Moderna begins phase 3 trials of potential Covid-19 vaccine, study finds US vaccines to be remarkably safe
After showing promising results in the earlier stages of the trial, experts will now test the vaccine, named mRNA-1273, on 30,000 participants
A potential Covid-19 vaccine, developed by Moderna Therapeutics, has entered phase 3 clinical trials — a crucial test that will determine if it offers protection against the disease. If successful, the US said it would have doses ready by the end of the year.
Moderna collaborated with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), to develop the vaccine. After showing promising results in the earlier stages of the trial, experts will now test the vaccine, named mRNA-1273, on 30,000 participants. Half of them will receive the shot and the remaining will get a saline placebo. “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,” NIAID Director Dr Anthony S. Fauci said in a statement. “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.”
Typically, it takes about 15 to 20 years to develop a safe and effective vaccine. Developing one by the end of 2020 is a "stretch goal, but it’s the right goal for the American people," NIH Director Dr Francis S. Collins. He added: "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 will investigate whether two doses of the vaccine candidate can keep volunteers from contracting Covid-19. Participants will either receive either two 100 micrograms (mcg) injections of the shot or a saline placebo — 28 days apart. Investigators and the participants will not know who is assigned to which group to prevent bias. Even if a potential Covid-19 shot successfully clears safety and efficacy tests, experts are concerned that some Americans might refuse to get themselves vaccinated. This could hurt the end goal: herd immunity. It can be achieved when a large proportion of individuals become immune to the disease by taking a vaccine.
"One of the things I'm worried about is there's a lot of skepticism in America about the vaccine, and something like 25% of people say I'm not sure I would take that vaccine," Collins told CNN earlier this month. "It'll be really critical to do that if we're going to develop the level of herd immunity across the country so that this doesn't come roaring back the next time, the next fall, the next summer," he added.
Twenty years of data show FDA-approved vaccines safe
A new study from researchers at Tel Aviv Sourasky Medical Center found that vaccines are remarkably safe by studying 57 FDA-approved shots between 1996 and 2015. They attribute this to the FDA's surveillance program that monitors vaccines once they enter the market. It allows health professionals and the public to report on the adverse side-effects of a vaccine.
Once alerted of the side-effects, the FDA made changes to the vaccine labels and updated the safety guidelines. For instance, they restricted vaccine use among the immunocompromised populations, pregnant women and preterm infants. "This study really shows once again that vaccines are one of the safest interventions we have," Tara Smith, a professor of epidemiology at Kent State University in Ohio, told NBC News. "The issues they saw were largely correctable just by changing who they give the vaccines to." Talking about vaccine skeptics, lead author of the study Dr Daniel Shepshelovich said: "Vaccines have almost no side effects and are especially safer than medical devices." He told NBC News, "If you look at the facts, they are very, very clear. Vaccines are safe."