Pfizer and BioNTech will submit an emergency use authorisation (EUA) for their COVID-19 vaccine candidate BNT162b2 today, the companies announced in a statement.
They added that this could mean BNT162b2 will be available in high-risk populations in the US by the middle of December.
Rolling submissions for BNT162b2 are already ongoing in a number of regions globally, including the UK, the EU, Australia, Canada and Japan.
Earlier this week, Pfizer/BioNTech revealed the final analysis for their COVID-19 shot, with the results from a phase 3 study showing that BNT162b2 has a 95% efficacy rate.
The efficacy rate was consistent across age, gender, race and ethnicity, with the observed efficacy in adults over 65 years of age coming in at over 94%.
Pfizer/BioNTech expect to produce up to 50 million doses of BNT162b2 globally in 2020 and up to 1.3 billion doses by the end of 2021. The companies added that they will be able to distribute the mRNA-based vaccine ‘within hours’ after receiving regulatory approval.
“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,” said Albert Bourla, chairman and chief executive officer, Pfizer.
“We intend to continue to work with regulatory agencies worldwide to enable the rapid distribution of our vaccine globally,” said Ugur Sahin, chief executive officer and co-founder of BioNTech
“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,” he added.
The data for BNT162b2 will now be reviewed by regulators, as well as a group of independent experts who will examine the results from all clinical trials and make their own recommendations to the FDA.
Pfizer also initiated a pilot delivery programme for BNT162b2 earlier this week, amid concerns over potential distribution issues relating to the vaccine, which must be stored at ultra-low temperatures if it is to remain stable.
The vaccine candidate needs to be both distributed and stored at -70˚C (minus 94°F), which is well below the typical vaccine storage temperature of +2˚C to +8˚C.
The pilot programme is being conducted in four states in the US and will aim to improve understanding for accurate planning, deployment and administration of BNT162b2.
For inclusion in the pilot, Pfizer selected Rhode Island, Texas, New Mexico and Tennessee based on the differences in each states’ overall size, diversity of populations and immunisation infrastructures, as well as the states’ need to reach individuals in varied urban and rural settings.
“This pilot programme and our collaboration with US and state officials will help us prepare for broader vaccine deployment in the near future, subject to authorisation or approval, as we work to address this urgent public health need,” said Angela Hwang, group president, Pfizer Biopharmaceuticals Group.