Novavax publishes positive efficacy data for its Covid-19 vaccine

Novavax today published positive data from the UK phase 3 study of its COVID-19 vaccine candidate, showing it to be 89.3% effective in preventing coronavirus in participants.

The study was conducted during the period the new Covid-19 variant was first observed in Kent and began to circulate widely, with today’s results showing it was effective against the variant during the phase 3 trial.

Thanks to the work of the Government’s Vaccines Taskforce, the UK has secured 60 million doses of Novavax’s vaccine to be delivered in the second half of this year, if approved for use by the Medicines and Healthcare products Regulatory Agency (MHRA), who will assess whether the vaccine meets robust standards of safety, effectiveness and quality.

Last August Novavax announced plans to manufacture the bulk of the vaccine using FUJIFILM Diosynth Biotechnologies’s facilities in Billingham, Stockton-on-Tees. This will ensure that, once available, the vaccine can be supplied to the British public as soon as possible.

Business Secretary Kwasi Kwarteng said:

“The results from the UK trial of Novavax’s vaccine look extremely promising, and I welcome the news that the company is planning to submit its data to the regulators.

“The UK moved quickly to procure 60 million doses from Novavax and I’m pleased to confirm the bulk of the vaccine will be manufactured on Teesside and delivered during this year, if approved for use.

“From the scientists and researchers to the thousands of UK trial volunteers, I am enormously grateful to everyone who is playing their part in this truly national effort to defeat this virus once and for all.”

Health Secretary Matt Hancock said

“This is positive news and, if approved by the medicines regulator, the Novavax vaccine will be a significant boost to our vaccination programme and another weapon in our arsenal to beat this awful virus.

“I’m proud the UK is at the forefront of another medical breakthrough and I want to thank the brilliant scientists and researchers, as well as the tens of thousands of selfless volunteers who took park in clinical trials.

“The NHS stands ready to roll this vaccine out as quickly as possible to those most at risk if it is authorised.”

Vaccines Minister Nadhim Zahawi said:

“Having taken part in Novavax’s vaccine trial myself, I am particularly thrilled to see such positive results. I want to thank the thousands of trial volunteers, without whom these results would not have been possible.

“It will now be for the regulator to do its crucial work in assessing the efficacy and safety of this vaccine, but if approved it will be a further boost to our vaccination programme.”

Novavax’s candidate differs from those currently being used in the UK, combining an engineered protein from the virus that causes Covid-19 with a plant-based ingredient to help generate a stronger immune response. Having a diverse portfolio of vaccines increases the chances of ensuring there is a vaccine available for everyone across the UK.

The data published today come from more than 15,000 people who were recruited through the National Institute of Health Research vaccine registry, which was launched in July 2020 to support the UK’s efforts to deliver vaccines for Covid-19. Nearly 4,000 people in the study were over the age of 65.

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 7.4 million people across the UK have now had a least one dose of the vaccine.

ENDS

Notes to editors

• The Government’s vaccine supply and scheduled deliveries will fully support our target of offering a first vaccine dose to every person in the top four priority groups by mid-February.
• The members of the Joint Committee on Vaccination and Immunisation (JCVI) are independent experts who advise the UK on prioritisation at a population level for all vaccination and immunisation programmes; they have developed the prioritisation list of patient groups that is guiding the NHS vaccination programme and the committee keeps its advice under review and updates it as appropriate.
• The Government has a set process for approving any vaccine, with regulatory oversight provided by the MHRA. This involves MHRA approving a product licence after the applicant has generated appropriate data to demonstrate the quality, safety and efficacy of the vaccine.
• In total, the Government has procured 60 million doses of the Novavax candidate, the bulk of which will be manufactured in the UK if the vaccine is approved by regulators.
• Through the Government’s Vaccine Taskforce, the UK has secured early access to 367 million doses of 7 of the most promising vaccine candidates, including:
• • BioNTech/Pfizer – Approved - 40 million doses secured
  • Oxford/Astra Zeneca – Approved - 100 million doses secured
  • Moderna – Approved - 17 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.
• The UK Government has invested £127 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 established a Rapid Deployment Facility with £8.75 million of investment which is manufacturing vaccines at scale.
• The Government has also 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.