Novavax Inc.
NVAX -6.08%
said Monday it is starting a new clinical trial of up to 30,000 people in the US and Mexico to test whether the experimental vaccine covid-19 safely protects people from the disease.
The injection of Novavax will be the fifth Covid-19 vaccine under final stage testing in the US, and if the results are positive, it could receive approval sometime in 2021. Public health officials say that despite the introduction of the first two Covid-19 vaccines in the US, additional vaccines are needed to meet demand and control the pandemic.
“We’ve come this far, so fast, but we have to make it to the finish line,” said Francis S. Collins, director of the National Institutes of Health, who is helping fund the Novavax study. “That will require multiple vaccines with different approaches to ensure that everyone is protected safely and effectively from this deadly disease.”
The company hasn’t said when it expects results from the new study, but it will likely be spring at the earliest. Studies of Pfizer’s first two vaccines Inc.
and Moderna Inc.
took nearly four months for the results to become available.
US regulators this month approved emergency use of the Pfizer and Moderna vaccines. Large US studies of two more vaccines, from Johnson & Johnson and from AstraZeneca PLC and Oxford University, could yield results and possible authorizations by February, federal officials recently said.
The Novavax vaccine contains proteins that resemble the “spike” proteins found on the surface of the coronavirus and are believed to cause an immune response to the virus after they are injected. Novavax makes the proteins in insect cells. It also contains an adjuvant, which is a substance designed to enhance the immune response. The Novavax adjuvant is derived from the bark of an evergreen tree native to Chile.
This approach to combining a protein with an adjuvant is similar to that of vaccines against some other diseases, including the shingles vaccine from GlaxoSmithKline PLC, Shingrix. But it’s a different mechanism than the Pfizer and Moderna Covid-19 vaccines, which use gene-based technologies, and those of Johnson & Johnson and AstraZeneca, which use viral vector technology.
Novavax of Gaithersburg, Maryland has previously reported positive results from early-stage testing of the Covid-19 vaccine, showing that it could elicit immune responses and was generally safe.
The company originally planned to start a large Phase 3 study of the vaccine in the US in the fall, but has encountered manufacturing issues that delayed the start.
The survey is being conducted at approximately 115 locations. About two-thirds of the study volunteers will receive the vaccine in two doses three weeks apart, while a third will receive a placebo. Researchers then keep track of how many people in each group develop Covid-19 with symptoms, starting seven days after the second injections.
It is being funded with a portion of the $ 1.6 billion Novavax received from the federal government in July. That funding, part of the Operation Warp Speed initiative, also covers setting up large-scale production and delivering 100 million doses of the vaccine for use in the US.
Other studies of the Novavax vaccine outside the US are continuing. The company said it has completed enrollment of 15,000 people in a late-stage, phase 3 study in the UK, and interim results from this study may become available in the first quarter of 2021, although timing will depend on coronavirus transmission rates in the UK.
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Write to Peter Loftus at [email protected]
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