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<blockquote data-quote="Fenris" data-source="post: 4987645" data-attributes="member: 35081"><p>Has anyone read the actual <u><a href="https://www.fda.gov/media/151710/download" target="_blank"><u>FDA approval lette</u></a>r</u> for the Pfizer vaccine? I saw a JPEG on another site and looked at the letter to validate. For those doubting potential long term risks, the FDA disagrees and is giving Pfizer to 2025 to conduct studies on known serious risks (page 6).</p><p></p><p>'We have determined that an analysis of spontaneous postmarketing adverse events</p><p>reported under section 505(k)(1) of the FDCA will not be sufficient<strong> to assess known </strong></p><p><strong>serious risks of myocarditis and pericarditis and identify an unexpected serious risk of </strong></p><p><strong>subclinical myocarditis. </strong></p></blockquote><p></p>
[QUOTE="Fenris, post: 4987645, member: 35081"] Has anyone read the actual [U][URL='https://www.fda.gov/media/151710/download'][U]FDA approval lette[/U][/URL]r[/U] for the Pfizer vaccine? I saw a JPEG on another site and looked at the letter to validate. For those doubting potential long term risks, the FDA disagrees and is giving Pfizer to 2025 to conduct studies on known serious risks (page 6). 'We have determined that an analysis of spontaneous postmarketing adverse events reported under section 505(k)(1) of the FDCA will not be sufficient[B] to assess known serious risks of myocarditis and pericarditis and identify an unexpected serious risk of subclinical myocarditis. [/B] [/QUOTE]
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