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Fri, 27 November 2020

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Here Are The Challenges The Government Faces To Get A Covid-19 Vaccine From The Lab Into People’s Arms

Here Are The Challenges The Government Faces To Get A Covid-19 Vaccine From The Lab Into People’s Arms
11 min read

Faced with a knife-edge logistical operation, getting hold of specialist ultra-low freezers, handling dry ice and adding to the workloads of already overstretched GPs - after the jubilation of recent vaccine breakthroughs, the hard part comes in actually delivering it.

LOGISTICS

Starting at the point of delivery, the department for health expects GPs and practise nurses to shoulder most of the burden in administering the vaccine, at least in the short-term until a mass inoculation programme can get underway.

Groups of surgeries, known as primary care networks, are being asked by NHS England to work together and choose one site per area to host a vaccine programme between 8am and 8pm, seven days a week “including bank holidays”, raising the prospect that some could get their jab on Christmas Day.

There will be 1,250 networks, with each told to deliver at least 975 doses a week, meaning one person must be vaccinated every 5 minutes, 12 hours a day, every single day. Doctors’ groups are worried whether capacity exists to do so, and what funding will be available.

Health secretary Matt Hancock has talked about a £150million funding package, but that cash is available to all surgeries in the country, and isn't targeted at those specifically involved in the vaccine roll out. 

According to a letter from the leaders of NHS England to GPs, the funds represent the "total available additional Covid funding for general practice until March 2021”, but surgeries involved in the vaccination effort will receive a £12.50 payment for each dose they administer.

Leaked reports have suggested volunteers may be required to help out, but the Pfizer version does not arrive with pre-filled syringes, unlike the annual flu vaccine, so it will require trained health-workers to dispense it from vials to then use.

Professor Martin Marshall, Chair of the Royal College of GPs, said: “We need to think about how to get the vaccines from storage to the patients in the most efficient way possible – from what we know, they will be stored in batches and will need to be defrosted, diluted and drawn up into syringes before use. 

“And each person will need two doses of the vaccine, several weeks apart, so mechanisms will need to be in place to ensure patients get their second dose. All these things need to be thought through, and whilst the programme may be GP led, it will require an effort across the health service and beyond – and we’ll need patients to be on board too.”

He said with an increased workload from the pandemic, the usual winter pressures and delivering the expanded flu vaccination programme this year, the addition of the Covid vaccine heaps more pressure on GPs.

“We need clarity on what work can be scaled back, in order to create capacity to deliver the Covid vaccination programme alongside continuing to deliver the vital care GPs and our teams do on a daily basis”, Professor Marshall added.

Dr Alexander Edwards, associate professor at the University of Reading’s Pharmacy Research Division, said: ”You know, the GP service was already falling apart in the last few years for various reasons. Thousands of GPs have retired in the last few years, the pressure on primary care services has only ever gone up, so there's been massive restructuring and innovation to try and deal with that...

“And then you're lumping another whole thing on it. So it doesn't matter if you give them money. There's still nobody to do that.”

Ruth Rankine, director of the primary care networks at the NHS Confederation, said due to the need for social distancing some PCNs “are looking at sites that aren't typically healthcare sites”, such as council properties which come with an added cost in terms of equipment. 

“You might get economies of scale but nevertheless there is an added cost to that,” she said. There’s no extra national funding for that sort of thing, but that doesn’t stop clinical commissioning groups funding reasonable costs locally.”

Ms Rankine said not all CCGs have the same cash available to hand over to the PCNs, so delivery could be “variable".

STORAGE

Quite apart from the pressure on GP surgeries, there’s potentially a bigger hurdle: storage. This is one of the key issues facing the rollout of the Pfizer/BioNTech version, which must be kept at -70C until shortly before it is delivered.

Known as an mRNA vaccine, it works by putting the material inside an envelope of lipid nanoparticles, and after being injected the fat degrades and the protein’s presence kickstarts the body’s antibody production.

But once the vaccine goes above -70C both parts degrade, lose integrity and eventually become useless.

Pfizer has designed special cases filled with dry ice which hold between 1,000 and 5,000 doses at the right temperature, so they can be transported from their production facility in Belgium without the need for refrigerated trucks.

And the cases, which have a GPS tracker and a thermal sensor, will need replacing with dry ice within 24 hours: they cannot afford to be held up on the way, and they will only last 10 days in total, so they must be sent out to the parts of the UK they are needed quickly.

Eddie Black, managing director of Eco, a dry ice manufacturer, is anticipating a “strain on the capacity” due to a lack of the CO2 gas needed to manufacture it.

He said: “You've got to think every country is going to be screaming for it. It’s not just the UK and especially with Brexit.”

There are also strict rules about the containers only being opened for a minute at a time: they should not be opened more than twice a day, and no more than four times total, adding a layer of complexity to how they will be utilised - especially in the first wave of the vaccine rollout, which is targeted specifically at care home residents, staff, the over-80s and healthcare workers.

What most observers say is that to get round this the NHS needs to have capacity to keep the vaccine at the right temperature itself, through the use of ultra-low freezers usually only found in medical research laboratories.

The Department for Health won’t say how many they currently have, although before the pandemic it is believed they had few, if any, on hand. According to the government’s contract finder website Public Health England put an order for £300,000 of ultra-low freezers back in April, one for £100,000 in July, and then another order of £150,000 at the start of this month. It’s unclear if this is enough to create regional hubs to store the vaccine.

Once defrosted, the doses for the Pfizer vaccine can be held in a standard refrigerator, at between 2C and 8C but possibly for just 24 hours, although Matt Hancock said it can be stored at a warmer temperature in the “two days” prior to being used, presenting an issue for vaccination centres expected to administer 1,000 jabs over the course of a full week.

Professor Beate Kampmann, director of the vaccine centre at the London School of Hygiene and Tropical Medicine, said: “Rolling out a vaccine that has to be kept at extremely low temperatures will need the provision of specialised-and expensive- refrigerators or transport hubs not currently found within the routine immunisation platforms.

"But bringing a vaccine to the elderly and people in care homes is also already not routine - beyond the annual flu campaigns, which already involve a range of health care providers, including pharmacies.

“Hence there will have to be joined-up thinking: simply ordering the supplies won’t solve the implementation issues.”

The MoD owns both static and mobile cold storage facilities for use by Defence Medical Services to transport pharmaceuticals overseas which could be commandeered, and it is understood two military liaison officers have been seconded to the vaccine taskforce, and five military planners are working on logistics for the rollout, as well as the Major Projects Authority.

David Pierpoint, managing director of UK life sciences and healthcare at logistics firm DHL, said: “The key challenge with the distribution of any vaccine is understanding the particular temperature requirements and the impact they have on the supply chain,” which he said will require public and private sector collaboration.

“For example, distributors will need to manage the number of shipments and the required volume of dry ice, both in terms of the availability of suitable packaging as well as the maximum- allowed quantities of dry ice in air cargo transport.

“Likewise, the physical handling of ultra-deep frozen shipments requires special equipment to avoid injury.”

And Gerry Brown, a cold chain logistics and healthcare expert, said: “Just administering 40 million vaccine doses - for 20 million people spread throughout the country (mainly the elderly) – requires that the vaccine be available in the right quantity at the right quality, at the right place, to the right person, at the right time and at the right temperature. 

“Government estimates of giving one million doses a week sounds ambitious at best."

Those particular issues in administering the Pfizer jab will not be there with the Moderna one or the much-anticipated Oxford/AstraZeneca vaccine, but Mr Brown said many of the logistical challenges remain regardless of which version is used.

Mission Impossible?

Dr Richard Vautrey, chair of the British Medical Association’s GP committee, said Mr Hancock’s end of the month timeline for the first rollout looks rather ambitious. 

“I think it's about being prepared for that but... we've haven’t got a vaccine that's been regulated yet so the likelihood of having a vaccine in large numbers that are on the doorstep on 1 December is pretty remote,” he said.

“So I think in all likelihood... the country will receive a proportion of vaccine potentially in December, then the government will decide how that's allocated. 

“Obviously there wouldn't be enough for over 1,000 vaccine sites to receive large amounts of vaccine so I think it would then, in all probability, be next year before your vaccine centres are being utilised in any meaningful way.”

He said NHS England and health ministers need to come up with “clear messaging to patients that clearly a vaccination team can't be in two places at the same time” and support GPs.

This need for support was echoed by Ms Rankine, who added: “And when I say support I don't mean an email that says ‘get in touch if you need anything’, I mean proper hands on support, whether it's project management, whether it's modelling, whatever, but basically making expertise and resources and people resources available to PCNs to help them work through this.”

And she said they need to manage the expectations of the public, as GPs have already been facing a backlash over the amount of care they have been able to provide this year. “And most of that unfairly because general practice is open, but not necessarily in the way people want to be,” she said.

Unite, the country's leading manufacturing union, has urged the PM to appoint a cabinet minister to coordinate the production and supply of Covid vaccines.

As well as deep freeze storage capacity they have identified the production of the borosilicate glass needed to contain the virus as another area of concern, with assistant general secretary

Steve Turner saying: "Our fear is that unless there is one clear voice around the government table tasked with getting this product manufactured and safely delivered the length and breadth of the country we will lag behind other nations in protecting our people and getting the economy moving again.”

And Dr Edwards added: “I think if we've learned anything from the testing saga, it would be really, really frustrating to see another centralised effort, when actually the correct thing to do now is how the flu service works, which is you delegate it and fund people to do it, and they all do it locally.

“Because they're going to have to do it locally anyway. So rather than telling them how to do it, then give them the money and get them to do it.”

But Professor Adam Cunningham at the Institute of Immunology and Immunotherapy at Birmingham University struck a more positive note, saying while the infrastructure and equipment might not yet be on hand for GPs, the NHS is used to both mass vaccination and transporting things along with cold chain.

“We haven't seen the details, but the two things that we can probably say very, very safely, is that the vaccine is likely to have no big adverse effects in the vast majority of people, because that would have been seen by now.

“And then the second thing is that, at least in the short term, is it provides what looks to be quite substantial protection. And I think those are really, really core positives.”

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