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Published Thursday, December 3, 2020
International News
The UK is the first country to
authorize vaccine against covid-19
By the A.M. Costa Rica staff and wire services
On Wednesday, the companies Pfizer Inc. and BioNTech SE announced that the Medicines & Healthcare Products Regulatory Agency, MHRA, in the United Kingdom granted temporary authorization for emergency use for their mRNA vaccine BNT162b2, against covid-19.
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.
The distribution of the vaccine in the U.K. will be prioritized according to the populations identified in guidance from the Joint Committee on Vaccination and Immunisation, JCVI.
“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.,” said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. “As we anticipate further authorizations and approvals, we are focused on moving with the same level of urgency to safely supply a high-quality vaccine around the world. With thousands of people becoming infected, every day matters in the collective race to end this devastating pandemic.”
The MHRA’s decision is based on a rolling submission, including data from the Phase 3 clinical study, which demonstrated a vaccine efficacy rate of 95% (p<0.0001) in participants without prior SARS-CoV-2 infection (first primary objective) and also in participants with and without prior SARS-CoV-2 infection (second primary objective), in each case measured from 7 days after the second dose.
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.
Now that the vaccine is authorized in the U.K., the companies will take immediate action to begin the delivery of vaccine doses. The first doses are expected to arrive in the U.K. in the coming days, with complete delivery fulfillment expected in 2021.
The companies have filed a request for Emergency Use Authorization with the U.S. Food and Drug Administration, FDA, and have submitted the final Conditional Marketing Authorization Application, CA, following rolling submissions with the European Medicines Agency, EMA, and several other regulatory agencies around the world.
In Costa Rica, authorities at the Ministry of Health announced in October an agreement with Pfizer and BioNTech for the purchase of 3 million doses of the BNT162b2 vaccine.
The cost of the purchases has not been disclosed due to a commercial confidentiality agreement required by the companies, the government said. The National Emergency Fund is paying for the vaccines and expects to receive the treatment gradually in the first quarter of 2021.
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Should public health authorities vaccinate the entirety of Costa Rica’s population against covid-19? We would like to know your thoughts on this story. Send your comments to news@amcostarica.com
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