Tag: Moderna

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.

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.”