Lothian MSP, Miles Briggs, has said that Edinburgh Council must urgently review their Space for People project to meet the needs of people with sight loss.
A recent FOI request by Mr Briggs revealed that no safety audits had been carried out by Edinburgh City Council ahead of putting new measures in place.
Guide Dogs Scotland have contacted Edinburgh City Council about a number of concerns they have with the Space for People initiative, the foremost being the lack of consultation with most vulnerable road users.
A key concern is that the Commonplace online map, an online tool for consulting on changes, has not been fully accessible to people with sight loss.
Another concern raised is a lack of transparency, with the walking and cycling charity Sustrans, managing the funds, providing advice and having developed the evaluation framework for the programme.
Particular safety concerns which have been highlighted include ‘floating bus stops’ and ‘bus boarders’ that require pedestrians to cross an uncontrolled crossing before and after they board a bus. For people with sight loss, this presents a particular challenge as many won’t be able to see approaching cyclists.
Lothian MSP, Miles Briggs, said:“The ill-thought-out Spaces for People initiative has created a number of significant changes to streets and roads across Edinburgh and has clearly impacted negatively on people with sight loss.
“From the outset Edinburgh City Council has failed to consult with local residents and must now act and take on board this guidance from Guide Dogs Scotland and fully consult with those who are visually impaired.
“Floating bus stops and bus borders are issues which have been highlighted as especially hazardous for people who have sight loss and these real concerns must be addressed urgently.”
This latest boost will help us to complete the proposed programme of temporary improvements first approved by Policy and Sustainability Committee in May. It will also allow the Spaces for People team to enhance schemes where possible, carry out more road and pavement resurfacing and increase the removal of street clutter.
Since May, we’ve introduced many temporary changes across the city to provide safe and protected routes, helping pedestrians and cyclists to travel while physically distancing. Amongst these are widened pavements in key shopping streets, segregated cycle lanes on main roads, closures on roads leading to popular parks and beauty spots, and improvements around schools.
Transport and Environment Convener Councillor Lesley Macinnes said: “This is fantastic news and is testament to the hard work of our Spaces for People team, who are developing schemes which support people to walk, cycle and wheel while COVID restrictions are in place.
Additional funding will help us to deliver an even better package of routes and improvements which not only create more room for physical distancing but help residents to make healthy, active travel choices whenever they can.
Transport and Environment Vice Convener Councillor Karen Doran said: “We’ve already delivered a whole range of projects – helping children to get to school safely, creating space to spend time on shopping streets and giving cyclists safer, segregated routes for travel.
“This funding will help us provide additional improvements including removing street clutter to help reduce obstacles to pedestrian movement and improving some projects already on the ground, for example by renewing surfacing, and potentially adding some new projects.”
An update report to Transport and Environment Committee last week outlined the next steps for Spaces for People in Edinburgh, including amendments to existing interventions, several more complex schemes and improvements developed as a result of public feedback.
This has been referred to Full Council today (Thursday 19 November) for final approval.
Scotland takes steps to mitigate UK funding policy
A further £278,784 is being made available to six organisations supporting people subject to No Recourse to Public Funds (NRPF).
The grants will support projects in Edinburgh and Glasgow which are helping people subject to the UK Government policy which imposes conditions on someone due to their immigration status and restricts access to welfare, housing, and financial support.
The projects receiving support focus on access to essentials, including food, clothing, essential travel and digital access. Outreach and advocacy support will also be delivered to help people understand and access essential services and maintain support networks.
The Scottish Government has repeatedly urged the UK Government to suspend its policy to enable people to access public services and health advice during the coronavirus (COVID-19) pandemic. This is a second round of funding and brings the total grants awarded through the Immediate Priorities Fund specifically for NRPF support during COVID-19 to £553,174.
Communities Secretary Aileen Campbell said: “These projects are part of the Scottish Government’s efforts to provide support for everyone living in our communities during COVID-19 and contribute to our overall response to the pandemic.
“The Scottish Government as well as many stakeholders have urged the UK Government to lift No Recourse to Public Funds restrictions during the pandemic, so far without success.
“Given the ongoing COVID-19 restrictions, it is crucial that people can access public services and also health guidance, the majority of which is provided online, keep in touch with friends, family and networks and access the accommodation and support they need to be safe.”
The six organisations receiving funding are:
Community InfoSource
Govan Community Project
Refugee Survival Trust
Refuweegee
Positive Action in Housing
The Welcoming
All are based in Glasgow, except for The Welcoming, which is in Edinburgh.
The funding support is for a 12 week project proposed by the grant recipient in response to the immediate needs of people who have limited support options due to NRPF restrictions.
Under the first round of grants, £274,390 was distributed between the six organisations to support 12 week projects which ran between April and July.
Further support is available to people subject to NRPF through wider COVID-19 response, including:
the £350 million Communities Funding Package announced in March (which the Immediate Priorities Fund is part of) provided funding to local authorities and third sector organisations to support people across communities. This new funding is not restricted by NRPF.ince 23 March, the Scottish Government has provided more than £1.5 million to third sector organisations to enable them to provide emergency hotel accommodation and support people experiencing or at risk of homelessness. This includes people who are rough sleeping or have NRPF.
£20 million has been made available to local authorities as a flexible fund to tackle financial insecurity. This is not restricted under NRPF and Local Authorities can use this funding to support people unable to afford essentials like food or fuel; they can also top-up Scottish Welfare Fund and Discretionary Housing Payment allocations.
a discretionary payment, equivalent to the Self Isolation Support Grant, can be provided to people with NRPF who are working on low incomes and would lose earnings where they need to self-isolate.
UK Government concludes negotiations with Moderna to secure access to 5 million doses of its promising coronavirus vaccine
vaccine could be delivered to the UK from Spring 2021, if approved by the medicines regulator
deal increases total number of doses secured by the UK to 355 million, as part of the government’s strategy to build a diverse portfolio of promising vaccines
The UK government has completed negotiations with biotech company Moderna to secure access to 5 million doses of its promising vaccine, enough for around 2.5 million people, the Business Secretary announced last night.
If it meets robust standards of safety and effectiveness and approved by the medicines regulator, the vaccine could be delivered to the UK and Europe as early as Spring 2021 with the potential for the government to procure more doses next year.
This would follow the first deliveries of the Pfizer/BioNTech and the Oxford University/AstraZenece vaccines which, once final data from their phase 3 clinical trials has been published and if they receive regulatory approval, could be available before the end of the year.
The agreement is part of the government’s strategy to develop a diverse portfolio of vaccines, increasing the UK’s chances of securing access to a promising vaccine. Today’s deal means the government has put in place agreements with 7 different developers and has secured 355 million vaccine doses, giving the UK the best possible chance of protecting the public from coronavirus as soon as possible.
The news comes as Moderna today publishes initial data showing that its candidate is nearly 95% effective in protecting against COVID-19, with no safety issues identified to date. The safety data is still to be released by Moderna to show whether the vaccine is both safe and effective.
Until a vaccine is found to meet robust standards of safety and effectiveness, the public must continue to take necessary actions to keep themselves and their loved ones safe, including following the Hands, Face, Space guidance and other public health advice.
Business Secretary Alok Sharma (top) said: “Today’s announcement is on top of the 350 million doses the UK has already secured from a range of other vaccine developers, putting us towards the front of the international pack on a per capita basis.
“The speed at which scientists around the world have worked on a vaccine has been incredible, and it is thanks to their ingenuity that we are on the cusp of one of the biggest scientific breakthroughs in recent years.
“While this is exciting news, I urge the public to not be complacent – we are at a critical point in the pandemic and in order to save lives we must continue to follow guidance by maintaining social distancing, wearing face masks and washing our hands regularly.”
Health Secretary Matt Hancock said: “Today’s announcement is excellent news and an encouraging step forward in our fight against COVID-19.
“We have moved swiftly to secure 5 million doses of this hugely promising vaccine meaning we are even better placed to vaccinate everyone who will benefit should the rigorous safety standards be met.
“But we are not there yet. Until science can make us safe, we must remain vigilant and keep following the rules that we know can keep this virus under control.”
Moderna is currently conducting phase 3 clinical trials of its vaccine and is using mRNA vaccine technology.
The Medicines and Healthcare products Regulatory Agency (MHRA) has started a rolling review of Moderna’s vaccine. MHRA will carefully and scientifically review the safety, quality and effectiveness data once it has all been submitted to determine how it protects people from COVID-19 and the level of protection it provides.
The data must include results from the lab and clinical trials; manufacturing and quality controls, product sampling, and testing of the final product.
Once they have thoroughly reviewed the data, the MHRA will seek advice from the government’s independent advisory body, the Commission on Human Medicines. They will critically assess the data too before advising the government on the safety, quality and effectiveness of any potential vaccine.
The MHRA is globally recognised for requiring the highest standards of safety, quality and effectiveness for any vaccine.
Chair of the government’s Vaccine Taskforce Kate Bingham said: “Today’s news from Moderna is very encouraging. The Moderna mRNA vaccine has posted excellent efficacy data to date from its initial phase 3 readout. The vaccine uses mRNA technology demonstrating that these novel vaccines are showing early promise in being effective against COVID-19.
“The government has now signed agreements with seven vaccine developers to secure the most promising vaccines for the UK. The government’s Vaccine Taskforce are pursuing a portfolio approach to obtaining vaccines for the UK across different vaccine formats, to maximise the chances of finding safe and effective vaccines.
“We will continue to monitor the field of promising vaccines, and are very encouraged by the effectiveness shown by these early frontrunners, but we must remain vigilant to the fact that no vaccine is yet approved for use by regulators.”
The #BigClimateDebate has now arrived. Join the most important discussion of our time.
We will hear the major political parties’ proposals to tackle the climate emergency and their achievements to date. Our guest politicians will give a short presentation on their party’s environmental actions and policies and then debate your questions.
Book your ticket here: https://thebigclimatedebate.eventbrite.co.uk
Our panellists are:
Sarah Boyack – Labour MSP for Lothian
Deidre Brock – SNP MP for Edinburgh North and Leith
Finlay Carson – Conservative MSP for Dumfries and Galloway
Christine Jardine – Liberal Democrat MP for Edinburgh West
The SNP’s Ethan Young has won the vacant council seat in the Craigentinny Duddingston ward.
The by-election was brought about by the resignation of SNP councillor Ian Campbell, who resigned for health reasons back in February.
The SNP candidate was well ahead in First Preference votes and was elected at Stage Six:
ETHAN YOUNG (SNP) … 2920
Eleanor Price (Scottish Conservatives ) … 1420
Margaret Graham (Scottish Labour) … 1205
Ben Parker (Scottish Greens) … 1185
Elaine Ford (Scottish Lib Dems) … 631
Andrew McDonald (Independent) … 93
Tam Laird (Scottish Libertarian Party) … 42
The result makes no difference to the running of the city, where the SNP remains in charge with the support of Labour in the ‘Capital Coalition’.
Despite efforts to encourage people to vote, the turnout was just 31.6% – fewer than one in three voters cast their ballot.
Returning Officer for Edinburgh, Andrew Kerr, said: I’d like to thank all those who took part in the by-election, despite the challenging circumstances we face. It’s been a difficult year but local democracy is still extremely important, so I’m pleased to welcome Ethan Young, who will help represent the community as we work to emerge from the crisis, and on a range of other issues affecting the ward and city.
“I also want to take this opportunity to acknowledge the hard work and planning that has gone into staging this election. I’ve heard from many constituents who have praised the safe, physically distanced voting process, which is with thanks to our Elections Team, who have spent months preparing for the event.
England death rate up to 6 times higher from coronavirus during the first wave of the pandemic than the general population, Public Health England study finds.
It found 451 per 100,000 people registered as having a learning disability died with COVID-19 between 21 March and 5 June, a death rate 4.1 times higher than the general population after adjusting for other factors such as age and sex.
But as not all deaths in people with learning difficulties are registered on these databases, researchers estimated the real rate may have been as high as 692 per 100,000, 6.3 times higher.
Deaths were also spread much more widely across the age spectrum among people with learning disabilities, with far greater mortality rates in younger adults, compared to the general population. The death rate for people aged 18 to 34 with learning disabilities was 30 times higher than the rate in the same age group without disabilities, researchers found.
Among people with learning disabilities, the rate of COVID-19 deaths for adults in residential care was higher than the rates of COVID-19 deaths of adults with learning disabilities generally. This difference is likely in part to reflect the greater age and disability in people in residential care.
People with learning disabilities are more likely to have other physical health problems such as obesity and diabetes, and certain kinds of learning disability, such as Down’s syndrome, can make people more vulnerable to respiratory infections, which can increase their risk of dying from COVID-19.
Professor John Newton, Director of Health Improvement at Public Health England, said: It is deeply troubling that one of the most vulnerable groups in our society suffered so much during the first wave of the pandemic. We must do everything possible to prevent this happening again.
“There are now regular tests in care homes to make sure cases of coronavirus can be quickly identified and isolated, even if people do not recognise the symptoms themselves.
“But with cases developing across the country, it is essential to practice rigorous infection control if you are in contact with someone with a learning disability, whether or not they live in a care home.
“Wash your hands, wear a mask and keep a safe distance. The fewer people you meet, the more you’ll stop the spread.”
A learning disability is a significantly reduced ability to understand new or complex information and learn new skills and a reduced ability to cope independently which started before adulthood, with a lasting effect on development.
That means that people with learning disabilities often may find it harder to manage basic everyday skills, and rely upon support for many tasks, including communicating, managing money or looking after themselves.
People with learning disabilities are likely to have had difficulty recognising symptoms of COVID-19, or following government advice about getting tested, self-isolation, social distancing and infection prevention and control, the report says. It may also be more difficult for people caring for them to recognise the onset of symptoms if these cannot be communicated.
Helen Whately, Minister of State for Social Care, said: “Every death from COVID-19 has been a tragedy, and my deepest sympathies go out to everyone who has lost loved ones during the pandemic. I know how difficult this pandemic has been for people with a learning disability and those who care for them.
“A third of those with learning disabilities who sadly died were living in residential care. There is now regular testing of staff and residents in care homes, and testing has also been rolled out to supported living settings in high risk areas.
“We’re also offering free PPE, and the Joint committee on vaccines and immunisation has proposed those living and working in care homes should be top of the list for vaccination.
“This report adds to our knowledge of COVID-19 and how those with learning disabilities are affected by this cruel disease. I am asking SAGE to review the findings and give advice on what more we can do to keep people safe.”
The first step towards a national thrombectomy service for stroke patients is underway with the launch of a pilot in the North of Scotland.
Thrombectomy is a highly skilled procedure in which blood clots are removed mechanically rather than broken down by medicines (thrombolysis). It is used to treat those with severe stroke and reduce their risk of long-term disability.
NHS Tayside developed a training programme in Mechanical Thrombectomy (MT), supported by the Scottish Government. Key staff were trained by Professor Iris Grunwald, one of the UK’s leading stroke thrombectomy interventional neuroradiologists, using advanced simulation techniques.
Initially the thrombectomy procedures in Dundee will be performed on patients in Tayside before the service is extended to patients across the North.
A fully operational 24/7 service is anticipated in Tayside by 2023, and will form part of a national network in line with the Scottish Government’s Programme for Government commitment.
In the West of Scotland, the Queen Elizabeth University Hospital campus will provide a ‘hub’ thrombectomy service for the West of Scotland by 2023, while the NHS Lothian service will also be operating from the Little France site within the same timeframe.
Health Secretary Jeane Freeman said: “Over the past 10 years, the number of people dying from stroke in Scotland has decreased by more than 35%. While this is significant progress, we can still achieve even better outcomes.
“A quality and clinically safe thrombectomy service is part of our wider commitment in this year’s Programme for Government to ensure those who experience severe stroke receive the best possible treatment and care.
“It is testament to our healthcare professions that we are now seeing this first step towards a national roll-out, despite the additional pressures placed on them during the pandemic and I want to thank them for their hard work.
“Funding will continue to be made available to other boards to develop the programme and the framework.”
Honorary consultant interventional radiologist in NHS Tayside Professor Graeme Houston said: “We are delighted to be able to launch this service to provide mechanical thrombectomy for patients in the North of Scotland.
“Thrombectomy delivers a significant benefit for some patients who have sudden onset of stroke with significantly improved outcomes and a reduced level of disability.”
Chest Heart & Stroke Scotland Chief Executive Jane-Claire Judson said: “It’s good that we are seeing tangible progress towards thrombectomies being available to stroke patients in Scotland.
“People in Scotland must be given the best possible chance of living without disability or dependency after a stroke. We know that at least 600 people a year in Scotland would benefit from a thrombectomy. Developing the skills to deliver this procedure is a key part of establishing the service in Scotland.
“This progress is being driven by inspirational stroke survivors campaigning for change. Together, we will keep campaigning to make sure that this game-changing stroke treatment is available as soon as possible.”
The Stroke Association in Scotland welcomes the announcement that mechanical thrombectomy is to be made available to some Scots for the first time since 2018.
This is a long overdue but a significant first step towards delivery of a national thrombectomy service for the whole of Scotland which should be in place by 2023.
Thrombectomy is vital. Around 700 stroke patients are eligible for the procedure in Scotland each year. Patients who have a stroke caused by a large blood clot in the brain would potentially benefit from a thrombectomy procedure.
It involves inserting a catheter into an artery, usually within six hours of someone having their stroke, to remove the blood clot. This allows blood flow to resume and oxygen to reach brain tissue.
The treatment can dramatically reduce the devastating consequences of stroke such as losing the ability to walk and talk. Around one in three people who receive a thrombectomy after their stroke will be less disabled as a result, and around one in five of those who receive it will be able to function completely independently afterwards.
Andrea Cail, Director Scotland for the Stroke Association said: “Thrombectomy is a game-changing treatment, and it is good to finally have it available in Scotland again. But it is only the first step. Stroke is now a clinical priority in Scotland and restarting a thrombectomy service for those need it will be the difference between living or dying; living permanently disabled or without any disabilities at all.
“Thrombectomy is an extraordinary, highly-specialised, procedure that can save lives, reduce disability and is absolutely cost effective. One thrombectomy patient is estimated to save the NHS £47,000 over a five year period.
“We congratulate everyone involved in the North of Scotland thrombectomy planning group on making this happen. We know it’s not been easy. It has required serious commitment from everyone involved. By working together, hundreds of people affected by stroke and their families will benefit over the next few years.
“All Scots deserve the same. Thrombectomy must also be made available to the larger population centres of Glasgow and Edinburgh as soon as possible.
“We urge all those involved in developments for these next two sites to work together with purpose, and for the Scottish Government and Health Boards involved to urgently resolve or remove any barriers towards implementation and delivery. The time it has taken and is taking Health Boards to sort this out is lengthy and unacceptable.”
Professor Rustam Al-Shahi Salman, consultant neurologist in Edinburgh and President of the British Association of Stroke Physicians, says: “Mechanical thrombectomy for acute ischaemic stroke is one of the most effective treatments in modern medicine.
“We knew this in 2015. In the last five years, about 45 people in Scotland have had this treatment, but about 700 people should have it each year. I am relieved that this dire disservice to patients with stroke is beginning to come to an end in Tayside. Patients elsewhere in Scotland deserve the same.”
Case study
Norrie Andrews, 77, from Glasgow had his stroke in Majorca last year. Only a few days into the holiday, Anne, Norrie’s partner, had gone to check on some electricity issues they had been experiencing. On her return, she found Norrie slumped over the side of his chair unable to talk and unable to move. Norrie had had a massive stroke.
He was taken to the local hospital quickly, and was administered with thrombolysis, a drug to break up the clot. Unfortunately the thrombolysis had no effect and the doctors decided Norrie would benefit from thrombectomy. He was immediately transferred to Son Espases University Hospital in Palma.
Anne had to give consent for Norrie to undergo thrombectomy (on his behalf.) It felt like an endless series of questions and forms that needed answered.
The procedure took 15 minutes and when Anne went up to the intensive care unit to see him she was amazed. He was alert, his speech was starting to come back and some movement too. They could hardly believe how something so horrifying had turned on its head.
Norrie still had some mild impairments, but the seriousness of his disability was saved (they believe,) by thrombectomy. And just over two weeks later, Norrie walked out of hospital without any difficulty and his speech was fine.
Anne said: “The doctors told me that had Norrie not had thrombectomy, he would never have been out of a wheelchair or spoken again. I was so relieved to hear this and we both felt very fortunate to have been in Majorca at the time.
“After returning home, I discovered thrombectomy would not have been available at the time of Norrie’s stroke. I was amazed to think a small island like Majorca had the treatment my husband so badly needed. Norrie is now back to his old life again.
“He walks every day and I am thrilled he has started to play golf again. He keeps his brain ticking over with puzzles, crosswords and word searches. He’s seeing his friends now, which has lifted his spirits and I’m able to see my own friends too.
“I am thrilled to hear thrombectomy is available in Scotland now. Stroke is a devastating illness and the disability caused by a stroke can be lifelong, destroying lives. I hope now there will be more people in Scotland making better recoveries from stroke because of thrombectomy.”
Prime Minister’s statement on coronavirus (COVID-19): 9 November 2020
Across the country and around the world this evening, people are asking one question about our fight against Covid. Does the news of progress towards a vaccine that’s been announced today mean we are at the beginning of the end of our troubles?
So, let me set out our assessment.
The Pfizer/BioNTech Vaccine has been tested on over 40,000 volunteers and interim results suggest it is proving 90 per cent effective at protecting people against the virus.
But we haven’t yet seen the full safety data, and these findings also need to be peer-reviewed.
So we have cleared one significant hurdle but there are several more to go before we know the vaccine can be used.
What I can say is that if and when this vaccine is approved, we, in this country, will be ready to start using it.
Earlier this year the UK Government ordered 40 million doses of the Pfizer vaccine – enough for about a third of the population, since you need two doses each.
That puts us towards the front of the international pack on a per capita basis – and I should add we’ve ordered over 300 million doses from 5 other vaccine candidates as well.
If the Pfizer vaccine passes all the rigorous safety checks and is proved to be effective then we will begin a UK-wide NHS led programme of vaccine distribution.
We will decide the order in which people are offered the vaccination taking account of recommendations from a group of scientific experts, the Joint Committee on Vaccination and Immunisation.
They’re looking at a range of factors, including the different characteristics of different types of vaccines, to work out the most effective way to protect as many people as possible and save as many lives as we can.
And we will be setting out more detail about that in due course.
But – and you know I am going to say this – I must stress, these are very, very early days.
We have talked for a long time, or I have, about the distant bugle of the scientific cavalry coming over the brow of the hill. And tonight that toot of the bugle is louder. But it is still some way off.
And we absolutely cannot rely on this as a solution.
The biggest mistake we could make now would be to slacken our resolve at such a critical moment.
On Friday, SAGE reported that the R is above 1 in England – though this does not take into account the current national restrictions.
Alas, the death figures are tragically rising, running at an average of over 300 a day – sadly double where they were 24 days ago
The number of Covid patients in hospital has risen from just over 10,000 two weeks ago to nearly 13,000 on 5 November, and we are heading towards the levels of the previous peak.
Irrespective of whether there is a vaccine on the way or not we must continue to do everything possible right now to bring the R down. And that is why we hope and believe that mass testing will help.
Our first pilot began in Liverpool on Friday, in partnership with Liverpool City Council.
We’ve tested thousands of people there but there are still a lot more to do, so please if you are in Liverpool, get yourself along to a testing centre – there are 19 at the moment with more still to come.
The more people get tested the better we can protect that great city, and drive the disease down in Liverpool so do it for your friends, for your relatives, for your community.
And I want to thank the fantastic support of the army, the people of Liverpool and Liverpool City Council.
And we are now going further by sending out hundreds of thousands of rapid lateral flow tests to local authorities right across England – and also of course to the Devolved Administrations.
We’re also working with universities to establish, as soon as possible, similar mass testing capacity for students up and down the country.
But while we are making progress this project is still in its infancy.
And neither mass testing nor progress on vaccines –both vital arrows in our epidemiological quiver, both key parts of our fight against Covid – are at the present time a substitute for the national restrictions, for social distancing, for hand hygiene and all the rest.
So it is all the more important to follow the rules.
I know it’s been a tough first weekend of these Autumn restrictions and I’m especially grateful to the Royal British Legion and all those who worked so hard to ensure that no virus would stop us yesterday from honouring the memory of those who gave their lives for our freedom.
But we must get through this to 2nd December, when these measures expire and we plan to move forward with a tiered approach.
Remember the basics, hands, face, space, and the follow the rules: that is how we can together protect our NHS, save lives and get this virus back in its box.
The first effective vaccine against coronavirus vaccine can prevent more than 90% of people from getting Covid-19, a preliminary analysis shows.The vaccine developers, Pfizer and BioNTech – have described it as a “great day for science and humanity”.
Vaccine candidate was found to be more than 90% effective in preventing COVID-19 in participants without evidence of prior SARS-CoV-2 infection in the first interim efficacy analysis
Analysis evaluated 94 confirmed cases of COVID-19 in trial participants
Study enrolled 43,538 participants, with 42% having diverse backgrounds, and no serious safety concerns have been observed; Safety and additional efficacy data continue to be collected
Submission for Emergency Use Authorization (EUA) to the U.S. Food and Drug Administration (FDA) planned for soon after the required safety milestone is achieved, which is currently expected to occur in the third week of November
Clinical trial to continue through to final analysis at 164 confirmed cases in order to collect further data and characterize the vaccine candidate’s performance against other study endpoints
Pfizer Inc. and BioNTech SE today announced their mRNA-based vaccine candidate, BNT162b2, against SARS-CoV-2 has demonstrated evidence of efficacy against COVID-19 in participants without prior evidence of SARS-CoV-2 infection, based on the first interim efficacy analysis conducted on November 8, 2020 by an external, independent Data Monitoring Committee (DMC) from the Phase 3 clinical study.
“Today is a great day for science and humanity. The first set of results from our Phase 3 COVID-19 vaccine trial provides the initial evidence of our vaccine’s ability to prevent COVID-19,” said Dr. Albert Bourla, Pfizer Chairman and CEO.
“We are reaching this critical milestone in our vaccine development program at a time when the world needs it most with infection rates setting new records, hospitals nearing over-capacity and economies struggling to reopen.
“With today’s news, we are a significant step closer to providing people around the world with a much-needed breakthrough to help bring an end to this global health crisis. We look forward to sharing additional efficacy and safety data generated from thousands of participants in the coming weeks.”
After discussion with the FDA, the companies recently elected to drop the 32-case interim analysis and conduct the first interim analysis at a minimum of 62 cases. Upon the conclusion of those discussions, the evaluable case count reached 94 and the DMC performed its first analysis on all cases.
The case split between vaccinated individuals and those who received the placebo indicates a vaccine efficacy rate above 90%, at 7 days after the second dose. This means that protection is achieved 28 days after the initiation of the vaccination, which consists of a 2-dose schedule.
As the study continues, the final vaccine efficacy percentage may vary. The DMC has not reported any serious safety concerns and recommends that the study continue to collect additional safety and efficacy data as planned. The data will be discussed with regulatory authorities worldwide.
“I want to thank the thousands of people who volunteered to participate in the clinical trial, our academic collaborators and investigators at the study sites, and our colleagues and collaborators around the world who are dedicating their time to this crucial endeavor,” added Bourla. “We could not have come this far without the tremendous commitment of everyone involved.”
“The first interim analysis of our global Phase 3 study provides evidence that a vaccine may effectively prevent COVID-19. This is a victory for innovation, science and a global collaborative effort,” said Prof. Ugur Sahin, BioNTech co-founder and CEO.
“When we embarked on this journey 10 months ago this is what we aspired to achieve. Especially today, while we are all in the midst of a second wave and many of us in lockdown, we appreciate even more how important this milestone is on our path towards ending this pandemic and for all of us to regain a sense of normality.
“We will continue to collect further data as the trial continues to enroll for a final analysis planned when a total of 164 confirmed COVID-19 cases have accrued. I would like to thank everyone who has contributed to make this important achievement possible.”
The Phase 3 clinical trial of BNT162b2 began on July 27 and has enrolled 43,538 participants to date, 38,955 of whom have received a second dose of the vaccine candidate as of November 8, 2020.
Approximately 42% of global participants and 30% of U.S. participants have racially and ethnically diverse backgrounds. The trial is continuing to enroll and is expected to continue through the final analysis when a total of 164 confirmed COVID-19 cases have accrued.
The study also will evaluate the potential for the vaccine candidate to provide protection against COVID-19 in those who have had prior exposure to SARS-CoV-2, as well as vaccine prevention against severe COVID-19 disease.
In addition to the primary efficacy endpoints evaluating confirmed COVID-19 cases accruing from 7 days after the second dose, the final analysis now will include, with the approval of the FDA, new secondary endpoints evaluating efficacy based on cases accruing 14 days after the second dose as well.
The companies believe that the addition of these secondary endpoints will help align data across all COVID-19 vaccine studies and allow for cross-trial learnings and comparisons between these novel vaccine platforms. The companies have posted an updated version of the study protocol at https://www.pfizer.com/science/coronavirus.
Pfizer and BioNTech are continuing to accumulate safety data and currently estimate that a median of two months of safety data following the second (and final) dose of the vaccine candidate – the amount of safety data specified by the FDA in its guidance for potential Emergency Use Authorization – will be available by the third week of November. Additionally, participants will continue to be monitored for long-term protection and safety for an additional two years after their second dose.
Along with the efficacy data generated from the clinical trial, Pfizer and BioNTech are working to prepare the necessary safety and manufacturing data to submit to the FDA to demonstrate the safety and quality of the vaccine product produced.
Based on current projections the companies expect to produce globally up to 50 million vaccine doses in 2020 and up to 1.3 billion doses in 2021.
Pfizer and BioNTech now plan to submit data from the full Phase 3 trial for scientific peer-review publication.
Prime Minister Boris Johnson is to hold a press conference at 5pm and Scotland’s First Minister Nicola Sturgeon says the vaccine announcement is welcome news.
The First Minister ended today’s lunchtime media briefing by saying: “It might not be all that visible at the moment but there is light at the end of this tunnel.
“The news we’ve heard this morning – that early indications show a vaccine being developed by the pharmaceutical company Pfizer, which has been trialled in other countries across the world, is 90% effective – is good news. Perhaps amongst the best news we have had in recent weeks.
“It’s not going to provide us with the way out of this today, or tomorrow, or next week, or perhaps not even in this calendar year. But this development, along with all of the work that is going into the development of other vaccines, does give us real hope that in the not too distant future, science is going to find us the way out of this terrible time.
“So hold onto that hope today, and also use it as a motivation. What we are living through right now, and all the restrictions that are so difficult for all of us, will not last forever. But it is really important we stick with them so that we get out of the other side of this with as few people as possible becoming ill, with as few people as possible losing their lives.
“That means all of us sticking with these tough restrictions that we are all fed up with but which we know will reduce the impact of this virus.
“So please stick with it for now and keep hold of the hope we have today that there is an end, and that we will see it in the not too distant future.”
Chancellor statement to the house – Furlough extension
Statement, as delivered by Chancellor Rishi Sunak in Westminter on 5 November 2020:
Mr Speaker,
On Monday, the Prime Minister set out the action we need to take between now and the start of December to control the spread of coronavirus.
In response, we’re providing significant extra support to protect jobs and livelihoods in every region and nation of the United Kingdom:
An extension to the Coronavirus Job Retention Scheme;
More generous support to the self-employed and paying that support more quickly;
Cash grants of up to £3,000 per month for businesses which are closed, worth over £1 billion every month;
£1.6 billion for English councils to support their local economy and local healthcare response;
Longer to apply for our loan schemes and the Future Fund;
The chance to top-up Bounce Back Loans;
And an extension to the mortgage payment holidays.
All on top of more than £200 billion of fiscal support since March.
This statement follows the Bank of England’s monetary policy decisions earlier today, meaning all economic and monetary institutions are playing their part.
As you would expect, the Governor and I are in constant communication as the situation evolves.
Our responses are carefully designed to complement each other and provide certainty and support to people and businesses across the UK. The Bank’s forecasts this morning show economic activity is supported by our substantial fiscal and monetary policy action.
And the IMF just last week described the UK’s economic plan as “aggressive”, “unprecedented”, successful in “holding down” unemployment and business failures and “one of the best examples of coordinated action globally”.
Mr Speaker,
Our highest priority remains the same: to protect jobs and livelihoods.
That’s why we’ve already decided to extend the Job Retention Scheme to December.
But people and businesses will want to know what comes next; how long we plan to keep the scheme open, and on what terms.
They want certainty.
The government’s intention is for the new health restrictions to remain only until the start of December.
But, as we saw from the first lockdown, the economic effects are much longer lasting for businesses and areas than the duration of any restrictions.
And as the Bank of England have said this morning, “the economic recovery has slowed”, and the economic risks are “skewed to the downside”.
Given this significant uncertainty, a worsening economic backdrop, and the need to give people and businesses security through the winter, I believe it is right to go further.
So we can announce today that the furlough scheme will not be extended for one month – it will be extended until the end of March. The government will continue to help pay people’s wages, up to 80% of the normal amount.
All employers will have to pay for hours not worked is the cost of Employer NICs and pension contributions.
We’ll review the policy in January to decide whether economic circumstances are improving enough to ask employers to contribute more.
Of course, as the furlough itself is now being extended to the end of March, the original purpose of the Job Retention Bonus to incentivise employers to keep people in work until the end of January – obviously falls away.
Instead, we will redeploy a retention incentive at the appropriate time.
And for self-employed people, I can confirm the next income support grant which covers the period November to January, will now increase to 80% of average profits, up to £7,500.
Mr Speaker,
I also want to reassure the people of Scotland, Wales and Northern Ireland. The furlough scheme was designed and delivered by the Government of the United Kingdom on behalf of all the people of the United Kingdom – wherever they live.
That has been the case since March; it is the case now; and will remain the case until next March.
It is a demonstration of the strength of the Union – and an undeniable truth of this crisis – we have only been able to provide this level of economic support because we are a United Kingdom.
And I can announce today that the upfront guaranteed funding for the devolved administrations is increasing from £14 billion to £16 billion. This Treasury is, has been, and will always be, the Treasury for the whole of the United Kingdom.
Mr Speaker,
I know that people watching at home will have been frustrated by the changes the government has brought in during the past few weeks. I have had to make rapid adjustments to our economic plans as the spread of the virus has accelerated.
So I’d like to take this opportunity to explain how and why this has happened.
During the summer, as we began slowly unlocking it was our hope the country would continue to be economically open, albeit with local restrictions being put in place as and when needed.
We knew there would likely be a resurgence in the spread of the virus, but with increased NHS capacity and Test and Trace, our belief was we would be able to stay ahead of the virus.
On this basis we designed an economic approach which continued providing wage support to people, incentivised businesses to retain staff beyond the end of the furlough scheme and created new job creation and training schemes, such as Kickstart.
All built to support an economy that was broadly open but operating with restrictions and overall lower demand.
At the time this approach was not Government acting alone. Our proposals secured wide ranging support, from the TUC to the CBI.
It was their hope, as it was ours, that the public health situation would allow us to keep businesses and workplaces open.
The virus however, continued to spread. Localised restrictions were having an impact, and so we intensified this approach and added further areas.
As these restrictions intensified, the economic impact, particularly on industries such as the hospitality sector, was significant.
So in response, we altered our approach to wage support, making it much more generous to employers and in turn protecting jobs.
We also introduced a range of grants to businesses, whether open or closed, to help them meet their fixed costs.
And additional funding for local authorities to respond to specific local economic challenges.
But again, the virus continued to spread, but more quickly.
And so we arrive at last week, when the government’s scientific and medical advisers presented data which showed that R is greater than 1 in all parts of the UK, that the NHS was at risk of being overwhelmed in a matter of weeks and the likely resultant loss of life that would accompany such an event.
The only viable solution left to protect our NHS was the re-imposition of temporary significant enhanced restrictions in England, in addition to those in Wales, Northern Ireland and Scotland.
And so, given these changed public health restrictions and the economic trauma they would cause in job losses and business closures I felt it best to extend the furlough scheme, rather than transition at that precise moment to the new Job Support Scheme.
Now political opponents have chosen to attack the government for trying to keep the economy functioning and to make sure the support we provide encourages people to keep working.
And they will now, no doubt, criticise the government on the basis we have had to change our approach.
But to anyone in the real world, that’s just the thing that you have to do when circumstances change.
We all hope for the best, but make sure we plan for any eventuality.
We can reintroduce the furlough now only because we kept the system on which it is based operational, because there was always the possibility that we would be back in this situation.
I’ll leave it to the people of this country to decide whether they believe the Government is trying its best to support people through an unprecedented crisis.
To decide whether it is a good or bad thing to alter our economic plans as the health restrictions we face change.
What I know is that the support we are providing will protect millions of jobs.
What I know is that it is never wrong to convey confidence in this country and our economy through our words and action.
And what I know is today’s announcement will give people and businesses up and down our country immense comfort over what will be a difficult winter.
And I commend this Statement to the House.
PM Boris Johnson later gave a statement at the coronavirus press conference:
Good evening everyone,
Across the whole United Kingdom, people are engaged in a huge joint effort to put the coronavirus back in its box. Throughout the pandemic, this government has done whatever it takes to protect lives and livelihoods – in England, Scotland, Wales and Northern Ireland.
We have put in place an unprecedented package of economic support, protecting the wages and jobs of millions of people.
We have built the largest testing capacity in Europe, with 32 million tests conducted so far and over half a million tests now available every day across the UK.
We have ensured that, as we head into winter, the NHS has at its disposal over 30,000 ventilators and billions of items of Personal Protective Equipment, most of it now manufactured here in the UK.
Across the whole of the UK, we have a shared goal – to suppress the virus, ensure the NHS is not overwhelmed, and in doing so to save lives.
The UK Government and the devolved administrations are working together on a joint approach to the Christmas period, because all of us want to ensure families can come together wherever they live.
The challenges we face are significant across the U.K.
The average number of new cases each day is now 22,398, that’s up from 9,716 a month earlier.
There are now 12,320 patients in hospital, up from 2,602 a month earlier.
1,142 patients are now in mechanical ventilation beds, up from 369 a month earlier.
Sadly 492 deaths were reported yesterday. The weekly average number of deaths each day is now 295, up from 53 a month earlier.
That’s why new restrictions are in place in each part of the UK.
In England, from today, we are once again asking you to stay at home.
As I explained on Saturday you can only leave home for specific reasons: for work if you can’t work from home, for education, and for essential activities and emergencies.
The full rules, all of the details, are available at gov.uk/coronavirus and on the NHS Covid-19 app – please log on to see what you can and can’t do.
I know how tough this is:
For staff in the NHS and care homes, who are facing a tough winter on the frontline.
For families, who can’t meet in the way they would want to.
For businesses, forced to shut just as you are getting back on their feet.
I know many of you are anxious, weary and quite frankly fed up with the very mention of this virus
But I want to assure you this is not a repeat of the spring.
Schools, universities and nurseries are all staying open.
And these measures though they are tough are time-limited.
The advice I have received suggests that four weeks is enough for these measures to make a real impact.
So these rules will expire, and on 2 December we plan to move back to a tiered approach.
There is light at the end of the tunnel.
We have better treatments and techniques to take care of those in hospital, thanks largely to the ingenuity of British scientists.
Rapid testing is being rolled out on a massive scale – with city-wide testing starting tomorrow in Liverpool.
I am hugely grateful to the people of Liverpool for their participation in this pilot. I hope that by working together, we can get that great city on top of the virus.
More broadly, there is also the very real chance of safe and effective vaccines.
So taking those things together, these scientific advances can show us the way ahead.
And in the meantime, the government will continue to support people affected by these new restrictions.
As you know, we have protected almost 10 million jobs through furlough, and as the Chancellor announced earlier today, we are now extending the scheme through to March.
We are also extending our support for the self-employed, so that the next payment increases to 80 per cent of average profits.
We’re providing cash grants for businesses who are closed, worth more than £1 billion every month.
We are giving £1.1 billion to Local Authorities in England to support businesses.
And a further £2 billion of funding is guaranteed for Scotland, Wales and Northern Ireland.
As we face these challenges together, we must look after those in most need.
As of September we have helped over 29,000 rough sleepers off the streets, two thirds of whom are now in settled accommodation.
Today we’re announcing a further £15 million to help councils offer safe accommodation for people who are sleeping rough or at risk of becoming homeless. This programme will help areas that need additional support most during the restrictions and throughout the winter.
These are difficult times.
And while it pains me to have to ask once again for so many to give up so much, I know that, together, we can get through this.
So please, for the next four weeks, stay at home, protect the NHS and save lives.
