Selasa, 08 Desember 2020

Coronavirus UK: Britain is the envy of the world as Covid vaccine is rolled out - Daily Mail

Britain is the envy of the world: Globe hails British first as Covid vaccine is rolled out (despite some sniping from the French)

  • Global media today praised Britain as it embarked on its mass vaccination plan
  • ABC News and Washington Post celebrated the UK's 'route out' of the pandemic
  • But French officials sniped at Britain for rushing through authorised use of jab 

Britain became the envy of the world today, with US media praising its roll-out of the  breakthrough Pfizer/BioNTech coronavirus vaccine in the country's biggest ever mass immunisation programme.

ABC News cheered the UK's authorisation of the emergency use of the Covid-19 jab, calling it a 'route out' of the pandemic.  

The Washington Post trumpeted Britain's 'victory' in the 'West's race for a coronavirus vaccine' that would bring an end to economy-crippling shutdowns.

The New York Times also praised the UK's mass roll-out today, on what has been dubbed 'V-Day' – though not without poking at what it called Downing Street's 'botched Covid response'.

CBS News and New Scientist in the US, and Deutsche Welle in Germany, ran stories about 90-year-old Margaret Keenan, the first patient in Britain to receive the Pfizer/BioNTech vaccine – which is 95 per cent effective at preventing infection – at Coventry University Hospital. 

But the UK's speedy approval of the Covid-19 vaccine provoked sniping from French officials who imply that its authorisation was 'rushed' – a claim which has been denied by Britain's drugs regulator. 

ABC News cheered the UK's authorisation of the emergency use of the Covid-19 jab, calling it a 'route out' of the pandemic

ABC News cheered the UK's authorisation of the emergency use of the Covid-19 jab, calling it a 'route out' of the pandemic

CBS News ran a story about 90-year-old Margaret Keenan, the first patient in Britain to receive the Pfizer/BioNTech vaccine at Coventry University Hospital

CBS News ran a story about 90-year-old Margaret Keenan, the first patient in Britain to receive the Pfizer/BioNTech vaccine at Coventry University Hospital

The Washington Post trumpeted Britain's 'victory' in the 'West's race for a coronavirus vaccine' that would bring an end to economy-crippling shutdowns

The Washington Post trumpeted Britain's 'victory' in the 'West's race for a coronavirus vaccine' that would bring an end to economy-crippling shutdowns

The New York Times also praised the UK's mass roll-out today, on what has been dubbed 'V-Day' – though not without poking at what it called Downing Street's 'botched Covid response'

The New York Times also praised the UK's mass roll-out today, on what has been dubbed 'V-Day' – though not without poking at what it called Downing Street's 'botched Covid response'

CBS News and New Scientist in the US, and Deutsche Welle in Germany, ran stories about 90-year-old Margaret Keenan, the first patient in Britain to receive the Pfizer/BioNTech vaccine at Coventry University Hospital

CBS News and New Scientist in the US, and Deutsche Welle in Germany, ran stories about 90-year-old Margaret Keenan, the first patient in Britain to receive the Pfizer/BioNTech vaccine at Coventry University Hospital

Sir Simon Stevens watches as a nurse administers the first of two Pfizer/BioNTech Covid-19 vaccine jabs to Frank Naderer, 8,  at the Covid-19 vaccination centre in Guy's Hospital

Sir Simon Stevens watches as a nurse administers the first of two Pfizer/BioNTech Covid-19 vaccine jabs to Frank Naderer, 8,  at the Covid-19 vaccination centre in Guy's Hospital

EU politicians defended the bloc's slow approach, with France's Europe minister Clement Beaune claiming the other 26 member states had 'opted for the collective approach – for speed and for safety'.

Beaune, who last week said Paris would veto any post-Brexit trade deal that threatened French interests, accused the British government of having 'opted for certain accelerated procedures'.

In a television interview today, he said: 'We [the EU] have chosen a procedure which provides access to all vaccines with a fast and perfectly safe procedure. 

'The UK has chosen an accelerated procedure which does not offer all the same guarantees.' 

German health minister Jens Spahn said the UK had chosen a different route – limited emergency authorisation – that Germany 'could have chosen too, but we consciously decided against it'.

Spahn said the European Medicines Agency's approval process was a 'more comprehensive one' and was necessary 'in order to strengthen citizens' confidence in the vaccine'. 

Pfizer chief executive Albert Bourla today said he understood concerns around the speed at which pharmaceutical companies have produced Covid-19 vaccines, but insisted that no corners had been cut. 

'We didn't cut any corners,' he told a virtual media briefing hosted by the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA).

The vaccine, based on new technology, has been tested 'in the exact same way as we are testing any vaccine that is circulating out there,' Bourla assured.

In fact, he added, 'this vaccine actually was tested, because of the scrutiny, with even higher standards in terms of how we do things.'  

The NHS has started the biggest vaccination drive in British history at 50 hospital sites where the UK's new weapon in the war on Covid is being rolled out to the over-80s, the vulnerable and frontline hospital and care home staff.

EU politicians defended the bloc's approach, with France's Europe minister Clement Beaune claiming the other 26 member states had 'opted for the collective approach – for speed and for safety'. Beaune, who last week said Paris would veto any post-Brexit trade deal that threatened French interests, accused the UK of having 'opted for certain accelerated procedures'

EU politicians defended the bloc's approach, with France's Europe minister Clement Beaune claiming the other 26 member states had 'opted for the collective approach – for speed and for safety'. Beaune, who last week said Paris would veto any post-Brexit trade deal that threatened French interests, accused the UK of having 'opted for certain accelerated procedures'

The moment Margaret Keenan, 90, became the first patient in the United Kingdom to receive the Pfizer/BioNtech covid-19 vaccine at University Hospital, Coventry, administered by nurse May Parsons, at the start of the largest ever immunisation programme in the UK's history

The moment Margaret Keenan, 90, became the first patient in the United Kingdom to receive the Pfizer/BioNtech covid-19 vaccine at University Hospital, Coventry, administered by nurse May Parsons, at the start of the largest ever immunisation programme in the UK's history

Prime Minister Boris Johnson speaks to to Lyn Wheeler before she received the Pfizer-BioNTech COVID-19 vaccine at Guy's Hospital in London. Mr Johnson was in intensive care at the same trust as he fought Covid earlier this year

At least 5,000 people are expected to be inoculated today – around 100 people in each centre – with 800,000 doses of the Pfizer /BioNtech vaccine already in the country as the UK's vaccine chief Kate Bingham predicted that in 2021 'we will all be going on summer holidays'. 

Incredibly the next to get the jab was 81-year-old William Shakespeare from near Stratford-upon-Avon – the Bard's home town – who appeared so relaxed many joked that to him, being the second person in the world to be vaccinated was 'much ado about nothing'. 

Health Secretary Matt Hancock said he was emotional as he watched Mrs Keenan getting the jab this morning after a grim 2020, and cried on Good Morning Britain as Mr Shakespeare hailed the 'groundbreaking' jab that will 'start changing our lives'. 

Mr Hancock wiped away tears as he told Piers Morgan and Susanna Reid: 'It's been such a tough year for so many people and there's William Shakespeare putting it simply for everybody that we can get on with our lives'. 

But in a gloomy warning for Britain he added: 'There's still a few months to go, I've still got this worry that we can't blow it now Piers, we've still got to get the vaccine to millions of people so we've got to keep sticking to the rules, there's so much work gone into this – it makes me proud to be British'. 

In a watershed moment, an emotional Mrs Keenan is clapped from the ward after she was vaccinated on the eve of her 91st birthday

In a watershed moment, an emotional Mrs Keenan is clapped from the ward after she was vaccinated on the eve of her 91st birthday

In a wonderful twist, the second person to get the jab in Coventry was.... a William Shakespeare from Warwickshire

Later in the Commons a more composed Mr Hancock gave a statement to MPs on the vaccine's rollout and joined in on the Shakespeare puns, declaring: 'If you prick us, do we not bleed?' 

Boris Johnson, who watched people getting vaccinated at Guy's Hospital this morning, said: 'It's a shot in the arm for the entire nation, but we can't afford to relax now'. 

At 6.30am, wearing a bright blue 'Merry Christmas' T-shirt, Mrs Keenan, known as 'Maggie' to friends and family, could be seen smiling under her mask as the nurse May Parsons at University Hospital Coventry & Warwickshire injected her with the life-saving medicine. 

Mrs Keenan, a former jewellery shop assistant who only retired four years ago, has a daughter, a son and four grandchildren. 

She said: 'I feel so privileged to be the first person vaccinated against Covid-19, it's the best early birthday present I could wish for because it means I can finally look forward to spending time with my family and friends in the New Year after being on my own for most of the year. 

'I can't thank May and the NHS staff enough who have looked after me tremendously, and my advice to anyone offered the vaccine is to take it – if I can have it at 90 then you can have it too.'  

EVERYTHING YOU NEED TO KNOW ABOUT PFIZER'S COVID VACCINE

Britain today began mass vaccination of the public with Pfizer/BioNTech's Covid vaccine, bringing the 'end in sight' to pandemic lockdown rules.

Here, MailOnline answers all the questions about the jab, including who will get it first, how much it costs and where people will be vaccinated.

What could the logistical challenges of delivering it be?

Both the Prime Minister Boris Johnson and Health Secretary Matt Hancock warned that transporting and storing Pfizer's breakthrough jab 'won't be easy', while Chris Hopson, chief executive of NHS Providers, described the logistics behind the mass roll out as 'formidable'. 

The problems stem from the fact the vaccine must be kept in long-term storage at -70C. 

To keep doses 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 2°C and 8°C for up to five days. 

Or they can be kept in their shipping boxes for up to 30 days if the containers are topped up with dry ice at least once a week.

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 sticking point for delivering the jab to places like care homes may be that BioNTech says that the vaccine can only be kept at between 2°C and 8°C for six hours in transit without going off. 

Because the Pfizer suitcases hold 5,000 vaccine doses, smaller quantities would have to be removed from the dry ice suitcases for transport to care homes. 

But once they are in transit the doses could perish after six hours. It's unclear exactly why this is the case.  

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. 

The JCVI's guidance says the order of priority should be the below.

1. Residents in a care home for older adults and their carers 

2. All those who are 80 years of age and over and frontline health and social care workers

3. All those who are 75 years of age and over

4. All those who are 70 years of age and over and clinically extremely vulnerable individuals, excluding pregnant women and those under 18 years of age

5. All those who are 65 years of age and over

6. Adults aged 18 to 65 years in an at-risk group, such as the morbidly obese

7. All those aged 60 and over

8. All those aged 55 and over

9. All those aged 50 and over

However, because of the aforementioned logistical problems, care homes cannot receive the vaccines straight away, so elderly NHS patients, care workers and NHS staff are receiving the first doses.

Where will people get the vaccine, and who will be administering it?

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. 

Vaccinations today started in 70 NHS hospitals and the operation will be scaled up in the coming days and weeks. 

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.  

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 stated that GP practices offering vaccines 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'.

How many doses of the Pfizer vaccine 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. 800,000 doses are already in the country and ready to be used.

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.  

 

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.

Where is the vaccine made?   

Pfizer's jab is being manufactured at the firm's plant in Belgium, as well as separate sites in the US. 

BioNTech — the other drug company involved in the vaccine — has two production facilities in Germany that are expected to start churning out doses in the New Year.   

Can the vaccine be transported in a fridge?

Yes, although the vaccine should be kept at -70°C to ensure its long-term preservation, it can be transported by car or van if refrigerated between 2°C and 8°C.

According to the latest data from BioNTech, the company that owns the vaccine, it is only safe to use within six hours of being defrosted if transported in a fridge.

Researchers say this would allow administration of the vaccine to high-risk populations who may be unable to visit vaccination centres, such as care home residents. However, it also says that the vaccine remains stable and viable for up to five days if kept in a stationary fridge — like in a GP surgery - at 2-8°C.

The only difference between the two scenarios is that one involves being chilled and transported, while the other is not moved while being cooled.

Why this difference shortens the vaccine's shelf-life is currently unexplained. 

Speaking today at a virtual press conference, the vaccine's developers hinted the restrictions would be eased as more data was gathered, indicating the limits are currently overly-cautious to ensure the vaccine reaches society's most vulnerable people with no drop-off in its efficacy. 

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.

Can you get the Covid vaccine privately? 

The Queen and the rest of the Royal Family will not be able to jump the queue for a Covid-19 vaccine and even Boris Johnson will have to wait his turn, it was revealed last month.

No one will be given 'special treatment' when the country launches its mass-immunisation drive, according to Government sources.

Even rich companies won't be able to skip the line, despite fears wealthy corporations would snap up vaccines directly to get their staff back to work and make up for the money haemorrhaged during lockdown. 

Could employers force staff to get a vaccine?

It is 'highly unlikely' private employers could force staff to get a Covid jab when one finally becomes available, according to lawyers.

Although most of Britain will need to get vaccinated to achieve herd immunity and stop the disease spreading, a jab can't be given without people's consent.

Lawyers at the global firm Morgan Lewis said it was not likely that firms in the UK could start enforcing vaccination.

They said: 'A vaccine could only be lawfully administered provided that the individual consented to such treatment. It is highly doubtful an employee could be described as consenting to treatment under any degree of compulsion by their employer.'

Will I get a vaccine passport if I get the jab?  

Immunity passports have been touted as the key for getting swathes of society back to normal life, and allowing millions to evade restrictions. This is because they would indicate someone is protected against the virus, and is able to fight it off without getting severely ill or dying.

Bars, cinemas and football stadiums could turn away Britons who have not been vaccinated against coronavirus, the UK's vaccine minister Nadhim Zahawi suggested.

But ministers have since denied Britons will need 'immunity certificates' to go to the pub. Michael Gove was asked yesterday during a round of interviews whether people could need to prove they had been given coronavirus vaccines to enter bars and restaurants. He replied flatly: 'No.'

Pressed on whether they could be required at theatres or sports centres, he said: 'No I don't think so, no.' 

Mr Hancock today said that a vaccine passport 'isn't part of our plan'. He told Sky News: '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.'

Don't vaccines take a long time to produce?

In the past it has taken years, sometimes decades, to produce a vaccine.

Traditionally, vaccine development includes various processes, including design and development stages followed by clinical trials – which in themselves need approval before they even begin.

But in the trials for a Covid-19 vaccine, things look slightly different. A process which usually takes years has been condensed to months.

While the early design and development stages look similar, the clinical trial phases overlap, instead of taking place sequentially.

And pharmaceutical firms have begun manufacturing before final approval has been granted – taking on the risk that they may be forced to scrap their work.

The new way of working means that regulators around the world can start to look at scientific data earlier than they traditionally would do.

Aren't there other vaccines?

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

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

But when people were given a half dose followed by a full dose at least a month later, its efficacy rose to 90 per cent, according to data. But the breakthrough results from trials of Oxford University's vaccine were based on 'shaky science', experts have warned.

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.

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

Which jab is best?

The early contenders all have high efficacy rates, but researchers say it is difficult to make direct comparisons because it is not yet known exactly what everyone is measuring in the trials.

Analysis shows the Pfizer vaccine can prevent 95 per cent of people from getting Covid-19, including 94 per cent in older age groups. 

A technician inspects vials of coronavirus disease (COVID-19) vaccine candidate BNT162b2 at a Pfizer manufacturing site in manufacturing site in St. Louis, Missouri

A technician inspects vials of coronavirus disease (COVID-19) vaccine candidate BNT162b2 at a Pfizer manufacturing site in manufacturing site in St. Louis, Missouri

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. 

How many doses of other jabs has the UK secured?

The UK has secured access to 100million 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.

The deals for 357million doses of seven different vaccines cover four different classes: adenoviral vaccines, mRNA vaccines, inactivated whole virus vaccines and protein adjuvant vaccines.  

How much does Pfizer's vaccine cost?

Pfizer/BioNTech is making its vaccine available not-for-profit.

According to reports, the Moderna vaccine could cost about 38 dollars (£28) per dose and the Pfizer candidate could cost around 20 dollars (£15).

Researchers suggest the Oxford vaccine could be relatively cheap to produce, with some reports indicating it could be about £3 per dose.

AstraZeneca said it will not sell it for a profit, so it can be available to all countries.

However, the details of the deals made by the UK Government have not been made public.

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 front-runners.

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 would the regulator have looked 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.

Husband and wife Ugur Sahin and Oezlem Tuereci are behind the Pfizer Covid-19 vaccine that could change the world

Husband and wife Ugur Sahin and Oezlem Tuereci are behind the Pfizer Covid-19 vaccine that could change the world

Regulators look at stacks of data before approving any vaccines (stock)

Regulators look at stacks of data before approving any vaccines (stock)

What is the difference between the MHRA and the CHM? 

The MHRA is the British regulator of medicines and medical devices, ensuring their safety, quality and effectiveness.

The CHM advises ministers on medicinal products. It is made up of an independent group of advisers responsible for advising on the need for, and content of, risk management plans for new medicines.

It also advises officials on the impact of new safety issues on the balance of risks and benefits of licensed medicines.

The CHM also offer advice on 'applications for both national and European marketing authorisations'.

Haven't pharmaceutical companies already started making vaccines?

Yes. Usually large-scale production and distribution begins only after regulatory approval. But in the case of Covid-19 vaccines, pharmaceutical firms have begun manufacturing before final approval had been granted – taking on the risk that they may be forced to scrap their work.

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2020-12-08 18:08:00Z
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Oxford Covid vaccine 'safe and effective' study shows - BBC News

Elisa Granato receiving the vaccine

The Oxford/AstraZeneca Covid vaccine is safe and effective, giving good protection, researchers have confirmed in The Lancet journal.

Most in the study were younger than 55, but the results so far indicate it does work well in older people too.

The data also suggest it can reduce spread of Covid, as well as protect against illness and death.

The paper, assessed by independent scientists, sets out full results from advanced trials of over 20,000 people.

Regulators, who will have seen the same data, are considering the jab for emergency use.

But there are still important questions about what dose to give, as well as who it will protect.

When the interim trial results were made public in a press release about a fortnight ago, the researchers reported three efficacy levels for the vaccine - an overall effectiveness of 70%, a lower one of 62% and a high of 90%.

That's because different doses of the vaccine were used in one part of the trial. Some volunteers were given shots that were half the strength than originally planned.

Yet that "wrong" dose turned out to be a winner - giving 90% protection - while two standard doses gave 62%.

The Lancet report reveals 1,367 people - out of many thousands in the trial - received the half dose followed by a full dose, which gave them 90% protection against getting ill with Covid-19.

The relatively small numbers means it is hard to draw firm conclusions.

None of that group were over the age of 55 though - and experts know it is older people who are most at risk of severe Covid illness.

In terms of safety, there was one severe adverse event potentially related to the vaccine and another one - a high temperature - that is still being investigated.

Both these participants are recovering and are still in the trial.

The study also measured protection against asymptomatic infection by asking volunteers to do regular swabs to check if they had Covid without feeling unwell.

More of these cases were seen in the group that did not receive the vaccine.

Pascal Soriot, chief executive officer for AstraZeneca said: "The results show that the vaccine is effective against Covid-19, with in particular no severe infections and no hospitalisations in the vaccine group, as well as safe and well tolerated.

"We have begun submitting data to regulatory authorities around the world for early approval and our global supply chains are up and running, ready to quickly begin delivering hundreds of millions of doses on a global scale at no profit."

Dr Charlie Weller, Head of Vaccines at Wellcome, said: "Today marks another key milestone in the Covid-19 vaccine journey.

"Although we await the trial completion and full data, it is highly encouraging to see the data behind the interim results announced last month, including an analysis of the different dosing regimens. This suggests that this vaccine could prevent asymptomatic disease."

Meanwhile, the UK has started a mass vaccination campaign with another Covid jab made by Pfizer/BioNTech.

The Oxford/AstraZeneca vaccine could also play a major role in fighting the pandemic if it is approved soon.

It is cheaper than some of the other Covid vaccines and easier to store and distribute.

Graphic

The UK government has pre-ordered 100 million doses of the Oxford vaccine, which uses a harmless virus altered to look a lot more like the virus that causes Covid-19.

AstraZeneca says it will make three billion doses for the world next year.

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2020-12-08 18:01:00Z
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Safety data on Pfizer jab released by US - BBC News

A vaccine
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US regulators have confirmed the Pfizer/BioNTech Covid vaccine is 95% effective, paving the way for it to be approved for emergency use.

The Food and Drug Administration (FDA) found no safety concerns to stop approval of the vaccine.

It is the first time this level of detail for the jab, which the UK has already started using for mass vaccination, has been published.

The FDA will meet on Thursday to make a formal decision.

The agency is yet to approve the vaccine, but has published a document stating the trial data was "consistent" with the recommendations set out in its emergency use guidance.

The UK's regulatory body, the MHRA, approved the vaccine last week.

Both countries have had advanced rolling access to the information on the vaccine's safety and effectiveness.

Last week Dr Anthony Fauci, the top US infectious disease expert, apologised for remarks that seemed to criticise the UK's vaccine approval process.

He told the BBC then that the US process was "one that takes more time than it takes in the UK. And that's just the reality. I did not mean to imply any sloppiness even though it came out that way."

Even at the time of his original remarks, he had said the US was only "a couple of days" behind.

The in depth material, published by the FDA, shows the vaccine is 95% effective against Covid-19, in keeping with the headlines published by the pharmaceutical company Pfizer.

Although two doses are needed to offer full protection, the first jab prevented 89% of the most severe cases.

And the vaccine gave similar levels of protection to people who had already had a Covid infection.

The document, published ahead of the FDA's meeting on Thursday, stated the most common side effect experienced by people who received the vaccine was pain, redness or swelling at the injection site (generally the arm).

That was followed by short-term fatigue, headache and muscle-pain.

But beyond these mild effects, there was no notable difference in health conditions between the vaccinated and control groups during the study period.

Pregnant women and under-16s were not included in the studied, and so the vaccine will not yet be approved for these groups.

UK and US regulators have slightly different approval procedures for new vaccines.

Both complete an internal assessment and consult an advisory board, but the FDA also looks at raw figures as well as trial write ups.

Using these raw figures it has come to more or less the same conclusion as the pharmaceutical company.

If the vaccine is authorised in the US, it will continue to be monitored for safety.

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2020-12-08 15:33:00Z
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Covid-19 vaccine: 'Hopefully next year we'll be living a normal life' - BBC News

The first Covid vaccinations have begun to take place across the UK.

Throughout the morning, patients and health workers at some 50 hospitals around the country have had the jab.

'It hasn't sunk in yet'

Grandmother Margaret Keenan initially thought it was a joke when hospital staff told her she would be the first person to get the Pfizer/BioNTech vaccine.

"It hasn't sunk in yet," she said. "At the moment I don't know how I feel, just so strange and so wonderful really."

Ms Keenan, who turns 91 next week, said it was "the best early birthday present I could wish for".

"It means I can finally look forward to spending time with my family and friends in the new year after being on my own for most of the year," she added.

She said she did not mind the media attention and was not nervous about being vaccinated.

"Hopefully it'll help other people come along and do what I did, and try and do the best to get rid of this terrible thing."

'I don't take this for granted'

Retired nurse Suzanne Medows (left) speaks to race relations campaigner Dr Hari Shukla, 87, and his wife Ranju before he receives the first of two Pfizer/BioNTech Covid-19 vaccine jabs at the Royal Victoria Infirmary in Newcastle
PA Media

Dr Hari Shukla was the first of around 100 people to be vaccinated in Newcastle, along with his wife Ranjan.

"I feel proud that I have had this privilege of participating in this very important activity," he said.

"I don't take this for granted because hundreds of people have worked for this vaccine day and night to make sure we got the vaccines in good time, so the lives of people can be saved."

Dr Shukla was born in Uganda and came to the UK in 1974. He was director of the Tyne and Wear Racial Equality Council, and has been honoured with a CBE and named a Hero of the City of Newcastle for his work in race relations.

He said he wanted to use his position in the community to tell others the vaccine was safe.

"I'm saying go for it. It's very important you have it, it's wonderful and the way it has been produced, all the work they have done, it's the best vaccine you could ever have."

'Hopefully next year we'll be living a normal life'

Jack Vokes

Jack Vokes, 98, has cancer and has been in hospital for five weeks - but will soon be fit to go home.

He described being the first person to be vaccinated in Bristol as "a bit of excitement".

Mr Vokes lives alone and hopes the vaccine will mean he is able to see more of his family, including his six granddaughters.

"I worry about my family more than me," he said.

"I live in hope that by the middle of next year we'll hopefully be living a normal life."

'Light at the end of the tunnel'

Mick Newell, Theatre co-ordinator at Salford Royal Infirmary

Mick Newell, who works in operating theatres at Salford Royal Infirmary, contracted Covid-19 in February and was quickly admitted to ICU.

"I stayed there for nine days being looked after by my colleagues," he recalled. "It was a pretty scary time."

He said of the NHS vaccination programme: "It's unbelievable, isn't it? There's people been shielding at home since February - this offers them some hope, they can finally see some light at the end of tunnel.

"They'll start going back to a semblance of life and take us into whatever this new normal is."

Mr Newell, 60, said that just because the vaccine is new doesn't mean it should be written off. "We should put our trust in the NHS like we do everyday," he added.

'I'll feel a bit safer'

Kathleen Viney getting the vaccine

After getting the vaccine at Derriford Hospital in Plymouth, Kathleen Viney, 81, said she wouldn't be so scared to leave the house.

"It'll mean that I can go out more because at the moment I have been completely confined at home and have hardly any social life at all and now I will feel as though I'm a bit safer," she said.

"It will be nice to go out and have a meal and be able to do some shopping."

Ms Viney was going into the hospital for a cancer check-up and said it took "about two seconds" to make up her mind when she was offered the vaccine.

"It would be very silly not to have it done," she said. "There's nothing to be afraid of."

'This feels like the last hurdle'

Sister Joanna Sloan getting the vaccine
PA Media

Sister Joanna Sloan, a 28-year-old nurse from Dundrum in County Down, said she felt "privileged" to be the first person to receive the vaccine in Northern Ireland.

"This feels like the last hurdle towards keeping people safe, myself and everyone around me," she told the BBC's Good Morning Ulster programme.

Ms Sloan, who will head up the vaccine roll-out in Belfast, had to put her wedding on hold due to the pandemic.

She's now looking forward to telling her five-year-old daughter about having the vaccine.

"I want her to be proud, I want all my family and friends to be proud," she said.

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2020-12-08 14:45:00Z
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Brexit: UK and EU reach deal on Northern Ireland border checks - BBC News

Michael Gove
EPA

The UK and EU have reached agreement on how rules in the Brexit divorce deal will be implemented, particularly in relation to Northern Ireland.

The government says an agreement in principle has been found for issues including border control posts and the supply of medicines.

The government says it will now withdraw controversial clauses in the Internal Market Bill.

However negotiations to reach a post-Brexit trade deal are still ongoing.

The details of the agreement have not been published but are expected to be rubber stamped in the coming days.

  • What is the Internal Market Bill?
  • Brexit: Will the borders be ready?
  • What happens if there's no trade deal?

They will apply regardless of whether the two sides can agree a trade deal.

Cabinet Office minister Michael Gove said he was "delighted" and thanked the European Commission Vice-President Maroš Šefčovič for his teams "constructive and pragmatic approach".

Irish Foreign Affairs Minister Simon Coveney welcomed the news and expressed the hope that this would "provide some of the positive momentum necessary to instil confidence and trust and allow progress in the wider context of the future relationship negotiations."

The withdrawal agreement - or divorce deal - sets out the details of the UK's exit from the EU.

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Brexit - The basics

  • Brexit happened but rules didn't change at once: The UK left the European Union on 31 January 2020, but leaders needed time to negotiate a deal for life afterwards - they got 11 months.
  • Talks are happening: The UK and the EU have until 31 December 2020 to agree a trade deal as well as other things, such as fishing rights.
  • If there is no deal: Border checks and taxes will be introduced for goods travelling between the UK and the EU. But deal or no deal, we will still see changes.
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Northern Ireland is the only land border between the UK and the EU.

Under an arrangement known as the Northern Ireland protocol - which is part of the withdrawal agreement - from January, goods will not need to be checked along the Irish border and the region will continue to enforce the EU's customs product standards rules.

This means, in order to comply with EU requirements, some checks will be needed on certain goods entering Northern Ireland from Great Britain (England, Scotland and Wales).

Over the past year, Mr Gove and Mr Šefčovič had been engaged in talks on how these checks should be implemented.

In September, the EU expressed anger when the UK government published its Internal Market Bill, which would have enabled ministers to ignore some of the Northern Ireland protocol requirements.

For example, under the Brexit deal, companies moving goods from Northern Ireland to Great Britain would have to fill out export declaration forms, but ministers would have been able to overrule this.

However as the UK and EU have now reached an agreement in principle, these clauses will be removed from the bill.

The government has also promised not to add similar clauses to the Taxation Bill.

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Analysis box by Chris Mason, political correspondent

This is a Brexit breakthrough.

But not on those three sticking points we've heard so much about in the last few days: fishing rights, competition rules and enforcing any agreement.

You may remember all of the rows over the last few years about the border on the island of Ireland: how do you keep it open, with Northern Ireland outside of the European Union, and the Republic within it?

That is what this is about: working out mutually acceptable rules that will keep Northern Ireland more closely aligned to the EU than the rest of the UK.

What has happened today is a necessary, but far from sufficient, step as the two sides attempt to reach a free trade deal.

But one thing it unquestionably does is improve relations between the two sides - with the UK no longer threatening to breach the last deal it did with Brussels, the withdrawal agreement, at just the point it's trying to sort out the next one.

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Meanwhile efforts to reach a UK-EU trade deal have stalled over disagreements on fishing rights, business competition rules and how any deal would be enforced.

Boris Johnson - who is due to travel to Brussels this week in a bid to break the deadlock - has described the situation as "very tricky" but added that "hope springs eternal".

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2020-12-08 14:41:00Z
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Brexit: UK to ditch Internal Market Bill clauses after reaching agreement in principle on Northern Ireland Protocol - Sky News

The government will drop parts of legislation that could have seen the UK break international law after reaching an "agreement in principle" on Brexit divorce issues.

Cabinet Office minister Michael Gove said he was "delighted" to have reached an agreement, including on post-Brexit arrangements for the Irish border, following talks with European Commission vice-president Maros Sefcovic.

As a result, the government said it would withdraw the most controversial parts of its Internal Market Bill.

LONDON, ENGLAND - DECEMBER 08:  Chancellor of the Duchy of Lancaster Michael Gove  returns to Downing Street following a cabinet meeting on December 8, 2020 in London, England. The meeting came on the first day of the country's covid-19 vaccination campaign and amid a final push for a post-Brexit trade deal with the European Union. (Photo by Leon Neal/Getty Images)
Image: Michael Gove said he was 'delighted' to have reached an agreement

The proposed legislation had seen the EU launch legal action against the UK as part of a bitter row.

The government also promised not to introduce any similar measures in its Taxation Bill, which is due to be debated by MPs in the House of Commons later on Tuesday.

Mr Gove and Mr Sefcovic are co-chairs of the EU-UK Joint Committee, which oversees the implementation of the Withdrawal Agreement - the divorce deal Britain agreed with the bloc last year - and the accompanying Northern Ireland Protocol for post-Brexit border arrangements on the island of Ireland.

Their discussions are separate from the ongoing negotiations on a post-Brexit trade deal, which are still deadlocked ahead of the end of the Brexit transition period on 31 December.

More from Brexit

Prime Minister Boris Johnson and European Commission President Ursula von der Leyen are due to meet in Brussels "in the coming days" in a bid to try and break the impasse on a EU-UK trade agreement.

The agreement between Mr Gove and Mr Sefcovic could help ease tensions between London and Brussels as trade negotiations go down to the wire.

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Brexit talks 'looking very, very difficult'

An EU-UK statement announcing the Joint Committee agreement said: "Following intensive and constructive work over the past weeks by the EU and the UK, the two co-chairs can now announce their agreement in principle on all issues, in particular with regard to the Protocol on Ireland and Northern Ireland.

"An agreement in principle has been found in the following areas, amongst others: border control posts/entry points specifically for checks on animals, plants and derived products, export declarations, the supply of medicines, the supply of chilled meats, and other food products to supermarkets, and a clarification on the application of State aid under the terms of the Protocol."

The two sides have also reached an agreement on how goods will be considered "not at risk" of entering the EU when moving from Great Britain to Northern Ireland, as well as on parts of state aid rules and the make-up of an arbitration panel for settling disputes after the Brexit transition period ends.

The statement added: "In view of these mutually agreed solutions, the UK will withdraw clauses 44, 45 and 47 of the UK Internal Market Bill, and not introduce any similar provisions in the Taxation Bill."

The agreement in principle and draft texts are subject to final approval from both sides, before being formally adopted.

The government's publication of the Internal Market Bill earlier this year brought condemnation from critics both in Westminster and across European capitals.

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'We can leave without EU free trade deal'

US president-elect Joe Biden also intervened to warn against the Good Friday Agreement in Northern Ireland becoming "a casualty of Brexit".

The bill's most controversial clauses, which will now be withdrawn, sought to allow ministers to override the UK's Withdrawal Agreement.

The government admitted this could have seen the UK breach international law, but argued it was needed to protect the integrity of the UK, as well as the Good Friday Agreement.

Labour's shadow Northern Ireland secretary Louise Haigh described the agreement by the EU-UK Joint Committee as "a welcome step forward, after months of crippling uncertainty for Northern Ireland".

"An agreement, not reckless threats, has always been the responsible way forward," she added.

Conservative MP Sir Roger Gale, who has been a critic of the government's Internal Market Bill, said: "I'm cautiously pleased that an unnecessary and self-inflicted national embarrassment appears to be resolved."

Analysis: Agreement shows the UK is willing to compromise - but is it enough?
By Kate McCann, political correspondent

In agreeing to remove law-breaking clauses in the Internal Market Bill, the UK government has drawn a line under a controversial and - some critics say - damaging chapter in the Brexit negotiations.

The decision to include them was, UK sources say, a result of a promise to protect Northern Ireland and the Good Friday Agreement whether the UK and EU agree a deal or not.

But including them drew derision from around the world, as well as MPs and peers from across the political spectrum.

So what does this agreement by the Joint Committee mean for a Brexit trade deal?

You could argue it changes everything and nothing at the same time.

In one sense it could be seen as a concession to the EU which had warned the clauses were completely unacceptable.

But the UK government gave a clear indication it was prepared to drop or neuter the clauses yesterday and this failed to move talks on. The decision was welcomed in Brussels but didn't cause major political ripples.

On the flip side, this agreement means that in the face of a no-deal Brexit there will be protections for those moving goods between mainland UK and Northern Ireland, something which previously had not been the case.

This could be seen as a safety net to allow no deal to happen in a less damaging way, at least for that particular market.

Either way the next steps for the talks may not be hugely impacted by the decision, although it will likely go some way to reassuring governments around the world that the UK will stick to international legal agreements in future.

We need to see the details as these are yet to be published, but it does show the UK side is willing to compromise. It is unclear yet whether it will be enough.

Analysis: Even this deal won't restore trust completely
By Adam Parsons, Europe correspondent

The spectre of the Internal Market Bill has always been hugely unpopular in the European Union.

Its controversial clauses were seen as an unwarranted threat to the sanctity of the Withdrawal Agreement, and a show of bad faith. Very few in Brussels will mourn their passing.

Trust has been bruised and even this deal won't restore it completely.

One diplomat summed it up to me like this: "When you've been punched in the face by someone, you don't start to trust them just because they stop punching you".

But clearly this is a problem that has been resolved, and there is relief over that.

The EU has always placed great weight on the Irish border question and the uncertainty around the Protocol was stretching patience.

Resolution, some time before the end of December, has been warmly welcomed, even before the details are known.

Does this make a deal more likely? Certainly it will calm anger, and crucially it will mean that any future deal is much more likely to pass easily through the European Parliament.

But the Internal Market Bill was not the main problem for trade negotiators.

Those, of course, are threefold - the competition rules known as the level playing field, fishing and governance.

And the deal agreed today probably won't make any substantial difference to those contentious areas. Welcome? Definitely. But a breakthrough in trade talks? Probably not.

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2020-12-08 14:26:15Z
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