The US company, which has worked in conjunction with BioNtech, will submit its Emergency Use Authorisation request to the US Food and Drug Administration (FDA) later today. The coronavirus vaccine will then be ready to distribute within hours of authorisation. 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 is also seeking approval for their vaccine in other countries across the world, including Australia, Canada and Japan.
The UK regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), is poised to fast-track authorisation of the vaccine.
The UK has secured 40 million doses of the vaccine, with 10 million due in the country by the end of the year if the jab is approved.
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.”
Earlier this week Pfizer said its final trial results suggest its vaccine is 95 percent effective.
The vaccine has been tested on 43,500 people in six countries and no safety concerns have been raised.
In the final trials, the jab showed 95 percent of participants were protected from the virus within 28 days of the first dose.
The jab also proved 94 percent effective among adults over 65, who are considered to be more vulnerable to the disease.
The researchers found there were no serious side effects to the drug, with only two percent of participants reporting a headache and 3.7 percent reporting fatigue.
Researchers followed about 38,000 participants for an average of two months following a second dose of the vaccine candidate.
The Pfizer vaccine works by producing both an antibody and T-cell response in the body to fight coronavirus.
BioNTech Chief Executive Ugur Sahin said he was optimistic the immunization effect of the vaccine would last for a year.
Commenting on the recent development in the vaccine, he 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.”
Pfizer and BioNTech expect to be able to produce up to 50million vaccine doses globally in 2020 and up to 1.3billion in 2021.
Published at Fri, 20 Nov 2020 12:03:00 +0000