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Friday, December 3, 2021

Moderna COVID-19 vaccine authorised by UK medicines regulator

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  • Moderna vaccine meets regulator’s strict standards of safety, efficacy and quality
  • The UK has ordered an additional 10 million doses of the vaccine, taking its total to 17 million
  • Doses available for UK from spring

The Moderna COVID-19 vaccine has been authorised for use by the medicines regulator.

The Medicines and Healthcare products Regulatory Agency (MHRA) has accepted the recommendation of the Commission on Human Medicines and authorised the Moderna vaccine following months of rigorous clinical trials involving tens of thousands of people and an extensive analysis of the vaccine’s safety, quality and effectiveness.

The vaccine is 94% effective in preventing disease, including in the elderly. The government was one of the first to sign an agreement with the company to supply the vaccine on behalf of the UK, Crown Dependencies and Overseas Territories.

The government has agreed to purchase an additional 10 million doses of the Moderna vaccine on top of its previous order of 7 million, taking the total to 17 million. As agreed when the UK originally pre-ordered the vaccine, supplies will begin to be delivered to the UK from spring once Moderna expands its production capability.

The vaccine will be available for free and the government is working with the devolved administrations to ensure it is deployed fairly across the UK.

Health and Social Care Secretary Matt Hancock said:

This is fantastic news and another weapon in our arsenal to tame this awful disease.

Through our vaccine delivery plan we have already vaccinated nearly 1.5 million people across the UK. The Moderna vaccine will boost our vaccination programme even further once doses become available from the spring.

While we immunise those most at risk from COVID, I urge everyone to continue following the rules to keep cases low to protect our loved ones.

Nearly 1.5 million people in the UK have already been vaccinated with the Pfizer/BioNTech and Oxford University/AstraZeneca vaccines, with more than 1,000 vaccination sites live by the end of the week across the UK to rapidly scale up the vaccination programme.

The Joint Committee on Vaccination and Immunisation (JCVI) will submit updated advice on which groups to prioritise for vaccination before doses become available.

Business Secretary Alok Sharma said:

Vaccines are the key to releasing us all from the grip of this pandemic, and today’s news is yet another important step towards ending lockdown and returning to normal life.

The UK was one of the first countries in Europe to sign a deal with Moderna, and I’m delighted our Vaccine Taskforce has secured an additional 10 million doses of their highly effective vaccine to protect the British public and save lives.

From the scientists and trial volunteers to our world-class regulators and clinicians, we are enormously grateful to everyone who has played their part in this national effort to defeat the virus and get our country back on its feet.

The NHS has decades of experience in rolling out successful widespread vaccination programmes and is putting into place extensive preparations for the roll-out of the Moderna vaccine ahead of the spring.

The Moderna vaccine will be deployed through similar methods:

  • hospital hubs for NHS and care staff and older patients to get vaccinated

  • local community services with local teams and GPs already signing up to take part in the programme

  • vaccination centres across the country, ensuring people can access a vaccine regardless of where they live

Vaccine Deployment Minister Nadhim Zahawi said:

The NHS is pulling out all the stops to vaccinate those most at risk as quickly as possible, with over 1,000 vaccination sites live across the UK by the end of the week to provide easy access to everyone, regardless of where they live.

The Moderna vaccine will be a vital boost to these efforts and will help us return to normal faster.

Through the Vaccines Taskforce, the UK has secured early access to 367 million doses of 7 of the most promising vaccines so far. To date, the government has invested over £230 million into manufacturing a successful vaccine. In the Chancellor’s Spending Review, published on 25 November, it was announced that the government has made more than £6 billion available to develop and procure successful vaccines.

Deputy Chief Medical Officer for England Professor Jonathan Van-Tam said:

The highly effective Moderna vaccine is another impressive success for science and is another testament to the hard work of researchers and selfless clinical trial volunteers.

This vaccine will save lives once doses become available, but it is crucial we all continue to follow the rules to protect each other until enough people have been protected.

Interim Chair of the government’s Vaccines Taskforce Clive Dix said:

This is another important milestone in our efforts to end this pandemic, and I would like to thank those in the government’s Vaccine Taskforce who have worked so hard to negotiate agreements with vaccine developers.

A key objective for the Vaccine Taskforce is to ensure we have a range of vaccines to deliver to the UK population. The addition of the Moderna vaccine to the UK’s portfolio is important to reach that goal.

Background information

The Pfizer/BioNTech and Oxford/AstraZeneca vaccines are being rolled out to priority groups. The full prioritisation list can be found here and is as follows (in order of priority):

  1. Residents in a care home for older adults and their carers
  2. All those 80 years of age and over and frontline health and social care workers
  3. All those 75 years of age and over
  4. All those 70 years of age and over and clinically extremely vulnerable individuals
  5. All those 65 years of age and over
  6. All individuals aged 16 years to 64 years with underlying health conditions which put them at higher risk of serious disease and mortality
  7. All those 60 years of age and over
  8. All those 55 years of age and over
  9. All those 50 years of age and over

Vaccination will be managed by the health services in each nation:

  • NHS England and NHS Improvement
  • NHS Wales
  • NHS Scotland
  • Health and Social Care Northern Ireland

Through the government’s Vaccines Taskforce, the UK has secured early access to 367 million doses of 7 of the most promising vaccine candidates, including:

  • BioNTech/Pfizer for 40 million doses

  • Oxford/AstraZeneca for 100 million doses

  • Moderna for 17 million doses

  • GlaxoSmithKline and Sanofi Pasteur for 60 million doses

  • Novavax for 60 million doses

  • Janssen for 30 million doses

  • Valneva for 60 million doses

UK vaccine manufacturing

The UK government invested £100 million to fund a state-of-the-art manufacturing innovation centre in Braintree, Essex, in collaboration with the Cell and Gene Therapy Catapult, to accelerate the mass production of a successful COVID-19 vaccine in the UK. Due to open in December 2021, the centre will have the capacity to produce millions of doses of vaccines each month, ensuring the UK has the capabilities to manufacture both vaccines and advanced medicines, including for emerging diseases, far into the future.

The government has also provided £4.7 million funding to the Catapult to ensure that the UK has the best skills and expertise in vaccine manufacturing and advanced therapies.

The government has created the UK’s first dedicated Vaccine Manufacturing and Innovation Centre (VMIC) and accelerated its development with £93 million of investment. This investment will rapidly accelerate the construction of the facility, enabling us to bring it online sooner. It will also have expanded capability for advanced vaccine process development, fill and finish and bulk manufacture. In addition, the facility’s capacity will be significantly increased to be able to respond to this pandemic. Once open, it will be able to manufacture 70 million vaccines doses in just 6 months – enough for the UK population. Located in Oxfordshire, the centre will be the UK’s first not-for-profit organisation established to develop and advance the mass production of vaccines. This will boost the UK’s long-term capacity against future viruses.

While VMIC is being built, the government established a Rapid Deployment Facility with £8.75 million of investment to manufacture at scale.

The government has made a multi-million-pound investment in a manufacturing facility in Scotland, creating a major UK vaccine facility and to support rapid scale-up if its candidate is successful. This unique facility will establish a permanent UK capability to manufacture inactivated viral vaccines – one of the most proven, widely used vaccine formats. It is one of few Biosafety Level 3 (BSL3) containment facilities in Europe and has the capacity to produce up to 200 million doses of COVID-19 viral vaccines in 2021.

(Source)

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