New Pfizer/BioNTech vaccine sees hopeful results in clinical trials – but Unite has expressed concerns over distribution and safety
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Hopes of a light at the end of the Covid-19 tunnel were running high after a new breakthrough on a coronavirus vaccine was announced this week, but Unite has urged caution.
US pharmaceutical giant Pfizer and German biotech company BioNTech said on Monday (November 9) that they had seen encouraging results from a phase 3 clinical trial, which showed that it could be 90 per cent effective in preventing people from contracting Covid-19.
The companies have said they now plan to seek emergency approval for the vaccine, which is one of 11 vaccine candidates that are in the final stages of testing, so that it may be ready for use by the end of November for a limited number of people.
Health secretary Matt Hancock highlighted that the UK has already purchased 40m doses – enough to vaccinate 20m people as the vaccine requires two doses to be effective.
Front of the queue for a potential vaccine would be health and care workers, people living in care homes and those over 80. A mass roll-out of any potential vaccine for the general public would not come for many more months after these priority groups received the vaccine.
Speaking to the BBC on Tuesday morning (November 10), Hancock was cautiously optimistic, but noted that we were nowhere near out of the woods yet.
“We still appeal this morning for people’s patience, firstly to follow existing rules, because this is still a deadly disease and this is not over yet,” he said.
“Even once we start to roll it out, we still need to look after ourselves, look after our community by following the rules and being careful to stop the spread of transmission.
“The NHS is ready, we’re prepared, I’ve put in the extra £150m today, the GPs are ready, we’re working with the pharmacists, the hospitals are going to play a very important role.”
‘Mammoth logistical operation’
He said that getting doses of the vaccine, which is made from genetic material known as mRNA, safely to the UK would be a “mammoth logistical operation”. This is because for the vaccine to be effective, it must be stored at -70C and cannot be removed from this temperature more than four times.
Doses of the vaccine are set to be delivered from Belgium to the UK in suitcase-sized containers packed with dry ice that will keep the doses at -70C up to 10 days, the Times reported.
It is understood that the military may help with distribution but they have warned that their ability to assist will be limited.
If the vaccine is approved, it will be the first RNA vaccine approved for human use, and so there is no transportation network already in place.
Lawrence Young, professor of molecular oncology at Warwick Medical School, told the Times, “We’re using technology platforms that have never been used before. At one level, this is going to be a massive experiment. Anything that has to be frozen is a real problem. It’s going to create capacity issues.”
Unite assistant general secretary Steve Turner also highlighted the lack of cold storage capacity – as well as other issues throughout the supply chain that means the UK will not have the sovereign capability needed to roll-out the vaccine.
“Generally vaccines must be stored and dispensed in vials made from borosilicate glass, more commonly known as Pyrex, which is also used in the production of cooking equipment as well as in its many other medical uses such as tubes and vases,” Turner explained.
“But we no longer manufacture borosilicate glass, having allowed the last two manufacturing facilities in Sunderland to close in 2007. The work went to France and hundreds of people lost their jobs.
“We’re now left with a potential vaccine that we don’t have the vials for and since we don’t make the glass to manufacture our own, we must rely on imported glass from Europe at a time when global demand is rocketing. The government has put forward the idea of setting up a manufacturing facility but this will take at least a year to 18 months.”
He added that even for the vials that the UK will be able to import from Europe, they can’t be stored in the numbers needed because of the lack of cold storage capacity.
“We also need to ensure that we produce the packaging and associated paperwork to support distribution here in the UK,” Turner went on to say.
“All of this could have been avoided with a detailed plan and recognition that medicines are a national security issue, just like energy, water, communications and defence, which requires us to maintain our own sovereign capability to produce, store and distribute through a resilient UK supply chain.”
Turner likened the lack of a vaccine supply chain to the PPE scandal earlier this year, where PPE had previously been offshored to China and so the UK didn’t have the supply when it so desperately needed it.
“It is incompetence and a gross failure of government not to have a coherent, cross-departmental plan for such vital, life-saving public health needs,” he said. “Joined-up thinking is not in their vocabulary of course and as a consequence we end up back of the pile just as global demand rockets.”
There are many other unknowns with Pfizer/BioNTech vaccine more than just its safe delivery and distribution in the UK. Questions have been raised too around successfully administering the vaccine.
The health secretary said that £150m in extra funding would be given to GPs to administer the vaccine, and that vaccination clinics would be open seven days a week.
New documents from NHS England show that GPs will be at the heart of plans to deliver the new vaccine. The country’s 1,250 primary care networks have been told to designate a single practice in each network to deliver the vaccines 7 days a week between 8am and 8pm, including on bank holidays if necessary.
But Doctors in Unite (DiU) chair Jackie Applebee, who is a GP herself, expressed concern over the government’s plans.
“I am worried about the capacity of General Practice to deliver it on top of everything else that we are expected to do,” she told UniteLIVE. “NHS England has produced some money but we need the workforce to deliver it — there is already too much collateral damage suffered by patients with other conditions who have not been able to get the care they need due to COVID. It’s not just about money; it is about the health workers needed to deliver the vaccine and the care.”
Applebee also said she was worried about the safety of a vaccine which will be rushed through an emergency approval process.
“I am no anti-vaxxer but I am concerned about the haste with which a vaccine appears to be being rolled out,” she noted.
“I appreciate that we are in a global pandemic and that there is a balance that must be struck between caution with rolling out a vaccine and wanting to prevent deaths and serious illness. But sadly none of the trials will show whether the vaccines cut morbidity and mortality — their endpoint is simply whether people catch Covid-19.
Applebee pointed out that because vulnerable groups are not included in the trials, she said there was “a risk of unintended consequences”.
“A hastily deployed Polio vaccine in the past led to an increased incidence of a nasty neurological condition called Guillan Barre disease, while the H1N1 vaccine caused narcolepsy, a chronic and often debilitating condition where people fall asleep involuntarily, in some people. We need a vaccine but we need to be confident that it is as safe as possible.
“My concern about a hastily rolled out vaccine is that it suits the government’s agenda to get the country back to work, putting the economy before people’s health,” she added.
Applebee said that a much more effective strategy, one which would allow a “much safer to return to life as normal” would be one where the virus was suppressed through what she called a “properly funded, locally driven Find, Test, Trace, Isolate and Support programme” led by local directors of public health – something that has worked very successfully in other countries.
“But the government refuses to do this and insists on pushing ahead with their thoroughly discredited and ineffective national system run by Serco and Deloitte,” she noted.
As we await the mass roll-out of a safe and effective vaccine – which could be further down the line than we may hope — Applebee urged people to follow the guidelines to help stop the spread of the virus.
“People should isolate as soon as they become symptomatic as we are most infectious for a couple of days before symptoms and in the first few days of symptoms,” she said. “Often the horse has bolted by the time a positive test result comes back.”
By Hajera Blagg