FDA advisory panel gives near-unanimous recommendation to Novavax’s COVID-19 vaccine

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BREAKING: FDA advisory panel gives near-unanimous recommendation to Novavax’s protein-based COVID-19 vaccine – the first of its kind

Novavax’s Covid vaccine received unanimous approval for use in adults over 18 years old this afternoon, paving the way for it to become the fourth jab rolled out in America.

Every voting member of the Food and Drug Administration’s (FDA) advisory committee gave the green-light to the jab at a meeting this afternoon.

It will now go to health chiefs at the agency, who are expected to rubber-stamp the shot in the next few days. The Centers for Disease Control and Prevention (CDC) will also need to approve it before it can be rolled out to pharmacies.

America has ordered more than 300million doses of the vaccine from the Maryland-based company.

But it is unclear how these will be deployed given that more than seven in ten Americans are already double-vaccinated against the virus.

Clinical trials found the jab was more than 90 percent effective against older variants, but it is yet to be tested against the now-dominant Omicron.

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Unlike Pfizer and Moderna’s shots it uses the same protein-based technology as flu vaccines, which expose the immune system to spike proteins from the virus.

Some experts hope that approving the vaccine will give the hardest to reach vaccine sceptics — or 27million un-jabbed Americans — the confidence to come forward. 

FDA advisory panel gives near-unanimous recommendation to Novavax’s COVID-19 vaccine

Novavax requested authorization for its shot to be used in the U.S. in January as a first course of vaccination.

It has not requested for its shot to be used as a booster, or to vaccinate age groups below the age of 18 years.

Other countries including India, Australia, the UK and many other countries have already approved the jab, although it has not been widely rolled out. 

In the meeting today 21 members of the committee — called the Vaccines and Related Biological Products Advisory Committee (VRBPAC) — said the jab should be approved.

Only one individual — who did not have voting rights — abstained, but said they would have liked to vote a provisional yes if that was possible.

Responding to today’s recommendation Dr Eric Rubin, an immunologist and member of VRBPAC, said: ‘In the U.S. there has been a lot of anxiety that has prevented some from getting life-saving vaccines.

‘I hope that the availability of a different option, that is more similar to existing vaccines, will make it easier for people to make the right choice.’

Dr Peter Marks, the FDA director for vaccine approval, said: ‘We do have a problem with vaccine uptake that is very serious in the United Stqates.

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‘Anything we can do to get people more comfortable to be able to accept these potentially lifesaving medical products is something that we feel we are compelled to do.’ 

Phase three trials by Maryland-based Novavax of more than 15,000 people in the UK found the jab had an efficacy rate of 96.4 against mild, moderate and severe disease caused by the original coronavirus strain.

Meanwhile, a trial of the vaccine on 30,000 people in the US and Mexico found it gave 100 per cent protection against moderate and severe disease.

EVERYTHING YOU NEED TO KNOW ABOUT THE NOVAVAX COVID VACCINE THAT PREVENTED MORE THAN 90% OF PEOPLE FALLING ILL

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. 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. The vaccine is given as two doses.

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.

It was also shown to cause less side effects than other Covid jabs.

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It also uses a more established technology that vaccine sceptics might trust. 

How effective is the vaccine?

Phase three trials by Maryland-based Novavax of more than 15,000 people in the UK found the jab had an efficacy rate of 96.4 against mild, moderate and severe disease caused by the original coronavirus strain. 

Meanwhile, a trial of the vaccine on 30,000 people in the US and Mexico found it gave 100 per cent protection against moderate and severe disease.  

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