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Covid-19: Pfizer/BioNTech Vaccine Judged Safe For Use In UK
The UK has become the first country in the world to approve the Pfizer/BioNTech coronavirus vaccine, paving the way for mass vaccination.
Britain's medicines regulator, the MHRA, says the jab, which offers up to 95% protection against Covid-19 illness, is safe to be rolled out.
The first doses are already on their way to the UK, with 800,000 due in the coming days, Pfizer said.
Health Secretary Matt Hancock said the NHS will contact people about jabs.
Elderly people in care homes and care home staff have been placed top of the priority list, followed by over-80s and health and care staff.
But because hospitals already have the facilities to store the vaccine at -70C, as required, the very first vaccinations are likely to take place there - for care home staff, NHS staff and patients - so none of the vaccine is wasted.
A further 648 deaths within 28 days of a positive Covid-19 test were recorded in the UK on Wednesday, with another 16,170 cases reported.
Prime Minister Boris Johnson urged the public not to get "carried away with over optimism or falling into the naive belief that our struggle is over".
He told a Downing Street news conference that, while the "searchlights of science" had created a working vaccine, significant logistical challenges remained.
The Pfizer/BioNTech jab is the fastest vaccine to go from concept to reality, taking only 10 months to follow the same steps that normally span 10 years.
The UK has already ordered 40 million doses of the jab - enough to vaccinate 20 million people.
The doses will be rolled out as quickly as they can be made by Pfizer in Belgium, Mr Hancock said, with the first load next week and then "several millions" throughout December.
Scottish First Minister Nicola Sturgeon said the first people in Scotland will be immunised on Tuesday.
Welsh Health and Social Care Minister Vaughan Gething said the rollout of the Pfizer jab to care homes would be particularly difficult because of how it needs to be stored.
Mr Gething said that it was not possible to transport the Pfizer vaccine to more than 1,000 care homes across Wales.
The bulk of the rollout across the UK will be next year, Mr Hancock said, adding: "2020 has been just awful and 2021 is going to be better."
There is a clear priority list for who gets the vaccine first - and care home residents and staff are top of it.
But operational complexities mean the reality will be somewhat different.
When the vaccines arrives, it will be sent straight to major hospitals who have the ultra-cold facilities to store it.
From there it can be moved just once - and when it is, it must be kept in batches of 1,000.
That means sending it out to care homes, where there may be only a few dozen residents in some places, would lead to a huge amount of vaccine being wasted.
Because of that, the NHS, which is in charge of distributing the vaccine, will run clinics from hospitals at first.
This will allow NHS and care home staff to get immunised first as well as, perhaps, some of the older age groups who come into hospital.
It looks like it will not be until much more of the Pfizer vaccine is available or the Oxford University one, which is easier to distribute, is approved that care home residents will be able to get it.
While Mr Hancock said that the government does not yet know how many people need to be vaccinated before restrictions can start being lifted, he added: "I'm confident now, with the news today, that from spring, from Easter onwards, things are going to be better. And we're going to have a summer next year that everybody can enjoy."
Mr Johnson added: "It's the protection of vaccines that will ultimately allow us to reclaim our lives and get the economy moving again."
Downing Street press secretary Allegra Stratton said Mr Johnson would not rule out receiving the vaccine jab live on television, though she said he would not want to take a jab meant for someone more vulnerable.
The free vaccine will not be compulsory and there will be three ways of vaccinating people across the UK:
Around 50 hospitals are on stand-by and vaccination centres - in venues such as conference centres or sports stadiums - are being set up now.
It is thought the vaccination network could start delivering more than one million doses a week once enough doses are available.
Health Secretary Matt Hancock: "This is a day to remember and, frankly, a year to forget"
NHS England chief executive Sir Simon Stevens said the health service was preparing for "the largest-scale vaccination campaign in our country's history".
But experts said people still need to remain vigilant and follow rules to stop the virus spreading - including with social distancing, face masks and self-isolation.
"We can't lower our guard yet," said the government's chief medical adviser Prof Chris Whitty.
The order in which people will get the jab is recommended by the Joint Committee on Vaccinations and Immunisations and decided by the government.
Mass immunisation of everyone over 50, as well as younger people with pre-existing health conditions, can happen as more stocks become available in 2021.
Pfizer confirmed that the first stocks of the vaccine will be for the NHS, which will give them out for free based on clinical need. People in the UK will not be able to bypass this and buy the vaccine privately to jump the queue.
The vaccine is given as two injections, 21 days apart, with the second dose being a booster. Immunity begins to kick in after the first dose but reaches its full effect seven days after the second dose.
Most of the side effects are very mild, similar to the side effects after any other vaccine and usually last for a day or so, said Prof Sir Munir Pirmohamed, the chairman of the Commission on Human Medicine expert working group.
The vaccine was 95% effective for all groups in the trials, including elderly people, he said.
The head of the MHRA, Dr June Raine, said that - despite the speed of approval - no corners have been cut.
Batches of the vaccine will be tested in labs "so that every single vaccine that goes out meets the same high standards of safety", she said.
Dr June Raine from the MHRA: "The safety of the public will always come first"
Giving the analogy of climbing a mountain, she said: "If you're climbing a mountain, you prepare and prepare. We started that in June. By the time the interim results became available on 10 November we were at base camp.
"And then when we got the final analysis we were ready for that last sprint that takes us to today."
The Pfizer/BioNTech was the first vaccine to publish positive early results from final stages of testing.
It is a new type called an mRNA vaccine that uses a tiny fragment of genetic code from the pandemic virus to teach the body how to fight Covid-19 and build immunity.
An mRNA vaccine has never been approved for use in humans before, although people have received them in clinical trials.
Because the vaccine must be stored at around -70C, it will be transported in special boxes of up to 5,000 doses, packed in dry ice.
Once delivered, it can be kept for up to five days in a fridge. And once out of the fridge it needs to be used within six hours.
Other coronavirus vaccines are also being developed:
The World Health Organization's Dr David Nabarro said the Pfizer vaccine would not replace the other measures "for a number of months, even a year, so we'll have to keep doing physical distancing, mask wearing, hygiene and isolating ourselves when we're sick".
He told BBC Radio 4's World at One programme "the vaccine will only start to dent the size of the pandemic somewhat later in the year".
The pace has been breathtaking.
From an unknown virus at the start of the year to a vaccine approved by the regulator and ready to use in early December is an unprecedented timescale.
At the Downing Street briefing, the MHRA's chief executive said it was like climbing Everest, with preparations starting in June and a team working "night and day" assessing early data and reaching "base camp" by early November when Pfizer/BioNtech published the trial results.
At the same time, the MHRA was adamant that the process had been robust with safety considerations paramount. A rapid emergency approval process was used by the UK regulator.
The European Medicines Agency is taking longer to reach a view and there has been some sniping from European politicians arguing their processes are more reliable and authoritative.
But the MHRA is an internationally respected independent watchdog and for now those about to receive the first jabs will rely on its ruling.
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Covid-19 Vaccine: First Person Receives Pfizer Jab In UK
Margaret Keenan was given the vaccine by May Parsons, at University Hospital in Coventry
A UK grandmother has become the first person in the world to be given the Pfizer Covid-19 jab as part of a mass vaccination programme.
Margaret Keenan, who turns 91 next week, said the injection she received at 06:31 GMT was the "best early birthday present".
It was the first of 800,000 doses of the Pfizer/BioNTech vaccine that will be dispensed in the coming weeks.
Up to four million more are expected by the end of the month.
Hubs in the UK are starting the rollout by vaccinating the over-80s and some health and care staff.
Senior NHS sources told the BBC "thousands of vaccinations" had taken place across the UK on Tuesday.
Dubbing the day "V-day", Health Secretary Matt Hancock said it was "a tribute to scientific endeavour and human ingenuity and to the hard work of so many people.
"Today marks the start of the fightback against our common enemy, the coronavirus," he said.
Prime Minister Boris Johnson, on a visit to a London hospital to see some of the first people getting the jab, said getting vaccinated was "good for you and good for the whole country".
Scotland's First Minister Nicola Sturgeon said: "Today we should all allow ourselves a smile - but we must not drop our guard."
On Tuesday, the UK government reported a further 616 people had died within 28 days of a positive test, taking the total, by that measure, to 62,033. A further 12,282 people tested positive for the virus.
How the vaccine rollout unfolded – and how a certain William Shakespeare was involved
At University Hospital, Coventry, matron May Parsons administered the very first injection to Ms Keenan.
"I feel so privileged to be the first person vaccinated against Covid-19," said Ms Keenan, who is originally from Enniskillen, Co Fermanagh.
"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.
"My advice to anyone offered the vaccine is to take it. If I can have it at 90, then you can have it too," she added.
Prof Stephen Powis, national medical director of NHS England, who witnessed the "historic moment", said: "We couldn't hug her but we could clap, and everybody did so in the room."
An emotional Sister Joanna Sloan said she had been looking forward to the vaccine for so long
Throughout the day, patients and health workers at some 50 hospitals around the UK have been getting the jab:
Matt Hancock says he is thrilled but warns that people must still stick to the rules
Speaking in the Commons, the health secretary stressed people did not need to apply for the vaccine. He said the NHS would be in touch with those eligible and urged them to "please step forward for your country".
Mr Hancock went on to warn that there was "still a long march ahead", saying there were "worrying signs" of the virus growing in Essex, London and Kent.
New data released by national statisticians for the week ending 27 November showed that of the 14,106 deaths registered in the UK, nearly 3,400 involved Covid. This is 20% higher than the five-year average but similar to the percentages seen in the past two weeks.
NHS England chief executive Sir Simon Stevens called the first vaccinations "remarkable achievement", but cautioned it was a "first step" and "incredibly important" people continued to act sensibly.
Boris Johnson: 'It will gradually make a huge, huge difference... But we haven't defeated this virus yet"
On a visit to London's Guy's Hospital, the prime minister spoke to 81-year-old Lyn Wheeler, who was the first to receive the vaccine there.
"It is really very moving to hear her say she is doing it for Britain, which is exactly right - she is protecting herself, but also helping to protect the entire country," Mr Johnson said.
Earlier, he thanked the NHS, volunteers and "all of the scientists who worked so hard to develop this vaccine".
Labour's shadow health secretary Jon Ashworth said it was "absolutely fabulous" to see people getting the vaccine and thanked everyone involved in making it happen.
Orders have been placed for 40 million in total - enough for 20 million people, as two courses are needed. However, most supplies are not expected to become available until next year.
Mr Hancock said he expected it to take "several weeks" to get the first group of health workers, care staff and over-80s vaccinated.
'A momentous day but huge task ahead'
This is a momentous day, but make no mistake the NHS faces a huge task in rolling out this vaccine.
First, there needs to be a smooth supply - and already there are reports of manufacturing problems, which means the UK is expecting less than half of the 10 million doses of the Pfizer jab it was planning for by the end of the year.
The fact it needs to be kept in ultra-cold storage and in batches of 975 units is an added complication that has meant it cannot yet be taken into care homes to vaccinate residents - the very highest priority group - or sent out to GPs to run vaccination clinics in the community.
NHS bosses hope to receive guidance from the regulator next week on how to get around this.
But these factors illustrate why the UK is still pinning its hopes on a second vaccine developed by Oxford University.
That one can be kept in fridges and so is easier to distribute, is British-made and - what is more - there is an ever-growing stockpile ready to use.
If that vaccine gets the green light from regulators, there will be a genuine hope the first few months of 2021 will see rapid progress in offering jabs to the most vulnerable people, so the UK can return to something closer to normality.
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Breakthrough In Bid To Develop Vaccines And Drugs For Neglected Tropical Disease
Scientists have developed a new, safe and effective way to infect volunteers with the parasite that causes leishmaniasis and measure the body's immune response, bringing a vaccine for the neglected tropical disease a step closer.
The breakthrough, by a team from the University of York and Hull York Medical School, is described in the journal Nature Medicine and lays the foundations for vaccine development and for testing new preventative measures.
Controlled human infection studies, where volunteers are exposed to small amounts of the microbes that cause disease, play a vital role in allowing scientists to provide evidence of the safety and efficacy of new vaccines, but their use in the fight against neglected tropical diseases has been limited.
Leishmaniasis is caused by infection with microscopic Leishmania parasites that are transmitted into the skin during the bite of an infected sand fly.
The disease affects over one million people every year, the majority developing a slow to heal ulcer at the site of the infection. Though the ulcer eventually heals, the scar has a significant impact on quality of life, especially for women and children and when the infection is on the face.
No vaccines or drugs are currently available to prevent people from becoming infected with leishmaniasis, in part due to the difficulties and costs associated with conducting clinical trials in the countries where these diseases are most common.
Lead investigator, Professor Paul Kaye from the Hull York Medical School at the University of York, said: "This is a landmark study that now provides a new approach to test vaccines and preventative measures for leishmaniasis in a rapid and cost-effective way. It also allows us to learn more about how our immune system fights the infection. Thanks to the generosity of the volunteers that took part in our study, we are now well-positioned to bring new hope to those that are affected by this disease."
Clinical lead for the study, Professor Alison Layton from the Medical School's Centre for Skin Research, said: "Research on skin diseases that affect people in the UK and in developing countries is a priority at the Medical School. This study, which demonstrates that this infection model is safe and well tolerated by participants, exemplifies our global approach to skin health and has the potential to impact the lives of many millions worldwide."
The study, which builds on significant achievements by the University of York and its international partners, involved 14 volunteers recruited from around York.
The volunteers were exposed to sand flies infected with a parasite species that causes one of the mildest forms of leishmaniasis. The researchers followed the development of the lesion at the site of the sand fly bite to evaluate the progress of the infection and then terminated the infection by biopsy of the skin. The scientists then studied the biopsy to examine the immune responses at the site of infection.
This major new approach uses natural transmission by sand fly to initiate infection and state of the art technologies, allowing the researchers to track the infection and the body's immune response in real-time.
The model will accelerate efforts to test new vaccines and understand how immunity to infection arises, the researchers say.
The researchers now hope to use their model to design clinical trials to test a vaccine developed at Hull York Medical School, along with other candidate vaccines available in the future. Controlled human infection models have already been used to support the development of vaccines for cholera, malaria, influenza, dengue fever and most recently COVID-19.
The research was a collaboration between the Hull York Medical School, York and Scarborough Teaching Hospitals NHS Trust, the Department of Parasitology at Charles University in Prague, the Center for Geographic Medicine and Tropical Diseases at Chaim Sheba Medical Center, Tel Aviv University and the Kuvin Centre for Study of Tropical & Infectious Diseases, Hebrew University-Hadassah Medical School, Jerusalem.
Funding for the research was through a Developmental Pathways Funding Scheme award from the UK Medical Research Council (MRC) and the UK Department for International Development (DFID) under the MRC/DFID Concordat agreement and is also part of the EDCTP2 program supported by the European Union.
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