Novavax bets fears over mRNA technology will give its Covid jab an edge

Novavax has stated that its protein-based Covid-19 vaccine will be a strong competitor to BioNTech / Pfizer and Moderna, despite the delay due to public concerns about the safety of RNA technology competitors.

But the U.S. biotech company, which began shipping its vaccine to Europe and Asia in January after months of long delays due to regulatory problems, has urged Washington to do more to promote its vaccine, which has not yet been approved by U.S. regulators.

“I’d like to hear more public support from the U.S. government, and I don’t know if they were too involved in some other vaccines or if they were too busy,” said Stan Erk, executive director of Novavax, adding U.S. permission to strike him. can happen “in a few weeks”.

The World Health Organization, the UK, the EU and Australia are among nearly a dozen countries and organizations that have approved the two-dose Novavax vaccine, the first product released by the company in its 34-year history. Novavax plans to ship 2 billion doses in 2022, which analysts predict could generate $ 5 billion in revenue, a transformative event for biotechnology that is constantly cost-effective.

But the company is struggling to provide data to the U.S. regulator that demonstrates that it can continually produce strikes. This has delayed the deployment of a two-dose vaccine, which clinical trials have shown to be 90 percent effective against symptomatic Covid-19. This came after the US government signed contracts for $ 1.8 billion with Novavax to develop a vaccine and supply 100 million doses.

Stan Erk at a meeting with the Coronavirus Task Force and Pharmaceutical Leaders at the White House in March 2020

Erk told the Financial Times that these issues have been resolved and Novavax will soon start sending doses to the US from its manufacturing partner, the Whey Institute of India. He said high-income countries still have high demand for the company’s injection, even though vaccination rates are high, citing contracts for 69 million doses agreed with the EU in December.

“This is a big sign of approval of our vaccine in high-income countries,” Erk said, adding that the company is in talks with U.S. authorities about how many doses it will deliver and when.

Novavax said its strike could help combat vaccine fluctuations in developed countries because it is produced using traditional vaccine production rather than mRNA technology, a new platform that has targeted disinformation proponents of anti-vaccines. The company has also suggested that its protein-based technology could provide stronger protection against Covid without the risk of myocarditis – a heart disease that is associated with mRNA injections.

Greg Glenn, president of R&D Novavax, said mRNA vaccines have some “safety” and problems in terms of adverse side effects, which will make Novavax a particularly attractive option if Covid-19 becomes endemic.

“Myocarditis. I mean, it’s really happening, “he told the FT.

“Today, it was assessed that the risk and outcome of this, which, as you know, is not uncommon, is balanced with the risk of Covid infection. . . But the presentation is pretty bad. People with myocarditis experience severe chest pain, family hardship, and 96 percent end up in hospital. ”

However, Novavax did not conduct a direct study against BioNTech / Pfizer or Moderna vaccines to provide accurate data comparing safety and adverse reactions.

David Daudi, an epidemiologist with Johns Hopkins School of Medicine, said the number one message was that existing data showed that all widely used vaccines were exceptionally safe.

“With such safe products, it is more important to get vaccinated than to trade about small differences in safety,” he said.

Daudi said the Novavax vaccine could change the game in some low-income countries because it does not need very cold storage – a factor that prevents the spread of mRNA vaccines in Africa.

Novavax has said it intends to win the race with its mRNA rivals to get permission for a combined flu and Covid-19 vaccine with a target date of 2024 and to put other respiratory drugs on the assembly line.

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