New Telegraph

December 11, 2023

COVID-19: Pfizer requests emergency authorisation for vaccine in US


Pfizer and BioNTech are submitting an emergency authorisation request in the US which could allow its coronavirus vaccine to be used to treat high-risk populations in the country by mid-December.
The UK has already ordered enough of the vaccine to treat 20 million people but it has not yet been approved by the Medicines and Healthcare Products Regulatory Agency (MHRA).
BioNTech told Sky News it had not submitted its vaccine for approval in the UK yet.
If the vaccine is approved in the US, it suggests a similar rollout of the treatment could soon take place in the UK.
Pfizer and BioNTech will submit its 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.
The companies intend to submit applications to other regulatory agencies worldwide in the coming days.
Pfizer and BioNTech expect to produce up to 50 million doses globally in 2020 and up to 1.3 billion doses by the end of 2021, and have said they will be ready to distribute the vaccine candidate within hours after authorisation.
The vaccine demonstrated an efficacy rate of 95% in the companies’ phase 3 clinical study.
There were no serious safety concerns observed in those who took part in the trials, with the treatment tested on people with and without a prior coronavirus infection.
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.
The submission includes data on approximately 100 children 12 to 15 years of age.
Around 42% of participants around the world and 30% of US participants in the phase 3 study were from racially and ethnically diverse backgrounds.
Some 41% of global and 45% of US participants were between 56 and 85 years of age.
Dr Albert Bourla, Pfizer’s chairman and chief executive, said: “Our work to deliver a safe and effective vaccine has never been more urgent, as we continue to see an alarming rise in the number of cases of COVID-19 globally.
“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: “Filing for emergency use authorization in the US is a critical step in making our vaccine candidate available to the global population as quickly as possible.
“We intend to continue to work with regulatory agencies worldwide to enable the rapid distribution of our vaccine globally.
“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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