drugs substance is essentially produced in two plants, one in the Netherlands, one in Belgium. The drug product is actually produced in Italy and Germany. So from a drug product viewpoint, we have full capacity. We have zero problems. The current problems have to do with manufacturing the drug substance".
As of last September, AstraZeneca had also agreed to the supply of 300 million shots of the same vaccine to the U.S. for $1.2 billion and up to 30 million doses to the U.K. for $86.5 million. Other deals are in place with India and Mexico. In related news, pharma company Merck & Co. has pulled the plug on its COVID-19 vaccine development, citing inferior immune responses. The company had two candidates under development: V591, which it got as part of its purchase of the Austrian vaccine company Themis Bioscience, and V590, which it was working on with nonprofit research group IAVI.
The company stated: "This decision follows Merck's review of findings from Phase 1 clinical studies for the vaccines. In these studies, both V590 and V591 were generally well tolerated, but the immune responses were inferior to those seen following natural infection and those reported for other SARS-CoV-2/COVID-19 vaccines."
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. Our European headquarters are located in Galway, Ireland. Follow IIR Europe on: Facebook - Twitter - LinkedIn For more information on our European coverage send inquiries to info@industrialinfo.eu or visit us online at Industrial Info Europe.
