News, Culture & Society

Coronavirus UK: NHS workers first in queue for Pfizer vaccine

Lorries loaded with the first batches of Pfizer/BioNTech’s coronavirus vaccine are already on their way to Britain after the breakthrough jab sealed approval from the UK’s medical regulator — amid confusion about who will be first to be inoculated. 

Thousands of doses of the vaccine were shipped from Pfizer’s factories in Belgium this morning within hours of it being given the green light by the Medicines and Healthcare Products Regulatory Agency (MHRA), making Britain the first country in the world to have a clinically authorised Covid-19 jab. The doses could reach Britain as soon as tomorrow, the companies said.

Health Secretary Matt Hancock claimed an end to the pandemic was now ‘in sight’ but warned the roll out will be ‘one of the biggest civilian logistical efforts that we’ve faced as a nation’. Boris Johnson declared the vaccine would ‘allow us to reclaim our lives and get the economy moving again’ — but the PM also warned Britons must not ‘get their hopes up’ about a rapid deployment of the jab. And Chancellor Rishi Sunak said it was ‘definitely positive news’ that would hopefully boost consumer confidence and bolster Britain’s economic recovery.

Some 800,000 doses of the Pfizer’s vaccine — which requires two doses being taken 21 days apart — will be made available ‘from next week’. The UK has pre-ordered 40million doses in total, with 10million due by the end of 2020 and the rest next year.

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/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. 

But transporting and storing the vaccine poses logistical challenges in rolling it out to care homes because it must be kept in long-term storage at -70C. 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.

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.

Fifty NHS hospitals in England are already equipped with super-cold freezers that can keep the vaccine at -70C, 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 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 Health Minister Vaughan Gething said the logistical issues meant ‘in practical terms at this stage that we cannot deliver this vaccine to care homes’.

The 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 meticulous care’ and ‘no corners had been cut’.   

The announcement comes on the day England emerged from its second national lockdown and came as figures showed Covid cases and deaths are continuing to fall, with another 648 fatalities and 16,170 cases as the second wave dies down.

In other vaccine developments on the back of Pfizer’s approval:

  • Organised criminal gangs may capitalise on the approval of the new Covid vaccine by stealing supplies to sell on or peddling fake doses, Interpol warned;
  • Comparisons between Pfizer’s vaccine and the Thalidomide scandal are ‘insulting’, a charity warned after the birth defect-causing drug began trending on Twitter in the wake of Britain approving the jab;
  • Supermarket giant Iceland’s boss told No10 it ‘stands ready’ to help the UK deliver the Covid vaccine, saying the firm’s ‘cold chain expertise’ may be helpful in local distribution of the jab;
  • Teachers, soldiers, and bus drivers could be first in line for a Covid vaccine once all over-50s and ‘at-risk’ Britons are protected, JCVI guidance suggests; 
  • Matt Hancock claims Brexit helped Britain become first country in the world to approve a Covid vaccine ‘because European regulators were moving too slowly’;
  • The Health Secretary says he’ll take the Covid vaccine live on TV to show it’s safe in attempt to quell any anxiety;
  • Britain may still need a circuit breaker lockdown in January or February – despite roll-out of Pfizer’s 95 per cent effective jab beginning next week, top scientist warns; 
  • The MHRA was so keen to approve Pfizer’s Covid vaccine that it responded to emails within ten minutes, according to Pfizer’s vice president for medical and scientific affairs;
  • Britons given Pfizer’s Covid vaccine will get partial immunity within 12 days of the first dose, MHRA regulators believe;
  • NHS workers in Leicester have received an email confirming Leicester racecourse will be transformed into a vaccination hub ‘as soon as the government says go’.

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

About 800,000 doses of the Pfizer's vaccine ¿ enough to vaccinate 400,000 people because it is administered in two shots ¿ will be made available in Britain 'from next week'. It's not clear if the lorry pictured was transporting the jabs

About 800,000 doses of the Pfizer’s vaccine — enough to vaccinate 400,000 people because it is administered in two shots — will be made available in Britain ‘from next week’. It’s not clear if the lorry pictured was transporting the jabs

This handout photo taken in October and provided by Pfizer shows part of a 'freezer farm,' a football field-sized facility for storing finished COVID-19 vaccines, in Puurs, Belgium

This handout photo taken in October and provided by Pfizer shows part of a ‘freezer farm,’ a football field-sized facility for storing finished COVID-19 vaccines, in Puurs, Belgium

The vaccine needs to be kept at -70C. To keep doses of the jab at this ultra-low temperature, they need to be packaged with dry ice and placed in a special thermal transport box (shown)

The vaccine needs to be kept at -70C. To keep doses of the jab at this ultra-low temperature, they need to be packaged with dry ice and placed in a special thermal transport box (shown)

 

Health Secretary Matt Hancock, making a statement to the Commons, told MPs: "Today marks a new chapter in our fight against this virus. 'Ever since the pandemic hit our shores almost a year ago we have known a vaccine would be critical to set us free.'

Health Secretary Matt Hancock, making a statement to the Commons, told MPs: ‘Today marks a new chapter in our fight against this virus. ‘Ever since the pandemic hit our shores almost a year ago we have known a vaccine would be critical to set us free.’

WHICH HOSPITALS WILL GET THE VACCINE FIRST? 

  1. Blackpool Teaching Hospitals
  2. Brighton and Sussex University Hospitals
  3. Cambridge University Hospitals
  4. Chesterfield Royal Hospital
  5. Countess of Chester Hospital
  6. Croydon University Hospital
  7. Dartford and Gravesham Hospitals
  8. Dorset County Hospitals
  9. East and North Hertfordshire Hospitals
  10. East Kent Hospitals
  11. East Suffolk and North Essex Hospitals
  12. Frimley Health NHS Foundation Trust
  13. Gloucestershire Hospitals
  14. Great Western Hospitals
  15. Guys & St Thomas NHS Trust
  16. James Paget University Hospitals
  17. Kings College Hospital
  18. Princess Royal University Hospital, Kings
  19. Lancashire Teaching Hospital
  20. Leeds Teaching Hospital
  21. Leicester Partnership NHS Trust
  22. Liverpool University Hospitals
  23. Medway NHS Foundation Trust
  24. Mid and South Essex Hospitals
  25. Milton Keynes University Hospital
  26. Norfolk and Norwich University Hospital
  27. Northampton General Hospital
  28. North Bristol NHS Foundation Trust
  29. North West Anglia Foundation Trust
  30. Nottingham University Hospitals
  31. Oxford Health NHS Foundation Trust
  32. Portsmouth Hospital University
  33. Royal Cornwall Hospitals
  34. Royal Free London NHS Foundation Trust
  35. Salford Royal NHS Foundation Trust
  36. Sheffield Teaching Hospitals
  37. Sherwood Forest Hospitals
  38. Shrewsbury and Telford NHS Trust
  39. Stockport NHS Foundation Trust
  40. St George’s University Hospitals
  41. The Newcastle Upon Type Hospitals
  42. University College Hospitals
  43. University Hospitals Birmingham
  44. University Hospitals Coventry and Warwickshire
  45. University Hospitals Derby Burton
  46. University Hospitals of North Midlands
  47. University Hospitals Plymouth
  48. United Lincolnshire Hospitals
  49. Walsall Healthcare
  50. West Hertfordshire Hospitals
  51. Wirral University Teaching Hospital
  52. Worcestershire Acute Hospitals
  53. Yeovil District Hospital 

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.’

Ben Osborn, Pfizer’s UK country manager, said that delivery was happening ‘right now’.

He told the PA news agency: ‘As you probably heard from the Secretary of State, Matt Hancock, earlier this morning, the delivery schedule has already been put in place.

‘We are delivering right now as we speak from Belgium into the UK – that process has already begun.

‘We anticipate that we will be providing some 800,000 doses or so in the coming days, ready for deployment next week by the NHS.’

He said the pharmaceutical company was not ‘giving an absolute figure’ on the total numbers which would be delivered to the UK this year.

Mr Osborn added: ‘You’ll understand this is a significant challenge to deliver. But we will be in a position to deliver millions of doses in the weeks ahead.

‘That is part of a bigger scale-up, which will essentially allow the UK to have 40million doses of the Pfizer/BioNTech vaccine.’

Sean Marett, chief commercial officer at BioNTech, said the first consignment of its newly-approved vaccine could reach Britain as soon as tomorrow.

He told BBC Radio 4’s World At One programme: ‘We’re packing them now as we speak and getting ready for shipping. What we can definitely say is it will arrive, the first consignment, in the next few days and that could be as early as tomorrow or it could be a few days later, but the UK will be the first country in the world to be receiving vaccine for administration to its population.

‘We will probably be shipping several consignments to the UK over the next few weeks and it might be that the numbers vary on size of packaging that we put together in a lorry and then ship, so the UK has a good number of vaccines coming to it in December.’

Before the first batch of doses were sent to Britain, batches were checked at a central depot 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. Defrosting the vaccine for use takes several hours and then extra time is needed to prepare the vaccine for administering as doses. 

Mr Hancock — who admitted he was unsure how many people need to be vaccinated before restrictions can be lifted — told the Commons the first batch of the vaccine was completed this morning.

He said the rollout of the vaccine will be ‘one of the biggest civilian logistical efforts that we’ve faced as a nation’.

Mr Hancock told the Commons: ‘It will be difficult. 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 said: ‘Today marks a new chapter in our fight against this virus.

‘Ever since the pandemic hit our shores almost a year ago we have known a vaccine would be critical to set us free. It’s no longer if there’s going to be a vaccine, it’s when.

‘In our battle against the virus, help is on its way. Today is a triumph for all those who believe in science, a triumph for ingenuity, a triumph for humanity.’

Professor Wei Shen Lim, chair of the JCVI, told a Downing Street press conference today: ‘The advice is aimed at maximising the benefit from vaccines and therefore it is aimed at the most vulnerable people, which are people in care homes.’ 

He added: ‘Whether or not the vaccine can be delivered to care homes is a valid point and there will be some flexibility [with the priority list]. Every effort should be made to supply and offer the vaccine to care home residents. Whether that’s doable is dependent on deployment and implementation.’ 

At Prime Minister’s Questions today, Mr Johnson admitted there would be ‘logistical’ issues in trying to get all care homes immunised first after being quizzed by Sir Keir Starmer.

The Labour leader asked: ‘What plans has he put in place to address these particular problems of getting the vaccine safely and quickly into care homes, given the practical difficulties of doing so and the anxiety that those in care homes will have about getting it quickly?’

Mr Johnson said: ‘It does need to be kept at -70C, as I think the House understands, so there are logistical challenges to be overcome to get vulnerable people the access to the vaccine that they need.

‘We are working on it with all four devolved administrations in order to ensure that the NHS across the country is able – and it’s the NHS that will be in the lead – to distribute it as fast and as sensibly as possible to the most vulnerable groups.’

Welsh Health Minister Vaughan Gething raised more doubts that care homes would be inoculated first this morning when asked about the vaccine’s deployment.

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 with UK officials’ claims the Covid-19 vaccine would be a logistical nightmare to get to care homes.

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.

Chancellor Rishi Sunak, pictured today at Hamleys toy shop in central London as it reopened after lockdown, said he hoped the vaccine roll-out would boost consumer confidence

Chancellor Rishi Sunak, pictured today at Hamleys toy shop in central London as it reopened after lockdown, said he hoped the vaccine roll-out would boost consumer confidence

Mr Sunak said: 'It's a moment of great hope and opportunity, but there's still work to do,' as the first vaccines began making their way to the UK today

Mr Sunak said: ‘It’s a moment of great hope and opportunity, but there’s still work to do,’ as the first vaccines began making their way to the UK today

Chancellor Rishi Sunak welcomed the news as ‘another positive step on our journey to beat this thing’ and paid ‘enormous tribute to everyone involved’.  

He said: ‘It’s a moment of great hope and opportunity, but there’s still work to do. We’ve got to get the vaccines, we got to roll them out. All that work is ongoing, people should feel reassured about that.’

Mr Sunak said he hoped the vaccine roll-out would boost consumer confidence, which was ‘critical’ for Britain’s economic recovery. ‘Hopefully, this is the start of a march back,’ he added.

Today’s announcement makes the UK the first country in the world to have a clinically authorised Covid-19 vaccine, which Professor Sir Munir Pirmohamed, of the Commission on Human Medicines advisory panel, described as an ‘historic moment’.

He told the press conference: ‘We are in the midst of a once-in-a-century pandemic and I think this is a historic moment. The UK is now one step closer to providing a safe and effective vaccine to help in the fight against Covid-19, a virus that has affected each and every one of us in some way. This will help to save lives.’  

Britain may still need a circuit breaker lockdown in January or February, top scientist warns 

Britain may still need a circuit-breaker lockdown in late winter despite the promising vaccine news today, a top scientist warned. 

Liam Smeeth, professor of clinical epidemiology at the London School of Hygiene and Tropical Medicine, said although some vulnerable groups will be inoculated by this year, mass vaccination won’t happen for months.

He warned this gives Covid-19 weeks to proliferate during the deep winter months, when viruses spread more easily as people stay indoors more.  

Professor Smeeth said: ‘The continued progress on vaccines is fantastic news.

‘A route towards a much better situation in the UK is becoming clear.

‘But a further circuit-breaker in January or possibly February is likely to be needed.’

Mr Hancock also hailed the news, saying: ‘We can see the dawn in the distance but we have to get through to the morning.’ Mass-vaccination is seen as the only way to put an end to the perpetual opening up and closing down of society through draconian lockdowns, which have had devastating consequences on the economy and wider health. 

Regulators today claimed Pfizer’s Covid vaccine offers ‘partial immunity’ within just twelve days of getting the first dose.

Professor Sir Munir Pirmohamed, chair of Commission on Human Medicine expert working group — which advises ministers on medicinal products, said that some protection occurs after receiving the first of the two-shot vaccine.

It offers a glimmer of hope that the roll-out of the vaccine beginning next week may have an effect before Christmas.

In a Downing Street press conference today, he revealed people ‘will be immune seven days after the second dose’ of the vaccine, which is taken roughly 21 days later.

Scientists remain unsure as to how long immunity against Covid lasts for, with fears protection may only be short-lived. But in-depth studies suggest that the majority of survivors will be able to fight off the disease within at least six months. 

Some experts have claimed people may need to be vaccinated against the disease every winter, like the flu.

MHRA chief executive Dr June Raine told the Downing Street briefing today that, despite the jab being approved in record time, the process had been done with ‘meticulous care’, adding: ‘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’. 

An employee at the Pfizer laboratories where they conduct research and development

Vials of the lifesaving jab are seen as an employee works on the Covid-19 vaccine

An employee at the Pfizer laboratories where they conduct research and development. Vials of the lifesaving jab are seen as an employee works on the Covid-19 vaccine

Volunteers given Pfizer’s jab reveal how it they had headaches and left them ‘aching all over’

Glenn Geshields (left), 44, said he was proud to have taken part. Carrie (right), 45, also from the US, was also involved in Pfizer’s vaccine trial

Volunteers on the Pfizer vaccine trial have compared the jab’s side effects to a ‘severe hangover’ and said it left them with headaches, fever and muscle aches similar to the flu vaccine.

One 45-year-old volunteer said the first dose left her suffering side effects similar to the flu jab but that her symptoms were ‘more severe’ after her second jab.

Another volunteer, 44-year-old Glenn Deshields, said Pfizer’s vaccine made him feel like he had a ‘severe hangover’ but that symptoms quickly cleared up.

More than 43,500 people in six countries took part in the phase three trials by the pharmaceutical giant in the hunt for an effective Covid-19 vaccine. 

Bryan, 42, an engineer from Georgia, believes he was one of the individuals that did not receive the vaccine.

He felt no immune response to the jabs, he said, and after having two shots he contracted Covid-19 after his daughter caught it last month. They have both since recovered.

Matt Hancock claims BREXIT helped Britain become first country in the world to approve a Covid vaccine

Health Secretary Matt Hancock said Brexit has helped the UK become the first country in the world to have a clinically authorised vaccine.

He told Times Radio: ‘And the reason we’ve been able to move this fast, and the UK is the first country in the world to have a clinically authorised vaccine, the reason is twofold.

‘Firstly, because the MRHA has done a great job of working with the company to look at that data as it’s come through and do things in parallel, rather than one after the other as they normally would, that’s the first reason.

‘The second reason is because, whilst until earlier this year we were in the European Medicines Agency (EMA), because of Brexit we’ve been able to make a decision to do this based on the UK regulator, a world-class regulator, and not go at the pace of the Europeans, who are moving a little bit more slowly.

‘We do all the same safety checks and the same processes, but we have been able to speed up how they’re done because of Brexit.’

Hancock says he’ll take a vaccine live on air to show it’s safe

ITV's Good Morning Britain presenter Piers Morgan made the suggestion before Mr Hancock said: 'Yeah, I'll take it with you, Piers'

ITV’s Good Morning Britain presenter Piers Morgan made the suggestion before Mr Hancock said: ‘Yeah, I’ll take it with you, Piers’

Health Secretary Matt Hancock has offered to get vaccinated live on television to help convince people it is safe.

ITV’s Good Morning Britain presenter Piers Morgan made the suggestion before Mr Hancock said: ‘Yeah, I’ll take it with you, Piers’.

Morgan said: ‘I’ll come to where you are anytime next week if we can do this. Let’s do it together, live on air. It would be powerful, it would send the right message.’

Mr Hancock said: ‘Well, we’d have to get that approved because, of course, there is a prioritisation according to clinical need and, thankfully, as a healthy, middle-aged man, you’re not at the top of the prioritisation.

‘But if we can get that approved and if people think that’s reasonable then I’m up for doing that because once the MHRA has approved a vaccine, they only do that if it is safe.

‘And so, if that can help anybody else, persuade anybody else that they should take the vaccine then I think it’s worth it.’

Boris Johnson’s press secretary suggested the Prime Minister could be prepared to be vaccinated against coronavirus live on TV – but only if it did not prevent someone more in need of a jab from receiving one.

Allegra Stratton told reporters: ‘We all know the character of the Prime Minister, I don’t think it would be something that he would rule out.

‘But what we also know is that he wouldn’t want to take a jab that should be for somebody who is extremely vulnerable, clinically vulnerable, and who should be getting it before him.’

More than 1,000 pages of data had been examined, she said. Dr Raine added: ‘We have carried out a rigorous scientific assessment of all the available evidence of quality, safety and effectiveness. The public’s safety has always been at the forefront of our minds – safety is our watchword.

‘I’m really pleased to say that the UK is now one step closer to providing a safe and effective vaccine to help in the fight against Covid-19 – a virus that has affected each and every one of us in some way – and in helping to save lives.’We are globally recognised for requiring high standards of safety, quality and effectiveness for any vaccine.

‘Our expert scientists and clinicians worked tirelessly, around the clock, carefully, scientifically, robustly and rigorously poring over hundreds of pages and tables of data, methodically reviewing the data.

‘Vaccines are the most effective way to prevent infectious diseases. They save millions of lives worldwide.’

During a round of interviews this morning, Mr Hancock said: ‘The NHS stands ready to start vaccinating early next week. The UK is the first country in the world to have a clinically approved vaccine for supply.’

The Health Secretary urged England to abide by the controversial three-tier lockdown system that came into force today after being approved last night, saying although the end is in sight ‘we’ve got to keep people safe in the meantime’.   

He told BBC Breakfast: ‘From Easter onwards, things are going to be better and we’re going to have a summer next year that everybody can enjoy.’ 

In total, Britain will receive 10million doses of Pfizer/BioNTech’s vaccine by the end of the year, enough to inoculate 5million people, with the remaining 30million doses due in the first quarter of 2021. 

The UK has also ordered 100million doses of Oxford University’s Covid vaccine, with up to 19million ready to go by Christmas, and 5million doses of Moderna’s vaccine, which won’t be ready until spring.

The JCVI confirmed its priority list for the first phase of the UK’s mass vaccine roll out, with care home residents and the staff who look after them first in line, followed by frontline NHS staff and everyone over the age of 80.

Those above the age of 75 next in the queue, followed by over-70s, over-65s and high-risk adults under 65 with diseases such as cancer, with moderate risk adults under 65 – including diabetics and asthmatics – next. 

Over-60s will follow, with over-55s and over-50s the final priority groups. It is hoped every vulnerable Brit will be protected by Easter, which has raised hopes of returning to normality by spring.

The general population will be last to get their hands on a jab and the JCVI says they will be prioritised based on age or underlying conditions.

But in guidance published today, the JCVI has left the door open to the possibility of teachers, soldiers and bus drivers getting priority once all over-50s are jabbed.

Though the body said this will be an ‘issue of policy’ rather than one for it to advise on. 

‘Vaccination of those at increased risk of exposure to SARS-CoV-2 due to their occupation could also be a priority in the next phase,’ the guidance says.

‘This could include first responders, the military, those involved in the justice system, teachers, transport workers, and public servants essential to the 10 pandemic response.  

Priority occupations for vaccination are considered an issue of policy, rather than for JCVI to advise on. JCVI asks that the Department of Health and Social Care consider occupational vaccination in collaboration with other Government departments.’ 

Making the announcement this morning, a spokesman for the DHSC said today: ‘The Government has today accepted the recommendation from the independent Medicines and Healthcare products Regulatory Agency (MHRA) to approve Pfizer/BioNTech’s Covid-19 vaccine for use.

‘This follows months of rigorous clinical trials and a thorough analysis of the data by experts at the MHRA who have concluded that the vaccine has met its strict standards of safety, quality and effectiveness.

‘The Joint Committee on Vaccination and Immunisation (JCVI) will shortly also publish its latest advice for the priority groups to receive the vaccine, including care home residents, health and care staff, the elderly and the clinically extremely vulnerable.

‘The vaccine will be made available across the UK from next week.’ 

The first delivery of 800,000 doses of Pfizer’s vaccine is expected next week. The doses are being manufactured at a factory in Belgium. 

Mr Hancock told the BBC: ‘This is why it will take a couple of days from now before people can start to have it injected in their arms starting early next week. We’re expecting a matter of millions of doses for the whole of the UK by the end of the year.’

But he said the number delivered this year would depend on the speed of manufacture and how quickly they could be tested before dispatch. 

Mr Hancock added there would be ‘three modes of delivery’ of the vaccine and revealed 50 hospitals were equipped and ready to start dishing out the vaccines as soon as they arrive.

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. 

‘Also vaccination centres, which will be big centres where people can go to get vaccinated. They are being set up now. 

‘There will also be a community rollout, including GPs and pharmacists. Now, of course, because of the -70C storage conditions of this vaccine, they will be able to support this rollout where they have those facilities.

‘But they’ll also be there should the AstraZeneca vaccine be approved because that doesn’t have these cold storage requirements and so is operationally easier to roll out.’ 

He added: ‘We’re the first country in the world to have a clinically-authorised vaccine to roll out.’

Britons given Pfizer’s jab ‘will get partial immunity within TWELVE DAYS of the first dose’

Regulators today claimed Pfizer’s Covid vaccine offers ‘partial immunity’ within just twelve days of getting the first dose.

Professor Sir Munir Pirmohamed, chair of Commission on Human Medicine expert working group — which advises ministers on medicinal products, said that some protection occurs after receiving the first of the two-shot vaccine.

It offers a glimmer of hope that the roll-out of the vaccine beginning next week may have an effect before Christmas.

In a Downing Street press conference today, he revealed people ‘will be immune seven days after the second dose’ of the vaccine, which is taken roughly 21 days later.

Scientists remain unsure as to how long immunity against Covid lasts for, with fears protection may only be short-lived. But in-depth studies suggest that the majority of survivors will be able to fight off the disease within at least six months.

Some experts have claimed people may need to be vaccinated against the disease every winter, like the flu.

Mr Hancock also claimed Brexit helped the UK become the first country in the world to have a clinically authorised vaccine, telling Times Radio: ‘And the reason we’ve been able to move this fast, and the UK is the first country in the world to have a clinically authorised vaccine, the reason is twofold.

‘Firstly, because the MRHA has done a great job of working with the company to look at that data as it’s come through and do things in parallel, rather than one after the other as they normally would, that’s the first reason.

‘The second reason is because, whilst until earlier this year we were in the European Medicines Agency (EMA), because of Brexit we’ve been able to make a decision to do this based on the UK regulator, a world-class regulator, and not go at the pace of the Europeans, who are moving a little bit more slowly.

‘We do all the same safety checks and the same processes, but we have been able to speed up how they’re done because of Brexit.’ 

Mr Hancock this morning also offered to get vaccinated live on television to help convince people it is safe, amid fears up to a fifth of Brits will refuse the jab.

ITV’s Good Morning Britain presenter Piers Morgan made the suggestion before Mr Hancock said: ‘Yeah, I’ll take it with you, Piers’. 

The presenter said: ‘I’ll come to where you are anytime next week if we can do this. Let’s do it together, live on air. It would be powerful, it would send the right message.’

Mr Hancock added: ‘Well, we’d have to get that approved because, of course, there is a prioritisation according to clinical need and, thankfully, as a healthy, middle-aged man, you’re not at the top of the prioritisation.

‘But if we can get that approved and if people think that’s reasonable then I’m up for doing that because once the MHRA has approved a vaccine, they only do that if it is safe.

‘And so, if that can help anybody else, persuade anybody else that they should take the vaccine then I think it’s worth it.’

There have been reports that shops, restaurants and travel companies could require customers to present so-called ‘vaccine passports’ – proof they had been vaccinated – before using their services.

But Mr Hancock said that ‘isn’t part of our plan’, adding: ‘While we know that this vaccine protects you from getting ill with Covid – we don’t yet know how much it stops you transmitting Covid until we roll it out broadly,’ he told Sky News.

‘We will, of course, be monitoring that very carefully.

‘Therefore, we will vaccinate according to protecting the people who need the protection most, according to those who are vulnerable from Covid.

‘So, that is part of the plan. The plan is to get this rolled out, according to the clinical prioritisation that the advisers will set out.’

Reacting to the vaccine news, Chris Hopson, chief executive of NHS Providers, said: ‘This is great news. An effective vaccine – along with advances in treatment and rapid turnaround mass testing – presents real hope for a way out of the pandemic.

‘It’s reassuring to know that the regulator has reached this decision only after very careful evaluation of safety, quality and effectiveness. 

‘The logistics of administering the Pfizer/BioNTech jab are formidable, but the NHS has been preparing for this, and trusts will play a key role.

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.’

‘The health service has an excellent track record of delivering vaccination programmes – though this will be on an unprecedented scale, with added challenges because of the need to run mass vaccination centres and the requirement for cold storage. 

‘And while this announcement gives great cause for hope, it’s important to remember that this does not mean life gets back to normal – at least until the spring or early summer.

‘For the time being our best defence against COVID-19 is to prevent infection by observing lockdown restrictions. 

‘We’ll need that to get through the tough winter weeks ahead. But now at least we have the prospect of better days ahead.’

Scotland’s interim chief medical officer Gregor Smith tweeted: ‘Wonderful news that MHRA has approved the authorisation to supply Pfizer BioNTech coronavirus vaccine.

‘First of several vaccines in pipeline and begins to change everything for our future.’ 

Independent scientists hailed Pfizer’s approval as ‘momentous’ and a huge landmark in the global efforts to address this pandemic.’

Professor Arne Akbar, president of the British Society for Immunology, said: ‘This is a momentous day for us all. Covid-19 has impacted all our lives in so many ways and hope of an exit strategy has relied on a safe and effective vaccine.

‘It is only 12 months since the first case recorded case of COVID-19 and in that time, researchers around the world have worked tirelessly to increase our understanding of this new disease and develop safe and effective vaccines.

‘To achieve this within this timescale is remarkable and the researchers should be applauded. However this announcement is not the end of the story and there is still much work to do. Roll out of the vaccine is going to be a logistical challenge and rely on our dedicated healthcare professionals around the country.

‘Additionally, building public confidence in the vaccine is going to be crucial in ensuring the high uptake needed to stop the spread of SARS-CoV-2 within our communities. It is essential that we have high profile and multifaceted engagement campaigns that listen and respond to the public’s questions around the vaccine.’

Dr John Tregoning, reader in respiratory infections at Imperial College London, added: ‘This is great news and remarkable progress given the first cases were less than a year ago. It shows what progress can be made through science and innovation.

‘The MHRA, the UK drug regulator, will have gone through all the safety data from the trials before approving and will continue to monitor as it is rolled out more widely. 

‘The next step will be to get the vaccine to the people who need it the most.’ 

Dr Michael Head, senior research fellow in global health at the University of Southampton, said: ‘This is excellent news and a huge landmark in the global efforts to address this pandemic. The regulators have clearly been satisfied with the data presented to them.

‘The Pfizer vaccine does require storage at around -70C, which will pose significant logistical challenges for all countries that choose to use it. These are not insurmountable but certainly challenging. 

‘Other vaccines, such as the Oxford AstraZeneca candidate, require storage at much lesser temperatures and will be simpler to transport. 

‘Given we will certainly need more than one licensed vaccine to maximise global coverage, everyone will still be eagerly waiting for further developments from Oxford and Moderna. But, for now, this is wonderful news to wake up to.’

Oxford University’s coronavirus vaccine is expected to be given the green-light by the MHRA in the coming weeks and is likely to become the second jab approved in the UK.

That vaccine is expected to cost just £2 per dose and can be stored in ordinary equipment, unlike Pfizer’s that needs to be kept in ultra-cold temperatures using expensive equipment. 

From the moment the Pfizer vaccine leaves the factory in Belgium it can only be taken out of minus 70C four times before it is injected into a patient’s arm.

Oxford’s is also a fraction of the price, with Pfizer’s costing around £15 per dose and Moderna’s priced at about £26 a shot. 

Oxford’s trials found its jab has a nine in ten chance of working when administered as a half dose first and then a full dose a month later. 

However, efficacy drops to 62 per cent when someone is given two full doses a month apart.

However, even with a 62 per cent efficacy, that still puts the vaccine on par with effective influenza vaccines. The World Health Organization (WHO) has set a target of 50 per cent effectiveness for a Covid-19 jab.

The Oxford vaccine is based on different technology to Pfizer and Moderna’s candidates, which are known as ‘mRNA’, or messenger RNA, vaccines. 

Both use genetic material called mRNA which instructs human cells to make coronavirus spike proteins. 

Unlike Oxford’s vaccine, which is produced using weakened forms of the virus, RNA vaccines can be constructed quickly using only the pathogen’s genetic code. 

The new mRNA vaccines have never been approved by regulators before, whereas the Oxford approach has been used in vaccines for diseases such as tuberculosis, malaria, MERS and Ebola.

Despite the news, Britain may still need a circuit-breaker lockdown in late winter despite the promising vaccine news today, a top scientist warned. 

Liam Smeeth, professor of clinical epidemiology at the London School of Hygiene and Tropical Medicine, said although some vulnerable groups will be inoculated by this year, mass vaccination won’t happen for months.

He warned this gives Covid-19 weeks to proliferate during the deep winter months, when viruses spread more easily as people stay indoors more.  

Professor Smeeth said: ‘The continued progress on vaccines is fantastic news.

‘A route towards a much better situation in the UK is becoming clear.

‘But a further circuit-breaker in January or possibly February is likely to be needed.’

It was also revealed today that the MHRA was so keen to approve Pfizer’s Covid-19 vaccine that it responded to emails in ten minutes, according to Pfizer’s vice president for medical and scientific affairs.

Professor Ralph Reinet, who is an expert in infectious diseases at the American pharmaceutical giant, said the regulator was ‘very quick’ in asking for information when contrasting it to others including the European Medical Agency (EMA).

‘The world is looking at the UK at the moment,’ he said. ‘Sometimes a country needs to lead and the UK is leading.’

Some countries are taking longer to approve Pfizer’s jab because they use a ‘different process’ for ensuring vaccines are safe for distribution.

But many have been in touch today to ask how Britain has managed to approve the vaccine so quickly – although he refused to detail which countries.

Professor Berkeley Phillips, Pfizer UK’s medical director, described the vaccine approval process as like a book with three chapters – effectiveness of the vaccine, its safety, and the quality of its manufacture.

He said the MHRA was satisfied that Pfizer’s jab met the standard in each of these, so had issued it with an emergency approval.

There is only the administrative work of writing the contents page and the summary left to do, he said, which the regulator said could be skipped to get the vaccine administered to those most in need sooner given the devastating impact of the pandemic.

It was suggested other countries may be following a more drawn out process.

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. 

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)

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.

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.

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.

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. 

Read more at DailyMail.co.uk