UK cleared to offer Pfizer-BioNTech Covid-19 vaccine from next week

London/Berlin — The UK became the first western country to approve a Covid-19 vaccine, with its regulator clearing Pfizer and BioNTech’s shot ahead of decisions in the US and EU.

The emergency authorisation clears the way for the deployment of a vaccine that Pfizer and its German partner have said is 95% effective in preventing illness. The shot will be available in Britain from next week, according to a government statement on Wednesday.

“We can see the way out, and we can see that by the spring we are going to be through this,” health secretary Matt Hancock said on Sky News. In a radio interview he added that 800,000 doses were ready to be delivered from Belgium. “This is going to be one of the biggest civilian projects in history,” he said, with 50 hospitals preparing to administer the vaccine.

BioNTech American depositary receipts rose 8% in early trading in Germany.

The UK had signalled it would move swiftly in approving a vaccine, and doctors across the country were put on standby for a possible rollout. For the government, it’s an opportunity to make up for missteps during the pandemic as Britain’s death toll nears 60,000.

The UK regulator, the Medicines and Healthcare Products Regulatory Agency, said on Wednesday that the vaccine “met its strict standards of safety, quality and effectiveness.” Pfizer, along with Moderna and the University of Oxford’s partner, AstraZeneca, have sprinted ahead in a bid to deliver coronavirus vaccines in record time.

EU application

Pfizer and BioNTech earlier this week sought regulatory clearance for their vaccine in the EU, putting the shot on track for potential approval there before the end of the year. In the US, a Food and Drug Administration (FDA) panel is set to meet on December 10 to discuss the vaccine.

China has given authorisation to its three front-runners for emergency use. Russia cleared a vaccine known as Sputnik V in August, while a second inoculation was approved in October, even as the last stage of trials to establish safety and efficacy are still taking place.

The British government in late November invoked a special rule allowing its drug regulator to move ahead of the EU as the country prepares for the Brexit transition period to conclude at the end of 2020.

The UK still needs other vaccines to reach the finish line to immunise enough of its population to end the pandemic. The country has ordered enough doses of the two-shot Pfizer-BioNTech shot to inoculate 20-million people, less than one-third of the population. While the companies have said they can produce 1.3-billion doses in 2021, much of that supply is already spoken for in deals to ship hundreds of millions of shots to Europe, the US, Japan and elsewhere.

The approval also marks the first time a vaccine based on messenger RNA has reached the market. The new technology essentially transforms the body’s cells into tiny vaccine-making machines, instructing cells to make copies of the coronavirus spike protein, which stimulates the production of protective antibodies.

The Pfizer-BioNTech shot dashed to the head of the queue after delays to the trials of the AstraZeneca-Oxford vaccine, which has also shown promising signs in preliminary results of broad studies. The UK partners have faced questions after acknowledging that a lower dosage level that appeared more effective resulted from a manufacturing discrepancy.

Bloomberg