Pfizer applies for emergency approval of Covid vaccine in Europe
Approval could be granted within weeks
Pfizer and its partner BioNTech have applied for emergency authorisation of their coronavirus vaccine in Europe.
The application to the European Medicines Agency (EMA) comes after emergency use was also sought in the US and Britain.
In their pursuit of a European launch, potentially this year, the partners are neck and neck with rival Moderna, which also said on Monday it would ask the EU regulator to recommend conditional approval for its shot.
Pfizer and BioNTech reported in mid-November that their vaccine candidate was 95 per cent effective in preventing coronavirus, with no major safety concerns.
It raises the prospect of US and European approval within weeks.
BioNTech can start shipping the first doses “within hours” after clearance, the company said.
If the EMA concludes that the benefits of the Pfizer-BioNTech shot outweigh the risks, it will recommend granting a conditional clearance that could enable the shot to be rolled out in Europe before the end of the year, the companies said.
The partners have signed deals to deliver hundreds of millions of doses of the vaccine, including an agreement with the EU for 200 million doses, with an option for an additional 100 million.
The UK, which is poised to become the first country to approve the vaccine, ordered 40 million doses.
Approval could be granted as soon as December 7, with an inoculation programme introduced within hours of authorisation.
The US could follow days later with emergency approval granted between December 8 and December 10.
The British regulator is also carrying out safety checks on the Moderna and University of Oxford/AstraZeneca vaccines, but approval for those is expected to come after the Pfizer shot is approved.
The Moderna and Pfizer/BioNTech vaccines are both based on a new technology that uses mRNA (messenger ribonucleic acid) to deliver genetic material to the body that makes human cells create a protein from the virus.
This trains the immune system to be ready to attack if it encounters coronavirus.
But Moderna's vaccine can be kept in long term storage at -20 degrees, while Pfizer's requires -70 degrees.
Meanwhile, new research suggests more than half of Britons worry that countries may be rushing or bypassing processes in order to lead the vaccine race.
The survey of 8,000 people, carried out by polling company Piplsay, also found 73 per cent of Britons backed the Oxford vaccine and were optimistic about its success.
Updated: December 1, 2020 03:28 PM