Novavax has received the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) conditional marketing authorisation (CMA) for Nuvaxovid, its recombinant, adjuvanted Covid-19 vaccine.
Also known as NVX-CoV2373, the vaccine has been authorised for active immunisation in people aged 18 years and above in Great Britain.
The biotechnology company said that its Nuvaxovid is the first protein-based vaccine to receive regulatory authorisation for use in Great Britain.
Novavax president and chief executive officer Stanley Erck said: “We are proud that Nuvaxovid will be the first protein-based vaccine option authorised by MHRA as the United Kingdom tackles this next phase of the pandemic.
“We thank the agency for its thorough review process and are tremendously grateful to the clinical trial participants and trial sites in the UK, as well as the Vaccines Taskforce, for their ongoing support and vital contributions to this program.”
In a separate development, Novavax has also won New Zealand’s Medsafe provisional approval for use of its Nuvaxovid Covid-19 vaccine in people 18 years and above.
The MHRA authorisation, and Medsafe provisional approval, both were based on the totality of quality, safety, and efficacy data, the company has submitted for review.
The data includes two ongoing Phase 3 clinical trials, PREVENT-19 in around 30,000 participants in the US and Mexico, and another trial in almost 15,000 participants in the UK.
In the two clinical trials, the vaccine showed efficacy with an encouraging safety profile.
Novavax has previously reached an advance purchase agreement (APA) with the New Zealand government for 10.7 million doses of its Covid-19 vaccine.
The provisional approval bets on Novavax’ manufacturing partnership with Serum Institute of India (SII), which will supply initial doses to New Zealand, under their APA.
Novavax president and chief executive officer Stanley Erck said: “The provisional approval of Nuvaxovid by Medsafe will enable Novavax to deliver the first protein-based Covid-19 vaccine to New Zealand.
“We thank Medsafe for its thorough review and, as the pandemic continues to evolve, we remain committed to supporting New Zealand and the world in the fight against Covid-19.”
NVX-CoV2373 has received conditional marketing authorisation in the European Union (EU), WHO emergency use listing (EUL), and provisional registration in Australia.
Also, the vaccine is currently being reviewed by multiple regulatory agencies worldwide, including the US Food and Drug Administration (FDA).
