Novavax said its protein-based Covid-19 vaccine will be a strong competitor to the BioNTech/Pfizer and Moderna jabs despite its late arrival because of public concerns over the safety of its rivals’ messenger RNA technology.
But the US biotech, which began shipping its vaccine to Europe and Asia in January following months of long delays because of regulatory challenges, has called on Washington to do more to promote its vaccine, which has still not been authorised by US regulators.
“I would love to hear more public support from the US government and I don’t know whether they’ve been too involved in some of the other vaccines or they’ve been too busy,” said Stan Erck, chief executive of Novavax, adding US authorisation for its jab could happen “within weeks”.
The World Health Organization, the UK, EU and Australia are among almost a dozen countries and organisations to approve Novavax’s two-dose vaccine, which is the first product launched by the company in its 34-year history. Novavax plans to ship 2bn doses in 2022, which analysts’ forecast could generate $5bn in revenues — a transformational event for a biotech that has been a perennial loss maker.
But the company has struggled to provide data to US regulators that demonstrate it can manufacture jabs in a consistent manner. This has caused delays to the roll out of its two-dose vaccine, which clinical trials show has 90 per cent efficacy against symptomatic Covid-19. It followed the award of US government contracts worth $1.8bn to Novavax to develop its vaccine and supply 100m doses.
Erck told the Financial Times these problems had been resolved and Novavax would soon begin shipping doses to the US from its manufacturing partner, the Serum Institute of India. He said there is still plenty of demand for the company’s jab in high-income countries even though vaccination rates are high, citing contracts for 69m doses agreed with the EU in December.
“This puts a big stamp of approval on our vaccine in high-income countries,” Erck said, adding the company is in talks with US authorities about how many doses it would deliver and when.
Novavax said its jab could help tackle vaccine hesitancy in developed nations because it is made using a traditional vaccine production method rather than mRNA technology, a new platform that has become a target for misinformation by antivax campaigners. The company has also suggested its protein-based technology could provide more durable protection against Covid without a risk of myocarditis — a rate heart condition that has been linked to mRNA jabs.
Greg Glenn, Novavax’s president of R&D, said the mRNA vaccines have some “safety” and issues in terms of adverse side effects, which would make Novavax a particularly attractive option when Covid-19 becomes endemic.
“Myocarditis. I mean it really happens,” he told the FT.
“The assessment has been made today that the risk and the outcome of that, which is you know not infrequent, is balanced with the risk of getting Covid . . . But the presentation is pretty bad. People who have myocarditis- they have severe chest pain, it’s difficult for the family and 96 per cent get hospitalised.”
However, Novavax has not done a head-to-head study pitting its jab against either the BioNTech/Pfizer or Moderna vaccines to provide accurate data comparing safety and adverse reactions.
David Dowdy, an epidemiologist at Johns Hopkins School of Medicine, said the number one message is that existing data showed that all of the widely used vaccines are exceptionally safe.
“With products that are this safe, it’s more important to get people vaccinated than to haggle over small differences in safety,” he said.
Dowdy said the Novavax vaccine could be a game-changer in some lower-income nations as it does not need very cold storage — a factor that has hampered distribution of mRNA vaccines in Africa.
Novavax said it intends to win a race with its mRNA competitors to gain approval for a combined flu and Covid-19 shot, with a target date of 2024, and deliver on a pipeline of other respiratory drugs.