Novavax FINALLY applies for FDA authorization for long awaited Covid vaccine

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Novavax FINALLY applies for FDA authorization for long awaited Covid jab that is believed to be the most effective yet

  • Novavax has finally submitted data to the FDA for its long awaited COVID-19 vaccine to receive regulatory authorization
  • The two-dose shot has been lauded for its safety and effectiveness, though it has faced repeated delays
  • Clinical trials show the shot is 90% effective at preventing symptomatic Covid infection, but data was collected before the emergence of the Omicron variant
  • If authorized, the Novavax shot will be the first protein based Covid jab to be used in the U.S. 


Another vaccine may soon be added to America’s arsenal in the fight against COVID-19, as Novavax announced it submitted data to the Food and Drug Administration (FDA) for its Covid vaccine.

The long awaited shot was expected to roll out in 2021 but faced repeated delays over the past year, which the company blames on supply issues.

Now, the company has finally prepared data to submit to regulators which shows its two-shot vaccine is 90 percent effective against the virus – though the data was collected before the discovery of the vaccine resistant Omicron variant late last year. 

The jab has been lauded as the safest and most effective yet after initial trials, and it is a ‘protein based’ vaccine that introduces a person’s immune system to inactive virus cells – similar to the flu shot and many other common vaccines – in order to mount a response.

Novavax has submitted data for its two-shot COVID-19 vaccine to the FDA in a bid to received FDA emergency use authorization to be used in the U.S. (file photo)

Novavax has submitted data for its two-shot COVID-19 vaccine to the FDA in a bid to received FDA emergency use authorization to be used in the U.S. (file photo)

In clinical trials, the vaccine showed that it was 90% effective at preventing at preventing symptomatic Covid infection. Trials were performed before the emergence of the Omicron variant, though

In clinical trials, the vaccine showed that it was 90% effective at preventing at preventing symptomatic Covid infection. Trials were performed before the emergence of the Omicron variant, though

‘We’re extremely proud of the work of our teams and we look forward to FDA’s review of our [emergency use authorization] request,’ Novavax CEO Stanley Erck said in a statement. 

‘We believe our vaccine offers a differentiated option built on a well-understood protein-based vaccine platform that can be an alternative to the portfolio of available vaccines to help fight the COVID-19 pandemic.’

The company published Phase 3 trial findings in the New England Journal of Medicine. 

Trials included 30,000 participants across the U.S. and Mexico, and a second 15,000 participant trial in the UK.

Both trials were conducted in late 2020 and early 2021, meaning they were before the rise of the Omicron variant. The company did not provide any information in the study or in the relevant statement about the jab’s interaction with Omicron. 

DailyMail.com reached out to Novavax for information about whether the shot is effective against the new strain and did not immediately receive a response.

The first trial in North America found that the vaccine had 90.4 percent effectiveness at preventing symptomatic Covid infection. The UK study found the jab had an effectiveness of 89.7 percent.  

Effectiveness against Omicron may be key to whether the jab receives authorization, though, as the FDA has shown it is willing to pull approval from treatments that are effective against other strains but not this one. 

Novavax notes that the most prevalent adverse reactions to the jab in trials was headaches, nausea or vomiting, myalgia, arthralgia, injection site tenderness/pain, fatigue, and malaise. 

The Novavax vaccine has been highly anticipated due to its high efficacy, and more standard approach of vaccination.

Some that are fearful of the mRNA technology in the Pfizer-BioNTech and Moderna vaccines may be willing to take.

‘In the US, the primary market I think in 2022 is going to be to supply a vaccine, our normal two-dose regimen, to a lot of people who have been hesitant to get other vaccines,’ Erck told CNN in November. 

The vaccine can also be stored in temperatures as high as 45F, making it much easier to transport the jab – especially in developing nations.

The company faced production issues in recent months, causing the delays.

If the jab does receive FDA authorization, it will be the fourth to do so in the U.S., and the third two-shot jab.

The Pfizer-BioNTech vaccine and now the Moderna vaccine – which received approval Monday – are the only two shots that have received full approval from the FDA.

The company has also been working on a new flu shot that can be a part of the Covid vaccine regimen. 

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