Novavax Covid vaccine could be approved for use in UK

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A new coronavirus vaccine could be approved for use in the UK within weeks in what is being described as a “medical breakthrough”.

Late-stage trials of the novavax vaccine suggested it was 89 per cent effective in preventing coronavirus.

The UK has secured 60 million doses of the Novavax jab – to be produced on Teesside – which is believed to offer protection against the new UK and South African variants.

It was shown to be 89.3% effective at preventing coronavirus in participants in its Phase 3 clinical trial in the UK, which involved more than 15,000 people aged between 18-84, of which 27% were older than 65, Novavax said.

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The vaccine will now be assessed by the Medicines and Healthcare products Regulatory Agency (MHRA), Prime Minister Boris Johnson confirmed, as he thanked volunteers who made the results possible.

Stan Erck, chief executive of Novavax, told the BBC the manufacturing plant in Stockton-on-Tees should be up and running by March or April, with the company hoping to get approval for the vaccine from the MHRA around the same time.

Good news that the @Novavax vaccine has proved effective in UK trials. Thank you to all the volunteers who made these results possible.

Our medicines regulator will now assess the vaccine, which will be made in Teesside. If approved, we have 60m doses on order.

— Boris Johnson (@BorisJohnson) January 28, 2021

Health Secretary Matt Hancock said the NHS stands ready to roll out the vaccine if it is approved, which he said would provide a “significant boost to our vaccination programme and another weapon in our arsenal to beat this awful virus”.

The chairman of the Government’s Vaccine Taskforce, Clive Dix, said the results were “spectacular”, adding: “The efficacy shown against the emerging variants is also extremely encouraging.

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“This is an incredible achievement that will ensure we can protect individuals in the UK and the rest of the world from this virus.”

The jab has shown around 60% effectiveness against the South African variant, which has been worrying scientists due to concerns vaccines may not work against it, but it offered 86% protection against the new UK strain.

Two vaccines have already been rolled out in the UK – from Pfizer and Oxford/AstraZeneca – while a third from Moderna has been approved for use.

The Novavax jab would be delivered in the second half of 2021 if it receives MHRA approval.

How does the vaccine work?

The Novavax vaccine works like other vaccines by teaching the immune system to make antibodies to the coronavirus spike protein.

Researchers inserted a modified gene into a virus, called a baculovirus, and allowed it to infect insect cells.

Spike proteins from these cells were then assembled into nanoparticles which, while they look like coronavirus, cannot replicate or cause Covid-19.

These nanoparticles are then injected into the body via the vaccine where the immune system mounts an antibody response.

If the body encounters coronavirus in the future, the body is primed to fend it off.

Are there advantages of the Novavax vaccine?

Yes. While the jabs from Pfizer/BioNTech and Moderna need to be kept at ultra-low temperatures, the Novavax jab is stable for up to three months in a normal fridge.

The jab should be available in the second half of this year and is being manufactured in Teeside.

Was the jab tested in the UK?

Yes. More than 15,000 people in the UK took part in the clinical trial, which was supported by the UK National Institute for Health Research.

Some 27% of those in the UK were over the age of 65.

The study assessed how effective the vaccine was when transmission of Covid-19 was high in the UK, and with the variant strain identified in the UK circulating widely.

The analysis, based on the first 62 cases of Covid-19 identified in the trial, reported 56 cases in people given a placebo (dummy) vaccine while six cases were in those given the vaccine.

More than 50% of cases related to the UK strain of the virus, with the vaccine offering 86% protection against this strain.

Against the original strain that has circulated since the start of the pandemic, the vaccine was 96% effective.

What about the South Africa strain?

Data from more than 20,000 people, including a trial in South Africa, has now been reported.

In the South African arm of the trial, where most cases of Covid-19 were the South African strain, the jab was 60% effective in preventing mild, moderate and severe coronavirus among those without HIV.

Including the HIV positive participants, whose immune systems are compromised, overall the protection was just over 49%.

Scientists continue to be concerned about the South African strain of the virus and one that emerged in Brazil, with the expectation that these strains will not work as well with current vaccines.

Novavax plans to immediately begin development on a vaccine specifically targeted to the South African variant.

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