US government grants $ 1.6 billion to Novavax for coronavirus vaccine

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The US government has granted Novavax $ 1.6 billion to cover the testing, marketing and manufacturing of a potential coronavirus vaccine in the United States, with the goal of delivering 100 million doses by January 2021 .Novavax shares jumped more than 35% in the pre-marketing of information.

The award is the largest ever awarded by “Operation Warp Speed”, the White House program to accelerate access to vaccines and treatments to fight the coronavirus that causes Covid-19.

“This Warp Speed ​​award funds the production of 100 million doses, which are expected to be delivered from the fourth quarter of this year and could be completed in January or February next year,” Reuters told Novavax Managing Director Stanley Erck. .

It will also cover the cost of running a large phase III trial – the last stage of human testing – which could start as early as October.

The announcement follows a $ 456 million investment in the Johnson & Johnson vaccine candidate in March, an allocation of $ 486 million to Moderna in April and support of $ 1.2 billion in May for the AstraZeneca vaccine developed with the University of Oxford. The United States government has also provided $ 628 million to Emergent Biosolutions to increase domestic manufacturing capacity for a coronavirus vaccine and potential drugs to treat Covid-19.

A safe and effective vaccine is considered essential to end a pandemic that has claimed more than half a million lives worldwide, including about a quarter in the United States.

The Gaithersburg, Maryland-based company is somewhat of a dark horse in the race for a coronavirus vaccine. The company was not on the New York Times’ list of finalists for Warp Speed ​​vaccines, which included Moderna, AstraZeneca, Pfizer, J&J and Merck.

In May, Novavax obtained additional funding of $ 388 million for the development of the COVID-19 vaccine from the Coalition for Epidemic Preparedness Innovations (CEPI) after an investment of $ 4 million in March. In June, the U.S. Department of Defense awarded the company $ 60 million to support the manufacturing of 10 million doses of its vaccine in 2020.

“A large scale”

The company is in the process of transferring its vaccine technology to an anonymous contract manufacturer with two large manufacturing facilities, said the CEO. This is in addition to the work done by Emergent Biosolutions, which manufactures doses to supply the company’s smallest clinical trials at the start and mid-term.The Novavax vaccine works in conjunction with an adjuvant – a substance that stimulates the immune response to help the body build a strong defense against the virus.

Novavax currently manufactures its adjuvant in Sweden. The company is strengthening the US manufacturing capacity of its adjuvant “so that we can manufacture more than a billion doses of adjuvant in the United States,” he said.

Novavax did not begin human security testing until the end of May. One reason for the delay is that the vaccine is grown in insect cells, a process that can take 30 days before company scientists can begin to purify and manufacture it in bulk.

“You lose about a month there, but I don’t think we are late because of our data,” he said, referring to animal data showing a strong immune response and high levels of anti-virus antibodies.

Erck said Novavax expects the results of its phase I safety trial within the next week. The company aims to start mid-term testing in August or September, with phase III testing starting in October, he added.

Early next year, the company plans to be able to deliver 50 million doses per month in the United States.

“It’s a large scale at a few different manufacturing sites in the United States,” said Erck. “What leaves us is the ability to do a lot more doses in the United States in 2021.”

Novavax also has a manufacturing plant in the Czech Republic and hopes to have two more in Europe and one in Asia, said Erck. The company also works with a manufacturer in India. The goal is to make more than 100 million doses per month, he said.

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