The first coronavirus (COVID-19) vaccinations could be given to health and social care staff, older care home residents and those over 80 years old who live in the community from as early as next month – December 2020.
Updating Parliament on the safe delivery of COVID-19 vaccines, Health Secretary Jeane Freeman outlined that the first groups to be prioritised for vaccination have been identified based on current independent clinical advice.
Once these initial priority groups have been vaccinated, those over 65 will be offered the vaccination along with those under 65 who are at additional clinical risk, before moving on to the wider population over the age of 18.
An agreement has also been reached with the British Medical Association on the terms and conditions of GPs’ involvement in the programme.
Health Secretary Jeane Freeman said: “I want to be clear that safety is paramount in our approach to the COVID-19 vaccination programme.
“The global scientific, research and pharmaceutical community has come together and worked as never before. That is why we are seeing the front running vaccines delivered in months rather than years, but it is not at the expense of safety.
“Any COVID-19 vaccines deployed in Scotland will be used on the basis of compelling public health grounds, and only when the regulatory bodies and those charged with providing independent clinical advice are satisfied in terms of vaccine safety and effectiveness. The groups we vaccinate first will also be those most at risk from COVID-19.
“Scotland has a strong track record of delivering immunisation programmes, but this programme will be the largest of its kind ever undertaken and we will need more than 2,000 vaccinators and support staff by the end of January for the first phase.
“This is a national vaccination programme which will set out clearly the parameters within which NHS Boards will lead local delivery.
“NHS Boards will identify acceptable and accessible locations, both for mass vaccination and for local access.
“Taking account of local population and geography, they will undertake recruitment and deployment of staff, and the management of local vaccination clinics.
People in priority groups could get the first #coronavirus vaccines from as early as December.
Find out more about how we’ll deliver vaccines in Scotland ⬇
“We will be getting in touch with the first priority groups in the coming weeks and I urge people to take up the vaccine when they are offered it. It offers additional protection that we don’t have by other means.
“I also want to thank those who are not in the first priority groups for their patience as we protect the most vulnerable people in our communities first, in line with the scientific and clinical evidence.
“The most important thing you can do to protect yourself and others from the virus in addition is to continue to check and follow the Scottish Government’s guidance for your area and above all to follow FACTS.”
Botanics calls for support from Edinburgh residents
The organisers of Christmas at the Botanics have announced a rescheduled opening date of Edinburgh’s festive illuminated trail. Due to begin on 26 November, the trail will now start on 2 December 2020 and continue for 28 nights on selected evenings until 3 January 2021.
The decision to delay the opening of Christmas at the Botanics has been made to enable additional refinements to the trail’s health and safety guidance in line with Scotland’s new Covid-19 local protection levels which are being regularly reviewed and updated by the Scottish Government.
Jonathan Marks, Chief Development Director at Raymond Gubbay, a division of Sony Music, which promotes the trail, commented: “The health and safety of visitors and our trail staff remain a top priority and we will continue to monitor and respond to Scottish Government guidelines as they are reviewed and amended.
“In this ever-changing situation, delays have been inevitable. This has impacted on the time required to build the trail. It takes hours of precision and expertise to install, and for the artists and production team to create an amazing light experience. The teams are working tremendously hard to facilitate the opening of the trail without further delay, created with safety in mind.”
This year, now more than ever before, the trail’s success is dependent on support from the residents of the City of Edinburgh local authority area.
Simon Milne MBE, Regius Keeper of Royal Botanic Garden Edinburgh said: “We are calling on the people of Edinburgh to show their support by visiting Christmas at the Botanics.
“By coming to the trail not only will visitors enjoy a wonderful festive experience but also help us and our work enormously. Profits from the trail go to help finance our important and innovative plant research and conservation programmes in Scotland and around the world. Never has our work been more crucial as we face the interrelated challenges of the COVID-19 pandemic, biodiversity loss and climate change.
“This has been a hugely difficult year for us all. At the Botanics, we want to end the year by creating something very special for the City and we hope everyone will come and enjoy some festive fun.”
The website also contains information for those people who held tickets between 26 November and 1 December with an option to transfer a ticket to another date, request a refund or option to donate the cost of the ticket to the Botanics which will help to support the vital research and conservation that the charity provides.
The UK Government yesterday opened a new walk-through coronavirus testing centre at Thimblerow Car Park (PH1 5QT), in Perth. The centre is easily accessible for people without a car.
The new facility is being provided by the UK Government as part of a UK-wide drive to continue to improve the accessibility of coronavirus testing for local communities. It is operated by Mitie on behalf of the UK Government.
The test centre is part of the largest network of diagnostic testing facilities created in British history. In Scotland, this comprises of 6 drive through sites, 13 walk through sites, 21 mobile units, plus the Glasgow Lighthouse Lab which is working round the clock to process samples.
A new Scottish megalab has also been announced – this will provide capacity to process an extra 300,000 tests a day, create thousands of jobs and play a key part of the UK’s national infrastructure response.
In Scotland, the UK Government is providing all Covid testing and test processing outside of the NHS. Around two thirds of all daily tests are provided by the UK Government, in support of Scotland’s health services.
Tests must be booked in advance at NHS Inform or by calling 0800 028 2816. People should only book at test if they have coronavirus symptoms (a high temperature, a new and continuous cough, or a loss or change to their sense of smell or taste).
Health Minister Lord Bethell said: “To respond to the coronavirus, we have built a major testing and tracing system from scratch. We are constantly working to expand and improve it with new technologies and innovations so everyone with symptoms can get a test.
“New walk-in sites like this one makes it even easier to get a test no matter where you live. If you have symptoms of coronavirus, I urge you to book a test today and follow the advice of NHS Test and Protect if you are contacted to protect others and stop the spread of the virus.”
Baroness Dido Harding, Interim Executive Chair of the National Institute for Health Protection, said: “Walk through sites offer communities better access to coronavirus testing, so everyone with symptoms can get a test.
“This new site is part of our ongoing work to expand our testing network across the UK which is now has the capacity to process more than 500,000 tests a day. We will continue to expand capacity to improve test turnaround times and push forward testing innovations to make sure anyone who needs a test can get one.
Please book a test if you have coronavirus symptoms: a new continuous cough, a high temperature and a loss or change in sense of smell or taste, and follow the advice of NHS Test and Protect if you are contacted.”
UK Government Minister for Scotland, Iain Stewart, said: The UK Government is helping all parts of the UK fight the coronavirus pandemic.
“Testing is vital, helping to manage local outbreaks and protecting people’s livelihoods. The UK Government is providing the bulk of Covid testing in Scotland, and this new walk-through centre is just the latest in our extensive testing network.
“We are pleased to be working with local and commercial partners. These sites are not possible without the hard work of many people. I would like to thank everyone involved for their incredible efforts for the good of the country at this difficult time.”
Dr Emma Fletcher, Director of Public Health for NHS Tayside said: “This new walk through testing centre is very welcome and provides an additional opportunity for people to access testing in the Tayside area.
“People are reminded that if they show any symptoms of COVID-19 they should isolate, along with their household, and seek testing immediately.
Simon Venn, Mitie Chief Government & Strategy Officer, said: Our priority during the pandemic is to support the nation’s efforts to fight COVID-19 and help keep the country running.
“Testing is a critical part of the UK’s strategy to combat coronavirus and we’re proud to support the UK Government with this vital task. A big thank you to all the NHS staff, Mitie employees and other frontline heroes in Perth, who are working tirelessly to keep us all safe.”
Drive-through testing sites
Testing under the UK programme in Scotland is currently conducted in drive-through sites operating at:
Glasgow Airport
Edinburgh Airport
Aberdeen Airport
Prestwick Airport
Inverness – University of the Highlands and Islands campus
Dundee – Dudhope Castle
There are also a number of mobile testing units which will be located in towns across Scotland for short periods each time.
Walk-through testing sites
You may be able to access testing via a walk-through testing site. You should walk or cycle to this site and avoid travelling by public transport or taxi.
You can book an appointment via the usual booking process. We have walk-through test sites in:
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.”
A leading charity is urging the Scottish Government to include parents of children with complex disabilities and life limiting conditions to be amongst the first to receive the promising COVID-19 vaccine.
The plea comes from Kindred, an advocacy organisation supporting parents of children with complex needs, which has warned of the impact on these children if their parents contract the virus and are unable to provide care.
The charity has released a report today (16th November) highlighting the “devastating” impact of the pandemic lockdown on families of children with exceptional health needs.
Kindred is calling for public acknowledgement of the extraordinary efforts of these parents, many of whom had started shielding weeks before lockdown, and has asked for a letter from the Scottish Government to families. Such a letter would enable parents to feel that their efforts had not gone unnoticed and, in some way, help them come to terms with the trauma experienced over this period.
The charity conducted a survey of parents from 17 local authorities to better understand the ramifications of the lockdown months on these vulnerable families in August 2020 as schools prepared to reopen.1
The results show that:
93 percent of these families experienced an impact on their ability to meet their children’s medical and care needs due to the pandemic; 63 percent said that the impact of the pandemic on their ability to provide care was ‘big’ or ‘severe’.
Two out of every three parents who took part in the survey said sleep deprivation was one of the main factors that impacted their ability to care for their children. It was the norm for these parents to get an average of five hours of broken sleep per night. Kindred has called for an urgent need to investigate the provision of overnight respite care across Scotland.
Over a third of parents received no respite care before the pandemic and this dropped to 60 per cent after the start of the pandemic. This highlights the importance of schools in supporting parents and giving them a break from caring. Almost all the children attended special school with access to therapy, and the expertise of Additional Support for Learning staff. There is no doubt that schools are preventing crisis and family breakdown where a child has high care needs.
The charity has written to the Cabinet Secretary for Health and Sport, Jeane Freeman MSP, and to Deputy First Minister and Cabinet Secretary for Education and Skills, John Swinney MSP, urging that these parents be given priority when distributing the recently announced vaccine.
The report provides evidence that parents were left caring entirely alone in the home environment. There was an even greater impact on single parents. Despite the high level of need of all the children, some parents did not even get a phone call from professionals during the pandemic. These parents fear falling sick and being unable to look after their vulnerable children.
This is the case for Alex Davey from East Lothian and her six-year-old son, Benjamin, who has complex medical needs including tube-feeding, epilepsy and overnight ventilation.
Alex received a letter instructing her that Benjamin met the criteria for shielding in March. For his safety all respite and at-home care services received were brought to a halt, leaving Alex and her husband to be the only people providing care for Benjamin and his two sisters. Since March, Benjamin has been hospitalised six times, often involving full-time ventilation in critical care.
Alex’s main concern is that she and her husband will themselves contract Covid-19, rendering them incapable of meeting Benjamin’s complex care needs, potentially for a long period of time.
Early access to the vaccine is therefore imperative according to Kindred to ensure that families like Alex’s can be sure that they can continue to care for their child.
Further recommendations to the Scottish Government:
The report shows a disparity between the experience of those families who received the support and advice from health professionals, particularly on shielding, compared to those who didn’t. On this evidence, Scottish Government is being urged to ensure that professionals contact parents and charities should be funded to provide peer support.
Siblings play a vital role in the care and support of a disabled brother or sister and Kindred is urging that Self-Directed Support is available for adult siblings to be paid as carers within the home in the event of another lockdown. (see case study of Dr Gael Gordon in Notes to Editors and image attached)
The needs of families for respite should be taken into consideration with regards to special schools, with consideration given to keeping them open in the event of a second lockdown and providing the resources to do this.
Sophie Pilgrim, Director of Kindred, commented: “Our report provides evidence that the Covid-19 pandemic had a devastating impact on families of children with complex needs and life limiting conditions.
“Anyone reading this report will be moved by their plight. Many families started shielding before schools closed with the loss of all care and support. Some of these children require two to one support in school and other care settings, and yet parents had to cope from March to August, many with no help at all.
“As the vaccine becomes available, we must prioritise parents who are providing medical care for their children and cannot afford to get sick themselves.
“Many parents received no respite care before the pandemic, and those that did lost their care with lockdown. Serious sleep deprivation puts parents at risk of depression, accidents and long-term conditions. One of the parents told us ‘I feel like I am drunk’. We found that many parents have to cope on five hours of broken sleep a night, well below the NHS recommendation of a minimum seven hours a night.
“We need to recognise the long-term exhaustion of these families. Special schools are all the more important and need to be supported to carry on their excellent work and to keep their doors open.
“Parents put their children first. And we must work together and ensure they are amongst the first to get the vaccine.“
Dangerous crowding and corridor care has returned to Emergency Departments in England.
NHS England Performance figures for October 2020 show that patients waiting for treatment on trollies has increased by 50%, with patients waiting longer than 12 hours from decision to admission having quadrupled from September 2020.
The data also shows:
patients waiting longer than 12 hours (from decision to admit) has nearly doubled from the same month last year
the proportion of patients attending A&E who require admission is up by 3 percentage points on last year
the number of ambulances dispatched by NHS111 is higher than last month
ambulances response times are up on last month and the same month last year
Performance of the four-hour target is down by 4.1 percentage points in type 1 Emergency Departments from last month, with nearly 1 in 4 patients waiting longer than four hours to be seen
Dr Katherine Henderson, President of the Royal College of Emergency Medicine, said: “I am appalled and alarmed; the data is massively worrying.
“Despite our repeated calls for action, crowding and corridor care is back and it has to stop. It is a dangerous and unsafe situation that puts enormous pressure on staff and departments and now increases the risk of hospital acquired infection to patients.
“We simply cannot leave patients for hours in crowded corridors without social distancing, making infection prevention control measures impossible; potentially exposing them to infections.
“Hospitals and trusts must, as a necessity, implement and follow strict IPC guidance ensuring staff are using the right PPE and are trained in how to fit it correctly to maximise safety for themselves and their patients. We welcome the news that there will be regular staff tests and look forward to hear how this will be operationalised. We need patients to be confident they are not being seen by staff who might be carrying the virus.
“But this only tackles part of the problem. To function as it should and provide the best care possible for patients, the Emergency Care system must have good flow. Without it ambulances are stuck waiting to offload patients and paramedics are unable to return to the community; waiting times increase across the board and patients suffer.
“The recent rise in covid infections in the community and a rise in general hospital admissions means there has been an increase in the number of patients in hospital. We already had a bed base far smaller than required, and the consequence of too few staffed beds is that patients are becoming stranded in EDs, putting them unnecessarily at risk. Hospitals need to be given guidance about how to prioritise the multiple demands they are trying to balance.
“Winter has only just begun and with the rise in community covid transmission it is only likely to get worse. We must stop crowding and corridor care now, we must ensure patients and staff are safe, we must ensure there is good flow so ambulances can admit patients into EDs quickly and waiting times are reduced. If these practices continue and we do not act I dread to think of the suffering this winter will bring.”
Plans announced to support students to return safely
Thousands of students in Scotland will be tested for coronavirus (COVID-19) under plans to allow those wishing to return home at the end of term, to do so safely.
In a statement to Parliament, Further and Higher Education Minister Richard Lochhead outlined the measures being taken by colleges and universities to support the safe return of up to 80,000 students ahead of the winter break.
The plans include a widespread COVID-19 testing scheme, which is expected to be rolled out by the start of December.
Enabling easy access to testing for students with COVID-19 symptoms has already proved to be effective in controlling outbreaks. Now Scottish students will be included in a UK-wide initiative to test some asymptomatic students prior to the end of term.
The Government is working in partnership with institutions and the UK Government’s testing programme on the logistics of offering both lateral flow testing – a new rapid test currently being used in Liverpool, which can deliver a COVID result in about 15-20 minutes – and if needed a more sensitive PCR (polymerase chain reaction) test, which may take up to a day or longer to produce a result.
The other measures outlined by Mr Lochhead include:
All students will receive early, clear advice on staying safe. Those who chose to stay in student accommodation over the holiday period will also be well supported
There will be staggered and early departure from campuses, with universities being asked to make any necessary adjustments to scheduling, to ensure in-person teaching and assessment ends early enough to allow students time to get home at the end of term
Any student who wants to return home for the end of term, is being asked to voluntarily reduce their social mixing for two weeks before going home. This means going out only for essential reasons and exercise
All college and university students travelling home will be given advice on how to do so safely, which includes following public health advice on the use of public transport
Mr Lochhead said: “Covid 19 is a challenge for all of us, our students included.We have all worked hard to support students in gaining an education this term, and like everyone else we have learnt and adapted as we have progressed.
“Our challenge is to look after the wellbeing of our students by enabling them to return home, while at the same time keeping them, their loves ones, and communities safe.
“Testing will play a role – but only a limited role. My message to students is, ‘thank you for all your efforts, and please keep doing all you can to keep yourself and others safe’.
“I have no doubt the majority of students will want to act responsibly, and will follow the measures that will be set out.”
The UK Government has published guidance for students to travel home at the end of the term while controlling Covid-19 transmission risk.
The Scottish Government is expected to follow suit with a statement at Holyrood later today.
University students will be able to travel home to spend Christmas with their families once the national restrictions end on 2 December, following steps set out in new Government guidance published today.
In order to travel home safely, students in England will be required to follow the current national restrictions in place until 2 December, completing this four-week period in their term-time accommodation.
From 3 December to 9 December, which will be known as the ‘student travel window’, students will be allowed to travel home on staggered departure dates set by universities, who will work with other institutions in the region to manage pressure on transport infrastructure.
The student travel window will mean students can travel having just completed the four-week period of national restrictions, reducing the risk of transmission to family and friends at home.
Universities should move learning online by 9 December so students can continue their education while also having the option to return home to study from there.
As announced by the Prime Minister this week, the Government will also work closely with universities to establish mass testing capacity. Tests will be offered to as many students as possible before they travel home for Christmas, with universities in areas of high prevalence prioritised.
This will provide further reassurance that where students test negative, they can return home safely and minimise the risk of passing coronavirus on to their loved ones.
If a student tests positive before their departure they will need to remain in self-isolation for the required period of ten days. Moving all learning online by 9 December gives enough time for students to complete the isolation period and return home for Christmas.
The guidance delivers on the Government’s pledge to ensure students can be with their families at Christmas while limiting transmission of the virus.
Universities Minister Michelle Donelan said: ”We know this Christmas will feel different, and following this incredibly difficult year we are delivering on our commitment to get students back to their loved ones as safely as possible for the holidays.
“We have worked really hard to find a way to do this for students, while limiting the risk of transmission. Now it is vital they follow these measures to protect their families and communities, and for universities to make sure students have all the wellbeing support they need, especially those who stay on campus over the break.”
Deputy Chief Medical Officer Dr Jenny Harries said: “The mass movement of students across the country at the end of term presents a really significant challenge within the COVID-19 response.
“The measures announced today will help minimise that risk and help students get home to their families as safely as possible for Christmas. It is crucial that students follow the guidance in order to protect their families and the communities they return to.”
Universities are expected to make plans to ensure students can travel home safely at the end of term, working with local public health officials and transport operators.
Students should follow the Government’s travel guidance, which includes wearing face coverings unless exempt, avoiding busy routes and times, and limiting car sharing with only their household or bubble where possible.
We are working with the other governments across the UK to ensure that all students, no matter where they live or study are treated fairly and can travel home as safely as possible to keep all our communities safe.
English students at universities in Scotland, Wales or Northern Ireland, should follow the guidance relevant to where they are living before returning home.
When they return to England, they should follow their local guidance for their home area. Students returning to their home in England who have not completed the 4 weeks of national restrictions should undertake at least 14 days of restricted contact either before or after return home to minimise their risk of transmission.
Universities have also been asked to provide additional help and practical support to students, particularly for students who remain on campus over Christmas, which can include care leavers, international students and students estranged from their families. Universities should ensure they are properly cared for and can access affordable food, medical and cleaning supplies if needed.
The Government has provided over £9 million to leading mental health charities to help them expand and reach those most in need, as well as working closely with the Office for Students to provide up to £3 million to fund Student Space, a new mental health support platform.
The department also worked with the Office for Students to clarify that providers were able to use existing funds, worth around £23 million per month for April to July this year and £256 million for Academic Year 2020/21, towards hardship support.
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.”
Police Scotland officers dealt with more than 300 house gatherings over last weekend, the vast majority of which were small groups of people in houses.
More than 300 Fixed Penalty Notices (FPNs) were issued and 24 people were arrested between Friday, 30 October, and Sunday, 1 November.
The majority of FPNs issued were to small groups from different households meeting in homes in clear breach of the regulations in place to tackle the spread of coronavirus.
Assistant Chief Constable Alan Speirs said:“Officers dealt with a significant number of calls to house gatherings over the weekend and we have been quite clear that we will enforce the law where necessary, as the public would expect us to do.
“We are not just talking about large parties. The vast majority were smaller groups of different households meeting indoors.
“House gatherings of any size cause the virus to spread and we are asking people to do the right thing and take personal responsibility.
“I fully understand the implications the current restrictions have on our daily lives, but we cannot have people twisting the rules and disregarding the law which is there to stop the spread of coronavirus and help save lives.
“Anyone clearly breaking the law should be in no doubt that they will be met with a robust response from Police Scotland.”
