3 Dec 2020

UK approves Pfizer-BioNTech’s COVID-19 vaccine. Rollout in week time

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The UK today became the first country to approve the Covid-19 vaccine developed by Pfizer Inc and its German partner BioNTech SE. The vaccine will be available in Britain from next week, according to a statement from the U.K. government. The emergency authorization clears the way for the deployment of a vaccine that’s expected to play a significant role in the global effort to halt the coronavirus.

“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,” the UK government said in a statement.

About Pfizer-BioNTech’s Covid 19 vaccine

Pfizer and BioNtech are collaborating to develop BNT162, a series of vaccine candidates for COVID-19. BNT162 was initially four candidates developed by BioNTech, two candidates consisting of nucleoside modified mRNA-based (modRNA), one of uridine containing mRNA-based (uRNA), and the fourth candidate of self-amplifying mRNA-based (saRNA). Pre-clinical results of the modRNA candidate BNT162b2 posted to the pre-print server bioRxiv showed the vaccine had “protective anti-viral effects in rhesus macaques, with concomitant high neutralizing antibody titers and a TH1-biased cellular response in rhesus macaques and mice.” The companies have selected BNT162b2 to move forward in a Phase 2/3 trial.

Key Notes about Pfizer-BioNTech’s COVID-19 vaccine

Pfizer-BioNTech’s COVID-19 vaccine candidate was found to be more than 90% effective in preventing COVID-19 in participants without evidence of prior SARS-CoV-2 infection in the first interim efficacy analysis
Analysis evaluated 94 confirmed cases of COVID-19 in trial participants
Study enrolled 43,538 participants, with 42% having diverse backgrounds, and no serious safety concerns have been observed; Safety and additional efficacy data continue to be collected
Submission for Emergency Use Authorization (EUA) to the U.S. Food and Drug Administration (FDA) planned for soon after the required safety milestone is achieved, which is currently expected to occur in the third week of November
UK become first country to approve the vaccine.