Pfizer and BioNTech have submitted their Covid-19 vaccine to the European Medicines Agency for conditional approval, the companies said in a statement on Tuesday, aiming to make their drug available in Europe by the end of the year.
Welcome to the permit application
The partners - a US pharma giant and a small German biotechnology firm specializing in nascent mRNA technology - said receipt of their application had been confirmed after it was submitted on Monday.
This puts the companies neck and neck with US firm Moderna, which also applied to the EU regulator for the conditional approval of its Covid-19 vaccine on Monday.
Pfizer chief executive Albert Bourla hailed the approval request as "another key milestone" in its efforts to alleviate the health crisis together with BioNTech.
The workability of the vaccine is 95 percent
Their vaccine has been found to be 95-per-cent effective against Covid-19.
In a final analysis of clinical trials released last month, based on tests involving tens of thousands of volunteers, Pfizer and BioNTech said their vaccine worked almost equally well across different demographic age groups and that no safety concerns were noted.
Among people aged over 65, a key risk group, the efficacy rate was over 94 per cent.
The drug protects against the Covid-19 lung disease caused by the novel coronavirus, which has led to over 1.4 million deaths worldwide so far in the pandemic.
It remains unclear whether the vaccine also prevents the carrier from passing on the virus.
Like Moderna, Biontech and Pfizer have also applied to the US Food and Drug Administration (FDA) for emergency approval.
"We will continue to work with regulatory agencies around the world to enable the rapid distribution, should the vaccine receive the approval, contributing to the joint efforts to let the world heal and regain its normal pace of life," BioNTech co-founder and chief executive Ugur Sahin said.
BioNTech and Pfizer have also applied for approval from Britain's Medicines and Healthcare Products Regulatory Agency (MHRA) and have initiated so-called rolling submissions with regulators across the globe, including in Australia, Canada and Japan.
The vaccine is available within a few hours
At a press conference with German Reseach Minister Anja Karliczek on Tuesday, BioNTech chief financial officer Sierk Poetting said the company was ready to deliver doses of the vaccine "within a few hours" of regulatory approval.
The vaccine would be delivered in boxes and could be kept cool in these boxes with dry ice for up to 30 days at vaccination centres, or for up to five days in a commercial refrigerator, Poetting said.
Freezers would only become necessary if the vaccine were to be stored for a longer period, he added.
BioNTech and its US partner expect to supply up to 50 million vaccine doses globally in 2020, increasing to up to 1.3 billion doses in 2021. The vaccine must be administered in two doses.
Both the Moderna and Pfizer/BioNTech vaccines use mRNA technology, which uses the virus' genetic code to train the body's immune system to create antibodies against it.
No vaccine of this kind has yet been granted regulatory approval.
In Russia, China and most recently Bahrain, vaccines have already been made available and some of the population has received the jab.
However, it remains unclear how effective these vaccines are and what side effects they could have.
The EU process for vaccine approval