Novavax Inc.
NVAX -5.20%
said on Monday that it is starting a new clinical trial with up to 30,000 people in the U.S. and Mexico to test whether its experimental Covid-19 vaccine safely protects people from the disease.
The Novavax injection will become the fifth Covid-19 vaccine to enter the final testing stage in the United States and, if the results are positive, it may receive authorization sometime during 2021. Public health officials say that despite the introduction of first two Covid-19 vaccines in the US, additional vaccines will be needed to meet demand and control the pandemic.
“We got here so fast, but we need to get to the finish line,” said Francis S. Collins, director of the National Institutes of Health, which is helping to fund the Novavax study. “This will require multiple vaccines using different approaches to ensure that everyone is safely and effectively protected against this deadly disease.”
The company did not say when it expects to generate results from the new study, but it will probably be in the spring, at the very least. Studies of Pfizer’s first two vaccines Inc.
and Modern Inc.
it took almost four months for the results to become available.
American regulators have authorized the emergency use of Pfizer and Moderna vaccines this month. Large US studies of two more vaccines, from Johnson & Johnson and AstraZeneca PLC and Oxford University, could yield results and possible authorizations until February, federal officials said recently.
The Novavax vaccine contains proteins similar to the “spike” proteins found on the surface of the coronavirus, which are supposed to trigger an immune response to the virus once injected. Novavax makes proteins in insect cells. It also contains an adjuvant, a substance designed to increase immune responses. The Novavax adjuvant is derived from the bark of an evergreen tree native to Chile.
This approach of combining a protein with an adjuvant is similar to that of vaccines against some other diseases, including the GlaxoSmithKline PLC shingles vaccine, Shingrix. But it is a different mechanism from the Pfizer and Moderna Covid-19 vaccines, which use gene-based technologies, and those from Johnson & Johnson and AstraZeneca, which use viral vector technology.
Novavax, from Gaithersburg, Maryland, previously reported positive early test results for his Covid-19 vaccine, showing that it could induce immune responses and was generally safe.
The company was originally planning to start a major Phase 3 trial of the vaccine in the United States in the fall, but had manufacturing problems that delayed the start.
The study will be carried out in about 115 locations. About two-thirds of study volunteers will receive the vaccine in two doses, three weeks apart, while a third will receive a placebo. The researchers will then track how many people in each group contracted Covid-19 with symptoms, starting seven days after the second injections.
It is being financed with part of the $ 1.6 billion that Novavax received in July from the federal government. This funding, part of the Operation Warp Speed initiative, also covers the establishment of large-scale manufacturing and delivery of 100 million doses of the vaccine for use in the United States.
Further studies of the Novavax vaccine outside the United States continue. The company said it had completed the enrollment of 15,000 people for a phase 3 trial at an advanced stage in the UK. The provisional results of this study may be available in the first quarter of 2021, although the time depends on the transmission rates of the coronavirus in the United Kingdom
While pharmaceutical companies distribute Covid-19 vaccines, cybersecurity experts warn against the growing threat of adulteration and theft by organized crime networks. WSJ explains how hackers are aiming to implement the vaccine during the pandemic. Illustration: George Downs
Write to Peter Loftus at [email protected]
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