/UK’s speedy coronavirus vaccine approval sparks hope (and questions)

UK’s speedy coronavirus vaccine approval sparks hope (and questions)

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The world is watching the U.K. — and this time not for the Brexit drama.

Excited webinars, press conferences and briefings today offered a first glimpse of what is likely to become the next big challenge for countries all over the world: delivering whole population immunization against coronavirus.

Leapfrogging the U.S. — and weeks ahead of a similar decision for the rest of Europe — among the first concerns is whether the U.K. has taken a shortcut in green lighting the Pfizer/BioNTech jab.

The message from the U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA) today was definitive. “No corners have been cut,” said Chief Executive June Raine during a televised briefing. 

Expert scientists and clinicians have been “working around the clock, carefully and methodically, pouring over tables and analyses and graphs for every single piece of data,” she said. 

That includes over a thousand pages of data. The work involved “critically analyzing pre-clinical evidence, clinical trials, manufacturing and quality controls and down to the final sampling,” Raine added. 

Asked how the process differed from the European Medicines Agency and the U.S. Food and Drug Administration’s own approval regime, Raine said the MHRA process was “equivalent to all international standards.” There will, she added, be longer term follow up on the vaccine. 

The MHRA backed a temporary authorization for supply of the jab, although manufacturer Pfizer said a regulatory review for a full license is running in parallel.

Berkeley Phillips, medical director at Pfizer U.K., said it was simply a case of administrative work before the full license is supported. “Think of the chapters of the book,” he said. The MHRA has reviewed the chapters on efficacy, safety, and quality, he said. It now needs to be “brought together, bound into a book,” with the contents and summary, which haven’t yet been written.

BioNTech’s Chief Business Officer Sean Marett said full licensure would come in “due course.” 

Europe looking to the UK

The European Medicines Agency said today it would potentially reach a decision by December 29 for its own conditional marketing authorization. Some raised concerns that the U.K. process accepted a lower level of evidence, or potentially a lower threshold for its risk-benefit assessment, given the emergency situation — but Pfizer pushed back.

“We have provided complete data packages unblinded to both regulators,” said Ben Osborn, Pfizer U.K.’s country manager, who argued it was more a case of the U.K. being quicker.

It’s a “difference in underlying processing timelines as opposed to any difference in data submission,” he said.

Meanwhile, “the world is looking at the U.K.,” said microbiologist Ralf Rene Reinert, Regional Lead Medical and Scientific Affairs, at Pfizer Vaccines, inferring that since the U.K. has successfully used an EU loophole to approve this vaccine during an emergency, other countries might be thinking of doing the same. “I just got an email [about this],” he began to say, but stopped short of revealing which country it came from.

“It’s a risk-benefit decision. There are many deaths a day,” he said, noting Germany, where he lives, today recorded its highest number of daily deaths.

“Sometimes a country needs to lead. The U.K. is leading. Let’s see how other countries move forward,” he said.

Vaccine rollout

In the U.K., no time is being wasted in drawing up plans to distribute the vaccine, with Pfizer/BioNTech partnering with the National Health Service and Public Health England to prepare for the program.

It’s a “hugely complicated logistical challenge to vaccinate our entire country,” said Osborn. 

The vaccine needs to be stored at minus 60 to minus 80 degrees Celsius in order to keep its messenger RNA stable. It can be moved four times in special containers with dry ice, but the companies recommend no more than this, to guarantee its stability. 

It can then be stored in a regular GP surgery fridge — for example, at 2 to 8 degrees celsius — for up to five days. After being taken from the fridge, Marett said, the vaccine can be transported at that temperature to care homes, for example, within a six hour window.

Doses are coming to the U.K. from Belgium, either by plane or lorry. The first batches will be on U.K. soil by this weekend, Osborn said, and up to 800,000 are expected to be delivered this year. The U.K. has ordered 40 million doses, enough for 20 million people.

However, there are also fears that delays at the border at the end of the Brexit transition period could hold up the vaccine. Marett is pragmatic about it. “If disruption happens we will find another route,” he said.

Before the first doses can be administered next week, there are still a number of steps that need that need to be taken. The first of these took place today, when the Joint Committee on Vaccination and Immunization (JCVI) published its priority schedule for the whole of the U.K.

Next, training materials for staff and patient information leaflets must be drawn up.  This particular vaccine requires the training of experienced immunizers. Meanwhile, in Wales, each Health Board needs to authorize the final legal frameworks which will allow registered health care professionals to administer the vaccine.

First in line

The first people to be called for vaccines will be residents in care homes for older adults, as well as their carers. 

But Georgie Whitworth, editor of Tomorrow’s Care, a magazine for the care sector, said the vaccine news may have taken the sector by surprise.

“What’s been clear in recent months is how hard care homes have been working to allow residents to be reunited with their loved ones. Following the successful testing pilot and the newly-announced rollout of one million further kits for homes this month, I expect care providers will welcome vaccinations as another positive step towards normality,” she said.

Health Secretary Matt Hancock told MPs today the vaccine will be distributed in three different ways: hospital hubs; through local community services such as GPs; and then through mass vaccination centers such as in sports and conference centers. 

Sam Monaghan, chief executive of Methodist Homes (MHA), the U.K.’s largest charitable care provider, said: “There will be considerable logistical challenges involved, and we are yet to receive details on how the vaccinations will be rolled out to our residents and staff although a number of our care homes have been contacted locally by GP surgeries and health authorities. 

“We now await further details from the government on how the roll out will start, who will be administering the vaccinations and where it will be done,” said Monaghan.  

The schedule will expand to more people in descending order of age. The vaccine is currently not authorized for those under 16, or for pregnant women. Pfizer said research in these areas was ongoing. 

A word of caution

Two major questions around the vaccine remain — how long it will remain effective for, and whether it prevents onward transmission of coronavirus. BioNTech’s CEO Uğur Şahin said the company is assessing whether the vaccine prevents transmission, but that this will only be known in the next three to six months.  

“This is a huge step forward in the effort to end this pandemic,” said Charlie Weller, Head of Vaccines at the Wellcome Trust. “But we must not be complacent.”

A snap poll by YouGov today also shed light on the skepticism some Brits feel about the breakthrough. While 27 percent said they are very confident the jab is safe and 43 percent said they were fairly confident, 20 percent were either not very confident or not confident at all.

Even Hancock — who said he was willing to be vaccinated live on television to help overcome doubt — said the U.K. was not yet at the stage of mass vaccination, and urged the public to continue to follow government guidance including advice on hygiene and social distancing. 

Boris Johnson himself urged caution this evening, with the U.K. prime minister calling on the public not to get “carried away with over-optimism, or fall into the naive belief that the struggle is over.”

Northern Ireland’s Health Minister Robin Swann was also wary of being overly optimistic, saying: “This is not the end of the coronavirus nightmare but it should represent the beginning of the end.”

This article is part of POLITICO’s premium policy service: Pro Health Care. From drug pricing, EMA, vaccines, pharma and more, our specialized journalists keep you on top of the topics driving the health care policy agenda. Email [email protected] for a complimentary trial.