US EditionFDA requires updated warning about rare heart risk with COVID shots
ISRAEL, JUN 23 – A large Israeli study found fetal losses increased to 13 per 100 pregnancies when mRNA COVID-19 vaccines were given between weeks 8-13, revealing potential dose-response effects.
- Pregnant women were excluded from early COVID-19 vaccine trials, with a small Pfizer study of 173 late-stage pregnancies; data shows dose-response risks with boosters between weeks 8-13.
- Analysis of 226,000 Israeli pregnancies shows a 43% rise in fetal losses after dose 1 and 19% after dose 3, with nearly half occurring post-week 24.
- The FDA expanded warnings on Pfizer and Moderna vaccines for myocarditis, covering ages 6 months to 64 years, with 8 cases per million doses, following emerging safety data.
- Under HHS Secretary Kennedy, efforts to dismantle PREP Act liability shields and new FDA vaccine label changes aim to restrict vaccine use, prompting calls for legal accountability.
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132 Articles
FDA slaps damning warnings on COVID-19 vaccines; highlights Biden administration's safety-risk gloss
Federal health authorities rebuked Florida Surgeon General Dr. Joseph Ladapo for suggesting in 2022 that the benefit of COVID-19 vaccination among healthy young men was outweighed by the risk of heart conditions, myocarditis in particular.Ladapo issued guidance that stated, "Based on currently available data, patients should be informed of the possible cardiac complications that can arise after receiving a mRNA COVID-19 vaccine."“Our goal is not…
FDA expanding COVID vaccine warnings over rare heart side effect
The Food and Drug Administration is now requiring two common COVID-19 vaccines to update their warning labels to include information on two rare heart side effects. Myocarditis — inflammation of the heart muscle — and pericarditis — inflammation of the thin sac surrounding the heart — are two conditions that a small number of…
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