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news.Novavax has received expanded conditional marketing authorisation (CMA) from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) for its Covid-19 vaccine, Nuvaxovid (NVX-CoV2373).
Novavax’s Covid-19 vaccine Nuvaxovid is approved for use in adolescents aged 12 to 17 years. Credit: Novavax.
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The vaccine has been authorised for use in adolescents aged 12 to 17 years.
The protein-based vaccine, Nuvaxovid is engineered from the genetic sequence of the initial SARS-CoV-2 virus strain.
It has been developed using the company’s recombinant nanoparticle technology.
The expanded regulatory authorisation was based on the data obtained from the ongoing paediatric expansion of the randomised, placebo-controlled, observer-blinded Phase III PREVENT-19 (the PRE-fusion protein subunit Vaccine Efficacy Novavax Trial | Covid-19) trial.
This trial was designed to assess Nuvaxovid’s effectiveness, efficacy, and safety in 2,247 subjects aged 12 to 17 years in 73 sites located in the US.
The vaccine showed 80% efficacy when the Delta variant of concern was the predominant circulating strain in the US and has also achieved its primary effectiveness endpoint, in the paediatric expansion trial.
Headache, fatigue, tenderness/pain, malaise, and myalgia were the most common adverse reactions observed.
Novavax president and CEO Stanley Erck said: “As we start to prepare for a potential fall surge, we are pleased to offer the first protein-based Covid-19 vaccine to adolescents aged 12 through 17 in the UK.
“We believe that our vaccine, developed using an innovative approach to traditional technology, may help increase adolescent vaccination rates.”
The Covid-19 vaccine has been previously approved for use in people aged 12 to 17 years in Australia, New Zealand, Japan, India, Thailand, the European Union, and the US.
In February this year, Nuvaxovid received CMA from MHRA for use in adults aged 18 years and above.
