First to Demonstrate Clinical Efficacy Against COVID-19 and Both UK and South Africa Variants
- Strong efficacy in Phase 3 UK trial with over 50% of cases attributable to the now-predominant UK variant and the remainder attributable to COVID-19 virus
- Clinical efficacy demonstrated in Phase 2b South Africa trial with over 90% of sequenced cases attributable to prevalent South Africa escape variant
Novavax, Inc. , a biotechnology company developing next-generation vaccines for serious infectious diseases, yesterday announced that NVX-CoV2373, its protein-based COVID-19 vaccine candidate, met the primary endpoint, with a vaccine efficacy of 89.3%, in its Phase 3 clinical trial conducted in the UK.
The study assessed efficacy during a period with high transmission and with a new UK variant strain of the virus emerging and circulating widely.
It was conducted in partnership with the UK Government’s Vaccines Taskforce.
Novavax also announced successful results of its Phase 2b study conducted in South Africa.
Stanley C. Erck, President and Chief Executive Officer, Novavax, said: “With today’s results from our UK Phase 3 and South Africa Phase 2b clinical trials, we have now reported data on our COVID-19 vaccine from Phase 1, 2 and 3 trials involving over 20,000 participants.
“In addition, our PREVENT-19 US and and Mexico clinical trial has randomized over 16,000 participants toward our enrollment goal of 30,000. NVX-CoV2373 is the first vaccine to demonstrate not only high clinical efficacy against COVID-19 but also significant clinical efficacy against both the rapidly emerging UK and South Africa variants.”
“NVX-CoV2373 has the potential to play an important role in solving this global public health crisis. We look forward to continuing to work with our partners, collaborators, investigators and regulators around the world to make the vaccine available as quickly as possible.”
Prime Minister Boris Johnson tweeted: “Good news that the @Novavax vaccine has proved effective in UK trials. Thank you to all the volunteers who made these results possible.
“Our medicines regulator will now assess the vaccine, which will be made in Teesside. If approved, we have 60m doses on order.”
The UK has so far approved three coronavirus vaccines for emergency use – one from Oxford University and AstraZeneca, another by Pfizer and BioNTech, and a third from Moderna.
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 yesterday 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 7 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.