<?xml version="1.0" encoding="UTF-8"?><rss version="2.0" xmlns:content="http://purl.org/rss/1.0/modules/content/"
     xmlns:dc="http://purl.org/dc/elements/1.1/"
     xmlns:atom="http://www.w3.org/2005/Atom"
     xmlns:sy="http://purl.org/rss/1.0/modules/syndication/"
     xmlns:slash="http://purl.org/rss/1.0/modules/slash/"
     xmlns:georss="http://www.georss.org/georss"
     xmlns:geo="http://www.w3.org/2003/01/geo/wgs84_pos#"
     xmlns:media="http://search.yahoo.com/mrss/">
    <channel>
        <title><![CDATA[Drugmakers pledge to put safety first in race for COVID-19 vaccine]]></title>
        <atom:link href="https://usagag.com/2020/09/08/drugmakers-pledge-to-put-safety-first-in-race-for-covid-19-vaccine/" rel="self" type="application/rss+xml" />
        <link>https://usagag.com/2020/09/08/drugmakers-pledge-to-put-safety-first-in-race-for-covid-19-vaccine/</link>
        <lastBuildDate>Tue, 08 Sep 2020 12:11:13 +0000</lastBuildDate>
        <sy:updatePeriod>hourly</sy:updatePeriod>
        <sy:updateFrequency>1</sy:updateFrequency>
        <generator>https://usagag.com</generator>
        <media:content url="/uploads/2020/09/drugmakers-pledge-to-put-safety-first-in-race-for-covid-19-vaccine.jpg" medium="image">
            <media:title type="html">Drugmakers pledge to put safety first in race for COVID-19 vaccine</media:title>
        </media:content>
        <content:encoded><![CDATA[<p>Nine drugmakers pledged Tuesday to make safety their top priority as they race to develop a vaccine for the deadly coronavirus — vowing they would not seek emergency authorization before large-scale Phase 3 clinical trials are completed.</p><p>The biopharma firms said in a joint statement that they would follow &#8220;high ethical standards and sound scientific principles&#8221; in their efforts to study and produce an inoculation that could help end the COVID-19 pandemic.</p><p>&#8220;We believe this pledge will help ensure public confidence in the rigorous scientific and regulatory process by which COVID-19 vaccines are evaluated and may ultimately be approved,&#8221; says the statement from AstraZeneca, BioNTech, GlaxoSmithKline, Johnson &amp; Johnson, Merck, Moderna, Novavax, Pfizer and Sanofi.</p><p>The companies added that they would not seek approval or emergency authorization for a vaccine until it is shown to be safe and effective through a so-called Phase 3 clinical trial, which generally involves a large number of participants and a scientifically rigorous design.</p><p>Such studies are currently underway for several vaccine candidates, including those developed by AstraZeneca, Moderna and Pfizer, which is collaborating with BioNTech.</p><p>That indicates the leaders of the vaccine race in the US won&#8217;t take Food and Drug Administration Commissioner Stephen Hahn up on his offer to possibly fast-track a shot by <strong>granting an emergency use authorization</strong> before Phase 3 research is complete. Such an authorization would make the vaccine available to certain groups before it is fully approved.</p><p>The pledge came amid a push by the Trump administration to distribute a coronavirus shot quickly through Operation Warp Speed, a federal initiative that has committed billions of dollars to vaccine research and development.</p><p>President Trump suggested Monday that a vaccine could be <strong>ready as soon as next month</strong>, and the Centers for Disease Control and Prevention recently told states to be ready to distribute one by Nov. 1 — a timeline that runs close to the Nov. 3 presidential election.</p><p>The drugmakers said their pledge was consistent with the FDA&#8217;s guidance for developing a COVID-19 vaccine, which requires that &#8220;scientific evidence for regulatory approval must come from large, high-quality clinical trials that are randomized and observer-blinded.&#8221;</p><p>&#8220;FDA has established clear guidance for the development of COVID-19 vaccines and clear criteria for their potential authorization or approval in the US,&#8221; the statement says.</p><p>&#8220;FDA’s guidance and criteria are based on the scientific and medical principles necessary to clearly demonstrate the safety and efficacy of potential COVID-19 vaccines.</p><p>The FDA did not immediately respond to a request for comment Tuesday morning.</p>]]></content:encoded>
                <dc:creator><![CDATA[USAGAG]]></dc:creator>
            </channel>
</rss><!--Time: 0.057498931884766-->