Released December 14, 2020 | GALWAY, IRELAND
en
Written by Martin Lynch, European News Editor for Industrial Info (Galway, Ireland)--The U.K. has become the first country to grant authorisation for emergency use of a COVID-19 vaccine to BioNTech SE and Pfizer Incorporated (NYSE:PFE).
It is the first Emergency Use Authorisation granted following a successful worldwide Phase 3 trial of the partners' BNT162b2 vaccine. The authorisation was green-lit by the U.K.'s Medicines & Healthcare Products Regulatory Agency (MHRA), just weeks before the country's planned exit, commonly called Brexit, from the European Union (EU). Industrial Info reported last month that the BNT162b2 vaccine was more than 90% effective in preventing COVID-19 among people without evidence of prior infection. For additional information, see November 11, 2020, article--'COVID-19 Vaccine Over 90% Effective' Claim Pfizer, BioNTech.
The U.K. has agreed initially to purchase 40 million doses of the BioNTech/Pfizer COVID-19 vaccine through its Vaccines Taskforce which should be enough to vaccinate 20 million people, as two doses per person are required for full protection. There is a 21 to 28-day gap between doses. One of the drawbacks to the vaccine so far is that it needs to be stored at between -70°C and -80°C. Others like Moderna's mRNA-1273 vaccine and another from Oxford University and AstraZeneca showed that they can be stored, transported and handled "at normal refrigerated conditions'' of 2°C to 8°C (36° to 46°F).
A statement from the U.K. Department of Health and Social Care read: "The government has today accepted the recommendation from the independent Medicines and Healthcare products Regulatory Agency (MHRA) to approve Pfizer/BioNTech's COVID-19 vaccine for use. This follows months of rigorous clinical trials and a thorough analysis of the data by experts at the MHRA who have concluded that the vaccine has met its strict standards of safety, quality and effectiveness. We will shortly publish final advice for the priority groups to receive the vaccine, including care home residents, health and care staff, the elderly and the clinically extremely vulnerable. The vaccine will be made available across the U.K. from next week."
"The Emergency Use Authorization in the U.K. will mark the first time citizens outside of the trials will have the opportunity to be immunized against COVID-19," said Ugur Sahin, M.D., CEO and co-founder of BioNTech. "We believe that the roll-out of the vaccination program in the U.K. will reduce the number of people in the high-risk population being hospitalized. Our aim is to bring a safe and effective vaccine upon approval to the people who need it. The data submitted to regulatory agencies around the world are the result of a scientifically rigorous and highly ethical research and development program."
Pfizer and BioNTech are also seeking Emergency Use Authorisation from the the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Permits are expected to be awarded in the coming weeks. Last month, Industrial Info reported that the European Commission (EC) had signed a deal for up to 300 million doses of BioNTech-Pfizer's COVID-19 vaccine. For additional information, see November 23, 2020, article - Europe Inks Deal for 300 Million Doses of COVID-19 Vaccine.
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.
It is the first Emergency Use Authorisation granted following a successful worldwide Phase 3 trial of the partners' BNT162b2 vaccine. The authorisation was green-lit by the U.K.'s Medicines & Healthcare Products Regulatory Agency (MHRA), just weeks before the country's planned exit, commonly called Brexit, from the European Union (EU). Industrial Info reported last month that the BNT162b2 vaccine was more than 90% effective in preventing COVID-19 among people without evidence of prior infection. For additional information, see November 11, 2020, article--'COVID-19 Vaccine Over 90% Effective' Claim Pfizer, BioNTech.
The U.K. has agreed initially to purchase 40 million doses of the BioNTech/Pfizer COVID-19 vaccine through its Vaccines Taskforce which should be enough to vaccinate 20 million people, as two doses per person are required for full protection. There is a 21 to 28-day gap between doses. One of the drawbacks to the vaccine so far is that it needs to be stored at between -70°C and -80°C. Others like Moderna's mRNA-1273 vaccine and another from Oxford University and AstraZeneca showed that they can be stored, transported and handled "at normal refrigerated conditions'' of 2°C to 8°C (36° to 46°F).
A statement from the U.K. Department of Health and Social Care read: "The government has today accepted the recommendation from the independent Medicines and Healthcare products Regulatory Agency (MHRA) to approve Pfizer/BioNTech's COVID-19 vaccine for use. This follows months of rigorous clinical trials and a thorough analysis of the data by experts at the MHRA who have concluded that the vaccine has met its strict standards of safety, quality and effectiveness. We will shortly publish final advice for the priority groups to receive the vaccine, including care home residents, health and care staff, the elderly and the clinically extremely vulnerable. The vaccine will be made available across the U.K. from next week."
"The Emergency Use Authorization in the U.K. will mark the first time citizens outside of the trials will have the opportunity to be immunized against COVID-19," said Ugur Sahin, M.D., CEO and co-founder of BioNTech. "We believe that the roll-out of the vaccination program in the U.K. will reduce the number of people in the high-risk population being hospitalized. Our aim is to bring a safe and effective vaccine upon approval to the people who need it. The data submitted to regulatory agencies around the world are the result of a scientifically rigorous and highly ethical research and development program."
Pfizer and BioNTech are also seeking Emergency Use Authorisation from the the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Permits are expected to be awarded in the coming weeks. Last month, Industrial Info reported that the European Commission (EC) had signed a deal for up to 300 million doses of BioNTech-Pfizer's COVID-19 vaccine. For additional information, see November 23, 2020, article - Europe Inks Deal for 300 Million Doses of COVID-19 Vaccine.
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.
