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July 15, 2020

Moderna's coronavirus vaccine shows promise. Here's what happens next.

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    New data from an early-stage clinical trial on Moderna's coronavirus vaccine candidate shows the vaccine appears to be safe and generates antibodies that could neutralize the virus, but it's still unclear whether the vaccine provides people with any immunity against the pathogen.

    US new coronavirus cases surpass 3.4M, deaths top 136K

    The new data comes as America's coronavirus epidemic continues to worsen. As of Wednesday morning, U.S. officials reported 3,445,500 total cases of the new coronavirus since the country's epidemic first began—up from 3,379,900 cases reported as of Tuesday morning.

    Data from the New York Times shows that Puerto Rico; the U.S. Virgin Islands; Washington, D.C.; and 41 states saw their average daily numbers of newly reported coronavirus cases rise over the past 14 days: Alabama, Alaska, Arkansas, California, Colorado, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Mexico, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, and Wisconsin.

    According to Axios' "Vitals," nine of the 20 U.S. metropolitan areas reporting the highest daily increases in new coronavirus cases are in Florida, which is now an epicenter of the global coronavirus pandemic. Rep. Donna Shalala (D-Fla.) on Monday said Florida officials should consider implementing a three-week shutdown to curb the virus' spread in the state. "We're in a very difficult situation at the moment, and unless we step back and reset our strategy, a lot more people are going to die," she said.

    Meanwhile, the Times' data shows that the average daily numbers of newly reported coronavirus cases over the past two weeks remained mostly stable in Guam and seven states: Arizona, Connecticut, Delaware, New Jersey, New York, South Dakota, and Wyoming.

    Maine and New Hampshire saw their average daily numbers of newly confirmed cases decrease over the past 14 days, according to the Times' data.

    While growth in America's national coronavirus-related death rate had declined in June, recent data suggests that rate is accelerating once again.

    According to the Times' data, Puerto Rico and 23 states saw their average daily numbers of newly reported deaths linked to the coronavirus rise over the past 14 days: Alabama, Arizona, California, Colorado, Florida, Georgia, Idaho, Iowa, Louisiana, Mississippi, Montana, Nevada, New Jersey, New Mexico, North Carolina, Oklahoma, Oregon, South Carolina, South Dakota, Tennessee, Texas, Utah, and Washington.

    On Tuesday, at least five states—Alabama, Florida, Nevada, North Carolina, and Utah—reported record-high, single-day increases in their numbers of new deaths linked to the coronavirus, the Washington Post reports.

    Overall, officials as of Wednesday morning had reported a total of 136,356 U.S. deaths linked to the new coronavirus—up from 135,402 deaths reported as of Tuesday morning.

    Data shows Moderna's coronavirus vaccine produces antibodies—but questions remain

    Scientists have been scrambling to develop a vaccine against the coronavirus and, on Tuesday, the results of a phase one clinical trial on Moderna's experimental coronavirus vaccine offered promising results.

    The vaccine candidate, which Moderna developed in partnership with NIH's National Institute of Allergy and Infectious Diseases (NIAID), uses genetic material called mRNA from the novel coronavirus to activate the body's immune system to fight the pathogen.

    In May, Moderna in a press release announced partial results from the phase one clinical trial, which involved 45 healthy adults ages 18 to 55, who received two vaccinations 28 days apart in March and April. The trial participants received either a low, medium, or high dose of the vaccine.

    The new data, which was published in the New England Journal of Medicine, shows that all of the trial's 45 participants developed the antibodies after they received their first dose of the vaccine. According to the study, researchers found that the participants had developed levels of the potentially neutralizing antibodies similar to the upper-range level of antibodies seen in patients who had been infected with the coronavirus and recovered. The researchers also found that the vaccine had generated a favorable immune response involving participants' T-cells.

    The data also indicates that the vaccine candidate is safe for use in humans. According to the study, more than 50% of the trial's participants experienced mild side effects, including chills and body aches, after being vaccinated. All participants who received a 100-microgram dose of the virus experienced mild or moderate side effects, while some participants who received a 250-microgram dose experienced more serious side effects, though no participants required hospitalization for the reactions.

    Moderna on Tuesday said it will begin a phase three trial of the 100-microgram dose of the experimental vaccine on July 27. The trial will involve 30,000 participants, and half will serve as a control group, receiving placebos. The company expects to complete the late-stage trial by late October.

    Experts who were not involved with the phase one trial said the new results show promise for the vaccine candidate, but they noted that it's still not clear whether the vaccine provides any immunity to the novel coronavirus.

    NIAID Director Anthony Fauci said, "The hallmark of a vaccine is one that can actually mimic natural infection and induce the kind of response that you would get with natural infection. And it looks like, at least in this limited, small number of individuals, that is exactly what's happening."

    But Angela Rasmussen, a virologist at Columbia University, said, "Just because you have antibodies doesn't mean you're completely immune."

    Researchers do not yet know the level of neutralizing antibodies humans may need to protect them against becoming infected with the new coronavirus or how long any immunity derived from those antibodies might last.

    However, Rasmussen said, even if a vaccine doesn't produce immunity, it may help reduce the severity of coronavirus infections. "If it's a choice between a bad cold and being on a ventilator, I'll take the bad cold," she said.

    Trump admin orders hospitals to send coronavirus data directly to HHS, bypassing CDC

    Separately, HHS in guidance issued Friday directed hospitals to send information regarding patients with Covid-19, the disease caused by the new coronavirus, to a central HHS database managed by the health data firm TeleTracking instead of to a CDC-managed database, as they'd been doing for the past few months.

    The instructions mean CDC will no longer oversee the daily collection of data from hospitals on their numbers of Covid-19 patients, available beds, ventilators, and other crucial information. Under the guidance, hospitals must report information daily to the new centralized system unless they have received a written notification saying their state will handle daily reporting to the federal government.

    HHS said the central database will streamline the federal government's data collection efforts and help the White House's coronavirus task force allocate personal protective equipment and other resources.

    Janis Orlowski, the Association of American Medical Colleges' chief health care officer, said Deborah Birx, the White House's coronavirus response coordinator, sought to change the federal government's data collection process after hearing concerns that hospitals were not adequately reporting their data. Birx convened a working group of government and hospital officials to develop the new reporting system.

    HHS spokesperson Michael Caputo said, under CDC's reporting system, the agency was experiencing a lag in information on America's coronavirus epidemic. "Today, the CDC still has at least a week lag in reporting hospital data," Caputo said. "America requires it in real time. The new, faster and complete data system is what our nation needs to defeat the coronavirus, and the CDC, an operating division of HHS, will certainly participate in this streamlined all-of-government response. They will simply no longer control it."

    Caputo said CDC will continue to publicly release data on the epidemic (Farzan et al., Washington Post, 7/15; Owens, "Vitals," Axios, 7/15; Fox, CNN, 7/14; Japsen, Forbes, 7/14; Grady, New York Times, 7/14; Herper, STAT News, 7/14; DeAngelis, Boston Business Journal, 7/14; Loftus, Wall Street Journal, 7/14; Brennan, Politico, 7/14; Neergaard, Associated Press, 7/14; Stolberg, New York Times, 7/14; Acosta/Cole, CNN, 7/15; Commins, HealthLeaders Media,7/14; New York Times, 7/15).

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