This link is to the "approval" letter. The first paragraph states it is approved in Germany and will be distributed from Belgium, NOT the US. Page 6 talks about the study submission dates for the US (final study due 2025). The letter specifically talks about myocarditis and pericarditis, so they knew all along about the issues with this shit. https://www.fda.gov/media/151710/download
This link is to the "approval" letter. The first paragraph states it is approved in Germany and will be distributed from Belgium, NOT the US. Page 6 talks about the study submission dates for the US (final study due 2025). The letter specifically talks about myocarditis and pericarditis, so they knew all along about the issues with this shit. https://www.fda.gov/media/151710/download