Tag: vaccine

Vaccine choice for pregnant women welcomed by maternity Royal Colleges

The Joint Committee for Vaccination and Immunisation (JCVI) has announced it will be offering pregnant women the COVID-19 vaccine, in line with the vaccine roll out plan for the UK. 

This comes after the Royal College of Obstetricians and Gynaecologists (RCOG) presented evidence to the JCVI on the impact of COVID-19 for pregnant women, leading the JCVI to recommend offering vaccination to all pregnant women in line with priority groups. This enables every pregnant woman to make an individual decision based on benefits and risks. 

Up until this point, the COVID-19 vaccination has only been offered to pregnant women when their risk of exposure to the virus is high, such as health and social care workers, or if the woman has underlying conditions that place her at high risk of complications of COVID-19. 

Clinical trials testing the vaccine in pregnant women are just starting, but robust real-world data from the US – where around 90,000 pregnant women have been vaccinated mainly with mRNA vaccines, such as Pfizer-BioNTech and Moderna – have not raised any safety concerns.

Therefore, the JCVI is advising that it is preferable for the Pfizer-BioNTech or Moderna mRNA vaccines to be offered to pregnant women in the UK, where available.  

Professor Lucy Chappell, consultant obstetrician and COVID-19 vaccine lead for the Royal College of Obstetricians and Gynaecologists, said: “This announcement from the JCVI brings the UK into line with the US and other countries who have been offering the COVID-19 vaccine to pregnant women since December, and should provide reassurance to pregnant women, as well as those planning a pregnancy or breastfeeding, that vaccination is an option for them.  

“We are continuing to work with healthcare professionals so they are able to counsel pregnant women on the risks and benefits of having the COVID-19 vaccine based on their individual circumstances. 

“We are also advocating for more data collection of pregnant women receiving the vaccine in the UK, and welcome the work that is going on to ensure that there is recording of pregnancy status in the national vaccination programme to enable linkage to outcomes.” 

Dr Mary Ross-Davie, Director for Professional Midwifery and COVID-19 vaccine lead at the Royal College of Midwives, said:  

“This is a sensible step by the Committee and one we welcome. It empowers pregnant women to make their own decisions about whether or not to receive the vaccine. Ultimately it will be a woman’s choice and midwives and obstetricians will be there to support them to make an informed decision that is right for them.  

“It is now vital that the national vaccination programme, GPs and maternity services are supported to develop systems and procedures that support women who wish to have the vaccine to have it as easily as possible. 

“We need to ensure that those providing counselling and information to women about the vaccine in pregnancy have up to date accurate information and have enough time to talk through questions and concerns with women.” 

Dr Edward Morris, President of the Royal College of Obstetricians and Gynaecologists, said: “We are grateful to the JCVI for taking into consideration our evidence and updating the guidance around the COVID-19 vaccine in pregnancy.  

“Vaccination offers pregnant women the best protection from COVID-19, which can be serious in some women. We know pregnant women can get unwell with COVID-19; one in five pregnant women who become unwell and are admitted to hospital will have a premature birth. 

“We believe it should be a woman’s choice whether to have the vaccine or not after considering the benefits and risks and would encourage pregnant women to discuss with a trusted source like their GP, obstetrician or midwife, or a healthcare professional in a vaccination centre. 

“This move will empower all the pregnant women in the UK to make the decision that is right for them, at the same time that the non-pregnant population in their age group receive protection from COVID-19.” 

UK government secures additional 40 million doses of Valneva vaccine

  • Deal means the UK has now secured early access to over 400 million total doses of vaccines for 2021 and 2022
  • 100 million doses of Valneva vaccine have now been secured
  • UK Government boosts Scotland vaccine production powerhouse at Valneva’s site in West Lothian, supporting 100 highly-skilled jobs

The UK Government has today signed a deal for a further 40 million doses of Valneva’s promising vaccine candidate. The latest deal will bolster long-term vaccine production in Scotland and brings the total UK vaccine portfolio to 407 million doses over the next two years.

The decision to purchase 40 million extra doses is based on the UK’s strategy to take a wide approach, using different technologies and viral targets to ensure the UK has the best chance of securing access to successful vaccines as quickly as possible. It will also give the UK future flexibility should we need to revaccinate any of the population.

The UK Government has invested a multi-million sum in Valneva’s manufacturing facility in West Lothian, which began manufacturing vaccine doses last week and is already raising Scotland’s profile in the international fight against Covid-19.

The site is already supporting 100 new highly-skilled local jobs for scientists and technicians.

Valneva’s coronavirus vaccine candidate is currently in phase I/II trials and will still need to meet the necessary safety and effectiveness standards and receive regulatory approval from the UK Medicines and Healthcare products Regulatory Agency (MHRA) before it is rolled out at the end of the year.

However, if it is approved, manufacturing at risk now will mean that the UK can roll the vaccine out across the country quicker.

Business Secretary Kwasi Kwarteng said: This latest deal is yet another weapon in our national arsenal against this terrible disease, and will ensure we have sufficient supplies to protect the British public in 2021 and beyond.

“Backed with major investment from the UK Government, Valneva’s site in Scotland will be a vaccine production powerhouse, working flat out to ensure we can quickly deploy jabs across the UK if their candidate is approved, while supporting top quality, local jobs.

Thanks to our incredible UK Vaccine Taskforce, we have now secured a bumper portfolio of over 400 million vaccines, putting our country in an exceptionally strong position to defeat this virus once and for all.”

Vaccines Minister Nadhim Zahawi said: “This deal provides a further boost to the UK’s already-strong vaccine portfolio, and I am enormously proud of all the work which has gone in to securing a vaccine for the UK as soon as possible.

“If approved, Valneva’s vaccine will not only help tackle Covid-19 here in the UK, but aid our mission to ensure there is a fair supply of vaccines across the globe.

“No one is safe till the whole world is safe.”

The Secretary of State for Scotland Alister Jack said: “This deal is an endorsement of the UK Government’s strategy of investing in vaccine development and in the skills of the Scottish life sciences sector.

“I pay tribute to the team in Valneva’s new Livingston manufacturing plant. If the vaccine is authorised by the health regulator, their expertise will play an important role in making the world safer from this virus.”

Health Secretary Matt Hancock said: The UK has developed and invested in some of the world’s most promising vaccines – supporting global efforts to fight this virus.

“The Valneva vaccine showcases the best of Scottish expertise right at the heart of our UK vaccine endeavour, demonstrating the strength of our union and what the UK can achieve when it works together. If the vaccine is authorised by the health regulator, it will be rolled out across the four nations as quickly as possible.”

Interim Chair of the UK government’s Vaccines Taskforce Clive Dix said: “Valneva’s manufacturing site in Scotland is already up and running, ready to supply their promising vaccine as soon as it has proven to be safe, and effective and is approved by the MHRA.

“To best ensure we have enough successful candidates to ensure maximum coverage of the UK population, the Vaccines Taskforce has invested in seven of the most promising vaccines. The further 40 million doses secured through today’s deal significantly bolsters our portfolio and gives us future flexibility should we need to revaccinate any of the UK population.

“I want to thank everyone involved in the development of this vaccine for the hard work that has helped us reach this point and also to pay tribute to those UK citizens who have volunteered to take part in the important clinical trials of this vaccine.”

If it is approved, 60 million doses could start to be delivered to the UK by the second half of 2021, with the remaining 40 million being delivered in 2022.

Valneva’s Livingston site will have the capacity to produce up to 250 million doses annually for shipment across the UK and around the world.

The UK Government is committed to supporting equitable access to vaccines worldwide. The UK is the largest donor to the COVAX facility, the global mechanism to help developing countries access a coronavirus vaccine, and has committed £548 million in UK aid to help distribute 1.3 billion doses of coronavirus vaccines to 92 developing countries this year.

To date, the UK government has invested over £300 million into manufacturing a successful vaccine.

January: the Last Post

As a dark and dreary January draws to a close, I’m pleased to share at least one wee nugget of positive news.

The NEN blog passed a memorable milestone this week. Your community news website reached and passed the one million hits mark on Thursday.

It’s taken a while – the NEN blog was set up ten years ago this month (the first post was made on 19 January 2011) – but we got there in the end!

Since that first blog post there have been more than 18,300 more. The blog has over 5,000 subscribers and thousands more followers on Facebook and Twitter

When that first post was written, I’m pretty sure the word ‘coronavirus’ didn’t exist. And I know I would have been using ‘lock in’ a lot more than ‘lockdown’ back then. Social distancing. Face Coverings. Blended learning. PPE. Nightingale hospitals. These words and phrases are part of our everyday language now.

It’s twelve months to the day since the first cases of the new virus were confirmed in the UK, on 31 January. Life has changed so much since then, perhaps forever. It’s a darker, more uncertain world.

The NEN first mentioned coronvirus in a post on 25th January 2020. Since then, coronavirus has been tagged 1300 times, COVID-19 1700 times and vaccine close to 300 times in NEN posts.

It’s been a relentless litany of grim statistics and horror stories, lightened only sometimes by tales of heroic workers and volunteers working flat out to support the most vulnerable people in our poorest communities.

But despite the daily awfulness of it all, I do think it’s important to record it. One day, we’ll look back on these unprecedented times to establish what we could have done better – and sooner – and where our leaders got it horribly wrong.

But for now, it’s encouraging that the word ‘vaccine’ is being used more and more in NEN posts; goodness knows we’ve needed a glimmer of light at the end of a terribly dark tunnel.

Last week, the UK death toll surpassed 100,000. One hundred thousand people; each and every one of those deaths will have affected so many friends and families. Coronavirus will leave it’s mark on us all for years to come – perhaps forever – but there will be life after the virus.

As more and more vaccines come on stream, the future is looking an awful lot brighter than it did a few short months ago. IF enough of us remain sensible – and there are still a surprising number of foolish people out there – we will get there.

So while passing the one million mark is a reason to celebrate in these cheerless times, I will put the celebration on hold until life gets back to something like normal again when I will enjoy a real pint in an open pub!

Until then, if you keep reading I’ll keep writing. Deal?

Stay safe everyone.

DAVE PICKERING

Editor, North Edinburgh News

Large-scale coronavirus vaccine manufacturing begins in Scotland

  • Valneva begins large-scale vaccine manufacturing at its Livingston site in West Lothian
  • up to 60 million jabs due to be manufactured by the end of 2021 if the vaccine is approved
  • UK government investment will support 100 new jobs at the site, a doubling of the workforce

This follows a multi-million-pound joint investment in the facility by the UK government last year as part of an agreement in principle to secure early access to Valneva’s vaccine by the end of 2021. 60 million doses have already been secured for the UK, with an option to acquire a further 130 million if the vaccine is proven to be safe, effective and suitable.

This investment will now support 100 new highly-skilled jobs for scientists and technicians at the Livingston facility – doubling the workforce, putting Scotland at the forefront of the UK’s fight against COVID-19, and boosting the UK’s resilience in dealing with current and future pandemics by establishing a permanent vaccine manufacturing base.

Valneva’s coronavirus vaccine candidate is currently in phase I/II trials and will still need to meet the necessary safety and effectiveness standards and receive regulatory approval before it is rolled out at the end of the year. However, if it is approved, manufacturing at risk now will mean that the UK can roll the vaccine out across the country quicker.

Business Secretary Kwasi Kwarteng said: “Thanks to the UK Vaccine Taskforce, we have ordered up to 60 million jabs of Valneva’s promising vaccine if it proves to be safe, effective and suitable in its clinical trials this year.

“By starting manufacturing, we will have a running start at rolling these out as quickly as possible to protect the British public if it receives regulatory approval.

“This facility in Scotland, backed by millions from the Government, will help us beat coronavirus and boost our resilience against future pandemics.”

The new facility establishes a permanent UK capability to manufacture inactivated viral vaccines – one of the most proven, widely used types which is also used for flu, polio and rabies jabs.

If the vaccine proves successful and receives regulatory approval following a rigorous assessment of available data, the Livingston facility will have the capacity to produce up to 250 million doses annually for shipment across the UK and around the world.

Scottish Secretary, Alister Jack said: “It’s incredibly exciting that a potential new COVID-19 vaccine will be manufactured right here in Scotland, at the Valneva plant in Livingston.

This big step forward is a testament to the talent and hard work of all the Valneva staff who have worked so far to get to this stage.

The UK government has invested millions into developing the Valneva vaccine, which is also supporting hundreds of highly skilled jobs in Scotland.

Chief Executive Officer of Valneva Thomas Lingelbach said: “We are extremely pleased to have achieved these 2 important milestones in such a short period of time. Our team in Scotland have done an amazing job to get manufacturing started so quickly.

“I would like to thank the UK Vaccines Taskforce and National Institute for Health Research who have played vital roles in the rapid recruitment and enrolment of the volunteers for the clinical study. We believe that our vaccine, assuming successful development, can make a major contribution in the UK and beyond.”

UK Health Secretary Matt Hancock said: “We’ve already secured 60 million doses of the Valneva vaccine which, if approved, will be another vital tool in our fight against this virus.​> The start of manufacturing in West Lothian today puts Scottish expertise right at the heart of the UK vaccine programme.

“Set to deliver millions more jabs across all four nations, this is yet another fantastic example of the strength of our Union, as we work together as one United Kingdom to tackle the virus.”

Interim Chair of the UK government’s Vaccines Taskforce Clive Dix said: “I am thrilled that manufacturing has begun in Livingston as a result of the excellent work being done by Valneva in conjunction with the Vaccines Taskforce.

“If approved this new vaccine will be a crucial part of our efforts to tackle coronavirus – not just in the UK but around the world.”

Lothian MSP, Miles Briggs, said: “This is excellent news that Valneva has started large-scale manufacturing of the Covid-19 vaccine, which the majority of us could be receiving.

“The Livingston site has the capacity to create hundreds of millions of vaccines that can be exported across the globe to help other countries in their fight to suppress Covid-19.

“UK government investment, doubling the workforce at the site, shows how Scotland is better prepared to overcome Covid-19 as part of the United Kingdom.”

Through the Vaccines Taskforce, the UK has secured early access to 367 million doses of seven of the most promising vaccines so far. To date, the UK government has invested over £230 million into manufacturing a successful vaccine.

The UK was the first country in the world to procure, authorise and then deploy both the Oxford/AstraZeneca and Pfizer/BioNTech vaccines.

Production of the Oxford University/AstraZeneca vaccine started last autumn where the bulk of the vaccine for the UK is being made in Oxfordshire and Staffordshire, with filling into vials taking place in North Wales.

In total, more than 7.1 million people across the UK have now had a least one dose of the vaccine.

Coronavirus: Valneva vaccine clinical trials get underway

  • Valneva begins first UK clinical trials for its promising COVID-19 vaccine, being developed in Livingston, West Lothian
  • the UK government has pre-ordered 60 million vaccine doses
  • follows a multi-million-pound UK government investment in Valneva’s manufacturing facilities, boosting its capacity to supply up to 250 million vaccine doses

Valneva has started UK clinical trials for its promising COVID-19 vaccine, currently being developed in Livingston, West Lothian.

Speciality vaccine company Valneva’s candidate will initially be tested on 150 UK volunteers at four National Institute for Health Research (NIHR) testing sites in Birmingham, Bristol, Newcastle and Southampton. These early phase 1 and 2 trials will show whether the vaccine produces a safe and effective immune response against COVID-19.

Should this early trial prove successful, larger clinical trials will be planned for April 2021 with over 4,000 UK volunteers testing 2 doses of the vaccine in 2 groups: those aged between 18-65 years and over 65s.

The UK government has already pre-ordered Valneva’s vaccine candidate and should studies prove it to be safe and effective, 60 million doses could be made available to the UK by the end of 2021.

This latest milestone follows a multi-million-pound up-front investment announced in August by the UK government and Valneva to expand its Livingston facility. This supports over 100 highly skilled jobs for technicians and scientists at the West Lothian site, while advancing Scotland’s vaccine manufacturing capacity.

Through this investment, if Valneva’s vaccine candidate proves successful, this permanent facility will potentially have the capacity to supply up to 250 million vaccine doses to the UK and internationally.

Valneva’s vaccine is the fifth to enter clinical trials in the UK, alongside Oxford/AstraZeneca, Imperial College London, Novavax and Janssen, whose studies are currently ongoing.

Business Secretary Alok Sharma, said: As we take the monumental steps in rolling out the first COVID-19 vaccine, we must remember that we need to have a range of vaccines available to protect the British public now and long into the future.

“Today we have more welcome news that life-saving clinical trials will begin across the country to test the safety and effectiveness of Valneva’s vaccine, which is being clinically developed right here in the UK.

“Having visited Valneva’s state-of-the art facility in the Summer, I have seen first-hand the incredible work our scientists and researchers are doing to develop this vaccine.

“Thanks to significant investment from the UK government, we are doing all we can to ensure our country has the capabilities in place to produce hundreds of millions of doses of this vaccine for the UK, and for those around the world.”

Secretary of State for Scotland Alister Jack said: “Today marks an important milestone not only in the UK’s fight against coronavirus but for the hundreds of staff at the Valneva facility in Livingston who have worked tirelessly over the last few months to develop this vaccine. This is a great example of the work of Scotland’s world-class life sciences sector.

“The UK government is doing everything it can to support all parts of the country throughout the pandemic including ordering and paying for vaccines for the whole of the UK. We are investing in Valvena’s manufacturing facility in Livingston, supporting hundreds of highly skilled jobs.

“With a number of other vaccines in development, this gives us all hope for the months ahead.”

The UK was the first country in the world to both procure and authorise the Pfizer/BioNTech COVID-19 vaccine, ordering 40 million doses – enough for around a third of the population. The UK was also the first country in the West to start a mass COVID-19 vaccination programme, which began on 8 December.

In total, the UK government has developed a portfolio of 7 different vaccine candidates and secured access to 357 million doses to date, putting the UK in the best position for a vaccine and increasing chances of finding vaccines that work for different people.

Chief Executive Officer of Valneva Thomas Lingelbach said: “Our teams have been working extremely hard to develop our differentiated vaccine candidate and I would like to thank them, as well as the UK government, for their dedication and support.

“While conducting our first clinical trials, we are already ramping-up our manufacturing capacities and commencing production at full-scale so that we can make the vaccine widely available across the world assuming the vaccine is safe and effective.

Interim Chair of the government’s Vaccines Taskforce Clive Dix: “Huge progress has been made in developing a successful COVID-19 vaccine. While this is very positive, we must remember there is no one size fits all approach, and we need to continue developing different types of vaccine so we can vaccinate the UK population.

“We believe that Valneva’s vaccine is promising and has the potential to tackle coronavirus now and into the future, which is why we have pre-ordered 60 million doses and are investing to help them expand their UK manufacturing facility. This will not only support them in manufacturing hundreds of millions of vaccines for the whole world but boost the UK’s resilience against possible future heath crises.

Chief Investigator for the Valneva study Professor Adam Finn said: “We are really pleased to be initiating this first-in-man phase 1 study in Bristol and continuing it in several other centres across the country in the New Year.

“This is a more traditional vaccine design than those that have been in the news recently, consisting of the whole SARS CoV2 virus that has been chemically inactivated. This kind of viral vaccine has been in widespread use for 60 years.

“Our team will be working hard through the Christmas holiday period to get the first participants enrolled and vaccinated. We are pleased to be adding further to the research already done via the NIHR in Bristol over recent months to test COVID-19 vaccines and we are really grateful to the many members of our community who continue to come forward and volunteer to take part in this important work.”

Lothian MSP, Miles Briggs said: “This is excellent news that Valneva, based in Livingston, are moving forward with clinical trials.

“The management of Covid-19 will take time and the Valneva Covid-19 vaccine will be part of the long term plan for beating the virus.

“I wish Valneva all the best with their clinical trials, so that a larger trial can be carried out early next year.”

Some of the volunteers taking part in Valneva’s clinical trials came through from the NHS Vaccines Registry, allowing the UK public to support the national effort to speed up vaccine research. Over 364,000 people have already signed up to the Registry, with more needed.

Additional information about volunteering for clinical studies can be found by visiting the NHS site to join the NHS Vaccine Research Registry.

The Registry was launched by the UK government in partnership with the NIHR, NHS Digital, the Scottish and Welsh governments and the Northern Ireland Executive in July. It aims to help create a database of people who consent to be contacted by the NHS to take part in clinical studies, to help speed up the development of a safe and effective vaccine.

Through the government’s Vaccines Taskforce, the UK has secured early access to 357 million doses of 7 of the most promising vaccine candidates, including:

  • BioNTech/Pfizer – Phase III – 40 million doses secured
  • Oxford/Astra Zeneca – Phase III – 100 million doses secured
  • Moderna – Phase III – 7 million doses secured
  • Novavax – Phase III – 60 million doses secured
  • Janssen – Phase III – 30 million doses secured
  • GSK/Sanofi – Phase I / II – 60 million doses secured
  • Valneva – Phase I / II – 60 million doses secured, with an option to acquire a further 130 million if the vaccine is proven to be safe, effective and suitable.

Covid vaccine: Prioritise people receiving palliative care, says Briggs

Lothian MSP Miles Briggs, who is Co-convenor of the Cancer Cross Party Group at the Scottish Parliament, has submitted a motion at the Parliament calling on the Scottish Government to consider prioritising people receiving palliative care and their immediate families in the forthcoming rollout of COVID-19 vaccines.

The motion acknowledged the immense strain that the COVID-19 pandemic and the necessary public health response have placed on many people with pre-existing medical conditions, especially people diagnosed with a terminal illness and who are receiving palliative care.

Prioritising people who have a terminal illness for a Covid-19 vaccine would allow them to live life as fully as possible with family and friends in the limited time they have left.

The motion also urged the Scottish Government to consider allowing clinicians discretion to fast-track individual patients and their immediate family members whose need for vaccination is deemed to be most urgent where it is clinically safe and appropriate to do so.

Lothian MSP, Miles Briggs, said: “The arrival of a vaccine for Covid-19 is what we have all been waiting for and means that Scotland can start recovering from this cruel virus.

“With the rollout out of the vaccine to start next week, the Scottish Government is now facing the difficult decisions of who should get the vaccine first.

“My motion at the Scottish Parliament, has called on Ministers to allows clinicians discretion to fast-track individual patients and their immediate family members, so that the people diagnosed with a terminal illness can see their families and loved ones in the limited time they have left.”

UK now has access to a total of 357 million doses of vaccines from 7 different developers

  • UK government has now secured 7 million doses of Moderna vaccine, which will be available in Europe as early as spring 2021
  • trials show vaccine is almost 95% effective
  • deal means the UK now has access to a total of 357 million doses of vaccines from 7 different developers

The UK government has signed a deal for a further 2 million doses of Moderna’s promising vaccine candidate, bringing the total to 7 million doses for the UK.

Following yesterday’s deal, the UK now has access to enough doses of Moderna’s vaccine candidate for around 3.5 million people.

To be approved for use in the UK, the Moderna vaccine must meet the strict standards of safety and effectiveness of the independent medicines regulator, the Medicines and Healthcare products Regulatory Agency (MHRA). If it is approved, 7 million doses could start to be delivered to the UK as early as spring 2021 – the same timetable as other countries in Europe.

The latest agreement is part of the government’s strategy to develop a diverse portfolio of promising vaccine candidates. The government has now secured 357 million vaccine doses from 7 different developers, giving the UK the best possible chance of protecting the public from coronavirus as soon as possible.

Business Secretary Alok Sharma said: “It is essential that we continue to bolster our portfolio of vaccine candidates to ensure we’re in the best possible position to protect the public once we see that breakthrough.

“The UK was one of the first countries in Europe to sign a deal with Moderna, and I’m delighted we have been able to secure a further 2 million doses of their promising candidate for the British public.”

On 16 November, Moderna published 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. Moderna is currently conducting phase 3 clinical trials of its vaccine and is using mRNA vaccine technology.

Until all the necessary stages are completed and a vaccine has been approved for use by the medicine regulator, the MHRA, 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 in line with the area they live in.

Health and Social Care Secretary Matt Hancock said: “Every week, we are getting more positive news about the range of vaccines in development, and thanks to the work of our taskforce the UK has pre-ordered hundreds of millions of doses from those companies most advanced in their work.

“This includes buying a further 2 million doses of Moderna’s vaccine, on top of the 5 million we’ve already secured.

“With a wide range of vaccine candidates in our portfolio, we stand ready to deploy a vaccine should they receive approval from our medicines regulator, starting with those who will benefit most.”

Chair of the government’s Vaccine Taskforce Kate Bingham said: “Since its inception in June, one of the most important stated aims of the Vaccines Taskforce has been to secure access to the most promising vaccines across a broad range of technologies – thereby increasing the chances of having a safe and effective prevention as soon as possible against COVID-19.

“Moderna’s vaccine was an important addition to our portfolio and securing an additional 2 million doses further adds to the protection we can provide to the public to end the pandemic.”

Sunday’s deal follows the independent regulator’s confirmation this week that it has received the necessary data of the Pfizer/BioNTech vaccine to progress their review into whether the vaccine meets the required standards. Encouraging results from the phase III trials of the Oxford University/AstraZeneca were also published this week.

The UK’s ability to respond to future pandemics will be strengthened thanks to a new £20 million fund to expand medicines manufacturing, Prime Minister Boris Johnson announced today (Monday 30 November).

The Prime Minister will launch the government’s new capital investment fund, the Medicines and Diagnostic Manufacturing Transformation Fund, while visiting North Wales later today.

This will open up investment opportunities for medicines manufacturers in England, Scotland and Wales – improving our domestic medicine supply chains and creating thousands of highly skilled jobs in the process.

This will put UK companies ahead of global competitors in advanced medicines manufacturing, while helping them respond to future healthcare needs – and increasing the overall health resilience of the UK.

Prime Minister Boris Johnson said: This new £20m fund will significantly increase the capacity and resilience of our medicines and diagnostics manufacturing supply chains and equip us to fight future health crises.

Throughout the pandemic we have seen a coming together of British scientific industry and innovation and this new fund will enhance the UK’s manufacturing capabilities even further.

Business Secretary Alok Sharma said: “The positive and timely response of our medicines manufacturers to the pandemic has been remarkable, but we want to ensure that the UK’s supply chains are even more resilient in the future.

There are huge opportunities for innovation in medicines and diagnostics, and this new fund will put the UK head and shoulders above others, boosting the UK’s capabilities and generating significant economic opportunities across the country.

The pandemic has shown the importance of having a strong domestic medicines and diagnostics manufacturing industry. This new fund has been established to grow and strengthen the UK’s capabilities, by encouraging companies to develop new technologies, build new factories and harness new advances, including bioprocessing, data and using greener manufacturing processes.

With two-thirds of life science manufacturing jobs already outside London and the South East, the fund will also open up economic opportunities in different parts of the UK, creating thousands of new, highly skilled manufacturing jobs while safeguarding existing jobs.

This fund will have an initial pot of £20 million, which will be available from next year, as part of the government’s 2021/2022 Spending Review announced by the Chancellor on 25 November.

Eligible manufacturing companies can bid for the fund to help with their capital costs.

More information will be made available over the coming months, ahead of the fund launching mid-next year. The fund will be run through a competitive process overseen by the Department for Business, Energy and Industrial Strategy.

“A vaccine for the world”

Oxford University vaccine shows 70% protection with single dose – and 90% with second dose

The University of Oxford, in collaboration with AstraZeneca plc, has today announced interim trial data from its Phase III trials that show its candidate vaccine, ChAdOx1 nCoV-2019, is effective at preventing COVID-19 (SARS-CoV-2) and offers a high level of protection.

The coronavirus vaccine developed by the University of Oxford stops 70% of people developing Covid symptoms, a large-scale trial has shown, and while the Oxford vaccine offers less protection than those produced by Pfizer and Moderna – both promising 95% protection – the Oxford vaccine is much cheaper and is easier to store. This gives the Oxford – AstaZeneca vaccine an advantage over the other two when trying to reach difficult to access areas across the world.

  • Phase 3 interim analysis including 131 Covid-19 cases indicates that the vaccine is 70.4% effective when combining data from two dosing regimens
  • In the two different dose regimens vaccine efficacy was 90% in one and 62% in the other
  • Higher efficacy regimen used a halved first dose and standard second dose
  • Early indication that vaccine could reduce virus transmission from an observed reduction in asymptomatic infections
  • There were no hospitalised or severe cases in anyone who received the vaccine
  • Large safety database from over 24,000 volunteers from clinical trials in the UK, Brazil and South Africa, with follow up since April
  • Crucially, vaccine can be easily administered in existing healthcare systems, stored at ‘fridge temperature’ (2-8 °C) and distributed using existing logistics
  • Large scale manufacturing ongoing in over 10 countries to support equitable global access

Professor Andrew Pollard, Director of the Oxford Vaccine Group and Chief Investigator of the Oxford Vaccine Trial, said: ‘These findings show that we have an effective vaccine that will save many lives.

“Excitingly, we’ve found that one of our dosing regimens may be around 90% effective and if this dosing regimen is used, more people could be vaccinated with planned vaccine supply. Today’s announcement is only possible thanks to the many volunteers in our trial, and the hard working and talented team of researchers based around the world.’

Professor Sarah Gilbert, Professor of Vaccinology at the University of Oxford, said: ‘The announcement today takes us another step closer to the time when we can use vaccines to bring an end to the devastation caused by SARS-CoV-2. We will continue to work to provide the detailed information to regulators.

“It has been a privilege to be part of this multi-national effort which will reap benefits for the whole world.”

Pascal Soriot, Chief Executive Officer, AstraZeneca, said: “Today marks an important milestone in our fight against the pandemic. This vaccine’s efficacy and safety confirm that it will be highly effective against COVID-19 and will have an immediate impact on this public health emergency.

“Furthermore, the vaccine’s simple supply chain and our no-profit pledge and commitment to broad, equitable and timely access means it will be affordable and globally available supplying hundreds of millions of doses on approval.”

Welcoming news of the breakthrough, Prime Minister Boris Johnson said: “This is incredibly exciting news. There are still further safety checks ahead but these are fantastic results.”

UK Government secures 5 million doses of Moderna vaccine

  • 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.”

More good news as another Covid vaccine shows impressive results

 A new vaccine that protects against Covid-19 is nearly 95% effective, early data from US company Moderna shows.

The latest news follows last week’s breakthrough announcement from Pfizer, and, while testing is still to be done, it’s looking more and more likely that vaccines to help bring an end to the pandemic will be available over coming months.

This study, known as the COVE study, enrolled more than 30,000 participants in the U.S. and is being conducted in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), and the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services.

The primary endpoint of the Phase 3 COVE study is based on the analysis of COVID-19 cases confirmed and adjudicated starting two weeks following the second dose of vaccine. This first interim analysis was based on 95 cases, of which 90 cases of COVID-19 were observed in the placebo group versus 5 cases observed in the mRNA-1273 group, resulting in a point estimate of vaccine efficacy of 94.5% (p <0.0001).

Moderna says it is a “great day” and they plan to apply for approval to use the vaccine in the next few weeks.

“This is a pivotal moment in the development of our COVID-19 vaccine candidate. Since early January, we have chased this virus with the intent to protect as many people around the world as possible”, said Stéphane Bancel, Chief Executive Officer of Moderna.

“All along, we have known that each day matters. This positive interim analysis from our Phase 3 study has given us the first clinical validation that our vaccine can prevent COVID-19 disease, including severe disease.

“This milestone is only possible because of the hard work and sacrifices of so many. I want to thank the thousands of participants in our Phase 1, Phase 2 and Phase 3 studies, and the staff at our clinical trial sites who have been on the front lines of the fight against the virus.

“They are an inspiration to us all. I want to thank the NIH, particularly NIAID, for their scientific leadership including through years of foundational research on potential pandemic threats at the Vaccine Research Center that led to the discovery of the best way to make Spike protein antigens that are being used in our vaccine and others.

“I want to thank our partners at BARDA and Operation Warp Speed who have been instrumental to accelerating our progress to this point. Finally, I want to thank the Moderna team, our suppliers and our partners, for their tireless work across research, development and manufacturing of the vaccine.

“We look forward to the next milestones of submitting for an EUA in the U.S., and regulatory filings in countries around the world, while we continue to collect data on the safety and efficacy of the vaccine in the COVE study. We remain committed to and focused on doing our part to help end the COVID-19 pandemic.”