The Playground

Autopsies Show: Vaccinating Teens for COVID Is Literally ‘Heartbreaking’

Autopsies of two teenage boys who died days after receiving Pfizer’s COVID vaccine prove the vaccine caused their deaths. Pathological findings suggest there…

childrenshealthdefense.org

Hongkong data shows heart inflammation risk after Pfizer CoV-21 gene tech chemo is at least 6x higher than Vaers reports. But of course CDC/FDA are run by big pharma and VAERS is spoiling business... Who thus wants to know the truth?!

May be fact checkers know it better? Like 7 boosters are needed to be happy. May be that time Whiskey...

Ventavia Whistleblower Lawsuit Takes Pfizer & CROs to Court for Allegations of Fraud & Data Manipulation Associated with COVID-19 Vaccine

Ventavia Whistleblower Lawsuit Takes Pfizer & CROs to Court for Allegations of Fraud & Data Manipulation Associated with COVID-19 Vaccine

Last year, a whistleblower lawsuit was filed with the United States District Court for the Eastern District of Texas Beaumont Division targeting Pfizer as

trialsitenews.com

Last year, a whistleblower lawsuit was filed with the United States District Court for the Eastern District of Texas Beaumont Division targeting Pfizer as a defendant. Filed by the plaintiff/Relator Brook Jackson, ex rel, the lawsuit alleges that Pfizer and two contract research organizations including ICON, Plc, and Ventavia Research Group LLC, committed egregious civil wrongs under the Federal False Claims Act. Although the case was filed quietly last year, there was little coverage associated with the actual lawsuit. Associated with the Pfizer COVID-19 vaccine called BNT162b2 (Comirnaty), the Texas whistleblower allegations were tracked by TrialSite, as well as the British Medical Journal (The BMJ); that prestigious medical journal was even censored by Facebook fact-checkers for reporting on the allegations of data manipulation and fraud associated with the whistleblower from Ventavia. If these allegations turn out to be true, the implications are frankly explosive for Pfizer, which has generated record revenues for the distribution of the COVID-19 vaccine. Not to mention for the federal government, which not only formally approved the vaccine but also issued mandates, forcing vaccinations as mandatory for employment, for example, in health care systems that received federal funding.

Demanding a jury trial, the plaintiff/relator Brook Jackson bought this action under the False Claims Act, 31 U.S.C. §§ 3729–3732, seeking to recover damages, penalties, and other possible remedies associated with this Act on behalf of the United States of America as well as on her own behalf totaling at least $2 billion.

What is the case?

Ms. Jackson comes up with over a dozen claims, which TrialSite breaks down in the table below:

Claim Description

Defendants in a race to test the COVID-19 vaccine candidate “withheld crucial information from the U.S. government that raises material concerns of vaccine safety and efficacy. The Defendants concealed violations of both their clinical trial protocol and federal regulations, including falsification of clinical trial documents.” Due to this claimed civil wrong, millions of Americans have received a misbranded vaccination, which is potentially not as effective as represented. The vaccine’s U.S. Food and Drug Administration (“FDA”) authorization resulted from a deeply flawed clinical trial that violated FDA regulations. Defendants have profited from the COVID-19 pandemic at the expense of the United States and its citizens by abusing the scientific process.

Pfizer was able to secure $1.95 billion in U.S. federal procurements for the vaccine initially developed by BioNTech called BNT162b2. This deal was based on a successful Phase 1 trial sponsored by BioNTech. The U.S. Federal gov. acquired 100 million doses.

Like many clinical trials, Pfizer delegated trial responsibilities to CROs, including ICON, a well-known Irish clinical trial outsourcing company. ICON was responsible for recruiting and onboarding 160 trial sites worldwide ensuring trial protocol compliance and reporting including oversight of any Serious Adverse Events (SAE)—required by the study protocol, federal regulations, and international standards (e.g., GcP). Yet, Pfizer is ultimately responsible.

Ventavia Research Group, LLC, a named Defendant, was contracted by Pfizer to provide Phase 3 test sites for the vaccine trial in Houston, Fort Worth, and Keller, Texas. This CRO (Ventavia) ultimately enrolled 1,500 patients for the trial. It was Ventavia that employed the Relator (Plaintiff) Brook Jackson serving the study as Regional Director. As such, the Relator was tasked with overseeing the trial site management, patient enrollment, quality, and event reporting, including corrective action plans, communication with management, and staff training at the three Texas-based trial sites.

Pfizer, aiming for the title of “first successful COVID-19 vaccine,” pushed Ventavia to enroll as many patients as possible in the vaccine trial as quickly as possible. Ventavia was compensated by Pfizer mainly on a per-patient basis—up to a weekly limit. Jackson claims that this pressure to enroll combined with the payment incentive led to “sloppy and fraudulent documentation practices, poor clinical trial protocol compliance, and little oversight.” Did Pfizer and ICON turn a blind eye to Ventavia’s misconduct? The Plaintiff/Relator suggests there were plenty of warning signs that should have been noticed.

Relator/Plaintiff alleges in lawsuit widespread regulatory violations during her period of employment. Those observations included:

• fabrication and falsification of blood draw information, vital signs, signatures and other essential clinical trial data;

• enrollment and injection of ineligible clinical trial participants, including Ventavia employees’ family members;

• failure to timely remove ineligible patients’ data from the trial;

• failure to maintain temperature control for the vaccine at issue;

• failure to monitor patients after injection as required by the trial protocol;

• principal investigator oversight failures;

• use of unqualified and untrained personnel as vaccinators and laboratory personnel;

• failure to maintain the “blind” as required, which is essential to the credibility and validity of the observer-blinded clinical trial;

• ethical violations, such as failure to secure informed consent and giving patients unapproved compensation;

• improper injection of the vaccine (i.e., by over-diluting vaccine concentrate or using the wrong needle size);

• failure to ensure that trial site staff were properly trained as required by good clinical practices;

• safety and confidentiality issues, including HIPAA violations; and

• other violations of the clinical trial protocol, FDA regulations, and Federal Acquisition Regulations and their DoD supplements These allegations, if proven true, represent an egregious violation of federal compliance rules and violation of GcP principles.

Ventavia failed to report most of its clinical trial protocol and regulatory violations to Pfizer or the external Institutional Review Board. Issues were improperly documented or hidden away in “notes to the file,” and not corrected. Icon and Pfizer communicated with each trial site to monitor compliance, but failed to follow up on missing information, ignored “red flags” of trial protocol violations and false data, and failed to exclude ineligible participants from the trial data. In Pfizer’s rush to be the “first,” it failed to address violations that compromised its entire clinical trial, including those raised by Relator. This resulted in Pfizer withholding material information from the United States and submitting false data and records in its clinical trial results.

The whistleblower turned Plaintiff (Relator) Jackson claims that she continuously raises her concerns and observations to the management of Ventavia. Moreover, later on, the Plaintiff reported the problems to Pfizer as well. What was the response? According to the Plaintiff, Ventavia ignored these serious allegations and started to harass Jackson instead. They terminated her for submitting reports in what the Plaintiff claims is an effort to perpetrate a fraud against the United States Department of Defense. Pfizer opted not to do anything with the Plaintiff’s reports.

While the Plaintiff’s observations were associated only with Texas-based trial sites, such mishaps, fraud, and concealment of blatant violations (if proven to be true) raise questions about the entire study. Is it reasonable to assume that comparable activities were occurring at other trial sites? The Plaintiff suggests so.

By December 11, 2020, the FDA issued EUA to Pfizer-BioNTech for the BNT162b2 mRNA vaccine. DOD was a sponsor. However, the Plaintiff claims that this decision was based on “falsified clinical trial results” in addition to the cover-up of vital trial information. The Plaintiff claims the DoD had purchased misbranded vaccines from Pfizer because they relied on the trial sponsor’s “fraudulent misrepresentations.” If the Plaintiff is correct, the trial wasn’t properly conducted.

The Plaintiff thus declares that if not for Pfizer, ICON, and Ventavia’s “fraudulent scheme,” the DOD would not have paid billions. The Plaintiff declares that the U.S. Federal Gov (DOD) was bilked via fraud, misrepresentation, and obfuscation in a blatant violation of federal compliance laws. Meanwhile, the Defendants, especially Pfizer, have enjoyed windfall profits based on record-breaking revenue of around $30 billion in the first 12 months of the EUA.

TrialSite will continue to monitor this lawsuit. An interview of the Plaintiff can be viewed here. Check out the actual lawsuit here. The case can be accessed via Law360.comhere.

United States of America ex rel. Brooks Jackson v. Ventavia Research Group, LLC et al

www.law360.com

Study Finds Ivermectin ‘Did Not Prevent’ Severe COVID-19, but Doctors Alliance Calls It ‘Misleading’

Study Finds Ivermectin 'Did Not Prevent' Severe COVID-19, but Doctors Alliance Calls It 'Misleading'

A peer-reviewed study in which researchers concluded that ivermectin treatment during early COVID-19 "did not prevent" severe disease in ...

www.theepochtimes.com

A peer-reviewed study in which researchers concluded that ivermectin treatment during early COVID-19 “did not prevent” severe disease in high-risk patients has been criticized by an alliance of doctors for being “misleading.”

In the open-label randomized clinical trial, also referred to as the “The I-TECH Randomized Clinical Trial,” published in the JAMA Internal Medicine journal on Feb. 18, researchers said their findings “do not support the use of ivermectin for patients with COVID-19.”

The study involved results from 490 patients with mild to moderate COVID-19 in Malaysia. Participants were aged 50 and over, with at least one documented comorbidity. People who did not develop symptoms or who had severe COVID-19 were not included in the trial.

The trial was conducted in 20 hospitals and a COVID-19 quarantine center in the country between May 31 and Oct. 25, 2021. Of the group, 249 participants received standard care, while 241 received a course of oral ivermectin over five days in addition to standard care.

Researchers said they found that 21.6 percent of patients in the ivermectin group and 17.3 percent in the standard care group progressed to “severe disease.”

They wrote that there were no statistically significant differences between the two cohorts in how many needed mechanical ventilation, had to be admitted to intensive care unit (ICU), or died within 28 days after having been admitted to the hospital.

Ivermectin is a generic medicine developed in the 1970s and is now widely used against roundworm parasites to treat river blindness and elephantiasis, as well as to treat scabies, lice, and rosacea in humans. William Campbell and Satoshi Omura in 2015 won the Nobel Prize in Physiology or Medicine for the drug’s discovery and applications.

Ivermectin has been praised by some doctors as a life-saving early treatment for COVID-19. At least two groups, the Front Line COVID-19 Critical Care Alliance (FLCCC) and the British Ivermectin Recommendation Development Group (BIRD), have been advocating for the off-label use of ivermectin to treat COVID-19 in its early stages.

The World Health Organization features ivermectin on its List of Essential Medicines. It is also approved as an antiparasitic agent by the U.S. Food and Drug Administration (FDA).

However, the FDA has not approved the drug to treat or prevent COVID-19 in humans. According to the FDA, side effects of ivermectin include skin rash, nausea, and vomiting.

The American Medical Association, the American Pharmacists Association, and the American Society of Health-System Pharmacists, said in a joint statement in September 2021 they were against its use to treat COVID-19 outside of a clinical trial.

Criticism

On Feb. 19, the FLCCC rejected the conclusions of the I-TECH Randomized Clinical Trial and called it “misleading” and “underpowered.” The group also said that the study authors reached “a conclusion that inexplicably departs from the study’s own data.”

Dr. Paul Marik, a neurocritical care doctor who is the chairman and chief scientific officer of the FLCCC, said the study was “clearly designed to fail.”

“The authors selected out patients with mild or moderate disease who were at low risk of having a major event. Consequently it was grossly underpowered for any meaningful patient-centered outcome,” he said in a statement, later adding, “It is clear that a massive study would have been far better to determine greater statistical significance.”

Dr. Pierre Kory, FLCCC president and chief medical officer, said the study’s conclusion is “flat out wrong and highly misleading.”

“In the study’s control group, two-and-a-half times more patients had to be placed on mechanical ventilation—and there were three times more deaths in the control group,” Kory, a pulmonologist, said in a statement. “This shows that ivermectin causes a 75 [percent] risk reduction in death and further strengthens metadata of ivermectin’s large mortality benefits in severe COVID.”

Kory was referring to the results of the study, which found that four people in the ivermectin group needed mechanical ventilation compared to 10 people in the control group; six people in the ivermectin group needed admission to ICU compared to eight in the control group; and three people in the ivermectin group died, compared to 10 people in the control group.

Meanwhile, FLCCC co-founder Dr. Keith Berkowitz noted that the strongest p-value in the entire study, which is the measure of statistical significance, was for the 28-day hospital mortality, which was at .09. A p-value of less than .05 would be considered statistically significant.

Berkowitz commented that the study was “too limited and small to even be randomized,” but despite that, the results still “trended in favor of ivermectin.”

The FLCCC also criticized the fact that all the study participants had been experiencing symptoms for five days when they were enrolled in the study, and said that ivermectin treatment started too late in the disease.

“As those of you who have been following the FLCCC know, early treatment (within the first ONE OR TWO DAYS of symptom onset) is critical to slow virus replication and impeded progression to severe disease,” the FLCCC said. “So the authors of the study reported that ivermectin was not helpful in preventing progression to severe disease—among study patients who had been started too late in their disease at the start. Nevertheless, the authors concluded that [ivermectin] was not helpful in the treatment of COVID.”

“This study is in line with the major medical journals which will only publish negative studies on ivermectin and hydroxychloroquine,” Marik said. “They simply will not publish any of the dozens of positive studies that have emerged. This constitutes enormous, deliberate publication bias, which is immensely injurious to scientific truth—and to patients throughout the world.”

The FLCCC group accused the I-TECH Randomized Clinical Trial and JAMA of having “[dismissed] the totality of peer-reviewed, published evidence (and a number of summary meta-analyses) showing repeatedly shorter times to clinical recovery, fewer hospitalizations, and far less death when COVID patients are treated with ivermectin.”

The Epoch Times has reached out to JAMA and the study’s corresponding author, Dr. Steven Chee Loon Lim, for comment.

Latest VAERS summary:: https://childrenshealthdefense…ries-covid-vaccines-data/

24'000 "vaccine" deaths

44'000 cripples.

As Hongkong study proves VAERS is at least under reporting 6x. So the above numbers even after kicking out the Background are at least 2x to low.

The mortality of Omicron is below 0.01% So the US vaccine cripple/death rate = 0.03% is much higher than the Omicron damage. Time to stop this fake!

Something to learn about Bias of official data::

covid_19/COVID19_Fallzahlen_Kanton_ZH_total.csv at master · openZH/covid_19

COVID19 case numbers of Cantons of Switzerland and Principality of Liechtenstein (FL). The data is updated at best once a day (times of collection and update…

github.com

About 1/4 of all Swiss ICU patient with Omicron are in the Zürich university hospital.

It is easy to see that most of them are with because there is a huge exchange in the ICU before/after weekend. So normal patients with Omicron head home others on entry are diagnosed with.

The reality is:: Effectively - at best - just a few people are in ICU because of Omicron. Zürich ICU sais none.

But why do they still report them in the CoV-19 statistics? Because from the beginning it was the intention to increase the fearmongering by showing high CoV-19 related figures. (These were always off 50% at least)

So basically today's data has nothing in common with pandemic data not even the cases reported as the positive rate still is 40%. Cases are much lower and only people with symptoms or people that are forced by profession go to a test.

So if USA today still reports > 2000 corona deaths then just laugh at this figure as it is a statistical fantasy only...At best some few 100 high fat/blood pressure etc. folks still are victims but these would also die from an other classic corona virus or from flu.

Omicron is not a CoV-19 virus it has a classic corona spike backbone. Thanks to forth Worth for releasing the counter virus!

Quote from Fm1

“We are at a much greater risk of misinterpreting the data with data vacuums, than sharing the data with proper science, communication and caveats,” Ms. Rivera said.

When the Delta variant caused an outbreak in Massachusetts last summer, the fact that three-quarters of those infected were vaccinated led people to mistakenly conclude that the vaccines were powerless against the virus — validating the C.D.C.’s concerns.

But that could have been avoided if the agency had educated the public from the start that as more people are vaccinated, the percentage of vaccinated people who are infected or hospitalized would also rise, public health experts said.

Just a point here.

W, on this site, shows that no amount of transparency and proper contextualisation will prevent antivaxxers from claiming that raw data supports their antifactual conspiracy-led stories.

Personally, I would still want all data published, and let real independent experts (like Mr. Covid Data Science) evaluate it.

But you will then get the 1% fanatic (or just mad) fringe who have no concern for accuracy of ability to accept criticism or self-criticise ffrom misinterpreting it, loudly, and all over social media.

TSN is a good example of much of this. They have never yet admitted to the existence of errors in their logic due to Simpson's Paradox. But that is maybe because they just don't understand it (unlike W, who clearly does, but has some block against applying it).

Quote from Wyttenbach

At best some few 100 high fat/blood pressure etc.

Since > 50% of US citizens come under this category I don't see that being fattist here helps anyone concerned with Public Health (rather than the health of some eugenics-inspired subgroup.

Still, the Christian Scientists would tend to like this viewpoint - seeing illness as a product of sin.

Quote from THHuxleynew

Just a point here.

W, on this site, shows that no amount of transparency and proper contextualisation will prevent antivaxxers from claiming that raw data supports their antifactual conspiracy-led stories.

Personally, I would still want all data published, and let real independent experts (like Mr. Covid Data Science) evaluate it.

But you will then get the 1% fanatic (or just mad) fringe who have no concern for accuracy of ability to accept criticism or self-criticise ffrom misinterpreting it, loudly, and all over social media.

TSN is a good example of much of this. They have never yet admitted to the existence of errors in their logic due to Simpson's Paradox. But that is maybe because they just don't understand it (unlike W, who clearly does, but has some block against applying it).

Display More

Really hard to get good data when it's held back.

Quote from Fm1

Really hard to get good data when it's held back.

"a billion dollars today"

and Pfizer gets immunity from all legal claims

Pfizer, BioNTech and Moderna making $1,000 profit every second while world’s poorest countries remain largely unvaccinated | Oxfam International

34 billion dollars....?

And the CDC will say.. We didn't know? We couldn't publish

Quote from RobertBryant

And the CDC will say.. We didn't know? We couldn't publish

Plenty of work for lawyers down the track.

and $ 6 billion that was just for baby powder in 6000 women

Johnson & Johnson ordered to pay $6.32b in talc cancer case

A US jury awards more than $6 billion in total damages to 22 women and their families after they claimed asbestos in Johnson & Johnson talcum powder…

www.abc.net.au

Quote from Fm1

Really hard to get good data when it's held back.

The other problem is the obvious data cheating that only in UK can be punished by law. Also Israel is heavily cheating its data to help the Pfizer friends.

But in USA the whole system is corrupt from top down. You cannot trust any US state medical data as it is not the states data. It's the data big pharma wants you to see.

Facts: between 12..17% of all CoV-19 death are because of CoV-19. But the big cheating countries USA/Germany/France/Israel claim else to protect the speculative income of the leaders group.

France has Sanofi. Holds the patent for the lipids to embed the RNA. Israel is the host of a few rich families that own huge stakes in Pfizer. The other two did fabricate the RNA crap gene tech chemo and the USA is responsible for the biggest medical crime in history by proliferating the virus and allowing a crap unstable RNA mixture to be sold as vaccine.

Irony of the history. The virus release ( after 2 unsuccessful attempts) somehow out paced the vaccine development and thus end of 2019 Moderna was still US state owned and not yet handed over for private profit. Thus somehow a deal had to be done with a German junk company....

In a few years everybody will know the details if he/she survives the war or/and the gene therapy.

Pfizer/Biontec did not complete any required test for a vaccine. This is uncovered since 1.5 years now. The Phase III study did not show any change in mortality among both groups. In fact Pfizer cheated away some 300 early infected people by instructing the supervisor company about possible early signs.

''severe' pericarditis/myocarditis after 2nd Pfizer.

For those with a VPN perhaps, 'counting up' an excellent 30 minute programme on BBC radio 4, available online looks at the statistics ( good bad and imaginary) about vaccinating children, and the value or otherwise of lockdowns.

BBC Radio 4 - More or Less, Vaccinating children, lockdowns, and ebikes

Jabs for five- to 11-year-olds, lockdown effectiveness, and being green on two wheels.

www.bbc.co.uk

Oral famotidine versus placebo in non-hospitalised patients with COVID-19: a randomised, double-blind, data-intense, phase 2 clinical trial

Oral famotidine versus placebo in non-hospitalised patients with COVID-19: a randomised, double-blind, data-intense, phase 2 clinical trial

Objective We assessed whether famotidine improved inflammation and symptomatic recovery in outpatients with mild to moderate COVID-19. Design Randomised,…

gut.bmj.com

Abstract

Objective We assessed whether famotidine improved inflammation and symptomatic recovery in outpatients with mild to moderate COVID-19.

Design Randomised, double-blind, placebo-controlled, fully remote, phase 2 clinical trial (NCT04724720) enrolling symptomatic unvaccinated adult outpatients with confirmed COVID-19 between January 2021 and April 2021 from two US centres. Patients self-administered 80 mg famotidine (n=28) or placebo (n=27) orally three times a day for 14 consecutive days. Endpoints were time to (primary) or rate of (secondary) symptom resolution, and resolution of inflammation (exploratory).

Results Of 55 patients in the intention-to-treat group (median age 35 years (IQR: 20); 35 women (64%); 18 African American (33%); 14 Hispanic (26%)), 52 (95%) completed the trial, submitting 1358 electronic symptom surveys. Time to symptom resolution was not statistically improved (p=0.4). Rate of symptom resolution was improved for patients taking famotidine (p<0.0001). Estimated 50% reduction of overall baseline symptom scores were achieved at 8.2 days (95% CI: 7 to 9.8 days) for famotidine and 11.4 days (95% CI: 10.3 to 12.6 days) for placebo treated patients. Differences were independent of patient sex, race or ethnicity. Five self-limiting adverse events occurred (famotidine, n=2 (40%); placebo, n=3 (60%)). On day 7, fewer patients on famotidine had detectable interferon alpha plasma levels (p=0.04). Plasma immunoglobulin type G levels to SARS-CoV-2 nucleocapsid core protein were similar between both arms.

Conclusions Famotidine was safe and well tolerated in outpatients with mild to moderate COVID-19. Famotidine led to earlier resolution of symptoms and inflammation without reducing anti-SARS-CoV-2 immunity. Additional randomised trials are required.

Here in Chinada, the federal mandates remain, yet I'm pleased to see that one by one the provinces are relaxing their restrictions.

As I've related before, my older brother was one of the protesters in Ottawa. He and a few friends took a six hour drive to Ottawa in a pickup truck at the end of January. Last Friday he texted me pictures of what looked like snipers on the rooftops of buildings in Ottawa. Finally I heard from him again on Monday. As it turns out, the fact of the snipers and encroaching police presence, combined with the realization that the protest was having no effect on Trudeau except to incite him to draconian measures, led him and his friends to decide that leaving Ottawa on Friday night was best, before things got really bad. He described his experience as bittersweet : the massive and joyous experience of community, camaraderie and celebration was countered by the misrepresentation and growing hostility by Ottawa bureaucrats and the mainstream media. It was truly a disconnect for him to experience the Ottawa downtown firsthand, and then see it later portrayed in the media.

Anyway, it turns out that the person who owned and drove the pickup truck from Ottawa had his bank account frozen. I guess police were collecting license plate data of parked vehicles and going from that.

So far my own bank account is still useable, we'll see.

I had to take a picture of a page of Saturday's Toronto Sun newspaper, enjoy.

The silver Lining is the truckers protest seems to have a huge effect on Europe's Covid policies.

Our friend Pfizer

The USA truckers turn.

COVID-19 and All-Cause Mortality Data by Age Group Reveals Risk of COVID Vaccine-Induced Fatality is Equal to or Greater than the Risk of a COVID death for all Age Groups Under 80 Years Old as of 6 February 2022

Authors: Kathy Dopp, Stephanie Seneff

As of 6 February 2022, based on publicly available official UK and US data, all age groups under 50 years old are at greater risk of fatality after receiving a COVID-19 inoculation than an unvaccinated person is at risk of a COVID-19 death. All age groups under 80 years old have virtually no benefit from receiving a COVID-19 inoculation, and the younger ages incur significant risk. This analysis is conservative because it ignores the fact that inoculation-induced adverse events such as thrombosis, myocarditis, Bell’s palsy, and other vaccine-induced injuries can lead to shortened life span. When one takes into consideration the fact that there is approximately a 90% decrease in risk of COVID-19 death if early treatment is provided to all symptomatic high-risk persons, one can only conclude that mandates of COVID-19 inoculations are ill-advised. Considering the emergence of antibody-resistant variants like Delta and Omicron, for most age groups COVID-19 vaccine inoculations result in higher death rates than COVID-19 does for the unvaccinated.

Submission history

[v1] 2022-02-13 23:24:08

https://www.vixra.org/abs/2202.0084

PDF available

Reported cases of multisystem inflammatory syndrome in children aged 12–20 years in the USA who received a COVID-19 vaccine, December, 2020, through August, 2021: a surveillance investigation

DEFINE_ME

Summary

Background

Multisystem inflammatory syndrome in children (MIS-C) is a hyperinflammatory condition associated with antecedent SARS-CoV-2 infection. In the USA, reporting of MIS-C after vaccination is required under COVID-19 vaccine emergency use authorisations. We aimed to investigate reports of individuals aged 12–20 years with MIS-C after COVID-19 vaccination reported to passive surveillance systems or through clinician outreach to the US Centers for Disease Control and Prevention (CDC).

Methods

In this surveillance activity, we investigated potential cases of MIS-C after COVID-19 vaccination reported to CDC's MIS-C national surveillance system, the Vaccine Adverse Event Reporting System (co-administered by CDC and the US Food and Drug Administration), and CDC's Clinical Immunization Safety Assessment Project. A multidisciplinary team adjudicated cases by use of the CDC MIS-C definition. Any positive SARS-CoV-2 serology test satisfied case criteria; although anti-nucleocapsid antibodies indicate previous SARS-CoV-2 infection, anti-spike protein antibodies indicate either past or recent infection or COVID-19 vaccination. We describe the demographic and clinical features of cases, stratified by laboratory evidence of SARS-CoV-2 infection. To calculate the reporting rate of MIS-C, we divided the count of all individuals meeting the MIS-C case definition, and of those without evidence of SARS-CoV-2 infection, by the number of individuals aged 12–20 years in the USA who received one or more COVID-19 vaccine doses up to Aug 31, 2021, obtained from CDC national vaccine surveillance data.

Findings

Using surveillance results from Dec 14, 2020, to Aug 31, 2021, we identified 21 individuals with MIS-C after COVID-19 vaccination. Of these 21 individuals, median age was 16 years (range 12–20); 13 (62%) were male and eight (38%) were female. All 21 were hospitalised: 12 (57%) were admitted to an intensive care unit and all were discharged home. 15 (71%) of 21 individuals had laboratory evidence of past or recent SARS-CoV-2 infection, and six (29%) did not. As of Aug 31, 2021, 21 335 331 individuals aged 12–20 years had received one or more doses of a COVID-19 vaccine, making the overall reporting rate for MIS-C after vaccination 1·0 case per million individuals receiving one or more doses in this age group. The reporting rate in only those without evidence of SARS-CoV-2 infection was 0·3 cases per million vaccinated individuals.

Interpretation

Here, we describe a small number of individuals with MIS-C who had received one or more doses of a COVID-19 vaccine before illness onset; the contribution of vaccination to these illnesses is unknown. Our findings suggest that MIS-C after COVID-19 vaccination is rare. Continued reporting of potential cases and surveillance for MIS-C illnesses after COVID-19 vaccination is warranted.

Funding

US Centers for Disease Control and Prevention