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The largest COVID-19 vaccine study in the world began Monday, with the first of 30,000 Americans volunteering to take the shots.
The experimental vaccine, developed by the National Institutes of Health (NIH) and Moderna Inc., is in phase three of the development process, which includes tests at clinical sites across the country.
“Having a safe and effective vaccine distributed by the end of 2020 is a stretch goal, but it’s the right goal for the American people,” NIH Director Francis S. Collins said in a statement. “The launch of this phase-3 trial in record time while maintaining the most stringent safety measures demonstrates American ingenuity at its best and what can be done when stakeholders come together with unassailable objectivity toward a common goal.”
The trial is expected to enroll approximately 30,000 adult volunteers who do not have COVID-19.
“Although face coverings, physical distancing and proper isolation and quarantine of infected individuals and contacts can help us mitigate SARS-CoV-2 spread, we urgently need a safe and effective preventive vaccine to ultimately control this pandemic,” said the National Institute of Allergy and Infectious Diseases Director Dr. Anthony Fauci. “Results from early-stage clinical testing indicate the investigational mRNA-1273 vaccine is safe and immunogenic, supporting the initiation of a Phase 3 clinical trial. This scientifically rigorous, randomized, placebo-controlled trial is designed to determine if the vaccine can prevent COVID-19 and for how long such protection may last.”
The vaccine efficacy trial is the first to be implemented under Operation Warp Speed, a multi-agency collaboration created by President Trump and led by the Health and Human Services Department that aims to accelerate the development, manufacturing, and distribution of medical countermeasures for COVID-19, NIH said.
“Thanks to President Trump’s leadership and the hard work of American scientists, the investigational vaccine developed by NIH and Moderna has reached this Phase 3 trial at record pace,” said HHS Secretary Alex Azar. “Operation Warp Speed is supporting a portfolio of vaccines like the NIH/Moderna candidate so that, if the results of clinical trials meet FDA’s gold standard, these products can reach Americans without a day’s delay.”
NIH said in a statement:
NIAID scientists developed the stabilized SARS-CoV-2 spike immunogen (S-2P). SARS-CoV-2 is the virus that causes COVID-19; the spike protein on its surface facilitates entry into a cell. Moderna’s mRNA-1273 uses the mRNA (messenger RNA) delivery platform to encode for an S-2P immunogen. The investigational vaccine directs the body’s cells to express the spike protein to elicit a broad immune response. A Phase 1 clinical trial found the candidate vaccine to be safe, generally well-tolerated and able to induce antibodies with high levels of virus-neutralizing activity. Moderna initiated Phase 2 testing of the vaccine in May 2020. …
The trial is designed to evaluate the safety of mRNA-1273 and to determine if the vaccine can prevent symptomatic COVID-19 after two doses. As secondary goals, the trial also aims to study whether the vaccine can prevent severe COVID-19 or laboratory-confirmed SARS-CoV-2 infection with or without disease symptoms. The trial also seeks to answer if the vaccine can prevent death caused by COVID-19 and whether just one dose can prevent symptomatic COVID-19, among other objectives.
During the trial, volunteers will receive two intramuscular injections about 28 days apart. Participants will be randomly assigned 1:1 to receive either two 100 microgram (mcg) injections of mRNA-1273 or two shots of a saline placebo. The trial is blinded, so the investigators and the participants will not know who is assigned to which group.