• Pfizer says it could apply for emergency use authorization of COVID-19

    From Ubiquitous@21:1/5 to All on Fri Oct 16 21:05:01 2020
    XPost: alt.tv.pol-incorrect, alt.fan.rush-limbaugh, sci.med.diseaeses

    Pfizer Inc. said Friday it could apply for emergency use authorization
    in the United States of its COVID-19 vaccine by late November. In an
    open letter, Pfizer Chairman and CEO Albert Bourla made the
    announcement about the progress in developing a coronavirus vaccine
    with its partner BioNTech, a biotechnology company that manufactures immunotherapies.

    "I know there is a great deal of confusion regarding exactly what it
    will take to ensure its development and approval, and given the
    critical public health considerations and the importance of
    transparency, I would like to provide greater clarity around the
    development timelines for Pfizer's and our partner BioNTech's COVID-19 vaccine," Bourla said.

    Bourla said Pfizer is "operating at the speed of science," but there
    are three steps that must happen before the company can release its
    COVID-19 vaccine.

    "First, the vaccine must be proven effective, meaning it can help
    prevent COVID-19 disease in at least a majority of vaccinated
    patients." Then the "vaccine must be proven safe, with robust safety
    data generated from thousands of patients." The last step is
    demonstrating that the "vaccine can be consistently manufactured at the
    highest quality standards."

    "We may know whether or not our vaccine is effective by the end of
    October," Bourla said, based on its 40,000-person clinical trial. "To
    do so, we must accumulate a certain number of COVID-19 cases in our
    trial to compare the effectiveness of the vaccine in vaccinated
    individuals to those who received a placebo."

    "So let me be clear, assuming positive data, Pfizer will apply for
    Emergency Authorization Use in the U.S. soon after the safety milestone
    is achieved in the third week of November," Bourla wrote. "All the data contained in our U.S. application would be reviewed not only by the
    FDA's own scientists but also by an external panel of independent
    experts at a publicly held meeting convened by the agency."

    Bourla noted, "The timelines above reflect our best estimates of when
    these important milestones could be achieved."

    A BioNTech spokesperson confirmed the time frame for the potential EUA application to the FDA.

    This is the first time any "leading Western vaccine developer provided
    such a specific timeline," according to the Wall Street Journal.

    "Moderna could also apply for an emergency use authorization (EUA) this
    year. It has said that it may have interim data on its 30,000 person
    trial as soon as November," as reported by Reuters.

    This comes at a time when COVID-19 cases in the U.S. are climbing
    slightly, but the coronavirus deaths are relatively level this month.

    "The spread of the coronavirus appeared to be accelerating this week in
    the U.S. with a key indicator in 44 of the 50 states and Washington,
    D.C. flashing an 'ominous' warning sign," a health official told the
    Wall Street Journal on Tuesday.

    On Monday, Johnson & Johnson announced it had paused a large, late-
    stage clinical trial of its coronavirus vaccine after one of its
    volunteers became ill with an unexplained sickness. The company pointed
    out that illnesses, even severe cases, "are an expected part of any
    clinical study, especially large studies."

    On Tuesday, pharmaceutical company Eli Lilly said it paused a government-sponsored antibody treatment trial because of a "potential
    safety concern."

    Last month, President Donald Trump said that a COVID-19 vaccine would
    be distributed within 24 hours of completion of phase 3 trials and FDA approval. The president touted that all Americans will have access to
    the coronavirus vaccine by April.

    "As part of Operation Warp Speed, my administration has manufactured
    one of the most promising vaccines in advance, and it will be fairly
    long in advance, as soon as a vaccine is approved, the administration
    will deliver it to the American people immediately. Distribution will
    begin within 24 hours," President Trump said.

    The coronavirus vaccine will be free for all Americans, but initially
    the COVID-19 vaccine will likely be available to higher-risk groups,
    such as health care workers, essential workers, the elderly, and those
    with health conditions that make them more vulnerable to COVID-19.

    Dr. Scott Atlas, a member of the White House coronavirus response task
    force, said the COVID-19 vaccine would not be a forced vaccination.

    In July, the U.S. Department of Health and Human Services and the
    Department of Defense (DoD) announced an agreement with Pfizer for an
    initial order of 100 million doses of a coronavirus vaccine for the
    price of $1.95 billion, following EUA or licensure. The agreement
    provides the U.S. government an option to purchase an additional 500
    million doses.

    Democrats and the liberal media hate President Trump more than they
    love this country.

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