A vaccine created by the National Institutes of Health and Moderna Inc. is set to begin final-stage testing on Monday.
Several sites in California will participate. The final stage testing in this study of 30,000 people will see if it really is safe and effective.
Moderna spokesperson Ray Jordan tells GV Wire℠ by email that everything is on track. “We still do expect our Phase 3 mRNA-1273 trial to begin dosing on July 27,” says Jordan.
Moderna reported it is possible that under emergency use, a vaccine could be available to some people, possibly including healthcare professionals, this fall.
Moderna’s latest vaccine trials
In a nutshell, the results are promising.
“At least they proved the concept,” Vanderbilt University Medical Center staff scientist and protein chemistry expert Sanjay Mishra told the Associated Press. “The results show that when you give this vaccine, the body makes antibodies. But we don’t know whether those antibodies will lead to immunity in the body because all of the results that we have are observed outside the body (in blood samples).”
COVID-19 antibodies were found in all 45 participants, the biotech company announced in a May news release.
Moderna said the early vaccine data indicated that it provided full protection against viral replication in the lungs in a mouse challenge model.
Older Age Group is Still a Question
Mishra says as we age, we do not produce as many antibodies, which generally leads to poor vaccine response.
The first batch of data is from the 18- to 55-year-old group. “Will they have to go for a higher dose, which is usually the case in flu vaccines?” Mishra said.
California Testing Sites
Several locations in California will be utilized, and volunteers are needed for each.
- Advanced Clinical Research, Rancho Paseo in Banning
- University of California San Diego in La Jolla
- eStudySite in La Mesa
- UCLA Vine Street Clinic CRS in Los Angeles
- Paradigm Clinical Research Institute Inc. in Redding
- Benchmark Research in Sacramento
- Medical Center For Clinical Research, M3 Wake Research in San Diego
If you are interested, contact Moderna Clinical Trials at (855) 663-6762 or email firstname.lastname@example.org
Up to 1 Billion Doses a Year
Moderna is working closely with Operation Warp Speed and the NIH, including NIAID’s COVID-19 Prevention Trials Network to conduct the Phase 3 study.
With the Phase 3 dose being finalized at 100 micrograms, the company remains on track to be able to deliver approximately 500 million doses per year, and possibly up to 1 billion doses per year, beginning in 2021 from the company’s internal U.S. manufacturing site and strategic collaboration with Lonza.
Under the agreement, Lonza’s facilities in the United States and Switzerland will manufacture the first batches of Moderna’s COVID-19 vaccine candidate this month.
Over time, the companies intend to establish additional production suites across Lonza’s worldwide facilities.
(The Associated Press contributed to this story.)