The UK’s quick approval of the Covid vaccine from Pfizer Inc. and BioNTech SE means Britons will get first dibs on a shot developed in two other countries — the US and Germany.

Britain’s drug regulator on Wednesday cleared the vaccine for emergency use, ahead of the US Food and Drug Administration and its European Union counterpart. The government cited a rule allowing the UK to authorize a shot independently ahead of the end of the Brexit transition period on Jan. 31. An accelerated review process in which regulators were able to monitor Pfizer’s trial data in real time also helped.

The UK’s Medicines and Healthcare Products Regulatory Agency “has done a great job of working with the company to look at that data as it’s come through and do things in parallel, rather than one after the other as they normally would,” Health Secretary Matt Hancock said in a radio appearance. He also credited Brexit, though the MHRA said the speedy authorization was conducted within EU guidelines.

The move is particularly striking because BioNTech, which pioneered the messenger RNA technology behind the vaccine, is based in Germany and received 375 million euros ($450 million) in funding from its government. Pfizer, meanwhile, has a deal to supply the US with 100 million doses, though it didn’t receive direct research support from the White House-led Operation Warp Speed Project.

Vaccine Race

Winning the race to vaccine approval has been important for UK Prime Minister Boris Johnson, with trust in his government in short supply after a series of missteps during the pandemic that left the UK with a death toll approaching 60,000 and its deepest recession for 300 years. Concerns have been raised over the time taken to develop the vaccine — 10 months rather than the usual 10 years — and why the MHRA was quicker to approve it than other regulators.

Researchers and and health officials, concerned about vaccine hesitancy, have been sensitive to any appearance of political pressure to cut corners. After US President Donald Trump suggested the FDA would drag out its review of vaccine trials to hurt him politically, major drugmakers including Pfizer pledged publicly to uphold safety standards.

The FDA also said it wanted to see two months of safety data before approving a vaccine — a time frame that did not bind the UK.

On Wednesday, British officials rushed to reassure people the newly licensed Pfizer vaccine is safe, ahead of its rollout across the country starting next week.

Approval Process

Everyone can be “absolutely confident that no corners whatsoever have been cut” in the approval process, said June Raine, chief executive of the UK regulator. Hancock even offered to receive the shot live on television.

But after the accelerated decision, ministers have a challenge to convince the vast majority of the population to be vaccinated in order to ensure the program is effective.

Drugmakers Pledge to Avoid Safety Shortcuts on Covid Vaccine

In a televised briefing, Raine said the MHRA carried out an “extremely thorough and scientifically rigorous review” and the vaccine had only been approved “because those strict tests have been done and complied with.”

Pressed on why the UK had approved the vaccine before the US and EU, she said her colleagues had worked nights and weekends. “The public can be absolutely confident that the standards we have worked to are equivalent to those around the world,” she said.

Rolling Review

The MHRA, like the European Medicines Agency, has been using a so-called rolling review process that lets officials monitor trial data as they arrive, rather than waiting for a full submission after a study is completed. BioNTech is awaiting a decision from the FDA in the middle of December, around the same time as it expects a ruling from the EU regulator, Chief Medical Officer Ozlem Tureci said in a press conference.

Ahead of the FDA’s scheduled Dec. 10 meeting to review the vaccine, agency staff members are going over the raw clinical trial data and checking Pfizer’s calculations as well as reviewing information on the manufacturing process. The agency’s regular approval process can take anywhere from six to 10 months for most drugs and vaccines.

“The amount of data submitted to the FDA includes thousands of pages of technical information that must be divided up and reviewed by experts from different disciplines,” an FDA spokesperson said in an emailed statement.

Source link

LEAVE A REPLY

Please enter your comment!
Please enter your name here