Novavax Inc.
NVAX -5.52%
said Monday it is launching a new clinical trial among 30,000 people in the U.S. and Mexico to test whether the experimental Covid-19 vaccine safely protects people from the disease.
The shot from Novavax becomes the fifth Covid-19 vaccine to be tested in the US in the final stages, and if the results are positive, it could get approval somewhere during 2021. Public health officials say that despite the launch of the first two Covid-19 vaccines. in the US, additional vaccines are needed to meet demand and control the pandemic.
“We came so fast, but we have to get to the finish line,” said Francis S. Collins, director of the National Institutes of Health. This helps fund the Novavax study. “For that, several vaccines are needed to use different approaches to ensure that everyone is protected safely and effectively against this deadly disease.”
The company did not say when they expect to generate results from the new study, but it will likely be in early spring. Studies of the first two vaccines from Pfizer Inc.
in Modern Inc.
took almost four months before the results were available.
U.S. regulators approved the use of the Pfizer and Modern vaccines this month. Major U.S. studies on two more vaccines, from Johnson & Johnson and AstraZeneca PLC and Oxford University, could yield results and potential authorization by February, federal officials said recently.
The Novavax vaccine contains proteins that resemble the spike proteins found on the surface of the coronavirus, which are thought to elicit an immune response to the virus once injected. Novavax produces the proteins in insect cells. It also contains an additive, a substance designed to enhance immune responses. The additive of Novavax is derived from the bark of an evergreen tree native to Chile.
This approach to combining a protein with an additive is similar to that of vaccines against some other diseases, including the shingles vaccine, Shingrix from GlaxoSmithKline PLC. 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, Md., Has previously reported positive results from early testing of its Covid-19 vaccine, which has been shown to elicit immune responses and is generally safe.
The company originally planned to launch a major phase 3 trial of the vaccine in the US in the fall, but experienced manufacturing problems that delayed the start.
The study will be conducted in approximately 115 sites. About two-thirds of the study volunteers will receive the vaccine in two doses, three weeks apart, while one-third will receive a placebo. Researchers will then keep track of how many people in each group develop Covid-19 with symptoms, starting seven days after the second injection.
It is funded by some of the $ 1.6 billion that Novavax allocated by the federal government in July. The funding, part of the Operation Warp Speed initiative, also covers the establishment of large-scale manufacturing and the delivery of 100 million doses of the vaccine for use in the US.
Other studies on the Novavax vaccine outside the US are ongoing. The company said the registration of 15,000 people in a Phase 3 trial in the UK was completed at a late stage. Interim results of this study may be available in the first quarter of 2021, although the timing depends on the coronavirus transmission rates in the United Kingdom
While drug dealers distribute Covid-19 vaccines, cyber security experts warn against the growing threat of fraud and theft by organized crime networks. WSJ explains how hackers target the rollout of vaccines during the pandemic. Illustration: George Downs
Write to Peter Loftus by [email protected]
Copyright © 2020 Dow Jones & Company, Inc. All rights reserved. 87990cbe856818d5eddac44c7b1cdeb8