Pfizer Requests Emergency Authorisation For Vaccine In US
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Pfizer and BioNTech, whose COVID-19 vaccine has shown a 95 per cent efficacy rate, are submitting an emergency authorisation request to US authorities, which could see the coronavirus vaccine being made available to high-risk populations in the country by mid-December.
BBC News reports that the UK has ordered enough of the vaccine to treat 20 million people, and should have received enough to treat 5 million people by the end of the year, but the vaccine has not yet been approved by the Medicines and Healthcare Products Regulatory Agency (MHRA).
The companies will submit an emergency use authorisation request to the US Food and Drug Administration (FDA) and is also seeking approval for their vaccine in other countries across the world including Australia, Canada and Japan.
Pfizer and BioNTech say they expect to produce up to 50 million doses globally in 2020 and up to 1.3 billion doses by the end of 2021. They also stated they will be ready to distribute the vaccine candidate within hours after authorisation.
The vaccine demonstrated an efficacy rate of 95 per cent in the companies’ phase 3 clinical study, and there were no serious safety concerns observed in the trial participants.
Pfizer and BioNTech’s submission to the FDA is supported by safety data from a randomised group of around 8,000 participants less than 18 years of age. It is also supported by data from around 38,000 trial participants who have been followed for an average of two months following a second dose of the vaccine candidate.
Dr Albert Bourla, Pfizer’s chairman and chief executive, said: “Filing in the US represents a critical milestone in our journey to deliver a COVID-19 vaccine to the world and we now have a more complete picture of both the efficacy and safety profile of our vaccine, giving us confidence in its potential.”
Ugur Sahin, the chief executive and co-founder of BioNTech, said: “As a company located in Germany in the heart of Europe, our interactions with the European Medicines Agency [EMA] are of particular importance to us and we have continuously provided data to them as part of our rolling review process.”
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