Researchers at the University of Washington’s Medical Resuscitation Laboratory at Harborview Medical Center in Seattle process samples from Novavax’s phase 3 COVID-19 vaccine clinical trial in February 2021.
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Researchers at the University of Washington’s Medical Resuscitation Laboratory at Harborview Medical Center in Seattle process samples from Novavax’s phase 3 COVID-19 vaccine clinical trial in February 2021.
Karen Ducey / Getty Images
A new COVID-19 vaccine is about to be rolled out around the world. While it won’t replace existing very successful vaccines, it could make a difference in the course of the pandemic, especially in lower-resourced countries.
These new vaccines are called protein subunit vaccine. They work by injecting a person with a small part of the virus. In the case of the COVID-19 vaccine, that fraction is the so-called mutant protein that is important for the virus to enter cells.
One advantage of protein subunit vaccines is that they tend to be very stable, so they don’t need a freezer for storage. An ordinary refrigerator is enough. This makes vaccine distribution much easier.
“We assumed that protein subunit vaccines would play a big role in driving the development of a COVID vaccine,” Julie McElrath directs the vaccines and infectious disease division at the Fred Hutchinson Cancer Research Center in Seattle. McElrath said she and her colleagues are confident that there are subunit vaccines on the market for infectious diseases.
When Operation Warp Speed began spending billions of dollars to facilitate the development of a COVID-19 vaccine, it chose three vaccine technologies to support it: the mRNA vaccine under development Pfizer and Moderna, the viral vector vaccine proposed by Johnson & Johnson, and the protein subunit vaccine. made by Sanofi and Novavax.
The first two technologies were successful and there are now billions of doses of vaccines in this country and around the world.
A year ago, Novavax confident that their vaccine will also be on the market.
“We have a large number of people working to scale up our vaccine,” Gregg Glenn, Novavax’s president of research and development said in an interview in September 2020. “I’m very optimistic by the end of the day we’re going to have a lot of products and we’re talking about over 2 billion doses of the drug. in 2021.”
But Glenn’s optimism was misguided. A major vaccine study took longer than expected, and the company ran into production problems.
Sanofi is also having trouble with its protein subunit vaccine.
McElrath believes that subunit vaccines can still play an important role in pandemic control. “It’s just that they’re just a little behind the others,” she said.
“Having multiple options is always a good idea,” Ali Ellebedy, an immunologist at Washington University in St. Louis.
Ellebedy mainly works on mRNA vaccines. These are new, he says, and scientists are still trying to understand their strengths and weaknesses. To do that, it would be helpful to have a large group of people vaccinated with a more familiar vaccine for comparison.
Medical laboratory scientist Aniela Sobel examines serum samples from the Novavax phase 3 COVID-19 vaccine clinical trial at the University of Washington’s Medical Resuscitation Laboratory at Harborview Medical Center in September. 2 year 2021.
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Medical laboratory scientist Aniela Sobel examines serum samples from the Novavax phase 3 COVID-19 vaccine clinical trial at the University of Washington’s Medical Resuscitation Laboratory at Harborview Medical Center in September. 2 year 2021.
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“From a scientific perspective, it would certainly be great to have a subunit vaccine,” he said.
That day seems to be coming. Major studies of the vaccine have shown it to be extremely effective and so far there have been no safety concerns.
Novavax has started filing for emergency use licenses with various regulators.
“We have applied for licenses around the world, including in the UK, Australia, Canada, New Zealand,” Silvia Taylor, Vice President of Global Corporate Affairs and Investor Relations at Novavax
These filings mean that Novavax thinks it has covered up its manufacturing problems, because getting a license requires regulatory authorities to convince you that you can reliably manufacture vaccines. .
Taylor expects the company to apply for emergency use authorization in the country early next year. She said that to increase production capacity, Novavax has cooperated with several vaccine manufacturers, including Serum Institute of India, the world’s largest vaccine producer.
“Therefore, we are extremely confident that with all that we have learned over the past year, as well as the expertise of all our partners, that we will be in a great position to produce more than 2 billion doses of the drug by 2022,” she said.
That sounds familiar. Maybe now it’s achievable.
