![]() Steven Woloshin of the Center for Medicine in the Media at the Dartmouth Institute for Health Policy and Clinical Practice, Dr. A false negative diagnostic test may be an even bigger problem, since it might mean that someone who is asymptomatic doesn’t stay home and will continue to spread the disease, argued Dr. Someone who has a false positive on a coronavirus test may quarantine unnecessarily and resources would be wasted on unnecessary contact tracing. Some antibody tests, the tests that can identify if someone had a prior infection, have come under criticism from the US Centers for Disease Control and Prevention and the US Food and Drug Administration for being inaccurate, but the diagnostic tests used in this pandemic have also had their share of problems, the experts argued. “All the vaccine scientists in the world, political scientists in the world can make predictions or be encouraged by the data, but the only data that matters at the end of the day is if we do a placebo-controlled study and can confidently say the vaccine works, it reduces the risk that somebody gets severe Covid,” Mascola said.Īs the United States continues to reopen, inaccurate diagnostic tests may undermine the country's ability to keep the Covid-19 pandemic from spreading, experts on health policy argued Friday in the New England Journal of Medicine. John Mascola, the director of the Vaccine Research Center at NIH’s National Institute of Allergy and Infectious Disease, who was also part of the town hall. The only thing that matters at the end of the day is the vaccine data, said Dr. Vaccine trials are now underway and Corey said they will require the cooperation and collaboration of the pharmaceutical industry, academia, research centers, the biotech industry and the NIH. So, could that potentially happen by January? Yes, it could potentially happen by January,” Corey added. “The higher the efficacy or the better the efficacy, the shorter the time is needed to show that a vaccine actually shows an effect as the number of cases occur are much fewer in the vaccine group than they are in the placebo group. “Obviously the first vaccine out of the box, which is this RNA vaccine, whether it's Pfizer or Moderna, are going to have to work terrifically well to get an answer by January." Larry Corey, a leading expert in virology, immunology and vaccine development and a member of Fred Hutch’s vaccine and infectious disease division. “Everything will have to go incredibly perfectly if that's going to happen,” said Dr. “It is showing the health disparities in our country,” Corey said. We are going in as a US government organization and whether events these last couple of few weeks are going to affect our ability to establish medical trust through the kinds of things that we need to do with community outreach, that becomes really a central issue for us to be able to enroll the people who have been most affected by Covid-19,” he said. “Our underserved populations are Black and Hispanic populations. Larry Corey, a leading expert in virology, immunology and vaccine development and a member of the Fred Hutchinson Cancer Research Center’s vaccine and infectious disease division.Īs national protests over police brutality and the US judicial system continue into a second week, vaccine developers may have a harder time convincing people of color to participate in the trials. “And frankly, this is one of the new worries,” Corey told the town hall. “We are working with HHS and predictive analytics to be able to track where the virus is to match that with where we do the vaccination campaigns, and also to make sure that we enroll the populations that are at highest risk,” said Dr. Since the government is helping fund the development of a coronavirus vaccine, that should help make it affordable, Mascola said.īut before that can even happen, clinical trials involving thousands of people are needed to help decide if a vaccine candidate is effective. “But there are built in provisions already that when the US government is involved in a substantial part of the funding for the effort, as it is here that in the United States, that vaccine will be available to the US government for distribution,” he said. ![]() ![]() ![]() For example, the US Centers for Disease Control and Prevention will make the recommendations on who gets it, Mascola said. Some context: When the US government is involved, as it is with the development of a coronavirus vaccine, there are a number of agencies that will make decisions during the development process. “As we think about how to test the vaccines and find out if they work … the question is can we make enough so that we can make it available to large parts of the population, and can it be accessible and can it be affordable,” Mascola said. ![]()
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