<p>The Food and Drug Administration (FDA) on Tuesday released a detailed analysis of the COVID-19 vaccine from Pfizer, deeming the two-shot immunization safe and effective.</p>
<p>The move comes two days ahead of an FDA meeting of the Vaccines and Related Biological Products Advisory Committee, a group of independent experts set to advise the agency on whether to grant the vaccine emergency use authorization (EUA).</p>
<p>The agency released two separate analyses, one from its own team of scientists and a second from the vaccine’s manufacturers, Pfizer Inc. and German partner BioNTech SE. They conclude that the vaccine “met the prescribed success criteria.&#8221; The vaccine, the FDA said, is &#8220;for active immunization for the prevention of COVID-19 caused by SARS-CoV-2 in individuals 16 years of age and older.&#8221;</p>
<p>&#8220;Safety data from approximately 38,000 participants [greater than or equal to] 16 years of age randomized 1:1 to vaccine or placebo with a median of 2 months of follow up after the second dose suggest a favorable safety profile, with no specific safety concerns identified that would preclude issuance of an EUA,&#8221; the FDA wrote.</p>
<p>The FDA&#8217;s <a href="https://www.fda.gov/media/144245/download">analysis</a> finds &#8220;no specific safety concerns identified that would preclude issuance of an EUA.&#8221; The analysis found that serious reactions were rare but side effects were common, including reactions at the site of injection, headaches and fatigue.</p>
<p>The analysis also confirmed that the vaccine is 95% effective assessed two doses, 21 days apart, but also said it was 82% effective to prevent COVID-19 after a single dose.</p>
<p>The vaccine is already in use: A 90-year-old woman in Britain on Tuesday became the first person in the world to receive the Pfizer vaccine.</p>
<p>Pfizer&#8217;s is one of three vaccines currently in the works. Biotech firm Moderna on Nov. 30 moved to win emergency use authorization from the FDA for its experimental COVID-19 vaccine.</p>
<p>Moderna&#8217;s request came after Pfizer filed their application on Nov. 20. Moderna said its data showed their vaccine was 94.1% effective in its late-stage clinical trial. The Moderna vaccine was developed in conjunction with the Trump administration’s Operation Warp Speed.</p>
<p>A key advantage of Moderna’s vaccine is that it does not need sub-zero storage like Pfizer’s, which needs to be stored at -94 degrees.</p>
<p>A third vaccine is also in the pipeline. AstraZeneca and Oxford University on Nov. 23 said their jointly created COVID-19 vaccine has proven to be up to 90% effective, and the makers claim it will be easier to distribute.</p>
<p>The CDC&#8217;s Advisory Committee on Immunization Practices (ACIP) on Dec. 2 voted to direct that healthcare workers and residents of long-term care facilities will be the first to get the shots in the initial rollout — once federal regulators authorize use of a vaccine. The recommendation was approved by CDC Director Robert Redfield, but governors will eventually have the final say on who gets the vaccine first.</p>
<p><strong>Related: <a href="https://www.dailywire.com/news/former-dem-rep-pay-americans-1500-to-get-covid-19-vaccine">Former Dem Rep: Pay Americans $1,500 To Get COVID-19 Vaccine</a></strong></p>

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FDA Confirms Pfizer Vaccine Safe, Effective; Approval Expected In Days

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FDA Confirms Pfizer Vaccine Safe, Effective; Approval Expected In Days