Care homes will have to wait to get hold of Pfizer’s coronavirus vaccine for its residents because they can’t be broken down into batches smaller than 975 at a time, the chief of the NHS said today.
Sir Simon Stevens, appearing at a Downing Street briefing alongside Boris Johnson, said the logistics of getting the vaccine out to people will be ‘complicated’.
Britain’s drug regulator the MHRA today became the first in the world to approve a coronavirus vaccine and the jab will become available to some members of the public as soon as next week.
But Pfizer’s vaccine, which must be stored at an ultra-cold -70°C (-94°F) until shortly before it is used, requires specialist storage that must be meticulously controlled for the entire distribution and storage process.
The Government and NHS will have to get extra permission from the MHRA to break the vaccine supplies down into smaller batches that could then be handed out to care homes to give to their residents. It is not yet clear how long this might take, but Sir Simon said most of the vaccinations would be given out in 2021, not this year.
Initial batches of the Pfizer/BioNTech vaccine are already heading to Britain after a clinical trial suggested it was 95 per cent effective. The vaccine will be distributed at hospitals first, followed by GP surgeries and city hubs in stadiums and conference centres.
Doses – which have to be packed in dry ice – are coming from Belgium to a central warehouse in the UK, from which they will be sent to NHS hospitals around the country.
But there is growing confusion about which groups will get the first doses. The Joint Committee on Vaccination and Immunisation (JCVI) published its Covid-19 priority list today, advising that care home residents and the staff who treat them should be the first in line to be inoculated.
However, officials warned they couldn’t promise care homes would get the vaccine before anyone else, admitting ‘whether or not that is actually doable depends on deployment and implementation’.
Pfizer’s ‘freezer farm’ – a warehouse the size of a football pitch that is storing finished Covid vaccines in Puurs, Belgium – shown in a photo taken today
To keep doses of the jab at this ultra-low temperature, they needs to be packaged with dry ice and placed in a special transport box the size of a suitcase (an example currently in Belgium is pictured today)
Sir Simon said in this afternoon’s briefing: ‘The vaccine that has been approved for the NHS to deploy today, the Pfizer/BioNTech vaccine, has been independently shown to be medically safe, but it is logistically complicated.
‘We have to move it around the country in a carefully controlled way initially at minus 70 degrees centigrade, or thereabouts, and there are a limited number of further movements that we are allowed by the regulator to make.
‘It also comes in packs of 975 people’s doses so you can’t at this point just distribute it to every individual GP surgery or pharmacy as we normally would for many of the other vaccines available on the NHS.
‘So the phasing of delivery, the way we will do it, is that next week around 50 hospital hubs across England will start offering the vaccine to the over-80s and to care home staff and others identified by the JCVI typically they may be people who were already down to come into hospital next week for an outpatient appointment.
‘So if you are going to be one of those people next week or in the weeks that follow the hospital will get in touch with you, you don’t need to do anything about it yourself.’
He added: ‘If the MHRA, the independent regulator, as we expect they will, give approval for a safe way of splitting these packs of 975 doses then the good news is we will be able to start distributing those to care homes.
‘And then as even more vaccine becomes available finally we will be able to switch on large vaccination centres across the country and indeed invite local community pharmacists probably at the beginning of January to begin to offer vaccination as well.’
This is how the vaccine roll-out could look:
- Next week: 50 hospitals around the UK will be set up as the first vaccination hubs and are expected to start work next week, the week beginning December 7. Patients over the age of 80 and health and care workers are expected to be the first people to be invited for vaccinations at hospitals.
- Following weeks: The NHS’s chief executive, Sir Simon Stevens, said he expected that doctors surgeries would be able to start offering vaccines to vulnerable people in the ‘subsequent weeks’.
- This month: The Government and NHS will have to get extra permission from the drugs regulator, the MHRA, to break down the vaccines into batches smaller than 975 doses at a time. Officials must wait for this approval before they can take the jabs out into care homes, because transporting them in any way that is less than perfect could make the vaccine unstable and stop it working once it is injected.
- January 2021: Sir Simon said that ‘as even more vaccine becomes available’ at the start of 2021, the NHS would be able to start opening more vaccination centres outside of hospitals and also make them available in local pharmacies. This is expected to be the last phase of the programme and will coincide with jabs being offered to younger and healthier groups of people.
To keep doses of the jab at this ultra-low temperature, they need to be packaged with dry ice and placed in a special transport box the size of a suitcase which hold 5,000 doses.
UK REGULATOR INSISTS ‘NO CORNERS WERE CUT’ IN APPROVING THE VACCINE
Britain’s Medicines and Healthcare Products Regulatory Agency (MHRA) moved with unprecedented speed to approve the jab within just a week of receiving the final data from Pfizer’s phase three trials. The watchdog had been conducting a ‘rolling review’ of the vaccine, scrutinising data from its studies in real-time.
MHRA chief executive Dr June Raine insisted that despite the rapid approval, the vaccine had been assessed with ‘with meticulous care’.
She told the Downing Street press conference: ‘That doesn’t mean that any corners have been cut, none at all.’
Dr Raine said experts had worked ’round the clock, carefully, methodically poring over tables and analyses and graphs on every single piece of data’.
More than 1,000 pages of data had been examined, she said.
She said: ‘The way of working in a rolling review ensures that our teams of clinicians and scientists are working in parallel to complete all of the work according to strict guidelines on safety, effectiveness and quality.’
The vaccine had ‘only been approved because those strict tests have been done and complied with’.
Dr Raine said: ‘If you are climbing a mountain, you prepare and prepare. We started that in June.
‘By the time the interim results became available on November 10 we were at base camp and then when we got the final analysis we were ready for that last sprint that takes us to today.
‘That is the exemplary nature of the work that has been done and the public deserve nothing less.’
These containers can prevent the vaccines from spoiling for 10 days if they remain unopened. Once the batches arrive at vaccination hubs, they can be stored in standard medical fridges at between 2°C and 8°C for up to five days. Or they can be kept in their shipping boxes for up to 30 days if the containers are topped up with dry ice at least once a week.
Fifty NHS hospitals in England are already equipped with super-cold freezers that can keep the vaccine at -70°C, meaning healthcare staff could be inoculated first. However, the sticking point for care homes may be that BioNTech says that the vaccine can only be kept at between 2°C and 8°C for six hours in transit without going off.
Because the Pfizer suitcases hold 5,000 vaccine doses, smaller quantities would have to be removed from the dry ice suitcases for transport to care homes.
But once they are in transit the doses could perish after six hours. Welsh Health Minister Vaughan Gething said the logistical issues meant ‘in practical terms at this stage that we cannot deliver this vaccine to care homes’.
Matt Hancock hailed the jab’s approval this morning, claiming an end to the pandemic was now ‘in sight’, while Boris Johnson declared it would ‘allow us to reclaim our lives and get the economy moving again’.
Some 800,000 doses of the Pfizer’s vaccine – which requires people getting two doses 21 days apart – will be made available ‘from next week’. The UK has ordered 40million doses in total, with 10m due by the end of 2020 and the rest next year.
Today, Mr Hancock declared the vaccine drive ‘one of the biggest civilian logistical efforts that we’ve faced as a nation’.
‘It will be difficult,’ he said. ‘There will be challenges and complications, but I know that the NHS is equal to the task.’
He added: ‘We will deliver according to clinical prioritisation and operational necessity because of the need to hold the vaccine at minus 70 – it makes this vaccine particularly challenging to deploy.’
Mr Hancock outlined how vaccines will be rolled out across the country, including using ‘conference centres and sports venues’.
He said: ‘While we begin vaccination next week the bulk of the vaccinations will be in the New Year, but I would urge anyone called forward for vaccination by the NHS to respond quickly to protect themselves, their loved ones and their community.
‘Over the next few months, we will see vaccines delivered in three different ways. First, we will begin vaccinations in hospital hubs. Second, we’ll deploy through local community services including GPs and, in due course, pharmacies too.
Once the vaccine arrives in the UK from Pfizer’s plant in Belgium, batches will be checked at a central warehouse to ensure their quality.
The vaccine will then be unloaded and moved to storage freezers where it will undergo an additional temperature check.
Public Health England (PHE) will process orders placed by the NHS for next day delivery to hospital hubs around the UK.
At this point, the first stage of the rollout process can begin.
Vaccine is initially administered at hospitals, followed by GP surgeries and city hubs
This morning, Matt Hancock revealed 50 hospitals were equipped and ready to start dishing out the vaccines as soon as they arrive.
Describing the national rollout, he told Sky News: ‘The first is hospitals themselves, which of course we’ve got facilities like this.
‘Fifty hospitals across the country are already set up and waiting to receive the vaccine as soon as it’s approved, so that can now happen.’
This morning, Matt Hancock revealed 50 hospitals were equipped and ready to start dishing out the vaccines as soon as they arrive. File photo
As more doses arrive, the rollout will extend to GP surgeries, and then city hubs in converted civic buildings.
The vaccination sites will be picked by primary care networks – groups of GP practices serving 30,000 to 50,000 patients which form the bedrock of the NHS.
Care home residents and the staff who treat them will be given the highest priority, according to a report published by the Joint Committee on Vaccination and Immunisation (JCVI).
However, officials warned they couldn’t promise care homes would get the vaccine before anyone else, admitting ‘whether or not that is actually doable depends on deployment and implementation’.
How jab will be transported in lorries inside special containers fitted with temperature and GPS trackers
Pfizer’s manufacturing site in Puurs, Belgium, is being used for European supply.
The vaccine will be delivered by planes as the company has already ruled out ocean transport due to timings.
The company has created special suit-cased size containers fitted with temperature and GPS trackers to ship the vaccine.
Once the vaccine supply arrives in the UK it will undergo quality checks to ensure it has been shipped safely.
The vaccine will then be unloaded and moved to storage freezers in a central warehouse where it will undergo a further temperature check.
Supplies will be shipped to hospitals.
It is believed that at first the rollout will begin in hospital sites with sub-zero freezing capacity.
Pfizer/BioNTech’s jab blocks 95 per cent of Covid-19 infections, according to trial results that shows it works just as well among over-65s, who are most at risk of the disease.
Transporting and storing the vaccine in care homes poses logistical challenges because it must be stored at -70C.
To keep doses of the jab at this ultra-low temperature, they needs to be packaged with dry ice and placed in a special transport box the size of a suitcase which hold 5,000 doses .
These containers can prevent the vaccines from spoiling for 10 days if they remain unopened.
Once the batches arrive at vaccination hubs, they can be stored in standard medical fridges at between 2C and 8C for up to five days. Or they can be kept in their shipping boxes for up to 30 days if the containers are topped up with dry ice at least once a week.
The sticking point for care homes may be that Biontech says that the vaccine can only be kept at between 2C and 8C for six hours in transit without going off.
Because the Pfizer suitcases hold 5,000 vaccine doses, smaller quantities would have to be removed from the dry ice suitcases for transport to care homes. But once they are in transit the doses could perish after six hours.
Welsh chief medical officer alluded to this issue when he said that the logistical issues meant ‘in practical terms at this stage that we cannot deliver this vaccine to care homes’.
He said the Government in Wales had been exploring ‘suitable options for initial deployment of this vaccine’, but ‘in practical terms at this stage that we cannot deliver this vaccine to care homes’.
But Sean Marett, who is chief commercial officer at BioNTech and responsible for distribution, took issue the claims.
He said: ‘We have stability studies now really supporting the evidence for being able to transport up to six hours at two to eight degrees, so you can really take vials from the vaccination centre – one of the large ones – put them in a bag at two to 8C and take them to the care homes where they can be administered directly to the patients.’
He added: ‘If you store the vaccine in a fridge, you can store it for up to five days. If you want to take some of those vials out of the fridge containing the vaccine, and ship them to a local care home, then you have to do that within six hours at two to eight degrees.’
Mr Marett said one option is pure storage where you take the vaccine out and use it for the patient, and the other is to put it in a van, and deliver those vaccines to a care home.
‘There you need to deliver within six hours, at two to eight and use the vaccine thereafter,’ he said.
A lorry leaves Pfizer’s manufacturing plant in Puurs, Belgium, this morning after the American firm’s Covid-19 vaccine was approved in the UK. It’s not clear if the lorry pictured was transporting the jabs
Volunteers from 750,000-strong NHS army help administer jab
The army of health volunteers who signed up to help the NHS in April will be deployed to deliver the vaccine to ensure it can be rolled out as swiftly as possible.
A screenshot of an email sent to NHS volunteers, and reported by LBC, says they will be ‘trained to deliver a vaccination to a patient.
They will also be ready to act if a patient has an adverse reaction’.
Can I volunteer and what roles are on offer?
Parliament recently changed the law to allow a wider group of people to undertake training and deliver vaccines.
This expanded group includes many health professionals such as paramedics, physios, dental professionals and healthcare scientists – many of whom will be paid.
Unpaid volunteers who have first aid qualifications and can undertake vaccine training provided by Public Health England will also be able to administer the jab.
The NHS is targeting people who have been furloughed or recently made redundant such as airline cabin crew and events staff.
Any volunteers must be over-18 and will be subject to an admissions process, which includes a criminal records check.
There are thousands of posts available in there main roles -
Volunteer vaccinator: Delivering vaccinations under the supervision of healthcare professionals;
Vaccination care volunteer: Welcoming patients and guiding them through the vaccination process, as well as providing first aid if needed;
Volunteer patient advocate: Concentrating solely on the welfare of patients and helping them access first aid if needed.
It also lists roles for volunteers as a vaccination carer or a patient advice.
Vaccine carers ‘will support patients all the way through, from arrival to discharge,’ it says.
‘They will help patients get to the right place to receive their vaccination and provide first aid if anyone has a medical emergency.’
It adds that patient advocates ‘will concentrate entirely on the welfare of patients, potentially looking after people and small groups all the way through the vaccination centres.’
The NHS volunteering page for Covid-19 says online NHS volunteers will have ‘further roles available supporting the Covid-19 vaccination efforts in future’.
St John Ambulance is leading a drive to recruit 30,000 volunteers to deliver the Covid-19 vaccine across England. It had signed up 1,500 by November 16.
Recruitment documents, seen by the Daily Mail, show that vaccination volunteers are only required to have two or more A-levels.
They will be ‘trained to deliver the actual injection to patients [and] potentially react to any immediate adverse reactions’.
The job specification adds: ‘We’ll provide training for non-first aiders, including administering injections.’ Volunteers must be aged 18 to 69, deemed at low risk of Covid-19 and willing to commit to at least two six to eight-hour shifts per month.
The organisation is also looking to recruit vaccination care volunteers – who will support patients before and after their jabs by ‘providing reassurance and potentially dealing with medical emergencies’ – as well as welcome team volunteers to help with the recruitment drive. Participants have been told they will be deployed as soon as the beginning of December.
Its chief operating officer, Richard Lee, said: ‘We are proud to have been asked to lead the voluntary sector’s contribution in helping the NHS deliver its mass vaccination programme.
‘This new agreement highlights just how much respect our charity has won during our ongoing response to the pandemic, as the nation’s health reserve and a trusted partner to the NHS.
‘St John people are best known for helping the events that bring communities together happen – everything from football matches to firework displays.
‘Like everyone else, we are keen to get back to normal and mass vaccination is a vital way of making that happen.’
Army called up to convert stadiums and conference centres into city vaccine hubs
The Army has been called upon to transform around 10 large buildings into vaccination hubs within a fortnight.
These centres will then be used in the second stage of the jab’s rollout, after hospitals and GP surgeries, with a central hub for each large city.
The Nightingale hospital at the London ExCel centre, Epsom racecourse in Surrey and the Robertson House conference facility in Stevenage will serve southern England, according to the Telegraph.
Work is already underway to build one of several national mass vaccination centres at the Ashton Gate stadium in Bristol
Soldiers in Army fatigues have been seen at the site this week as work to convert the site into a vaccination centre continues
… And even Iceland has offered to help!
The supermarket chain Iceland has offered to use its expertise to help store the vaccine, which has to be kept in temperatures far below freezing.
Richard Walker, its Managing Director, said today: ’Fantastic news that the Pfizer/BioNtech vaccine is now approved in the UK. As I told the Prime Minister last month, if helpful Iceland stands ready to support with our cold chain logistics.’
However, MailOnline understands the vaccine’s complex storage and distribution requirement’s are likely to be beyond the expertise of a regular retailer. In addition, the Government has already secured enough additional freezers and fridges to store the jab, sources said.
The Centre for Life science park in Newcastle, Manchester Tennis and Football Centre and Leicester racecourse will cover the North and Midlands.
Work is already underway at the Ashton Gate stadium in Bristol, with personnel in Army fatigues spotted in the car park on Monday.
The regional centre will be run by the army in the South Stand at the home of Bristol City and Bristol Bears in BS3, with tens of thousands of people expected to be vaccinated against the virus every week.
The NHS, which is leading the vaccine programme, is believed to have requested help from the Ministry of Defence via the ’Military aid to the civil authorities’ (Maca) protocol.
This allowed the military to aid civil authorities in special cases where their resources are insufficient.
The military was widely praised during the early stages of the pandemic for the speed at which is built Nightingale hospitals to provide extra beds for the NHS.
Soldiers are already monitoring cyberspace for Covid-19 content to find out how British citizens are being targeted online, leaked documents showed.
It comes amid a rise in the number of anti-lockdown and anti-vaccine protests taking place around Britain as three potential vaccines were found to have around 90 per cent effectiveness.
Revealed: EVERYTHING you need to know about Pfizer’s Covid vaccine, from the science behind how the 95% effective jab works, how it costs five times more than Oxford’s, and the list of the 50 hospitals ready to begin roll-out next week
How many doses of the Pfizer has the UK bought?
The UK has secured 40million doses of the Pfizer/BioNTech vaccine, with 10million due in the UK by the end of the year. Matt Hancock revealed 800,000 doses will be available next week.
Patients need two doses, meaning Number 10 has only secured enough doses for around a third of Britain.
Aborted foetus cells and thalidomide: Vaccine myths DEBUNKED
Within hours of the news that the UK has become the first country in the world to approve the Pfizer/BioNTech vaccine, both ‘Thalidomide’ and ‘Bill Gates’ began trending on Twitter.
Both relate to widely-circulated but false claims from opponents of vaccination, which have been debunked.
MYTH: The speed with which the vaccine was created means it’s not clear if it’s safe
FACT: It is true that most vaccines usually take several years to be developed.
However, as deputy chief medical officer Jonathan Van-Tam explained, this is usually because they are produced by companies which make an ‘investment decision about whether to move on’ at each stage.
‘But with Covid vaccines it is clear that we have a global public health emergency on our hands and that even waiting five years for a Covid vaccine if we don’t have to is completely the wrong thing to do.’
He said this meant the ‘shackles had come off in terms of investing’, and governments such as the UK had invested hundreds of millions of pounds ‘to try and speed it up’.
The standards for safety and effectiveness have not, however, changed due to the speed of production and testing – and it is still subject to independent regulation.
In the UK’s case, this comes from the Medicines and Healthcare Products Regulatory Agency (MHRA).
MYTH: But didn’t the regulators cut corners to test the vaccine quickly?
FACT: No. Part of the reason the MHRA was able to test the vaccine faster than usual is because clinical trials overlapped rather than happening one by one at the end of the process.
This work enabled more than 1,000 pages of data to be examined in tandem with the progress of scientists, meaning the work could be completed far more quickly.
The safety checks, however, were still the same.
June Raine, head of regulator MHRA, said after news of its approval: ‘That doesn’t mean that any corners have been cut, none at all.’
Dr Raine said experts had worked ’round the clock, carefully, methodically poring over tables and analyses and graphs on every single piece of data’.
Additionally, most adverse side-effects to a vaccine occur shortly after receiving it, rather than after many months, said Professor Robin Shattock, head of mucosal infection and immunity at Imperial College London.
MYTH: The Oxford vaccine contains parts of aborted foetus
FACT: A Facebook user falsely claimed the vaccine uses MRC-5 cell lines, which were ‘originally developed from research deriving lung tissue of a 14-week-old aborted Caucasian male foetus’.
AstraZeneca has confirmed its vaccine was not developed using MRC-5 cell lines but does use a different cell strain, taken from a female foetus aborted in the 1970s.
The cells are used to propagate the virus for the vaccine but these cells do not make it into the final jab.
MRC-5 cells are also not the same cells from an aborted foetus. They are cell lines that have been grown in a laboratory from a primary cell culture originally taken from a foetus.
MYTH: The Government is bringing in a law that means unlicensed, untested vaccines can be given to people and no-one is liable if they go wrong
FACT: This is incorrect – the Government held a consultation on whether it should change the rules around unlicensed vaccines. Unlicensed is not the same as untested. A manufacturer would still be liable if it did not meet safety standards, or if it was defective.
MYTH: Bill Gates is using the vaccine to secretly microchip the world
FACT: Mr Gates is regularly the subject of conspiracy theories due to his charity’s work in vaccine development.
However, there is no evidence that the Microsoft founder, or anyone else, is trying to implant microchips in anyone through vaccines. Mr Gates has also repeatedly denied these claims.
This conspiracy theory may have originated from a December study published by a team at the Massachusetts Institute of Technology. The study was funded, in part, by the Bill and Melinda Gates Foundation.
The team had developed an ‘approach to encode medical history on a patient’ by including a small amount of dye with a vaccine.
However, it never experimented on humans and did not include any hardware technology, such as microchips.
MYTH: The Covid vaccine is another repetition of the Thalidomide scandal
FACT: Thalidomide is a drug that was marketed as a treatment for morning sickness in pregnant women in the late 1950s and early ’60s and later caused birth defects. This has understandably prompted distrust in Government guidance on public health issues.
However, Thalidomide is not comparable to a vaccine. Thalidomide went directly into the bloodstream, whereas the Covid-19 vaccine gives antibodies which help fight off the virus.
Thalidomide was not properly tested and never went through the monitoring system as the coronavirus vaccine has done.
EveryDoctor, a campaigning organisation run by doctors, tweeted: ”They said Thalidomide was safe’ entirely ignores the transformation in medicines safety which took place as a consequence of that tragic failure. There is little reason to suggest the Pfizer Covid vaccine approval by the MHRA is anything but robust.’
However, it is likely other vaccines, including one from Oxford University that the UK has bought 100million doses of, will be approved in the coming weeks and months.
How long does it protect you for?
Regulators today said there was evidence of ‘partial immunity’ just seven days after the first dose, offering a glimmer of hope that the roll-out beginning next week may have an effect before Christmas.
But they insisted the best immunity comes seven days after the second dose, which is given three weeks after the first.
It remains a mystery as to how long immunity against Covid lasts for, with top scientists warning that people may need to be vaccinated against the disease every winter, like the flu.
How will a vaccine be rolled out?
Work was going on behind the scenes to ensure that NHS staff were ready to start delivering vaccines to the most vulnerable from the start of December.
Nightingale Hospitals and sports stadiums have been prepared as sites for mass vaccination clinics, while GPs and pharmacists will also be involved in the mammoth Army-backed operation to deliver the jab.
Mr Hancock also told Sky News that ’50 hospitals across the country are already set up and waiting to receive the vaccine as soon as it’s approved’.
New regulations allowing more healthcare workers — and NHS volunteers — to administer flu and potential Covid-19 vaccines have also been introduced by the Government. They will be supervised by a healthcare professional.
NHS England last night published its full contract specification for GP practices delivering Covid jabs.This stated that they must be able to operate from 8am to 8pm, seven days a week including bank holidays when required for reasons such as needing to use up supplies of a vaccine without wasting any.
A letter sent to all practices suggests that it may be necessary for some staff to vaccinate patients on Christmas Day. Vaccination sites are expected to be able to deliver at least around 1,000 jabs per week. The contract to vaccinate begins next Tuesday and GPs will be paid £25.16 for every two jabs they administer.
Volunteers without medical training can put themselves forward through the GoodSAM app to give injections working with St John Ambulance. The role description states: ‘Volunteer vaccinators will be trained to deliver a vaccination to a patient. They will also be ready to act if a patient has an adverse reaction.’
People are also being sought to act as vaccination care volunteers. They will help patients get to the right place for their jab and be on hand to provide first aid if anyone becomes unwell.
Volunteer patient advocates, the third type of helper, will ‘concentrate on the welfare of patients through their experience’.
What type of vaccine is this?
The jab is known as a messenger RNA (mRNA) vaccine.
Conventional vaccines are produced using weakened forms of the virus, but mRNAs use only the virus’s genetic code.
An mRNA vaccine is injected into the body where it enters cells and tells them to create antigens. These antigens are recognised by the immune system and prepare it to fight coronavirus.
What are the advantages of this type of vaccine?
No actual virus is needed to create an mRNA vaccine. This means the rate at which it can be produced is dramatically accelerated. As a result, mRNA vaccines have been hailed as potentially offering a rapid solution to new outbreaks of infectious diseases.
In theory, they can also be modified reasonably quickly if, for example, a virus develops mutations and begins to change. mRNA vaccines are also cheaper to produce than traditional vaccines, although both will play an important role in tackling Covid-19.
Are there any downsides?
One downside to mRNA vaccines is that they need to be stored at ultra-cold temperatures and cannot be transported easily.
Pfizer’s Covid vaccine must be stored at minus 70C — about four times colder than a household freezer — in special suitcase-like storage boxes. Special GPS trackers will mean that the temperature of the Pfizer/BioNTech vaccine can be remotely monitored to ensure it stays at the correct heat to keep it effective.
Details of how the vaccine could be transported and stored emerged following concerns that the NHS may face difficulties handling a vaccine which needs to be stored at minus 70C.
Chris Hopson, chief executive of NHS Providers, said: ‘The logistics of administering the Pfizer/BioNTech jab are formidable.’
Mr Hancock said while rollout was not ‘easy’, he was confident that the NHS can deliver the vaccine despite the logistics involved.
Pfizer has designed a suitcase-sized container that will keep the doses at minus 70C for up to 10 days using dry ice.
Each of the containers, dubbed ‘shippers’, holds around 1,000 doses and will be fitted with thermal sensors to enable the pharmaceutical giant to track the location and temperature of the frozen vaccine vials.
The thermal shipping systems can be recharged with dry ice if needed, Pfizer said. Vaccines will be shipped by air and road, but not boat due to the time constraints.
And once the vaccine has been transported it can be stored in a fridge for up to five days at 2-8C – which is entirely feasible in a standard medicine fridge at a GP practice.
Are they safe?
All vaccines undergo rigorous testing and have oversight from experienced regulators.
Some believe mRNA vaccines are safer for the patient as they do not rely on any element of the virus being injected into the body. mRNA vaccines have been tried and tested in the lab and on animals before moving to human studies.
The human trials of mRNA vaccines – involving tens of thousands of people worldwide – have been going on since early 2020 to show whether they are safe and effective.
Pfizer will continue to collect safety and long-term outcomes data from participants for two years.
HOW DO THE OXFORD, MODERNA AND PFIZER/BIONTECH VACCINES COMPARE?
Moderna and Pfizer/BioNTech have both released interim results of the final stage clinical trials of their vaccines, with both suggesting they are extremely effective.
Oxford University has published the findings from its second phase, which show the jab provokes an immune response and is safe to use – it is not yet clear how well it protects against coronavirus in the real world.
Here’s how they compare:
PFIZER (US) & BIONTECH (DE)
OXFORD UNIVERSITY (UK)
How it works:
mRNA vaccine – Genetic material from coronavirus is injected to trick immune system into making ‘spike’ proteins and learning how to attack them.
mRNA vaccine – both Moderna’s and Pfizer and BioNTech’s vaccines work in the same way.
Recombinant viral vector vaccine – a harmless cold virus taken from chimpanzees was edited to produce the ‘spike’ proteins and look like the coronavirus.
How well does it work?
94.5% effective (90 positive in placebo group, 5 positive in vaccine group) .
95% effective (160 positive in placebo group, 8 positive in vaccine group).
62% – 90% effective, depending on dosing.
How much does it cost?
Moderna confirmed it will charge countries placing smaller orders, such as the UK’s five million doses, between £24 and £28 per dose. US has secured 100million doses for $1.525billion (£1.16bn), suggesting it will cost $15.25 (£11.57) per dose.
The US will pay $1.95bn (£1.48bn) for the first 100m doses, a cost of $19.50 (£14.80) per dose.
Expected to cost £2.23 per dose. The UK’s full 100m dose supply could amount to just £223million.
Can we get hold of it?
UK has ordered five million doses which will become available from March 2021. Moderna will produce 20m doses this year, expected to stay in the US.
UK has already ordered 40million doses, of which 10million could be available in 2020. First vaccinations expected in December.
UK has already ordered 100million doses and is expected to be first in line to get it once approved.
What side effects does it cause?
Moderna said the vaccine is ‘generally safe and well tolerated’. Most side effects were mild or moderate but included pain, fatigue and headache, which were ‘generally’ short-lived.
Pfizer and BioNTech did not produce a breakdown of side effects but said the Data Monitoring Committee ‘has not reported any serious safety concerns’.
Oxford said there have been no serious safety concerns. Mild side effects have been relatively common in small trials, with many participants reporting that their arm hurt after the jab and they later suffered a headache, exhaustion or muscle pain. More data is being collected.
HOW HAS A VACCINE BEEN APPROVED SO QUICKLY?
Traditionally vaccines can take years to research and develop, so how has a vaccine been approved for use so quickly?
How has this come about so quickly?
The timetable for developing and approving a Covid vaccine has been condensed due to the coronavirus crisis.
What is the usual process for developing a vaccine?
Traditionally vaccine development takes several years and includes various processes, including design and development stages followed by clinical trials – which in themselves need approval before they even begin.
The trials take place in three sequential stages – also known as phases. The research will show whether a vaccine generates antibodies but also protects people from disease. They will also identify any safety issues.
Once the trials are complete, the information gathered by researchers is sent to regulators for review.
This is thoroughly analysed by clinicians and scientists before being approved for widespread use.
Then, after approval from regulators, people can start to receive the vaccine.
Is this different because of the pandemic?
The process looks slightly different in the trials for a Covid vaccine.
While the early design and development stages look similar, the clinical trial phases have overlapped – instead of taking place sequentially.
But won’t that mean that safety is compromised?
Even though some phases of the clinical trial process have run in parallel rather than one after another, the safety checks have still been the same as they would for any new medicine.
The Medicines and Healthcare products Regulatory Agency (MHRA) has adopted the phrase ‘safety is our watchword’.
Regulators have said they will ‘rigorously assess’ the data and evidence submitted on the vaccine’s safety, quality and effectiveness.
And, in most clinical trials, any safety issues are usually identified in the first two to three months – a period which has already lapsed for most vaccine frontrunners.
How are regulators acting so quickly?
Regulators have been carrying out ‘rolling reviews’, which means that instead of going through reams of information at the conclusion of the trials, they have been given access to the data as the scientists work.
A rolling review of the vaccine data started several months ago.
This means regulators can start to look at scientific data earlier than they traditionally would do, which in turn means the approval process can be sped up.
Regulators sometimes have thousands of pages of information to go over with a fine-tooth comb – which understandably takes time.
Once all the data available on the vaccine is submitted, MHRA experts will carefully and scientifically review the safety, quality and effectiveness data – how it protects people from Covid-19 and the level of protection it provides.
After this has been done, advice is sought from the Government’s independent advisory body, the Commission on Human Medicines (CHM).
What does ‘approved for use’ mean?
For a medicine to be used in the UK it has to be granted a licence. This means that it has been through all the rigorous safety and efficacy checks and regulators are confident in the findings of the clinical trials.
By reviewing the data as they become available, the MHRA can reach its opinion sooner on whether or not the medicine or vaccine should be licensed without compromising the thoroughness of their review.
So what data will the regulator look at?
The information provided to the MHRA will have included what the vaccine contains, how it works in the body, how well it works and its side-effects, and who it is meant to be used for.
This data must include the results of all animal studies and clinical trials in humans, manufacturing and quality controls, consistency in batch production, and testing of the final product specification.
The factories where the vaccines are made are also inspected before a licence can be granted to make sure that the product supplied will be of the same consistent high standard.
How did Covid REALLY spread around the world? New damning test results that show antibodies were in US in December – WEEKS before China raised the alarm – add to growing global evidence of a cover-up
Sam Blanchard, Health Reporter for MailOnline
A new study that found traces of coronavirus in US blood samples from December last year is adding to the growing evidence that the virus was circulating for months before China announced its existence, casting more shadows over the truth about the pandemic and fuelling suspicions of a cover-up by Beijing.
Claims the global outbreak began in a livestock market in Wuhan last winter have crumbled in the face of scientific evidence proving the virus was all over the Western world weeks and even months before China declared the first cases to the World Health Organization on December 31.
Research published on Monday revealed that 39 blood samples taken between December 13 and 16 last year in California, Oregon and Washington state had tested positive for Covid antibodies, meaning the people who gave them had been infected weeks earlier.
The evidence is the earliest trace so far of the virus on US soil, and a further 67 samples from between December 30 and January 17 tested positive in Connecticut, Iowa, Massachusetts, Michigan, Rhode Island and Wisconsin.
It adds to a growing body of proof that the virus had spread thousands of miles outside of China long before its existence was acknowledged. Scientists in Italy say they now have proof the virus was there in September 2019, traces of it were found in Brazil in November, a French hospital patient had it in his lungs in December, and the virus was present in sewage in Spain in January.
The CDC study is the latest in a string of global papers that smash through claims that the virus didn’t emerge until December:
- September 3, 2019 – Veneto, Italy: A study carried out in Italy, by the National Cancer Institute in Milan, found coronavirus antibodies in 111 people out of 959 blood samples taken before March 2020. The first sample that tested positive was dated September 3 and collected in the Veneto region of the country. Italy announced its first official case on February 20.
- September 4 and 5, 2019 – Emilia Romagna and Liguria, Italy: The National Cancer Institute study found antibodies in blood samples taken from the two regions, which are to the south-west of Veneto.
- September 9, 2019 – Lombardy, Italy: The first two antibody-positive samples from Lombardy, the Alpine region that contains Milan and was one of the worst hit places in the world during the first wave, date back to September 9. By the time all of September’s samples had been analysed, 13 out of 23 that were antibody positive had been taken in Lombardy.
- September 11, 2019 – Lazio, Italy: The first antibody-positive specimen found from the Lazio region was dated September 11.
- November 2019 – Brazil: Analysis of past human sewage samples from the southern Brazilian region of Santa Catalina found traces of the SARS-Cov-2 coronavirus as early as November 27. In the city of Florianopolis, samples from between October 30 and March were analysed, will all samples from November 27 onwards testing positive. Brazil announced its first official case on February 26.
- November 2019 – China: Leaked government documents show cases of coronavirus were being recorded in Wuhan as early as November 17, the South China Morning Post reported in March. China announc
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