Novavax, whose COVID-19 vaccine is manufactured in RTP, reports positive early tests

A potential COVID-19 vaccine candidate being made by Novavax showed a promising immune response in early clinical trials, the Maryland-based company said Tuesday.

The findings could have an impact in North Carolina, as the potential vaccine is being manufactured at a Fujifilm Diosynth facility in Research Triangle Park.

Just last week, President Donald Trump toured the RTP facility where the vaccine is being made. Fujifilm Diosynth is ramping up employment in RTP to handle the contract from Novavax.

Novavax’s Phase 1 trials evaluated two doses of its vaccine in 131 healthy adults in Australia between the ages of 18 and 59, the company said in a release.

The biotech company said the doses were “well-tolerated” with no serious adverse reactions, and that the vaccine elicited robust antibody responses superior to those seen in the blood of patients already recovered from COVID-19. The company said all of the test subjects developed antibodies after a single dose of the vaccine.

Symptoms reported following the vaccine included tenderness and pain, headache, fatigue and muscle pain, Novavax said.

“The Phase 1 data demonstrate that NVX-CoV2373 ... is a well‑tolerated COVID-19 vaccine with a robust immunogenicity profile,” Novavax’s president of research and development, Gregory Glenn, said in a statement.

The batches of the vaccine created in North Carolina would be used in the Phase 3 trial, which would include up to 30,000 subjects, the company said last week. That trial is dependent on success in the first two stages of studies.

Novavax is one of a handful of companies selected to be part of the federal government’s Operation Warp Speed, an effort to manufacture vaccines as they progress through scientific tests in order to have them ready if they are found to be effective in clinical trials.

Novavax was awarded $1.6 billion from the federal government as part of Operation Warp Speed, though the company has never brought a vaccine to market in its 33-year history, The New York Times reported.

In an interview with the N&O last week, Novavax CEO Stanley Erck said this was the company’s third coronavirus vaccine, including one it made for SARS. He said the company didn’t take the other vaccines to market “because the virus went away” on its own, while COVID-19 is still running rampant across the globe.

The COVID-19 vaccine is built off similar technology and is showing some of the best data Novavax has ever seen, he said.

A vaccine is seen as critical to getting the country back to normal. The United States surpassed 4 million coronavirus cases last month, leading to economic shutdowns and school closures. In North Carolina as of Tuesday, more than 2,000 people have died due to COVID-19.

The Novavax candidate is currently in Phase 1 trials and the company anticipates moving into a larger Phase 2 study this month. The final Phase 3 trial, which would include tens of thousands of volunteers, would come sometime in the fall, The News & Observer previously reported.

The trials will determine the safety and effectiveness of the vaccine and will help the Food and Drug Administration determine whether to approve it for use.

During a trip to RTP last week with Vice President Mike Pence, Stephen Hahn, the FDA commissioner, said that despite the speed at which clinical trials are moving the FDA is not cutting corners when it comes to safety.

“These clinical trials are going to produce the data that the FDA is going to use to make the judgment about the safety and effectiveness of a vaccine,” he said during a roundtable at the N.C. Biotechnology Center. “We are an independent regulatory body, we are not a part of Operation Warp Speed, and we will make a determination based upon our very rigorous criteria.”

Vaccine candidates from Moderna and Pfizer are further along, with both of those companies starting Phase 3 clinical trials last week.

This story was produced with financial support from a coalition of partners led by Innovate Raleigh as part of an independent journalism fellowship program. The N&O maintains full editorial control of the work. Learn more; go to bit.ly/newsinnovate