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	<title>Pfizer and BioNTech booster &#8211; Cincy Link</title>
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		<title>Pfizer asks FDA to authorize its COVID booster for all adults</title>
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					<description><![CDATA[NEW YORK, N.Y. — Pfizer and BioNTech announced Tuesday that they’ve made a request for the Food and Drug Administration (FDA) to authorize their COVID-19 booster shot for all adults. Specifically, the companies have requested that the FDA amend the emergency use authorization it granted for the booster dose to include all individuals 18 years &#8230;]]></description>
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<p>NEW YORK, N.Y. — Pfizer and BioNTech <a class="Link" href="https://cdn.pfizer.com/pfizercom/2021-11/Booster_10K_Efficacy_EUA_Submission_Statement_Final_11921.pdf?linkId=139453336">announced</a> Tuesday that they’ve made a request for the Food and Drug Administration (FDA) to authorize their COVID-19 booster shot for all adults.</p>
<p>Specifically, the companies have requested that the FDA amend the emergency use authorization it granted for the booster dose to include all individuals 18 years of age and older.</p>
<p>The request is based on results from a Phase 3 randomized, controlled trial evaluating the efficacy and safety of a 30-microgram booster dose of the Pfizer vaccine, according to the companies.</p>
<p>Next, the FDA will consider the request and make a final decision in the coming weeks. If the FDA amends its authorization as asked, the Centers for Disease Control and Prevention (CDC) would then need to recommend it.</p>
<p>Under the FDA’s current <a class="Link" href="https://www.fda.gov/news-events/press-announcements/fda-authorizes-booster-dose-pfizer-biontech-covid-19-vaccine-certain-populations">emergency use authorization</a> granted in September, Pfizer’s booster dose is available to those 65 and older, people between 18 and 64 who are at a high risk of severe COVID-19, and those 18 to 64 whose frequent exposure to the coronavirus puts them at risk of serious complications from COVID-19.</p>
<p>The Pfizer booster is also available for eligible individuals who have completed a primary vaccination with a different authorized COVID-19 vaccine.</p>
<p>That includes people who initially got a Johnson &amp; Johnson vaccine. All adults who got the J&amp;J shot are now eligible for a booster and they can receive any of the three options available in the U.S. As for those who got the Moderna vaccine initially, the criteria to get a booster matches Pfizer’s conditions.</p>
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