Novavax Begins U.S. Phase 3 Trial of Coronavirus Vaccine

(Bloomberg) -- Novavax Inc. will start the final-stage trial of its Covid-19 vaccine with 30,000 people in the U.S. and Mexico, opening another avenue for shots to fight the pandemic, the National Institute of Allergy and Infectious Diseases said.

The trial, to be completed across 115 locations, is the latest large-scale effort in the U.S. to evaluate vaccines to protect against the virus that’s killed more than 330,000 Americans. The company is also studying the vaccine in a large trial in the U.K. that’s completed dosing. Initial results from that trial should be released early next year, Chief Executive Officer Stan Erck said Monday in an interview on Bloomberg Television.

Erck said the trials underway will show whether the Novavax vaccine is similarly effective to shots already authorized in the U.S. that have demonstrated greater than 90% protection from illness.

“We don’t know until we know,” Erck said. Based on earlier studies of the immune response prompted by the Novavax shot, “we expect similar results,” he added.

Novavax shares were down 2.3% to $126.31 at 11:43 a.m. in New York trading.

If successful, Novavax’s shot would expand an arsenal that includes vaccines from Pfizer Inc. and Moderna Inc. that were authorized for emergency use this month. Other vaccines from Johnson & Johnson and AstraZeneca Plc are also in large-scale trials.

Novavax’s experimental NVX-CoV2373 vaccine uses a different mechanism than the Pfizer and Moderna shots, which rely on messenger RNA, a technology being used in vaccines for the first time. The Novavax shot is made from a “stabilized” form of the coronavirus spike protein incapable of causing infection. It also contains an adjuvant, a substance designed to enhance the immune system response.

Erck also said he thought the Novavax shot would likely prove effective against a new variant of the SARS CoV-2 virus spreading in the U.K. and elsewhere that is suspected of being more easily transmitted.

The company has been working to build manufacturing capacity across the globe, with commercial-scale factories worldwide ready to produce millions of doses, Erck said.

The U.S. trial of Novavax’s vaccine will be conducted with Operation Warp Speed, the federal government’s effort to accelerate vaccine development.

“The launch of this study -- the fifth investigational Covid-19 vaccine candidate to be tested in a phase 3 trial in the United States -- demonstrates our resolve to end the pandemic through development of multiple safe and effective vaccines,” Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said in a statement.

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