Phase 3 Clinical Trial of Vaccine Candidate Underway; 30,000 Volunteers to Take Part
The largest U.S. clinical trial to test a COVID-19 vaccine candidate has started, announced co-developers Moderna and the National Institutes of Health.
The “phase 3 trial” is expected to enroll approximately 30,000 adult volunteers who do not have COVID-19. Researchers will evaluate if the investigational vaccine can prevent symptomatic coronavirus in adults.
Moderna is a Cambridge, Massachusetts-based biotechnology company. It co-developed the vaccine candidate with the National Institute of Allergy and Infectious Diseases (NIAID), part of the U.S. National Institutes of Health.
“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,” said NIAID Director Anthony S. Fauci, M.D., in a news release . “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.”
A committee of the National Academies of Sciences, Engineering and Medicine and the National Academy of Medicine is drafting recommendations on how to prioritize distribution of a vaccine, if the U.S. Food and Drug Administration (FDA) grants approval.
The “mRNA-1273 vaccine candidate” will be tested at approximately 89 clinical research sites in the U.S. that are near COVID-19 hotspots.
“Investigators will use public health data and incidence trajectory modeling to identify sustained high-incidence areas and emerging hot zones, so sites near these locations can be prioritized for enrollment,” states the National Institutes of Health in its news release.
Researchers: Rapid Drop of Antibodies in Those Who had Mild COVID-19 Symptoms
Antibody levels in recovered patients with mild COVID-19, the level of disease most infected people experience, seem to decrease by half within 36 days, a new study indicates.
The research, published in a letter to the editor of The New England Journal of Medicine , was conducted by physicians, researchers and other experts associated with the David Geffen School of Medicine at University of California, Los Angeles (UCLA).
The antibody decrease at five weeks is striking compared to other viral infections, researchers said.
The UCLA team followed 34 coronavirus patients with mild symptoms for three months. They said they found “rapid decay” of the antibodies, a faster breakdown rate than that of other viruses, including SARS which is another coronavirus. The participants included 20 women and 14 men, ranging in age from 21 to 68.
The letter’s authors conclude: “Our findings raise concern that humoral immunity  against (COVID-19) may not be long lasting in persons with mild illness, who compose the majority of persons with COVID-19. It is difficult to extrapolate beyond our observation period of approximately 90 days because it is likely that the decay will decelerate.”
Hand sanitizers sold at Major Retailers Added to FDA’s Recall List as ‘Toxic’
The U.S. Food and Drug Administration (FDA) continues to warn consumers and health are professionals not to use certain alcohol-based hand sanitizers because of the ingredient methanol, or wood alcohol, a substance often used to create fuel and antifreeze that can be toxic when absorbed through the skin.
Over the past two weeks, the FDA’s hand-sanitizer recall list has grown, adding brands that had been sold at major U.S. retailers including Walmart, Target and Costco.
The said it issued a warning earlier this month about an increasing number of adverse events, including blindness, cardiac effects, effects on the central nervous system, and hospitalizations and death, primarily reported to poison control centers and state departments of health. “The agency continues to see these figures rise,” the FDA states.
“Consumers must also be vigilant about which hand sanitizers they use, and for their health and safety we urge consumers to immediately stop using all hand sanitizers on the FDA’s list of dangerous hand sanitizer products,” said FDA Commissioner Stephen M. Hahn, M.D.
Here is the FDA’s do-not-use list of dangerous hand sanitizer products .