After a bleak year, the glimmer of light we all hoped for has appeared on the horizon in the form the coronavirus vaccine.
With more than 50,000 UK deaths so far, no one can argue that time is of the essence, and Matt Hancock announced on Friday that he had formally asked the regulator – the MHRA – to assess the Pfizer/BioNTech coronavirus vaccine for use in the UK and it could be here next month.
Hancock told a No.10 press conference the speed of the roll-out of a vaccine would depend on the speed it could be manufactured, adding: “If the regulator approves a vaccine we will be ready to start the vaccination next month with the bulk of roll-out in the new year.”
The first to receive the vaccine will understandably be the country’s most vulnerable – older adults in care homes and care home workers, followed by those aged 80 and over, and health and social care workers.
The health secretary has called the vaccine roll-out programme “one of the biggest civilian projects in history” and has confirmed volunteers are currently being trained to deliver it.
There are a number of vaccines on order at present, including one by Pfizer, which needs to be stored at -70C, thus bringing its own logistical issues.
The UK is currently set to get 10 million doses of the Pfizer vaccine by the end of the year, with another 30 million in the pipeline after that. Each vaccination comprises two doses to be injected three weeks apart, so the first 10 million doses will potentially cater to five million people.
Earlier on Friday the Health Service Journal exclusively revealed that the NHS plans for the whole adult population to begin receiving it before the end of January, with everyone who wants to being vaccinated by early April.
While applauding news of the vaccine, some medics have raised concerns about the speed at which this vaccination programme has been announced and the safety of using non-medically trained volunteers to distribute it – particularly the Pfizer vaccine.
Dr Lizzie Toberty is a GP in Sunderland and a member of the Doctors’ Association UK, a doctor-led grassroots lobbying and campaigning group advocating for the medical profession and the wider NHS.
Hurried
One of her main concerns is that the roll-out is being rushed.
She said: “We can do it, I believe that we can, but we need to be given the right support, we need to be given the right information and we need to be given the right resources and right now we’re lacking on all three.
“The way it’s been negotiated with NHS England and between the GP committee (GPC) at the British Medical Association (BMA) has been rushed. I think it was initially released two weeks ago and then the GPC had to make a decision and vote within 24 hours.”
Dr Toberty said there are still issues that need addressing around planning.
“The first group we want to deliver it to is the frail, over 85s,” she continued. “By definition that’s a lot of housebound and nursing home patients.
“We still haven’t got the specification for this vaccine, we still haven’t got the full safety data and for us to be able to plan the service and to advise appropriately to our patients, we need time to look at that and to absorb that ourselves.”
Logistics
Dedicated GP clinics being set up to deliver coronavirus vaccines across England will need to have fridge space available by December 1 and the capacity to administer at least 975 doses per week each, according to new documents.
The logistics of administering the Pfizer vaccine in particular, are complex.
The vaccine must be kept at -70C and therefore require specialist freezers for storage. Once it is defrosted, it can be stored in refrigeration for five days. Each vial contains five doses, which must be reconstituted with saline before it is administered.
In contrast, Moderna’s vaccine needs to be stored at -20C for up to six months and kept in a standard fridge for up to a month.
Dr Toberty said: “Once the vial is open you’ve got two hours to deliver it. That’s fine if you’ve got four or five patients lined up in the surgery. If you’re a rural GP practice, serving farms for instance, that’s a logistical problem isn’t it?
“If you’ve got practice nurses, pharmacists and doctors having to draw this up and deliver it, what happens to their routine work?
“We’re already seeing excess mortality because of delayed presentations for heart attacks, strokes, cancer and NHS England are asking us to continue routine work. What’s happening is there are lot of places that are just saying: ‘We can’t do that.’
“Yes, Covid-19 is a pandemic and we need to deal with that and that is the urgent issue, but we’re already seeing these excess deaths from non-Covid and that’s just as important in my mind. It doesn’t matter the reason that someone’s died, it’s just all of this is causing chaos and causing our health as a nation to go backwards.”
Peter Openshaw, professor of experimental medicine at Imperial College London, said he was “pretty sure” the logistical hurdles in terms of delivering any Covid-19 vaccine on a mass scale could be overcome.
Speaking about the implications for transporting vaccines across the country, he told BBC Radio 4’s Today programme: “I shouldn’t think it will be too much of a problem in the UK because we do have quite a lot of cold storage and even ultra-low freezers in different regions.
“So you can imagine that the bulk stock might be held in hospital departments where they do have ultra-cold freezers and then sent out every Monday to GP surgeries where they do have well-regulated fridges that have been designed for the use of vaccines.”
Asked about whether the right amount of kit was available, he added: “I think we have to manage public expectations – this is not an easy feat and there are many slips between cup and lip here.
“If you think about the challenge of scaling-up manufacture, running out of supplies, like vials that need to be filled or maybe carbon dioxide supply if we need to use dry ice to transport stuff.
“There are lots of different logistical problems that need to be overcome and it is a huge effort to get all this done but I’m pretty sure we can do it.”
Pharmacists and dedicated clinics set up in places such as sports halls are also likely to be used.
Safety
In anticipation of this, thousands of volunteers are being sought to help support the NHS as it prepares for the rollout.
St John Ambulance is leading a drive that hopes to take up 30,000 volunteers for a range of roles from delivering the vaccines, supporting roles and helping people who need one-to-one support in the process.
Those who will be delivering vaccines will receive clinical training, including courses developed by Public Health England, and they will be given PPE. The charity believes it will have its first cohort ready in December.
But Dr Toberty told HuffPost UK she had “huge reservations” about using volunteers.
“Nurses, doctors, pharmacists, paramedics are all tightly regulated,” she said. “We’ve all been trained and this is a novel vaccine. We need to get it right. We owe that to our patients.”
Vaccines on order by the government
- 100 million doses of University of Oxford/AstraZeneca vaccine – phase 3 clinical trials
- 40 million doses of BioNTech/Pfizer vaccine – phase 3 clinical trials (10 million to arrive next month)
- 5 million doses of Moderna vaccine – phase 3 clinical trials
- 60 million doses of Novavax vaccine – phase 3 clinical trials
- 60 million doses of Valneva vaccine – pre-clinical trials
- 60 million doses of GSK/Sanofi Pasteur vaccine – phase 1 clinical trials
- 30 million doses of Janssen vaccine – phase 2 clinical trials
Dr Toberty is particularly concerned about the safety aspect of asking non-medically trained volunteers to deal with a vaccine which does not come pre-filled, such as the flu vaccine, which needs to be drawn up and mixed with saline in precise measurements.
She said: “I think it’s fraught with difficulties, what happens if something does go wrong? This is a novel vaccine, when we’re not used to it and we’re not sure… until we’ve built our confidence with it, should we be relying on volunteers to roll this out?
“I’m not saying that later down the line, when it’s prefilled, when we’ve got a good, solid training package that we’re confident in, absolutely, volunteers may well have a place.
Confidentiality
Volunteers delivering the vaccine are likely to need access to confidential patient medical records.
“Are our patients comfortable and happy that volunteers have got access to their records?” asks Dr Toberty.
“Those volunteers still need to have information governance training, they still need to have a police check, they still need to have check that they’ve got qualifications that are good enough to do this, that they’ve got character references, they still need to undergo training.
“When our health and economy is so dependent on the accurate and efficient delivery of this vaccine, surely we should be paying the people who are delivering it and having some sense of reliability there?”
Confidence
Dr Toberty feels that general practice has been side-lined throughout the coronavirus pandemic. It has not been involved in NHS Test and Trace and only recently have GPs been able to administer swab testing.
Speaking at an online RCGP conference last month, University College London’s Professor Anthony Costello questioned why primary care had been “bypassed totally” in the government’s strategy to contain the virus and labelled its reliance on private contractors as “crazy”.
GPs’ “flexibility and innovation”, he said, made them suited to take on a key role in responding to the pandemic – insisting that the government should have mobilised and funded them instead.
Professor Costello argued patients would prefer to speak to a GP if they tested positive for Covid-19, emphasising the importance of strong relationships between practices and their communities.
Dr Toberty concurred: “We know our patients, we have got their full medical records so if there’s any stipulations over who should and shouldn’t have the vaccine, we are best placed to advise the patient on that and also hopefully the patient should have a level of trust in us as well.
“So it’s no good saying ’right today it’s been approved by MHRA, you’re getting a delivery of the vaccine today and you need to line up 975 patients to deliver it to… because we need to have that trust as well, that this is safe.
“Can we give it to transplant patients? Can we give it to patients on immunosupressants? These are all going to be the patients that are first in line.
“We need time to absorb the detail and also we need the right support.”
Workload and costs
Practices will receive a £12.58 payment for each dose of a coronavirus vaccine, meaning they will receive £25.16 for each patient vaccinated in a two-dose course, the documents show.
However, as Dr Toberty points out, GPs stand to incur costs if there are problems with the supply chain.
She said: “If the vaccine doesn’t turn up you’ve got additional admin costs because you’ve then got to contact 975 patients and rearrange them.”
Recent communication upgrades mean GPs can text message patients from their desktops, but this could still leave problems for patients without mobile phones.
Dr Toberty said: “We are being told all the costs have to be fronted up front by the GP partners themselves. We know from the flu vaccine there are problems in the supply chain, and that is something we’ve delivered every year.”
While Hancock is expecting 10 million doses by the end of the year, Dr Toberty believes there are too many variables to hazard a guess at how many vaccinations could practically be delivered by Christmas.
As well as supply practicalities, she believes uptake will depend on enough information being available to the public and clinicians so that people have confidence to come forward to have the vaccine.
She said: “These problems though, aren’t insurmountable.
“What a shame if this vaccine becomes available and either we haven’t got the resources and things set up to deliver it. I do believe that we can do this, whether we can do it before Christmas, who knows. But I believe we need more prominent nurses from the Royal College of Nursing and we need more frontline GPs involved in the discussions.”