The United Kingdom becomes the first country to approve Pfizer-BioNTech’s COVID-19 vaccine for widespread use from as early as next week.
Care home residents, health and care staff, the elderly and people who are clinically extremely vulnerable will be first in line to receive the vaccine.
The UK is currently battling Europe’s worst outbreak of COVID-19, with more than 1.6 million cases of the novel coronavirus having been recorded since the pandemic began in late 2019.
More than 59,000 people have died, according to official figures.
Pfizer said the UK’s emergency use authorisation marks an historic moment in the fight against COVID-19.
“This authorisation is a goal we have been working toward since we first declared that science will win, and we applaud the MHRA for their ability to conduct a careful assessment and take timely action to help protect the people of the UK,” said CEO Albert Bourla.
“As we anticipate further authorisations and approvals, we are focused on moving with the same level of urgency to safely supply a high-quality vaccine around the world.”
One concern is that Pfizer’s vaccine must be stored and shipped at ultra-cold temperatures of around minus 70 degrees Celsius, adding to the challenge of distributing the vaccine around the world.
Pfizer says it has developed shipping containers that use dry ice to keep the vaccine cool. GPS-enabled sensors will allow the company to track each shipment and ensure they stay cold, the company says.
The UK will start vaccinating people early next week after it gets 800,000 doses from Pfizer’s manufacturing centre in Belgium.
While some experts welcomed the UK’s move, some questioned the speed for approval.
“The timeline has been fast, but also we need to think about this unique context that we are in – we have over 200 companies that have been focusing on developing a vaccine, they have unlimited resources and all of the world’s talents have been focused on this problem,” Oksana Pyzik, a teaching fellow at University College London’s School of Pharmacy said.
Sterghios Moschos, a molecular biologist at the UK’s Northumbria University, sought to assuage concerns over the speed at which the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), approved the vaccine.
“The review process used has not been the classical approval process … this is what is known as an emergency use authorisation, which has certain facilitations where the risk/benefit proposition is looked at and the need for society and the economy is put at parity with safety,” he said.
“But every single batch of the vaccine will be tested and confirmed to be of the same quality, quantity and composition.”
Fifty hospitals are set up across England and waiting to accept the vaccine, large vaccination centres are being set up now, and in time local health centres known as general practitioners (GPs) and pharmacists will provide the jab in the community if they have those capabilities
UK regulators also are considering another shot made by AstraZeneca and Oxford University.
But PM Johnson has warned “we must first navigate a hard winter” of restrictions to try to curb the virus until there is enough vaccine to go around.
Every country has different rules for determining when an experimental vaccine is safe and effective enough to use.