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The Centers for Disease Control and Prevention (CDC) today released new data showing a total of 1,268,008 reports of adverse events following COVID-19 vaccines were submitted between Dec. 14, 2020, and May 13, 2022, 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 28,141 reports of deaths — an increase of 173 over the previous week — and 230,364 serious injuries, including deaths, during the same time period — up 1,887 compared with the previous week. There were 6,859 additional total adverse events reported to VAERS over the previous week.
Foreign reports are reports foreign subsidiaries send to U.S. vaccine manufacturers. 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 12,961 U.S. deaths reported as of May 13, 16% occurred within 24 hours of vaccination, 20% occurred within 48 hours of vaccination and 59% occurred in people who experienced an onset of symptoms within 48 hours of being vaccinated.
In the U.S., 581 million COVID-19 vaccine doses had been administered as of May 13, including 343 million doses of Pfizer, 219 million doses of Moderna and 19 million doses of Johnson & Johnson (J&J).
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.
U.S. VAERS data from Dec. 14, 2020, to May 13, 2022, for 5- to 11-year-olds show:
- 10,745 adverse events, including 279 rated as serious and 5 reported deaths.
- 22 reports of myocarditis and pericarditis (heart inflammation).The CDC uses a narrowed case definition of “myocarditis,” which excludes cases of cardiac arrest, ischemic strokes and deaths due to heart problems that occur before one has the chance to go to the emergency department.The Defender has noticed over previous weeks that reports of myocarditis and pericarditis have been removed by the CDC from the VAERS system in this age group. No explanation was provided.
- 43 reports of blood clotting disorders.
U.S. VAERS data from Dec. 14, 2020, to May 13, 2022, for 12- to 17-year-olds show:
- 31,572 adverse events, including 1,824 rated as serious and 44 reported deaths. VAERS reported 44 deaths in the 12- to 17-year-old age group last week.
- 64 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.
- 651 reports of myocarditis and pericarditis with 639 cases attributed to Pfizer’s vaccine.
- 168 reports of blood clotting disorders with all cases attributed to Pfizer.
U.S. VAERS data from Dec. 14, 2020, to May 13, 2022, for all age groups combined, show:
- 20% of deaths were related to cardiac disorders.
- 54% of those who died were male, 41% were female and the remaining death reports did not include the gender of the deceased.
- The average age of death was 73.
- As of May 13, 5,527 pregnant women reported adverse events related to COVID-19 vaccines, including 1,732 reports of miscarriage or premature birth.
- Of the 3,622 cases of Bell’s Palsy reported, 51% were attributed to Pfizer vaccinations, 40% to Moderna and 8% to J&J.
- 880 reports of Guillain-Barré syndrome, with 42% of cases attributed to Pfizer, 30% to Moderna and 28% to J&J.
- 2,291 reports of anaphylaxis where the reaction was life-threatening, required treatment or resulted in death.
- 1,707 reports of myocardial infarction.
- 13,972 reports of blood-clotting disorders in the U.S. Of those, 6,266 reports were attributed to Pfizer, 4,989 reports to Moderna and 2,679 reports to J&J.
- 4,194 cases of myocarditis and pericarditis with 2,570 cases attributed to Pfizer’s, 1,427 cases to Moderna’s and 183 cases to J&J’s COVID-19 vaccines.
CDC vaccine advisory panel follows FDA lead, endorses 3rd Pfizer shot for kids 5 to 11
CDC Director Dr. Rochelle Walensky signed off on the Advisory Committee on Immunization Practices (ACIP) recommendation, clearing the way for healthcare workers to begin administering the shots.
The ACIP recommendation came two days after the FDA granted Pfizer’s request for Emergency Use Authorization (EUA) of a single booster dose for this age group, saying the third shot should be administered at least five months after the initial two-dose primary series with the Pfizer-BioNTech vaccine.
The FDA granted the EUA without convening its vaccine advisory panel of independent experts to discuss Pfizer’s data on 5- to 11-year-olds.
The authorization was based on a study subset of only 67 children who exhibited higher antibody levels one month after receiving a booster dose.
The FDA granted EUA for the boosters despite data showing higher infection rates among fully vaccinated children in the 5-to-11 age group compared to unvaccinated children, no studies testing the efficacy of the vaccine against the current dominant BA.2 COVID-19 variant and two new studies showing that for vaccinated people who get Omicron, the infection provides better protection against future infections than a second booster dose.
The FDA said it did not identify any new safety concerns and found the children in the trial experienced the same mild side effects other people do after receiving a booster.
However, a subset of only 67 children is not large enough to detect potential adverse events like myocarditis, and it is unknown how rapidly any protection provided wanes because trial participants were not followed beyond a 28-day period.
Pfizer documents show many adverse events deemed ‘unrelated’ to vaccine
The latest release by the FDA of Pfizer vaccine documents raises questions about how frequently adverse events experienced by clinical trial participants were reported as “unrelated” to the vaccine.
The 80,000-page document cache released May 2 includes an extensive set of Case Report Forms (CRFs) from Pfizer trials conducted at various locations in the U.S.
The reports are from participants who suffered some type of adverse event during their participation in Pfizer’s vaccine trials.
As the documents reveal, despite the occurrence of a wide range of symptoms including serious cardiovascular events, almost none were identified as being “related” to the vaccine.
Only one adverse event is clearly specified as being related to the vaccination: a participant who suffered from psoriatic arthritis, with no prior history of the condition.
In addition, several CRFs indicated exposure during pregnancy or during a partner’s pregnancy. However, the documents provided do not appear to have provided any follow-ups regarding any outcomes or potential adverse events for the participants, their partners or their newborn babies once born.
In some instances, while the CRFs claimed the adverse events suffered by patients were unrelated to the vaccine, their cause was unspecified — simply indicated as “other” — while in another case, a participant’s “unplanned” small bowel obstruction and panic attacks were listed as being unrelated to the vaccination despite no relevant medical history pertaining to the severe adverse events in question.
Louisiana governor reverses COVID vaccine mandate for students
Louisiana Democratic Governor John Bel Edwards on Wednesday reversed the state’s mandate requiring students in daycare through college to be fully vaccinated against COVID-19.
The announcement reversed an earlier decision by the governor’s administration and the Louisiana Health Department (LHD) requiring students to be fully vaccinated beginning in the 2022-23 school year.
Edwards said he based the decision on the fact that the FDA has not fully approved the vaccines for people under age 16, and his administration will continue to recommend all children age 5 and over get the vaccine — a recommendation the LHD endorsed Wednesday in a news release.
In their statements, the governor and the LHD implied COVID-19 vaccines for people over age 16 are fully approved.
However, while the FDA did grant full licensing to Pfizer’s Comirnaty and Moderna’s Spikevax COVID-19 vaccines — for people 16 and older and 18 and older, respectively — those vaccines are not available in the U.S.
All COVID-19 vaccines being administered in the U.S. are still available only under EUA.
CHD seeks help from Texas parents in lawsuit
A U.S. District Court on Tuesday gave CHD 45 days to amend its lawsuit against the FDA’s authorization of COVID-19 vaccines for children ages 5 to 11.
CHD’s lawsuit, filed Jan. 24 in the U.S. District Court for the Western District of Texas, alleges, among other things, that the FDA — under pretext of EUA powers — “authorized a dangerous drug for minor children as young as 5 years old to address COVID-19, which poses less risk to a 5-year-old than the ordinary flu.”
CHD last month filed a motion to stay asking the court to suspend the FDA’s authorization of the vaccine for young children until the lawsuit is resolved.
During Tuesday’s hearing, Judge Alan Albright heard arguments on CHD’s motion to stay and also on the FDA’s motion to dismiss CHD’s lawsuit.
Judge Albright denied CHD’s motion to stay, stating he was skeptical of CHD’s organizational standing and the standing of the two parents named in the suit, given the lack of any children’s COVID-19 vaccine mandate in the district at this time.
Judge Albright also dismissed CHD’s lawsuit against the FDA, but granted CHD 45 days to amend the lawsuit. He also provided a roadmap for how CHD could amend the complaint in a way to prove the plaintiffs have standing.
CHD is asking parents in 13 counties in the Western District of Texas who have information about coercive COVID-19 vaccine policies for children or adolescents to submit that information to firstname.lastname@example.org with the subject line “CHD v. FDA.”
The 13 counties are: Bell, Bosque, Coryell, Falls, Freestone, Hamilton, Hill, Leon, Limestone, McLennan, Milam, Robertson and Somervell.
CHD is especially interested in these types of situations occurring in the counties listed above:
- Hospitals or medical facilities that require COVID-19 vaccination for treatment.
- Children in foster care, correctional settings or other institutional settings who are required to receive COVID-19 vaccinations.
- Vaccination clinics or vaccination stations in schools or youth facilities promoting COVID-19 vaccines for kids.
- Evidence of school pressure to vaccinate children even without an explicit mandate.
- After-school programs or extra-curricular activities requiring COVID-19 vaccines.