{"id":40543,"date":"2020-12-08T12:08:05","date_gmt":"2020-12-08T16:08:05","guid":{"rendered":"http:\/\/stateofthenation.co\/?p=40543"},"modified":"2020-12-08T12:08:05","modified_gmt":"2020-12-08T16:08:05","slug":"how-does-the-fda-even-approve-a-covid-vaccine-that-has-severe-adverse-reactions","status":"publish","type":"post","link":"https:\/\/stateofthenation.co\/?p=40543","title":{"rendered":"How does the FDA even approve a Covid vaccine that has ‘severe adverse reactions’"},"content":{"rendered":"

FDA Confirms Pfizer Vaccine 95% Effective, Warns Of ‘Severe Adverse Reactions’ After Dose 2<\/h1>\n

ZeroHedge.com<\/p>\n

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Pfizer and partner BioNTech\u2019s COVID-19\u00a0vaccine meets expectations on agency guidance and is enough to spur an agency review<\/strong>, according to staff of the U.S. Food and Drug Administration.<\/p>\n

The finding is one of several significant new results featured in the\u00a0briefing materials<\/strong>, which span 53 pages of data analyses from the agency and from Pfizer.<\/p>\n

On Thursday, F.D.A.\u2019s vaccine advisory panel will discuss these materials<\/strong>\u00a0in advance of a vote on whether to recommend authorization.<\/p>\n

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On the bright side,\u00a0efficacy in preventing confirmed COVID-19 occurring at least 7 days after the second dose of vaccine was 95.0%.<\/strong><\/p>\n

the study sponsors\u00a0\u201cprovided adequate information to ensure the vaccine\u2019s quality and consistency for authorization of the product under an EUA\u201d<\/strong>\u00a0agency reviewers said in briefing documents ahead of a Thursday panel.<\/p>\n

Additionally, the study confirms that\u00a0the vaccine worked well regardless of a volunteer\u2019s race, weight or age.<\/strong><\/p><\/blockquote>\n