Coronavirus Vaccine Manufacturer Scaling Production

A new coronavirus vaccine was administered to volunteers last week in an experimental study by the vaccine’s developer, Moderna Therapeutics. Even though it could take another year to complete the testing on the vaccine to determine its side effects and efficacy, the study will provide valuable information on how the body's immune system can fight coronaviruses and could give scientists valuable insight in case another outbreak occurs in the future. The essential staff at Moderna Therapeutics’ manufacturing facility, in Norwood, Massachusetts that are intimately involved in manufacturing the vaccine are ready to scale up production if the first phase of testing confirms the safety of the vaccine. The first group of volunteers included 45 healthy volunteers, who have not been infected with SARS-CoV-2, the virus that causes COVID-19. Within this initial control group, scientists are looking to see if the vaccine is safe, and to test three different dosages to see which seems to trigger the strongest and best immune response. If the initial 45 test subjects don’t develop any severe side effects or reactions, then researchers will scale the testing to include hundreds more healthy volunteers to confirm those results. The current testing is overseen by the National Institutes of Health (NIH) which has multiple centers in the United States. Assuming the trials show the vaccines safety, Moderna is preparing for an anticipated incredible demand to scale up the vaccine very quickly to produce millions of doses. Moderna uses mRNA, which is a genetic form of the virus’ genome, in its vaccine. When injected into people, cells then process it so immune cells can recognize it and target it for destruction. Unlike the processes used to make most traditional vaccines, this method does not require growing huge amounts of the virus, which is time-consuming. This process using the mRNA allows for quicker production. Chinese researchers first posted the genetic sequence of SARS-CoV-2 in mid-January, and three weeks later, Moderna had vials of the vaccine ready for testing needed before the treatment could be cleared for human trials. At the end of February, Moderna sent vials to the NIH for further review by its scientists. Both Moderna and NIH then filed for a request to the Food and Drug Administration, which regulates trials of experimental therapies, to start injecting the vaccine in people for human testing. Moderna is hopeful that it can continue to shave valuable time off the process while producing a safe and effective vaccine. The original goal when the director of the NIH’s National Institute of Allergy and Infectious Diseases, Dr. Anthony Fauci, first announced the vaccine, was to inject it into humans within three months. Moderna managed to do it in 63 days. Human testing on patients who have contracted the virus may still be months away, and Dr. Fauci predicts that the trials may not conclude for another 12-18 months.