Novavax has received full marketing authorisation from the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) for its prototype Covid-19 vaccine Nuvaxovid (NVX-CoV2373).
The vaccine is approved for individuals aged 12 years and above for active immunisation to prevent Covid-19.
MHRA authorised the vaccine based on data from two Phase III studies, PREVENT-19 carried out in the US and Mexico, a Phase III study in the UK and a Phase IIa/b trial in South Africa.
Novavax has shown the safety and efficacy of its prototype vaccine as a primary series in individuals aged 12 and above, along with its safety and immunogenicity as a booster in those aged 18 and above.
The protein-based vaccine NVX-CoV2373 is produced by creating copies of the surface spike protein of the SARS-CoV-2 virus that causes Covid-19.
With the recombinant nanoparticle technology of Novavax, the non-infectious spike protein acts as the antigen that primes the immune system to recognise the virus.
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The vaccine comes in a liquid form that is ready for use and should be stored between 2°C and 8°C.
Novavax president and CEO John Jacobs stated: “Full marketing authorisation of our prototype Covid-19 vaccine in the UK is a stepping stone to enable authorisation of updated strains of our vaccine in the future.
“We are working with the MHRA to provide the information needed for the rapid review of our updated protein-based non-mRNA Covid-19 vaccine as an important step to ensuring access to vaccine options in the UK this coming vaccination season.”
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