Covid vaccine – Pfizer jab approved with mass vaccination from next week as UK is first country to give green light

THE UK is the first country in the world to give a Covid vaccine the green light – with mass vaccinations planned from next week.

The jab – which is 95 per cent effective and developed by pharmaceutical giant Pfizer and German firm BioNTech – is safe for use, health regulators say.

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The drug has been backed by independent regulator the Medicines and Healthcare Products Regulatory Agency (MHRA).

The Health Secretary Matt Hancock tweeted earlier this morning: "Help is on its way.

"The MHRA has formally authorised the Pfizer/BioNTech vaccine for Covid-19.

"The NHS stands ready to start vaccinating early next week."


Mr Hancock urged everyone to "double their resolve" in the next few months while the tiered system is in place and waiting for the roll-out of the jab.

He said: "We can see the dawn in the distance but we got to get through 'till morning."

The Prime Minister Boris Johnson hailed tweeted this morning the vaccine would "allow us to reclaim our lives and get the economy moving again".

The news means that millions of Brits will soon receive it – in line with the Government's pledge to get the most vulnerable as soon as possible.

Care home residents, those over 80years old and health and social care staff will be among the first to receive the jab, the Joint Committee on Vaccination and Immunisation (JCVI) confirmed today.

The initial 800,000 doses, covering 400,000 people, will be available from next week after final checks at the manufacturing warehouse in Belgium today.

"Several millions" more will come throughout December, but the bulk of the bulk of the roll-out will take place in the new year.

Professor Chris Whitty, the chief medical officer for England, tweeted: "It will take until spring until the vulnerable population who wish to are fully vaccinated. We can't lower our guard yet."

It comes as:

  • Britain is first country in world to approve a jab
  • Mass vaccination programme to start from next week
  • 50 hospital set up and waiting to accept the jab
  • Pfizer vaccine offers 95 per cent protection
  • Care home residents and the elderly will be among the first to receive drug
  • UK has secured 40 million doses of the Pfizer/BioNTech vaccine, with 10 million due in the UK by the end of the year
  • Around 800,000 doses will be available from next week, with the first shipments arriving as early as today

Just days ago, it was announced that the drug was set to get the green light for use – and medics were told to prepare for approval in early December.

The UK regulator was formally asked by Health Secretary Matt Hancock to check the Pfizer vaccine and approve it.

He said on BBC Radio 4's Today programme this morning: "I'm just absolutely thrilled. The UK is the first country in the world to have a clinically authorised vaccine for Covid-19.

"This will start small and ramp up. The vast majority of vaccines we expect to be in the new year.

"We are expecting a matter of millions of doses for the whole of the UK by the end of this year."

He said also said on BBC Breakfast this morning: "From Easter onwards, things are going to be better and we’re going to have a summer next year that everybody can enjoy."

Confirming that hundreds of thousands of people will get the vaccination from next week, he said the speed at which we go will be determined by how quickly Pfizer can manufacture in Belgium.

"We'll then deploy at the speed that it's manufactured," he said.

"What we do know is that we can get started next week with that first load and then several millions will be coming throughout December."

Who will get the jab first?

The Joint Committee on Vaccination and Immunisation (JCVI) published the official list of vaccine prioritisation today.

The vaccine will be given out in this order:

1. Residents in a care home for older adults and their carers
2 All those 80 years of age and over
Frontline health and social care workers
3 All those 75 years of age and over
4 All those 70 years of age and over
Clinically extremely vulnerable individuals*
5 All those 65 years of age and over
6 All individuals aged 16 years to 64 years with underlying health
conditions which put them at higher risk of serious disease and
mortality
7 All those 60 years of age and over
8 All those 55 years of age and over
9 All those 50 years of age and over

Professor Wei Shen Lim, chair of the JCVI, said at a Downing Street briefing this morning this first wave of vaccination will aim to cover 99.9 per cent of those who are at highest risk of Covid-19.

The group have chosen the elderly to receive the jab first because they are most at risk of dying from Covid-19. Healthcare workers will be next in line because they are at higher risk of catching the virus, and spreading it in healthcare facilities.

Professor Lim said by protecting the NHS workforce, lives will be saved.

The Government ordered a total of 40 million doses – with 10 million expected by the end of 2020 to cover five million people, it has been reported.

But Mr Hancock today refused to put a number on how many will arrive by the end of the year.

Patients need two doses 21 days apart for protection against Covid-19, meaning not enough shots have yet been secured for the entire UK population.

People will be protected from the virus seven days after their second dose, Professor Sir Munir Pirmohamed, chair of Commission on Human Medicine Expert Working Group, said at the Downing Street briefing this morning.

It's not clear how long immunisation lasts, with the possibility of booster jabs needed. This will be studied over time.

The green light from the MHRA means that Britain will be ahead of the US in receiving the jab even though it was developed using US government funding. 

The roll-out

The Pfizer/BioNTech jab is an mRNA vaccine, which makes it easier to produce on a mass scale.

However, it needs to be storedat -70C, way below a typical vaccine which only needs to be stored in a fridge, making it challenging to transported.


How does the Pfizer vaccine work?

How does the vaccine work?

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.

How effective and safe is it?

The Pfizer/BioNtech vaccine can prevent 95 per cent of people from getting Covid-19, including 94 per cent in older age group.

The vaccine has been tested on 43,500 people in six countries and no safety concerns were raised.

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.

Pfizer will continue to collect safety and long-term outcomes data from participants for two years.

How quickly can it be made and distributed?

No actual virus is needed to create an mRNA vaccine. This means the rate at which it can be produced is dramatically accelerated.

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.

Pfizer doses will be transported to the UK from Belgium, where each batch of vaccines has to be checked.

Mr Hancock said: "It’s not just the overall authorisation for this vaccine, but it is for each batch that needs to be tested [by the MHRA].

"The batch testing happens at the factory, so that has to happen from this morning onwards.

"That's why it will take a couple of days from now until people can have it injected into arms, protecting them from this disease, from early next week."

Hospitals are now preparing their staff to start receiving the vaccine from Monday. An army of helpers will then issue the jab to those most in need.

Many people will be immunised at "vaccination centres", which are already being set up, while others will receive the jabs from GPs and pharmacies, Mr Hancock said.

The NHS Nightingale Hospitals have also been earmarked as sites for mass vaccination clinics.

Royal Liverpool University Hospital trust is one of 50 sites that will be rolling out the vaccine.

Because the vaccine must be kept at such cold temperatures, Pfizer has designed a suitcase-sized container that will keep the doses at the ultra-low temperature for up to 10 days using dry ice.

It can only remain stable for five days in a fridge, such as those in GP surgeries, and can only be thawed in batches of 1,000 before immunisation.

Health bosses are gambling the Oxford-developed AstraZeneca jab, which can be kept in a normal fridge, will be approved soon after.

Are there other effective vaccines?

A number of vaccines are currently being tested – with good results

Recent data from the Oxford/AstraZeneca and Moderna vaccine trials suggests their candidates also have high efficacy, just like the Pfizer jab.

Oxford data indicates the vaccine has 62 per cent efficacy when one full dose is given followed by another full dose.

However, when people were given a half dose followed by a full dose at least a month later, its efficacy rose to 90 per cent.

The combined analysis from both dosing regimes resulted in an average efficacy of 70.4 per cent.

Final results from the trials of Moderna's vaccine suggest it has 94.1 per cent efficacy, and 100 per cent efficacy against severe Covid-19.

Nobody who was vaccinated with the vaccine known as mRNA-1273 developed severe coronavirus.

The UK has secured access to 100 million doses of the AstraZeneca/Oxford University vaccine, which is almost enough for most of the population.

It also belatedly struck a deals for seven million doses of the jab on offer from Moderna in the US.

All vaccines undergo rigorous testing and have oversight from experienced regulators.

The UK has secured access to:

– 100 million doses of the Oxford vaccine

– 60 million doses of the Novavax vaccine

– Some 30 million doses from Janssen

– 40 million doses of the Pfizer/BioNTech vaccine – the first agreement the firms signed with any government

– 60 million doses of a vaccine being developed by Valneva

– 60 million doses of protein adjuvant vaccine from GlaxoSmithKline (GSK) and Sanofi Pasteur

– Seven million doses of the jab on offer from Moderna in the US.

An official from the Department of Health and Social Care said: "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 vaccine will be made available across the UK from next week.

"The NHS has decades of experience in delivering large scale vaccination programmes and will begin putting their extensive preparations into action to provide care and support to all those eligible for vaccination."

Sir Simon Stevens, chief executive of the NHS in England, said the vaccination programme would be the "largest-scale vaccination campaign in our country's history".

In a statement, he said: "This is an important next step in our response to the coronavirus pandemic and hospitals will shortly kick off the first phase of the largest-scale vaccination campaign in our country's history.

"The NHS has a proven track record of delivering large-scale vaccinations from the winter flu jab to BCG and, once the final hurdles are cleared and the vaccine arrives in England's hospitals, health service staff will begin offering people this ground-breaking jab in a programme that will expand to cover the whole country in the coming months."

Pfizer chief executive Albert Bourla described the announcement as an “historic moment” – and said "science has won".

“With thousands of people becoming infected, every day matters in the collective race to end this devastating pandemic," he said.

Stick to the rules for now

The Government has urged Brits to keep to the new tier system, which came into force at midnight today, to "further suppress the virus and allow the NHS to do its work without being overwhelmed".

An effective vaccine is seen as the main weapon in fighting the pandemic, which has claimed more than 1.4 million lives worldwide.

When a high proportion of the population are protected against the virus, it struggles to spread, and cases will go down.

The crippling measures to contain the virus, including the closure of restaurants, gyms, pubs and schools, can only be abolished this way.

"A momentous day for us all"

British scientists rejoiced at the news this morning after anticipating the MHRA's decision for around two weeks.

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.  Today that hope has been realised.

“However this announcement is not the end of the story and there is still much work to do."

 Liam Smeeth, a professor of clinical epidemiology, and dean of the Faculty of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, said: "A route towards a much better situation in the UK is becoming clear.

"A further circuit breaker in January or possibly February is likely to be needed.

"But, it is realistic to hope that by March or April the vast majority of older people, care home residents, and those with severe conditions will have been immunised."

Dr Michael Head, a senior research fellow in Global Health, University of Southampton, said it was "wonderful news to wake up to".

He commented: “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.

"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."

The vaccines from Oxford/AstraZeneca and Moderna require storage at much lesser temperatures and will be simpler to transport than the one from Pfizer/BioNTech.

Recent data from the Oxford/AstraZeneca, and Moderna vaccine trials suggests their candidates also have high efficacy.

The UK has secured access to 100 million doses of the AstraZeneca/Oxford University vaccine, which is almost enough for most of the population.

It also belatedly struck a deals for seven million doses of the jab on offer from Moderna in the US.

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