Rapid approval of coronavirus vaccine in UK raises hopes (and questions) – POLITICO

The world is watching the UK – and this time not for the Brexit drama.

Passionate webinars, press conferences and briefings today offered a first glimpse of what is likely to become the next big challenge for countries around the world: ensuring that everyone is immunized against the coronavirus.

Bouncing the United States – and weeks before a similar move for the rest of Europe – among the first concerns is whether the UK has taken a shortcut by lighting the Pfizer / BioNTech jab green.

The UK Medicines and Healthcare Products Regulatory Agency (MHRA) message was final today. “No corners were cut,” CEO June Raine said in a televised briefing.

Expert scientists and clinicians “worked around the clock, with care and method, going through tables, analyzes and graphs for each piece of data,” she said.

This includes over a thousand pages of data. The work involved “a critical analysis of preclinical evidence, clinical trials, manufacturing and quality controls and up to final sampling,” Raine added.

When asked how the process differs from that of the European Medicines Agency and the US Food and Drug Administration’s approval regime, Raine said the MHRA process is “equivalent to all international standards ”. There will be, she added, a longer-term follow-up of the vaccine.

The MHRA supported a temporary authorization for the supply of the jab, although manufacturer Pfizer said a regulatory review for a full license was taking place in parallel.

Berkeley Phillips, medical director of Pfizer UK, said it was just a case of administrative work before the full license was taken over. “Think about the chapters of the book,” he says. The MHRA reviewed the chapters on efficacy, safety and quality, he said. It must now be “put together, bound in a book”, with the content and the summary, which have not yet been written.

BioNTech’s commercial director, Sean Marett, said the full license would come “in due course”.

Europe in search of the United Kingdom

The European Medicines Agency said today that it could possibly make a decision by December 29 for its own conditional marketing authorization. Some have expressed concerns that the UK process will accept a lower level of evidence, or potentially a lower threshold for its risk-benefit assessment, given the emergency – but Pfizer has pushed back.

“We delivered full, unblinded data packages to both regulators,” said Ben Osborn, country director of Pfizer UK, who argued that the UK was faster.

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

Meanwhile, “the world is watching the UK,” said microbiologist Ralf Rene Reinert, regional head of medical and scientific affairs at Pfizer Vaccines, deducing that since the UK has successfully used a loophole from the ‘EU to approve this vaccine in an emergency, other countries might think about doing the same. “I just received an e-mail [about this]He started to say, but stopped before revealing which country he was from.

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

“Sometimes a country needs to lead. The UK is in the lead. Let’s see how other countries are doing, ”he said.

Vaccine deployment

In the UK, no time is wasted developing vaccine distribution plans, with Pfizer / BioNTech teaming up with the National Health Service and Public Health England to prepare the program.

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

The vaccine should be stored between minus 60 and 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 companies do not recommend anything more, to ensure its stability.

It can then be stored in a regular general surgery refrigerator – for example, between 2 and 8 degrees Celsius – for up to five days. After being taken out of the refrigerator, Marett said, the vaccine can be transported at that temperature to nursing homes, for example, within six hours.

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

However, there are also concerns that border delays at the end of the Brexit transition period could delay the vaccine. Marett is pragmatic about this. “If there is a disruption, we will find another way,” he said.

Before the first doses can be given next week, there are still a number of steps to follow. The first of these took place today when the Joint Committee on Vaccination and Immunization (JCVI) released its schedule of priorities for the whole of the UK

Next, training materials for staff and information brochures for patients should be developed. This particular vaccine requires the training of experienced immunizers. Meanwhile, in Wales, each board of health must authorize final legal frameworks that will allow registered healthcare professionals to administer the vaccine.

First in line

The first people to be vaccinated will be residents of nursing homes for the elderly and their caregivers.

But Georgie Whitworth, editor-in-chief of Tomorrow’s Care, a magazine for the healthcare industry, said the vaccine news may have taken the industry by surprise.

“What has been clear in recent months is how well intensive care homes have worked to enable residents to reunite with their loved ones. Following the success of the pilot test and the recently announced launch of one million additional household kits this month, I expect healthcare providers to welcome vaccinations as another positive step towards normalcy, ” she declared.

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

Sam Monaghan, Managing Director of Methodist Homes (MHA), the UK’s largest charitable care provider, said: “There will be considerable logistical challenges, and we have yet to receive details on how vaccinations will be rolled out to our residents and staff. although a number of our care homes have been contacted locally by general practitioner practices and health authorities.

“We are now awaiting more details from the government on how the deployment will begin, who will administer the vaccinations and where it will be done,” Monaghan said.

The schedule will be extended to more people in descending order of age. The vaccine is currently not authorized for children under 16, nor for pregnant women. Pfizer said research in these areas is ongoing.

A word of warning

Two major questions regarding the vaccine remain: how long it will remain effective and whether it prevents transmission of the coronavirus. BioNTech CEO Uğur Şahin said the company is evaluating whether the vaccine prevents transmission, but that 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.”

An instant poll conducted by YouGov today also shed light on the skepticism some Britons feel about the breakthrough. While 27% said they were very confident the jab was safe and 43% said they were somewhat confident, 20% were not very confident or not at all confident.

Even Hancock – who has said he is ready to be vaccinated live on television to help overcome doubt – said the UK was not yet at the stage of mass vaccination and urged the public to continue to follow government guidelines, including advice on hygiene and social distancing.

Boris Johnson himself has called for caution tonight, with the UK Prime Minister urging the public not to get carried away by overly optimism or naively believe the fight is over.

Northern Ireland’s Health Minister Robin Swann was also worried about being overly optimistic, saying: ‘This is not the end of the coronavirus nightmare, but it should be the beginning of the end.’

This article is part of POLITICOPremium Police Service: Pro Health Care. Whether it’s drug prices, EMAs, vaccines, pharmaceuticals and more, our expert journalists keep you up to date on the topics driving the healthcare policy agenda. E-mail [email protected] for a free trial.