Yet only phase III clinical trials can show which vaccines-if any-will actually provide protection. Results from animal tests and early human safety studies look promising: vaccines generate encouraging immune responses, and the side effects they trigger-usually headache, arm pain, fatigue and fever-resolve quickly in most people. And the trials have to answer key questions about how well human immune systems protect against SARS-CoV-2, the novel coronavirus behind the disease. Adding to the challenge, a growing number of people have shown skepticism toward an eventual vaccine. Experts say such trials should also include adequate representation from vulnerable subgroups at high risk from COVID-19, including the elderly, minority racial groups and individuals with underlying health problems. officials have insisted their own vaccines will be thoroughly vetted before approval. (The concerns are not without merit: on August 11 Russia announced it had approved a vaccine despite the fact that the drug has not been tested in large-scale trials.) U.S. But vaccine developers now plan to test their candidates on rushed schedules that have sparked concerns over political meddling. Phase III clinical trials often take years to reach their conclusion. The institute is not directly involved in the efforts to develop a vaccine against COVID-19, but it is working on vaccines for other viral diseases around the world. These assessments “will ultimately support regulatory approval and recommendations for how vaccines can be used,” says Penny Heaton, CEO of the Bill & Melinda Gates Medical Research Institute. During the trials, enrolled subjects will get experimental shots or a placebo, and investigators will observe whether those who received the vaccine develop infections and illness at lower rates. The vaccine, which was co-developed by the pharmaceutical giant Pfizer and the German company BioNTech, is among front-runner efforts worldwide to develop immunizations for COVID-19 that are currently conducting or preparing to start phase III clinical trials-late-stage studies that test for efficacy and safety.* Six of these efforts are backed by Operation Warp Speed, a Trump administration program with the optimistic goal of beginning mass inoculations against the disease in the U.S. “People are fed up with this disease and very motivated to help.” The more than 1,000 names on the waiting list suggest the local response to the trial “has been outstanding,” says Mark Mulligan, an infectious disease specialist who directs NYU Langone’s Vaccine Center. In late July, volunteers began receiving doses of a potential COVID-19 vaccine in the latest stage of a clinical trial at NYU Langone Health in New York City. In this story, Scientific American describes how the fast-track vaccine trials work and how they measure effectiveness and safety. Centers for Disease Control and Prevention just alerted states to prepare for a novel coronavirus vaccine as early as November.
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