Teesside Novavax vaccine becomes first protein-based Covid jab authorised in UK

• Live report from our Health Correspondent Helen Ford.

The Novavax vaccine has been approved for use by the Medicines and Healthcare products Regulatory Agency (MRHA) after meeting the required safety, quality and effectiveness standards.

Novavax previously announced an agreement for up to 60 million doses.

The authorisation was based on data including an ongoing pivotal Phase 3 trial conducted in the UK with almost 15,000 participants.

Their approval of the vaccine will allow the Billingham-based drugs company, Fujifilm, to actively immunize people over the age of 18 to prevent Covid-19.

In a statement, the company said: "We are all immensely proud to be part of this endeavour, and across our network we continue to work hard to support Novavax to advance the manufacturing and supply of Nuvaxovid for patients."

President of Novavax, Stanley C. Erck added: "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."

The MHRA decision was based on the totality of preclinical, clinical, and chemistry, manufacturing and controls (CMC) data reviewed by the agency.

This includes two pivotal ongoing Phase 3 clinical trials:

• PREVENT-19 which enrolled approximately 30,000 participants in the U.S. and Mexico, the results of which were published in the New England Journal of Medicine (NEJM)

• Trial with almost 15,000 participants in the U.K., the results of which were also published in NEJM

In both trials, the vaccine demonstrated efficacy with a reassuring safety profile. Serious and severe adverse events were low in number and balanced between vaccine and placebo groups.

The most common adverse reactions observed during clinical studies were headache, nausea or vomiting, myalgia, arthralgia, injection site tenderness/pain, fatigue, and malaise.

Novavax says it will continue to collect and analyse the data, and will continue monitoring the safety and the evaluation of variants, as the vaccine is distributed.