Novavax to start Phase 3 trials in U.S., Mexico

Maryland-based vaccine developer at next step

Novavax, the Maryland-anchored coronavirus vaccine developer, is set to launch a large Phase 3 study of its vaccine candidate in the U.S. and Mexico, complementing another trial underway in the United Kingdom.

Headquartered in Gaithersburg, the company has received $1.6 billion from the federal government to develop its vaccine candidate and make 100 million doses. Unlike Pfizer’s and Moderna’s messenger RNA-based vaccines, Novavax’s uses the so-called “spike” proteins, which are attached to microscopic particles and then inserted into the body. Preliminary results from Phase 1 and 2 trials show promising results, with the vaccine said to generate “highly neutralizing antibodies against the virus,” and “generally well tolerated” immune responses, the company said in a Monday news release.

The vaccine maker seeks to enroll 30,000 participants in this study, dubbed “PREVENT-19 — double the number enlisted in the U.K. Two-thirds of enrollees will receive the active vaccine, according to the release, and volunteers could be selected from as many as 115 sites in the U.S.

Novavax’s vaccine would add depth to the nation’s aggressive mass vaccination campaign, which began officially two weeks ago after the U. S. Food and Drug Administration granted emergency authorization to Pfizer and BioNTech’s candidate, followed by Moderna’s about a week later. So far, about 1 million people have been vaccinated, including 20,812 Marylanders — health care workers, nursing home residents and long-term-care staffers among them.

Public health experts and researchers consider vaccinations a critical step in combating the coronavirus pandemic, which swept into the U.S. in March and has killed some 330,000 Americans since, devastating parts of the economy and upending daily life.

Vaccine and drug development usually take years, but those designed to protect people from the coronavirus have been accelerated to record pace. The Trump Administration’s Operation Warp Speed has formed a partnership between federal agencies, private- sector biotech and pharmacology firms, and academic centers to quickly identify, produce and distribute vaccines.

In a statement, Stanley C. Erck, Novavax’s president and CEO, called the Novavax trial “a critical step in building the global portfolio of safe and effective vaccines to protect the world’s population,” and credited Operation Warp Speed for bringing the FDAand Mexico’s government together.

The company plans to enroll a diverse participant body, which would include Black Americans, American Indians and Latinos as well as white people. At least a fourth of the study population will be 65 years old or older, according to the release. Subjects must be 18 years or older to participate.

Novavax’s candidate — which requires two doses, three weeks apart — can be stored in refrigerators. Phase 1 and 2 studies have been conducted on both humans and monkeys. Phase 3 trial data could be released by the first quarter of 2021, the company said, though the timing will depend on transmission rates in the regions.

Last month, the company announced plans for expansion, adding 122,000 square feet of space for research and development, manufacturing and offices. The company has said it will add at least 400 Maryland jobs by the end of 2024, according to Gov. Larry Hogan’s office.