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Released October 19, 2020 | GALWAY, IRELAND
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Written by Martin Lynch, European News Editor for Industrial Info (Galway, Ireland)--The European Union (EU) has begun a "rolling review" of the COVID-19 vaccine being developed by Germany's BioNTech (NASDAQ: BNTX) and U.S. major Pfizer (NYSE:PFE) with a view to fast-tracking its rollout.
The rolling review was announced by the European Medicines Agency (EMA) and is described as one of the tools that EMA uses to "speed up the assessment of a promising medicine or vaccine during a public health emergency." The EMA announced its first rolling review at the start of the month for a COVID-19 vaccine being developed by AstraZeneca in collaboration with the University of Oxford in the U.K.
The BNT162b2 vaccine candidate is based on BioNTech's proprietary mRNA technology and supported by Pfizer's global vaccine development and manufacturing capabilities. The vaccine candidate is currently being evaluated in a global Phase 3 study ongoing at more than 120 clinical sites worldwide with 37,000 participants, with more than 28,000 having received their second vaccination.
"The start of the rolling review means that the committee has started evaluating the first batch of data on the vaccine, which come from laboratory studies (non-clinical data)," the EMA stated. "This does not mean that a conclusion can be reached yet on the vaccine's safety and effectiveness, as much of the evidence is still to be submitted to the committee. The decision to start the rolling review of BNT162b2 is based on preliminary results from non-clinical and early clinical studies in adults which suggest that the vaccine triggers the production of antibodies and T cells (cells of the immune system, the body's natural defences) that target the virus. Large-scale clinical trials involving several thousands of people are ongoing, and results will become available over the coming weeks and months. These results will provide information on how effective the vaccine is in protecting people against COVID-19 and will be assessed once they are available."
In early September, Pfizer and BioNTech finalised a deal with the EU agreement to supply 200 million doses with an option to purchase an additional 100 million doses, with deliveries starting by the end of 2020. Later that month, Industrial Info reported that BioNTech has announced that it is buying a manufacturing site in Germany from Novartis to increase the production capacity for its planned COVID-19 vaccine. The plant in Marburg will enable the company to eventually churn out 750 million doses per year--or more than 60 million doses per month--of the BNT162 vaccine. For additional information, see September 28, 2020, article - BioNTech Buys German Plant to Boost COVID-19 Vaccine Production.
Commenting on the rolling review, Ugur Sahin, M.D., chief executive officer and Co-founder of BioNTech said: "It is our duty to ensure that while we are working to develop a potential vaccine at unprecedented speed to help address this pandemic, we do so with the highest ethical standards while adhering to sound scientific principles. We will continue to have regular and open dialogue with the EMA throughout the rolling review process."
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 rolling review was announced by the European Medicines Agency (EMA) and is described as one of the tools that EMA uses to "speed up the assessment of a promising medicine or vaccine during a public health emergency." The EMA announced its first rolling review at the start of the month for a COVID-19 vaccine being developed by AstraZeneca in collaboration with the University of Oxford in the U.K.
The BNT162b2 vaccine candidate is based on BioNTech's proprietary mRNA technology and supported by Pfizer's global vaccine development and manufacturing capabilities. The vaccine candidate is currently being evaluated in a global Phase 3 study ongoing at more than 120 clinical sites worldwide with 37,000 participants, with more than 28,000 having received their second vaccination.
"The start of the rolling review means that the committee has started evaluating the first batch of data on the vaccine, which come from laboratory studies (non-clinical data)," the EMA stated. "This does not mean that a conclusion can be reached yet on the vaccine's safety and effectiveness, as much of the evidence is still to be submitted to the committee. The decision to start the rolling review of BNT162b2 is based on preliminary results from non-clinical and early clinical studies in adults which suggest that the vaccine triggers the production of antibodies and T cells (cells of the immune system, the body's natural defences) that target the virus. Large-scale clinical trials involving several thousands of people are ongoing, and results will become available over the coming weeks and months. These results will provide information on how effective the vaccine is in protecting people against COVID-19 and will be assessed once they are available."
In early September, Pfizer and BioNTech finalised a deal with the EU agreement to supply 200 million doses with an option to purchase an additional 100 million doses, with deliveries starting by the end of 2020. Later that month, Industrial Info reported that BioNTech has announced that it is buying a manufacturing site in Germany from Novartis to increase the production capacity for its planned COVID-19 vaccine. The plant in Marburg will enable the company to eventually churn out 750 million doses per year--or more than 60 million doses per month--of the BNT162 vaccine. For additional information, see September 28, 2020, article - BioNTech Buys German Plant to Boost COVID-19 Vaccine Production.
Commenting on the rolling review, Ugur Sahin, M.D., chief executive officer and Co-founder of BioNTech said: "It is our duty to ensure that while we are working to develop a potential vaccine at unprecedented speed to help address this pandemic, we do so with the highest ethical standards while adhering to sound scientific principles. We will continue to have regular and open dialogue with the EMA throughout the rolling review process."
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.
