Affiliated vaccine injury attorney David Carney recently elected to President of the VIP Bar Association

University of Pittsburgh Makes Breakthrough with Coronavirus Vaccine

The University of Pittsburgh School of Medicine has announced a new potential vaccine against the coronavirus that is decimating the world. In a peer-reviewed study published in EBioMedicine, the researchers said their new potential vaccine is predicated on earlier vaccines from prior coronavirus outbreaks. The first outbreak was SARS, which broke out in China in 2003, and MERS, which targeted Middle Eastern countries and South Korea in 2014. Andrea Gambotto, an associate professor of surgery at the Pitt School of Medicine and one of the study's two lead authors, stated that they have been designing coronavirus vaccines since 2003. Due to their 17 years of experience with the virus, the researchers repurposed earlier vaccines to target a specific protein that protrudes from the new version. The study published in EBioMedicine showed that when tested in mice, the vaccine produced antibodies that were specific to the current coronavirus, and in quantities that can neutralize the virus. The Pitt-developed vaccine would be a unique technique where a fingertip-sized patch is applied to the recipient’s skin. Scientists believe the immune system will react more strongly to the skin application and fight the coronavirus more quickly than a needle injection. This delivery method is similar to the smallpox vaccine and human testing is said to be next. "We'd like to begin testing in patients as soon as possible," said Louis Falo, chair of the dermatology department at the Pitt School of Medicine and the University of Pittsburgh Medical Center. "We would like to be in a phase one clinical trial in weeks. Not a week, maybe a month." While human testing typically requires at least a year, Falo said Pitt is working with federal agencies to speed the process. “This particular situation is different from anything we’ve ever seen, so we don’t know how long the clinical development process will take. Recently announced revisions to the normal processes suggest we may be able to advance this faster,” said Falo, who is senior co-author of the research. The researchers are applying for approval from the U.S. Food and Drug Administration. Public health experts around the world agree that there could be another outbreak of the novel coronavirus in the Fall of 2020. Dr. Anthony Fauci, head of the National Institute of Allergy and Infectious Diseases and a member of the White House coronavirus task force, reinforced that assessment during a White House press briefing Wednesday. “The ultimate solution to a virus that might keep coming back would be a vaccine,” Fauci said, noting that the soonest a vaccine is likely to be ready is in about 12 to 18 months. Pitt isn’t the only institution participating in the global race to develop a vaccine, which Fauci called “the ultimate game-changer.” At least 50 other potential vaccine candidates are in development worldwide, and two candidates — one developed by researchers in Beijing, the other by the Cambridge, Mass.-based biotechnology company Moderna and the U.S. National Institutes of Health — have proceeded to clinical trials, according to a tally kept by the World Health Organization. Moderna and the U.S. National Institutes of Health started clinical trial testing in humans of the first experimental vaccine for the new coronavirus March 16 in Seattle. That vaccine uses genetic material that prompts the body’s immune system to start preparing to fight the virus. PittCoVacc, short for Pittsburgh Coronavirus Vaccine, is similar to the influenza vaccine in that laboratory constructed pieces of the viral protein, referred to as antigens, are introduced to prompt the body to start building immunity against the particular virus. Mice that received PittCoVacc started generating a surge of antibodies against SARS-CoV-2 within two weeks. “This vaccine is designed to be safe, in part because it delivers very low doses of antigen,” Falo said. “Much lower doses than the traditional flu vaccine. Secondly, it delivers that antigen to a very confined space within the skin, so that it’s very unlikely that we would see any type of systemic responses that have been seen with some patients in the flu vaccine.” Researchers believe that in order to increase potency, the vaccine would be administered using a microneedle array, which is a patch the size of a fingertip, and contains 400 tiny needles made out of sugar and pieces of the spike protein. The patch is applied to the skin and the needles then dissolve into the skin, where the immune response is the strongest. “We developed this to build on the original scratch method used to deliver the smallpox vaccine to the skin, but as a high-tech version that is more efficient and reproducible patient to patient,” Falo said. “And it’s actually pretty painless — it feels kind of like Velcro.” The vaccine is expected to be effective across age groups. Similar to the flu shot, elderly patients may require a slightly higher dose. The process for making the vaccine does not require significantly complex or expensive equipment, which makes it very scalable, Falo said. The vaccine does not need to be kept frozen or refrigerated, which could reduce shipping costs and help with distributing the vaccine. “When the vaccine is actually ready for widespread deployment, it would most likely be ready broadly so that we would not have to ration the vaccine,” Falo said. “I would expect that the manufacturing and scale-up would occur during the testing process, so that plenty of vaccine would be available if it proved to be effective.”

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