MHRA issues CMA for Novavax COVID-19 vaccine

Novavax has announced that the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has issued a conditional marketing authorisation for its Nuvaxovid COVID-19 vaccine, which offers up to 89% protection against COVID-19.

The US Food and Drug Administration (FDA) has not yet issued an authorisation for Nuvaxovid’s use in the US.

The MHRA has confirmed that it is safe as a first and second dose in people aged 18 years and over, making this the fifth COVID-19 vaccine to be approved in the UK. It is also the first protein-based vaccine approved for use in the UK.

Novavax – a US biotechnology company known for developing and commercialising vaccines for infectious diseases – has an agreement with the UK Vaccines Taskforce to supply up to 60 million doses of Novavax' COVID-19 vaccine.

UK health secretary Sajid Javid said: “The next step will be for the independent Joint Committee on Immunisation and Vaccination to consider its use as part of the UK COVID-19 vaccination programme.” Following this, the vaccine could then be used as part of the UK vaccination programme.

The MHRA based its authorisation on two trials – PREVENT-19 which enrolled approximately 30,000 people in the US and Mexico and a separate trial involving around 15,000 participants in the UK. The results of both trials were published in the New England Journal of Medicine.

Speaking on behalf of the regulator, June Raine, MHRA’s chief executive, said: “Our approval of Nuvaxovid follows a rigorous review of the safety, quality and effectiveness of this vaccine and expert advice from the government’s independent scientific advisory body, the Commission on Human Medicines.”

Stanley Erck, president and chief executive officer, Novavax, said: "Nuvaxovid will be the first protein-based vaccine option authorised by MHRA as the United Kingdom tackles this next phase of the pandemic.”