As Reports of Injuries After COVID Vaccines Near 1 Million Mark, CDC, FDA Clear Pfizer, Moderna Boosters for All Adults

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by Megan Redshaw, Childrens Health Defense:

The Centers for Disease Control and Prevention (CDC) released new data today showing a total of 894,145 adverse events following COVID vaccines were reported between Dec. 14, 2020, and Nov. 12, 2021, to the Vaccine Adverse Event Reporting System (VAERS). VAERS is the primary government-funded system for reporting adverse vaccine reactions in the U.S.

The data included a total of 18,853 reports of deaths — an increase of 392 over the previous week — and 139,126 reports of serious injuries, including deaths, during the same time period — up 3,726 compared with the previous week.

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Excluding “foreign reports” to VAERS, 654,413 adverse events, including 8,664 deaths and 54,962 serious injuries, were reported in the U.S. between Dec. 14, 2020, and Nov. 12, 2021.

Foreign reports are reports received by U.S. manufacturers from their foreign subsidiaries. Under U.S. Food and Drug Administration (FDA) regulations, if a manufacturer is notified of a foreign case report that describes an event that is both serious and does not appear on the product’s labeling, the manufacturer is required to submit the report to VAERS.

Of the 8,664 U.S. deaths reported as of Nov. 12, 10% occurred within 24 hours of vaccination, 15% occurred within 48 hours of vaccination and 26% occurred in people who experienced an onset of symptoms within 48 hours of being vaccinated.

In the U.S., 436.9 million COVID vaccine doses had been administered as of Nov. 12. This includes: 254.5 million doses of Pfizer, 166.3 million doses of Moderna and 16.1 million doses of Johnson & Johnson (J&J).

Every Friday, VAERS publishes vaccine injury reports received as of a specified date.

Every Friday, VAERS publishes vaccine injury reports received as of a specified date. Reports submitted to VAERS require further investigation before a causal relationship can be confirmed. Historically, VAERS has been shown to report only 1% of actual vaccine adverse events.

This week’s U.S. data for 5- to 11-year-olds show:

  • 444 adverse events have been reported in the 5 to 11 age group since Nov. 1.
  • The rest of the reports in VAERS for children in the 5 to 11 age group occurred prior to the authorization of Pfizer’s COVID vaccine, and are due to ”product administered to patient of inappropriate age.”

This week’s U.S. data for 12- to 17-year-olds show:  

The most recent death includes a 16-year-old girl from Missouri (VAERS I.D. 1823671) who died after receiving her second dose of Pfizer.

Other reported deaths include a 17-year-old female from Washington (VAERS I.D. 1828901) who died Oct. 29 reportedly from a heart condition after receiving her second dose of Pfizer; a 12-year-old girl from South Carolina (VAERS I.D. 1784945) who hemorrhaged 22 days after receiving Pfizer’s COVID vaccine; and a 13-year-old girl from Maryland (VAERS I.D. 1815096) who died from a heart condition 15 days after receiving her first dose of Pfizer’s vaccine.

  • 59 reports of anaphylaxis among 12- to 17-year-olds where the reaction was life-threatening, required treatment or resulted in death — with 96% of cases attributed to Pfizer’s vaccine.
  • 559 reports of myocarditis and pericarditis (heart inflammation) with 549 cases attributed to Pfizer’s vaccine.
  • 134 reports of blood clotting disorders, with all cases attributed to Pfizer.

This week’s U.S. VAERS data, from Dec. 14, 2020, to Nov. 12, 2021, for all age groups combined, show:

FDA, CDC sign off on Pfizer, Moderna COVID boosters for all adults

The U.S. Food and Drug Administration (FDA) today authorized Moderna and Pfizer COVID boosters for all adults. The agency made its decision without input from its advisory committee, whose members, on Sept. 17, voted 16 to 2 against recommending boosters, citing a lack of long-term data and stating the risks did not outweigh the benefits.

Hours after the FDA announced its decision, the CDC’s Advisory Committee on Immunization Practices (ACIP) signed off with an unanimous endorsement.

The ACIP said 18- to 49-year-olds “may” get a booster, but people 50 and older should get one. CDC Director Dr. Rochelle Walensky is expected to clear the doses, which will allow boosters to be administered broadly to the general public.

Speaking for the FDA, Dr. Peter Marks, head of the agency’s Center for Biologics Evaluation and Research, said in a statement:

“The FDA has determined that the currently available data support expanding the eligibility of a single booster dose of the Moderna and Pfizer-BioNTech COVID-19 vaccines to individuals 18 years of age and older.”

Dr. Paul Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia, and an FDA advisory panel member took issue with how the FDA arrived at its decision.

In an email to The Epoch Times, Offit said, “I think it would have been of value for the public to hear an open discussion about the need for boosters. I wish we had had the chance to discuss this.”

The FDA said it did not hold a meeting because “the agency previously convened the committee for extensive discussions regarding the use of booster doses of COVID-19 vaccines and, after review of both Pfizer’s and Moderna’s [Emergency Use Authorization] requests, the FDA concluded that the requests do not raise questions that would benefit from additional discussion by committee members.”

Pfizer and BioNTech requested authorization last week after submitting the results of a phase 3 trial involving more than 10,000 participants.

Moderna resubmitted its application for its 50-microgram booster dose for all adults just two days ago. The company said the FDA based its decision on the “totality of scientific evidence shared by the company,” including data that showed neutralizing antibodies had waned at about six months.

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