UK grants Pfizer, BioNTech historic first OK for mRNA vaccine, expects millions of doses by year end
Pfizer and BioNTech have scored a historic OK for their Covid-19 vaccine in the UK, where the first doses are expected to be delivered within days.
Days after the British government authorized its Medicines & Healthcare Products Regulatory Agency to make a call independent of the European Union — from which it’s in the process of exiting — the regulators gave the green light for emergency use of BNT162b2.
It marks the first time an mRNA vaccine has been sanctioned for widespread distribution.
While Russia and China have each started administering homegrown vaccines, they all lack the late-stage data that Pfizer and Moderna have offered to prove their shot works: In a 44,000-person trial, investigators recorded 170 cases of Covid-19, of which only 8 were in the vaccine group. That translated to a 95% efficacy for the 2-dose regimen, bolstered by positive safety results with 2 months of median follow-up.
“We believe that the roll-out of the vaccination program in the U.K. will reduce the number of people in the high-risk population being hospitalized,” BioNTech CEO and co-founder Ugur Sahin said in a statement, adding:”The data submitted to regulatory agencies around the world are the result of a scientifically rigorous and highly ethical research and development program.”
FDA and EMA decisions are expected later in December. The US agency likely won’t have a final verdict before Dec 10, when an advisory committee is convening to discuss the emergency use authorization.
European regulators and lawmakers apparently aren’t impressed with the speed, criticizing the move as “hasty.” In a statement to Reuters, the EMA said it has a more appropriate procedure that is longer because it takes more evidence into account and involves more checks. It expects to decide by Dec 29.
But the MHRA stood by its process, and BioNTech execs said the UK agency had asked questions to the same level of detail as their international counterpars. Having first teamed up on the unprecedented development effort, Pfizer and BioNTech started a rolling submission at the MHRA in late October, later than they went to the EMA.
In a statement, they emphasized that observed efficacy in adults age 65 or over — a key, vulnerable group that will also likely be prioritized for vaccination — is more than 94%. UK regulators also reviewed chemistry, manufacturing and control data before giving out the OK.
In a statement, Pfizer CEO Albert Bourla applauded the MHRA “for their ability to conduct a careful assessment and take timely action to help protect the people of the U.K.”
The next challenge will be getting the vaccines to hospitals and clinics efficiently. Experts and analysts have expressed concerns about rolling out a vaccine that requires storage at -70 degrees Celsius (-94 Fahrenheit), but Pfizer and BioNTech say they have invested in the infrastructure, from freezer boxes to charter flights, to get them where they need to be.
Each vial, BioNTech COO Sean Marett added in a press conference, contains 5 doses that need to be diluted with saline solution at the point of administration. Transport studies they have conducted with Pfizer suggested that the vaccine can retain stability in transport at 2-8 degrees Celsius for up to 6 hours, for delivery from vaccination hubs to satellite sites such as care homes.
When asked why their shot requires tougher cold chain conditions than Moderna’s, Sahin noted that stability studies are still ongoing and they’re expecting more data in January or February that might support updating the requirements.
“So there should be no big differences between the different messenger RNA vaccines, but the data needs to be generated,” he said. “We have just to understand that our candidate was selected end of July for this clinical trial — we had multiple candidates and we wanted to identify the best candidate — So the stability studies for this candidate started significantly later than the data that were already available for other candidates.”
With a supply deal already in place for 40 million doses, the UK authorization opens the door to phased delivery throughout 2020 and 2021. The companies say the first doses should arrive from Pfizer’s facility in Belgium within a few days, whether by lorry or plane. Health Secretary Matt Hancock said on BBC Radio 4 that he expects “a matter of millions of doses for the whole of the UK by the end of the year.”
Based on a prioritization guidance prepared by the Joint Committee on Vaccination and Immunisation, the 66 million-plus UK residents should receive the vaccine in the following order:
- older adults’ resident in a care home and care home workers
- all those 80 years of age and over and health and social care worker
- all those 75 years of age and overall those 70 years of age and over
- all those 65 years of age and overhigh-risk adults under 65 years of age
- moderate-risk adults under 65 years of age
- all those 60 years of age and over
- all those 55 years of age and over
- all those 50 years of age and over
- rest of the population (priority to be determined)
So how does it feel to have the first vaccine emergency approval backed by Phase III data?
“Actually I don’t think we’ve had time to think about it because we’re too busy packing vials for shipping to the UK with our colleagues at Pfizer,” Marett said.
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