Novavax Covid jab approved by UK drugs regulator


Novavax Covid jab approved by UK drugs regulator

By Jim Reed
Health reporter

Published
Related Topics

Image source, Reuters

The UK has approved a fifth Covid-19 vaccine, developed by US company Novavax, which offers up to 89% protection against Covid illness.

The Medicines and Healthcare products Regulatory Agency has said it is safe as a first and second dose in adults.

Millions of doses are currently being manufactured at a plant on Teesside.

Health Secretary Sajid Javid says independent scientists on the Joint Committee on Vaccination and Immunisation will now consider its use.

‘Invaluable research’

The vaccine could then be used immediately as part of the UK vaccination programme.

But, with more than 91% of the UK population already double vaccinated, it is more likely to be used later in the year as part of a possible autumn or winter booster rollout.

Before that can happen, the company would need additional authorisation from the medicines regulator.

“It’s a testament to the country’s first-rate research and development capabilities for vaccines,” Mr Javid said, “with tens of thousands of people taking part in clinical trials here in the UK, contributing to the invaluable research that shows our vaccines are safe and effective.”

The Novavax product – known by the brand name Nuvaxovid – was shown to be 89% effective against catching symptomatic Covid-19 in clinical trials.

The original research was conducted against both the earlier Wuhan and Alpha variants of the virus.

Image source, PA
Image caption,

Politicians – including then Vaccines Minister Nadhim Zahawi, Communities Minister Kemi Badenoch (pictured) and Labour MP Naz Shah – were among volunteers in the UK part of the Novavax trial

In December, Novavax said two doses were also effective in generating an immune response against the now dominant Omicron variant, first identified in South Africa.

The company has also started working on a version specific to Omicron.

MHRA chief executive Dr June Raine, 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.”

Immune response

The jab, a protein adjuvant vaccine, is based on technology used for decades to protect people from diseases such as hepatitis and shingles.

It delivers copies of the spike protein on the surface of the virus directly into a person’s cells, stimulating the immune system to produce antibodies and T-cells.

An extra ingredient, an adjuvant, then helps boost the immune response.

Scientists say this approach makes it simpler to produce than some other vaccines and means it can be stored in a refrigerator.

Prof Sir Munir Pirmohamed, who chairs the independent Commission on Human Medicines, said: “Nuvaxovid is distinct from other Covid-19 vaccines currently in use in the UK as it uses recombinant protein-based technology which has been used for many years in the development of vaccines to prevent other illnesses, for example hepatitis B.”

Manufacturing setbacks

In August 2020, the government agreed to buy 60 million doses and support the final – or phase-three – trials of the jab.

And a factory in Billingham, Stockton-on-Tees, has been producing a key ingredient of the vaccine since February 2021.

But setbacks to the approval process around the world have led to concerns about jobs in the area.

Novavax had to delay its submission to US regulators multiple times because of development and manufacturing setbacks.

It was eventually filed on Monday.



Source link