FDA announcement only says jabs are “authorized,” not “approved.”
- The Food and Drug Administration (FDA) announced on Friday that it had authorized the first COVID-19 shots for infants and preschoolers following its advisory panel’s unanimous recommendation for Moderna’s and Pfizer’s formulations.
- The FDA did not clarify whether the Pfizer and Moderna shots for children are “approved”—which requires a more rigorous testing process (here, here)—but only that they are “authorized”: “Today, the U.S. Food and Drug Administration authorized emergency use of the Moderna COVID-19 Vaccine and the Pfizer-BioNTech COVID-19 Vaccine for the prevention of COVID-19 to include use in children down to 6 months of age,” the announcement reads. The word “approve[d]” does not appear in the FDA’s announcement.
- The health agency argues that its “evaluation and analysis of the safety, effectiveness and manufacturing data of these vaccines was rigorous and comprehensive” and that “the known and potential benefits of the Moderna and Pfizer-BioNTech COVID-19 vaccines outweigh the known and potential risks in the pediatric populations authorized for use for each vaccine.”
- U.S. children under 5 are now eligible for the vaccinations, which will commence next week.
- There have been 2,170,161 vaccine-linked injuries reported to the U.S. Centers for Disease Control and Prevention’s (CDC) Vaccine Adverse Event Reporting System (VAERS) since the system began collecting data in 1990. More than half of those injuries (1,295,327) are linked to the COVID-19 jab despite COVID vaccines only becoming available in 2020. In other words, there have been more vaccine-linked injuries in the last two years than there have been in the 30 years prior to the COVID vaccine’s distribution.
READ THE FDA AUTHORIZATION NEWS RELEASE:
- The Department of Health and Human Services commissioned a study in 2010 showing only 1% of vaccine adverse events are reported to the CDC’s VAERS tracking system in the first place.
- VAERS is the main government-funded system for reporting adverse vaccine reactions in the U.S.
- Moderna’s website explains that “the Moderna COVID‑19 Vaccine has not been approved or licensed by the US Food and Drug Administration (FDA), but has been authorized for emergency use by the FDA, under an Emergency Use Authorization (EUA).”