Reports related to this article:
Plant(s): View 1 related plant in PECWeb
Released November 11, 2020 | GALWAY, IRELAND
en
Written by Martin Lynch, European News Editor for Industrial Info (Galway, Ireland)--Germany's BioNTech (NASDAQ: BNTX) and U.S. major Pfizer (NYSE:PFE) have announced their coronavirus vaccine is more than 90% effective in preventing COVID-19 among people without evidence of prior infection.
The results of the first interim data from the Phase 3 trials--the final stage before commercial licensing--indicate that up to 50 million doses could be ready before the end of the year and up to 1.3 billion doses in 2021. The companies stated that the vaccine candidate BNT162b2, which is based on BioNTech's proprietary mRNA technology, was found to be more than 90% effective in preventing COVID-19 in participants without evidence of prior SARS-CoV-2 infection. The study highlighted that 94 participants who received the two-dose vaccine were protected against the disease 28 days after their first inoculation. The companies will seek emergency use authorisation from the U.S. Food and Drug Administration (FDA) in the coming weeks.
Industrial Info reported last month that the European Union (EU) had begun a "rolling review" of the vaccine with a view to fast-tracking its rollout. The EU has already agreed to buy 200 million doses with an option to purchase an additional 100 million doses, with deliveries starting by the end of 2020. For additional information, see October 19, 2020, article - Europe Fast Tracks Process for BioNTech/Pfizer.
In September, BioNTech announced that it was buying a manufacturing site in Germany from Novartis to increase the production capacity for the 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. For additional information, see September 28, 2020, article - BioNTech Buys German Plant to Boost COVID-19 Vaccine Production.
"Today is a great day for science and humanity," claimed Dr. Albert Bourla, Pfizer chairman and chief executive officer. "The first set of results from our Phase 3 COVID-19 vaccine trial provides the initial evidence of our vaccine's ability to prevent COVID-19. We are reaching this critical milestone in our vaccine development program at a time when the world needs it most with infection rates setting new records, hospitals nearing over-capacity and economies struggling to reopen. With today's news, we are a significant step closer to providing people around the world with a much-needed breakthrough to help bring an end to this global health crisis. We look forward to sharing additional efficacy and safety data generated from thousands of participants in the coming weeks."
Prof. Ugur Sahin, BioNTech co-founder and chief executive officer, commented: "The first interim analysis of our global Phase 3 study provides evidence that a vaccine may effectively prevent COVID-19. This is a victory for innovation, science and a global collaborative effort. When we embarked on this journey 10 months ago this is what we aspired to achieve. Especially today, while we are all in the midst of a second wave and many of us in lockdown, we appreciate even more how important this milestone is on our path towards ending this pandemic and for all of us to regain a sense of normality. We will continue to collect further data as the trial continues to enroll for a final analysis planned when a total of 164 confirmed COVID-19 cases have accrued. I would like to thank everyone who has contributed to make this important achievement possible."
In related news, the FDA issued emergency use authorisation for Eli Lilly's single coronavirus antibody drug, Bamlanivimab, to treat mildly or moderately ill COVID-19 patients. While the safety and effectiveness of the therapy continues to be evaluated, the FDA said that bamlanivimab was shown in clinical trials to reduce COVID-19-related hospitalisation or emergency room visits in patients at high risk for disease progression within 28 days after treatment when compared to placebo.
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 results of the first interim data from the Phase 3 trials--the final stage before commercial licensing--indicate that up to 50 million doses could be ready before the end of the year and up to 1.3 billion doses in 2021. The companies stated that the vaccine candidate BNT162b2, which is based on BioNTech's proprietary mRNA technology, was found to be more than 90% effective in preventing COVID-19 in participants without evidence of prior SARS-CoV-2 infection. The study highlighted that 94 participants who received the two-dose vaccine were protected against the disease 28 days after their first inoculation. The companies will seek emergency use authorisation from the U.S. Food and Drug Administration (FDA) in the coming weeks.
Industrial Info reported last month that the European Union (EU) had begun a "rolling review" of the vaccine with a view to fast-tracking its rollout. The EU has already agreed to buy 200 million doses with an option to purchase an additional 100 million doses, with deliveries starting by the end of 2020. For additional information, see October 19, 2020, article - Europe Fast Tracks Process for BioNTech/Pfizer.
In September, BioNTech announced that it was buying a manufacturing site in Germany from Novartis to increase the production capacity for the 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. For additional information, see September 28, 2020, article - BioNTech Buys German Plant to Boost COVID-19 Vaccine Production.
"Today is a great day for science and humanity," claimed Dr. Albert Bourla, Pfizer chairman and chief executive officer. "The first set of results from our Phase 3 COVID-19 vaccine trial provides the initial evidence of our vaccine's ability to prevent COVID-19. We are reaching this critical milestone in our vaccine development program at a time when the world needs it most with infection rates setting new records, hospitals nearing over-capacity and economies struggling to reopen. With today's news, we are a significant step closer to providing people around the world with a much-needed breakthrough to help bring an end to this global health crisis. We look forward to sharing additional efficacy and safety data generated from thousands of participants in the coming weeks."
Prof. Ugur Sahin, BioNTech co-founder and chief executive officer, commented: "The first interim analysis of our global Phase 3 study provides evidence that a vaccine may effectively prevent COVID-19. This is a victory for innovation, science and a global collaborative effort. When we embarked on this journey 10 months ago this is what we aspired to achieve. Especially today, while we are all in the midst of a second wave and many of us in lockdown, we appreciate even more how important this milestone is on our path towards ending this pandemic and for all of us to regain a sense of normality. We will continue to collect further data as the trial continues to enroll for a final analysis planned when a total of 164 confirmed COVID-19 cases have accrued. I would like to thank everyone who has contributed to make this important achievement possible."
In related news, the FDA issued emergency use authorisation for Eli Lilly's single coronavirus antibody drug, Bamlanivimab, to treat mildly or moderately ill COVID-19 patients. While the safety and effectiveness of the therapy continues to be evaluated, the FDA said that bamlanivimab was shown in clinical trials to reduce COVID-19-related hospitalisation or emergency room visits in patients at high risk for disease progression within 28 days after treatment when compared to placebo.
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.
