Pfizer and BioNTech achieve first authorization in the world for a vaccine to combat COVID-19
London, UK | THE INDEPENDENT | Medicines and Healthcare Products Regulatory Agency (MHRA) in the United Kingdom has granted a temporary authorization for emergency use for their COVID-19 vaccine (BNT162b2) against COVID-19.
The UK will start distribution of the vaccine manufactured jointly by German company BioNtech and Pfizer from the US, next week. Each doze will cost £20.
This constitutes the first Emergency Use Authorization following a worldwide Phase 3 trial of a vaccine to help fight the pandemic. Pfizer and BioNTech are anticipating further regulatory decisions across the globe in the coming days and weeks and are ready to deliver vaccine doses following potential regulatory authorizations or approvals.
BNT162b2 vaccine’s primary efficacy analysis demonstrates it to be 95% effective against COVID-19 beginning 28 days after the first dose. Efficacy was also consistent across age, gender, race and ethnicity demographics. Observed efficacy in adults over 65 years of age was over 94%.
“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, 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.”
Albert Bourla, Chairman and Chief Executive Officer, Pfizer, hailed his team for the breakthrough.
“Today’s Emergency Use Authorization in the U.K. marks a historic moment in the fight against COVID-19. This authorization is a goal we have been working toward since we first declared that science will win, and we applaud the MHRA for their ability to conduct a careful assessment and take timely action to help protect the people of the U.K.,” he said.
In July 2020, Pfizer and BioNTech announced an agreement with the U.K. to supply 30 million doses of the BNT162b2 mRNA-based vaccine, once authorized for emergency use. That agreement was increased to 40 million doses in early October.
The delivery of the 40 million doses will occur throughout 2020 and 2021, in stages, to ensure an equitable allocation of vaccines across the geographies with executed contracts.
India in race for vaccine
India are also in the race to get approval for the vaccines being developed in their country. The manufacturers have a deal with GAVI and WHO, to also supply to several developing countries including Uganda.
When it is ready, the COVID-19 vaccine will be distributed initially in India, before being given to developing countries, including Uganda, in an arrangement code named COVAX that is being driven by the World Health Organization (WHO), the Coalition for Epidemic Preparedness Innovations (CEPI) and vaccine alliance fund, GAVI.
Adar Poonawalla, CEO, Serum Institute of India told the press after Modi’s visit that “the vaccine will be distributed initially in India, then we will look at the COVAX countries which are mainly in Africa. The UK and European markets are being taken care of by AstraZeneca and Oxford. Our priority is India and COVAX countries.”
Uganda on list of 92 countries to benefit from COVAX AMC
The low income nations: Afghanistan, Benin, Burkina Faso, Burundi, Central African Republic, Chad, Democratic Republic of the Congo, Eritrea, Ethiopia, Gambia, Guinea, Guinea-Bissau, Haiti, Democratic People’s Republic of Korea, Liberia, Madagascar, Malawi, Mali, Mozambique, Nepal, Niger, Rwanda, Sierra Leone, Somalia, South Sudan, Syrian Arab Republic, Tajikistan, Togo, Uganda, United Republic of Tanzania and Yemen.
How India will help Uganda secure #COVID19 vaccine https://t.co/19g0jWoksA#COVAX #GAVI #MODI
FILE PHOTO pic.twitter.com/S6gy42vQbH
— The Independent (@UGIndependent) November 30, 2020