- The Washington Times - Thursday, September 24, 2020

A biotech firm in Gaithersburg, Maryland, will start phase three trials for a coronavirus vaccine in a few weeks, the company’s CEO announced Thursday.

Novavax will be the fifth company in the U.S. to start the final trial phase for a vaccine, enrolling 30,000 participants to test its candidate, said CEO Stanley Erck. The company also will launch phase three trials in the United Kingdom and India.

“We have a global presence. This is a global disease. I don’t think it’s sufficient that we have a vaccine that is just used for the United States,” Mr. Erck said. “To protect the United States, you need to protect the world. It’s a global economy. And that’s what we’re doing.”

Novavax’s announcement follows the Wednesday launch of Johnson & Johnson’s phase three trial, which aims to enroll up to 60,000 adults at more than 200 research sites in the U.S. and abroad.

Drug manufacturers AstraZeneca, Pfizer and Moderna began their phase three trials a few months ago. They expect to know if their vaccine candidates work as early as late October.



Unlike other candidates, the Novavax vaccine can remain stable at room temperature and does not need to be stored in freezers at a temperature of minus 70 degrees. Johnson & Johnson also said its vaccine candidate doesn’t require extremely cold storage temperatures and can be given in a single dose.

For its phase three trials, Novavax will work to include a diverse group of participants including people who are older, obese, Latino or Black, and HIV positive, according to Dr. Gregory Glenn, the company’s president of research and development. Novavax also is considering whether to include adolescents in the trials.

Mr. Erck said his company is using the same candidate platform it used to develop a vaccine for Severe Acute Respiratory Syndrome (SARS) years ago. It also made a vaccine for Middle East Respiratory Syndrome (MERS), another coronavirus.

After touring labs at Novavax on Thursday, Maryland Gov. Larry Hogan touted the vaccine candidate and the state’s hustle in the race to inoculate Americans to protect them from the respiratory illness.

“The coronavirus vaccine candidate that’s been developed by Novavax is one of the most promising in the country, if not the world,” Mr. Hogan said, adding that it’s one of the few vaccine candidates that has undergone numerous clinical developments.

Novavax has secured two deals with the U.S. government — one under Operation Warp Speed, the other with the Department of Defense. Operation Warp Speed awarded Novavax $1.6 billion to deliver 100 million doses of its coronavirus vaccine. The Defense Department gave the biotech firm an additional $70 million to deliver 10 million doses for the armed forces.

Novavax has plants in the U.S., Europe and Asia, and has the capacity to produce 2.5 billion doses of its vaccine. Last month, the company reached a tentative agreement to supply Canada with up to 76 million doses of its COVID-19 vaccine.

Nearly 40 other Maryland companies are working to develop coronavirus vaccines and therapeutics, and improve diagnostic tests, according to Mr. Hogan.

Maryland on Thursday reported a record low, seven-day positivity rate of 2.57%. The daily positivity rate has hovered at 2.63% and has been under 5% for more than three months.

The statewide coronavirus case rate is 8.1 infections per 100,000 people, which is the lowest since July 11, according to Mr. Hogan. In total, the coronavirus has sickened 121,800 Maryland residents and killed more than 3,760.

Earlier this month, nine CEOs from biopharmaceutical companies, including Novavax, pledged to stick to “high ethical standards” and “sound scientific principles” when it comes to developing and testing potential vaccines for COVID-19. The pledge came amid concerns the Trump administration will force quicker government approval of a vaccine before it is thoroughly reviewed.

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