Britain’s regulators today approved Pfizer/BioNTech’s coronavirus vaccine, paving the way for mass-vaccination to start within days.

Officials said the jab — which the UK has ordered 40million doses of — will be made available ‘from next week’ as Health Secretary Matt Hancock declared the end of the pandemic was now ‘in sight’.

Department of Health and Social Care officials made the announcement just after 7am this morning, as England left its second national lockdown and shops reopened for ‘wild Wednesday’. 

Pfizer/BioNTech’s vaccine has been shown to block 95 per cent of Covid-19 infections in late-stage trials, with equal efficacy among younger volunteers and those over 65 who are most at risk from Covid.  

Mr Hancock declared ‘help is on its way’ this morning, revealing that 800,000 doses of the jab will be available next week — enough to vaccinate 400,000 people because it is administered in two shots.

He 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.’ Mr Hancock revealed those ‘who are vulnerable from Covid’ will be first in line, meaning care home residents and workers will be first to be contacted — despite claims NHS workers would be first. 

And Mr Hancock 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.’ 

Boris Johnson also hailed the vaccine’s approval this morning, saying it would ‘allow us to reclaim our lives and get the economy moving again’. 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. 

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 40million 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 Joint Committee on Vaccination and Immunisation (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.

However, Pfizer’s jab has to be stored at -70C which makes transporting the vaccine to care homes a logistical nightmare. Fifty NHS hospitals are already equipped with the super-cold freezers, meaning healthcare staff are likely to be immunised first. 

The Covid-19 vaccine from Pfizer /BioNTech has been approved by the Regulatory Agency

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

The first priority groups for vaccination are care home residents and the staff who look after them, according to an official list drawn up by the Joint Committee on Vaccination and Immunisation (JCVI)

A graph showing vaccine orders made by the EU, US, Canada, UK, Japan and Australia

In other coronavirus developments today:

Boris Johnson got his brutal post-lockdown tiers approved by the Commons last night thanks to Sir Keir Starmer’s tacit support after suffering the biggest Tory revolt of this Parliament as more than 50 Tories defied the whip;England’s lockdown is over and shoppers used their new freedom to queue outside Primark before dawn to grab pre-Christmas bargains on Wild Wednesday;Care home residents will finally be able to hug their families again, after ministers announced a national roll-out of rapid tests will mean relatives who are free of Covid will be allowed visits for the first time since March;Private hospitals received millions in funding this summer despite most around two-thirds of extra capacity going unused, according to leaked documents;Britain last night recorded another 13,430 Covid infections and 603 deaths as the second wave of the disease continues to tail off. WHO WILL GET THE JAB, WHEN AND HOW?

What’s in the pipeline for the UK?

The Government has secured 40million doses of the Pfizer/BioNTech vaccine, with 10million due in the UK by the end of the year.

Patients need two doses, meaning not enough shots have been secured for the entire UK population.

How will a vaccine be rolled out?

Work has been going on behind the scenes to ensure that NHS staff are ready to start delivering jabs to the most vulnerable, as well as health and care workers, as a priority.

Fifty hospitals are already on standby ready to start dishing out the vaccines as soon as they arrive next week.

In addition, NHS leaders have said there will be ‘roving teams’ deployed to vaccinate care home residents and workers.

Based on the current information, the vaccines being developed require two doses per patient, with a 21 to 28 day gap between doses.

New regulations allowing more healthcare workers to administer flu and potential Covid-19 vaccines have also been introduced by the Government.

Who is top of the list to get a coronavirus vaccine?

The Joint Committee on Vaccination and Immunisation (JCVI) has examined data on who suffers the worst outcomes from coronavirus and who is at highest risk of death.

Its =guidance says the order of priority should be:

Older adults in a care home and care home workersAll those who are 80 years of age and over and frontline health and social care workersAll those who are 75 years of age and overAll those who are 70 years of age and over and clinically extremely vulnerable individuals, excluding pregnant women and those under 18 years of ageAll those who are 65 years of age and overAdults aged 18 to 65 years in an at-risk groupAll those aged 60 and overAll those aged 55 and overAll those aged 50 and over HANCOCK SAYS HE’LL TAKE VACCINE LIVE ON AIR TO SHOW IT’S SAFE 

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.’

After NHS staff and care homes, everyone over the age of 80 will be prioritised for a vaccine, with those above the age of 75 next in the queue.

They will be 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.

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 MHRA moved with unprecedented speed to approve Pfizer’s vaccine for emergency use authorisation within just a week of receiving the final data from the jab’s phase three trials. The watchdog had been conducting a ‘rolling review’ of Pfizer’s vaccine, scrutinising data from its trials in real-time.   

MHRA Chief Executive, Dr June Raine said: ‘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.’

The first delivery of 800,000 doses of Pfizer’s vaccine is expected next week, though Brits could get their hands on 10million doses by the year’s end.

The doses are being manufactured at a factory in Belgium. Mr Hancock told the BBC this morning: ‘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. 

During a round of interviews this morning, 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.’

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.

PFIZER’S COVID-19 VACCINE TIMELINE AT A GLANCE

March 17: Pfizer and Germany firm BioNTech announce they are co-developing a Covid-19 vaccine.

The companies team up after previous collaborations on flu jabs.

July 13: Their vaccine is granted fast-track status by the FDA.

It gives regulators in the US the ability to review data from studies into the jab in real time, so it can be approved and rolled out quicker.

July 20: Phase one trial on 12 adults show the vaccine stimulates antibody response.

July 27: Phase two trial is launched in a much larger group of people and compared to a placebo to see if the jab is safe.

August 12: Results from the study of 45 adults find the jab is well tolerated with few side effects and stimulates the immune response thought to be needed to fend off Covid-19 infection.

Mid-August: Phase three trials are launched in the US. These trials see researchers administer the jab then wait to see if people get infected naturally in the community.

September 12: Phase three trials are expanded to include 44,000 people at more than 120 clinical sites across the US, Brazil, South Africa and Argentina.

October 6: The European Medicines Agency agrees to initiate a rolling review, which the FDA had done months earlier.

October 30: The UK Medicines and Healthcare Products Regulatory Agency (MHRA) also undertakes rolling review. It opens the door for the US, UK and Europe to get doses by the end of 2020.

November 9: Early results from phase three suggest nine out of 10 people who get their jab are protected by it. 

November 18: The pharmaceutical giant claimed the final results of the trial showed it was safe, 95 per cent effective and works in older people who are most at risk of dying from the disease.

December 2 : The The Medicines and Healthcare products Regulatory Agency approves the jab and Matt Hancock says mass-vaccination will begin from the following week.

‘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.

‘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.’

WHICH HOSPITALS WILL GET THE VACCINE FIRST?  Blackpool Teaching HospitalsBrighton and Sussex University HospitalsCambridge University HospitalsChesterfield Royal HospitalCountess of Chester HospitalCroydon University HospitalDartford and Gravesham HospitalsDorset County HospitalsEast and North Hertfordshire HospitalsEast Kent HospitalsEast Suffolk and North Essex HospitalsFrimley Health NHS Foundation TrustGloucestershire HospitalsGreat Western HospitalsGuys & St Thomas NHS TrustJames Paget University HospitalsKings College HospitalPrincess Royal University Hospital, KingsLancashire Teaching HospitalLeeds Teaching HospitalLeicester Partnership NHS TrustLiverpool University HospitalsMedway NHS Foundation TrustMid and South Essex HospitalsMilton Keynes University HospitalNorfolk and Norwich University HospitalNorthampton General HospitalNorth Bristol NHS Foundation TrustNorth West Anglia Foundation TrustNottingham University HospitalsOxford Health NHS Foundation TrustPortsmouth Hospital UniversityRoyal Cornwall HospitalsRoyal Free London NHS Foundation TrustSalford Royal NHS Foundation TrustSheffield Teaching HospitalsSherwood Forest HospitalsShrewsbury and Telford NHS TrustStockport NHS Foundation TrustSt George’s University HospitalsThe Newcastle Upon Type HospitalsUniversity College HospitalsUniversity Hospitals BirminghamUniversity Hospitals Coventry and WarwickshireUniversity Hospitals Derby BurtonUniversity Hospitals of North MidlandsUniversity Hospitals PlymouthUnited Lincolnshire HospitalsWalsall HealthcareWest Hertfordshire HospitalsWirral University Teaching HospitalWorcestershire Acute HospitalsYeovil District Hospital 

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.

HOW DOES THE PFIZER VACCINE WORK?

A new Covid-19 vaccine from pharmaceutical giant Pfizer, working with German biotech company BioNTech, has been approved for use in the UK. 

Is this a reason to celebrate?

Yes. Analysis shows the vaccine can prevent 95 per cent of people from getting Covid-19, including 94 per cent in older age groups. The vaccine has been tested on 43,500 people in six countries and no safety concerns were raised. Approval means the UK can begin rolling out the vaccine to those most in need, including frontline NHS workers.

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.

One downside to mRNA vaccines is that they need to be stored at ultra-cold temperatures and cannot be transported easily.

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.

Do we have enough doses to vaccinate the UK population?

The UK has secured 40million doses of the Pfizer/BioNTech vaccine, with 10million due in the UK by the end of the year.

Patients need two doses, meaning not enough shots have been secured for the entire UK population.

However, it is likely other vaccines, including one from Oxford University, will be approved in the coming weeks and months.

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. 



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