UK approves Novavax's jab for novel coronavirus

The United Kingdom drug regulator has approved a COVID-19 vaccine from United States pharmaceutical company Novavax, becoming the fifth jab to get the green light in the UK, and the first protein-based shot to enter the market.

The UK Medicines and Healthcare products Regulatory Agency, or MHRA, granted regulatory approval for use in adults aged 18 and above, after the jab, which is called Nuvaxovid, was deemed safe and conferred 89.7 percent protection against infection in a phase-3 trial of 15,000 participants in Britain.

That study, which was published in the New England Journal of Medicine, followed on from a separate late-stage trial of 30,000 participants in the US and Mexico, which achieved 90.4 percent efficacy overall.

The UK has already ordered 60 million doses of the vaccine, which is administered in a two-dose regimen, 21 days apart.

"It is great to see our world-renowned medicines regulator approve another COVID-19 vaccine," said UK Health Secretary Sajid Javid. "The next step will be for the independent Joint Committee on Vaccination and Immunisation to consider its use as part of the UK COVID-19 vaccination program."

Nuvaxovid has gained approval in several countries over the last few months including South Africa, India, South Korea and Australia, and Novavax has submitted the treatment for approval to US regulators.

The company is poised to emerge as one of the largest distributors of COVID-19 vaccines in 2022, with plans to manufacture 2.44 billion doses. This would place it in the top five manufacturers this year, along with Pfizer (4.1 billion), Sinovac (1.88 billion), Sinopharm (1.85 billion) and AstraZeneca (1.75 billion), according to projections provided to China Daily by science consultancy Airfinity.

Novavax was bookmarked last year as one of the most promising COVID-19 treatments, following encouraging results in early trials. The jab has a long shelf life of nine months, and does not require ultracold storage. This makes the treatment ideal for distribution in the developing world, and the COVAX vaccine equity project reserved 350 million shots in May 2021.

However, development of the jab has been significantly delayed. Novavax is a relatively small company, and a number of supply and manufacturing issues pushed distribution back to 2022.

The shot from Novavax is the first protein-based COVID-19 vaccine to gain approval in the UK, and experts say that having different varieties of jabs is key to maintaining robust protection in populations against the novel coronavirus. Already in use in treatments for other diseases including Hepatitis B, the technology involves injecting a protein into the body that encourages an immune response, rather than introducing genetic material, as is the case in mRNA vaccines, or using inactivated virus, as seen in several currently available COVID-19 jabs.

June Raine, MHRA chief executive, said the approval followed a "rigorous review of the safety, quality and effectiveness of this vaccine".

Novavax said that serious side effects to the vaccine were low in clinical trials, and the most commonly-reported reactions included headache, nausea or vomiting, muscle pain, joint stiffness, injection site tenderness and fatigue.