Novavax Starts Late-Stage Trial of Covid-19 Vaccine

“We’ve come this far, this 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. “That will require multiple vaccines using different approaches to ensure everyone is protected safely and effectively from this deadly disease.”

The company didn’t say when it expects to generate results from the new study, but it will likely be spring at the earliest. Studies of the first two vaccines from Pfizer Inc. and Moderna Inc. took nearly four months for results to become available.

U.S. regulators authorized emergency use of the Pfizer and Moderna vaccines this month. Large U.S. studies of two more vaccines, from Johnson & Johnson and from AstraZeneca PLC and Oxford University, could yield results and potential authorizations by February, federal officials said recently.

Novavax’s vaccine contains proteins resembling the “spike” proteins found on the surface of the coronavirus, which are supposed to trigger an immune response to the virus once injected. Novavax manufactures the proteins in insect cells. It also contains an adjuvant, a substance designed to enhance immune responses. Novavax’s 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 GlaxoSmithKline PLC’s 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, of Gaithersburg, Md., has previously reported positive results from early-stage testing of its Covid-19 vaccine, showing that it could induce immune responses and was generally safe.

The company was originally planning to start a large Phase 3 trial of the vaccine in the U.S. in the fall, but it has experienced manufacturing issues that delayed the start.

The study will be conducted at about 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 contract Covid-19 with symptoms, starting seven days after the second injections.

It is being funded with some of the $1.6 billion that Novavax was awarded in July by the federal government. That funding, part of the Operation Warp Speed initiative, also covers establishing large-scale manufacturing and delivering 100 million doses of the vaccine for use in the U.S.

Other studies of the Novavax vaccine outside the U.S. are continuing. The company said it has completed enrollment of 15,000 people in a late-stage, Phase 3 trial in the U.K. Interim results from this study could become available in the first quarter of 2021, though timing depends on coronavirus transmission rates in the U.K.

Write to Peter Loftus at [email protected]