American drug maker, Pfizer and its German partner, BioNTech are submitting an emergency authorisation request in the US which would grant its coronavirus vaccine to be used in treatment of coronavirus 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).
According to BioNTech, it had not submitted its vaccine for approval in the UK yet. However, 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.
“Our work to deliver a safe and effective vaccine has never been more urgent,” Pfizer CEO Albert Bourla said in a statement.
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.