Novavax bets fears over mRNA know-how will give its Covid jab an edge


Novavax mentioned its protein-based Covid-19 vaccine shall be a robust competitor to the BioNTech/Pfizer and Moderna jabs regardless of its late arrival due to public issues over the protection of its rivals’ messenger RNA know-how.

However the US biotech, which started transport its vaccine to Europe and Asia in January following months of lengthy delays due to regulatory challenges, has referred to as on Washington to do extra to advertise its vaccine, which has nonetheless not been authorised by US regulators.

“I might love to listen to extra public help from the US authorities and I don’t know whether or not they’ve been too concerned in among the different vaccines or they’ve been too busy,” mentioned Stan Erck, chief govt of Novavax, including US authorisation for its jab may occur “inside weeks”.

The World Well being Group, the UK, EU and Australia are amongst virtually a dozen international locations and organisations to approve Novavax’s two-dose jab, which is the primary vaccine launched by the corporate in its 34-year historical past. Novavax plans to ship 2bn doses in 2022, which analysts’ forecast may generate $5bn in revenues — a transformational occasion for a biotech that has been a perennial loss maker.

However the firm has struggled to supply knowledge to US regulators that exhibit it may well manufacture jabs in a constant method. This has triggered delays to the roll out of its vaccine, which scientific trials present has 90 per cent efficacy towards symptomatic Covid-19. It adopted the award of US authorities contracts value $1.8bn to Novavax to develop its vaccine and provide 100m doses.

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Stan Erck at a gathering with the Coronavirus Activity Pressure and pharmaceutical executives on the White Home in March 2020

Erck advised the Monetary Instances these issues had been resolved and Novavax would quickly start transport doses to the US from its manufacturing associate, the Serum Institute of India. He mentioned there may be nonetheless loads of demand for the corporate’s jab in high-income international locations though vaccination charges are excessive, citing contracts for 69m doses agreed with the EU in December.

“This places an enormous stamp of approval on our vaccine in high-income international locations,” Erck mentioned, including the corporate is in talks with US authorities about what number of doses it will ship and when.

Novavax mentioned its jab may assist sort out vaccine hesitancy in developed nations as a result of it’s made utilizing a conventional vaccine manufacturing methodology relatively than mRNA know-how, a brand new platform that has change into a goal for misinformation by antivax campaigners. The corporate has additionally advised its protein-based know-how may present extra sturdy safety towards Covid and not using a danger of myocarditis — a price coronary heart situation that has been linked to mRNA jabs.

Greg Glenn, Novavax’s president of R&D, mentioned the mRNA vaccines have some “security” and points when it comes to antagonistic unwanted effects, which might make Novavax a very enticing choice when Covid-19 turns into endemic.

“Myocarditis. I imply it actually occurs,” he advised the FT.

“The evaluation has been made right now that the chance and the end result of that, which is you recognize not rare, is balanced with the chance of getting Covid . . . However the presentation is fairly dangerous. Individuals who have myocarditis- they’ve extreme chest ache, it’s tough for the household and 96 per cent get hospitalised.”

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Nevertheless, Novavax has not completed a head-to-head research pitting its jab towards both the BioNTech/Pfizer or Moderna vaccines to supply correct knowledge evaluating security and antagonistic reactions.

David Dowdy, an epidemiologist at Johns Hopkins College of Drugs, mentioned the primary message is that current knowledge confirmed that all the extensively used vaccines are exceptionally protected.

“With merchandise which are this protected, it’s extra essential to get folks vaccinated than to haggle over small variations in security,” he mentioned.

Dowdy mentioned the Novavax vaccine could possibly be a game-changer in some lower-income nations because it doesn’t want very chilly storage — an element that has hampered distribution of mRNA vaccines in Africa.

Novavax mentioned it intends to win a race with its mRNA rivals to realize approval for a mixed flu and Covid-19 shot, with a goal date of 2024, and ship on a pipeline of different respiratory medication.