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More Than 726,000 COVID Vaccine Injuries Reported to VAERS as CDC, FDA Overrule Advisory Committees’ Recommendations on Third Pfizer Shot

Data released Sept. 17 by the Centers for Disease Control and Prevention (CDC) showed that between Dec. 14, 2020, and Sept. 17, 2021, a total of 726,965 adverse events following COVID vaccines were reported to the Vaccine Adverse Event Reporting System (VAERS). The data included a total of 15,386 reports of deaths — an increase of 461 over the previous week.

There were 99,410 reports of serious injuries, including deaths, during the same time period — up 7,887 compared with the previous week.

Excluding “foreign reports” filed in VAERS, 569,294 adverse events, including 6,981 deaths and 44,481 serious injuries, were reported in the U.S. between Dec. 14, 2020, and Sept. 17, 2021.

Of the 6,981 U.S. deaths reported as of Sept. 17, 12% occurred within 24 hours of vaccination, 17% occurred within 48 hours of vaccination and 30% occurred in people who experienced an onset of symptoms within 48 hours of being vaccinated.

In the U.S., 383.6 million COVID vaccine doses had been administered as of Sept. 17. This includes 220 million doses of Pfizer, 149 million doses of Moderna, and 15 million doses of Johnson & Johnson (J&J).

From the 9-17-21 release of VAERS data

The data come directly from reports submitted to VAERS, the primary government-funded system for reporting adverse vaccine reactions in the U.S.

Every Friday, VAERS makes public all vaccine injury reports received as of a specified date, usually about a week prior to the release date. Reports submitted to VAERS require further investigation before a causal relationship can be confirmed.

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

The most recent deaths involve a 17-year old male (VAERS I.D. 1689212) with cancer who was vaccinated April 17, tested positive for COVID on July 20, was hospitalized, and passed away Aug. 29; and a 16-year old female (VAERS I.D. 1694568) who died from a pulmonary embolism nine days after receiving her first Pfizer dose.

Other recent reported deaths include two patients [VAERS I.D. 1655100] who died after their second dose of Pfizer, including a 13-year old female, a 15-year-old boy (VAERS I.D. 1498080) who previously had COVID, was diagnosed with cardiomyopathy in May 2021 and died four days after receiving his second dose of Pfizer’s vaccine when he collapsed on the soccer field and went into ventricular tachycardia; and a 13-year-old girl (VAERS I.D. 1505250) who died after suffering a heart condition after receiving her first dose of Pfizer.

This week’s U.S. VAERS data, from Dec. 14, 2020, to Sept. 17, 2021, for all age groups combined, show:

CDC overrules agency’s own vaccine safety committee, sides with FDA on boosters

In an “unusual move,” Dr. Rochelle Walensky, CDC director, on Thursday overruled her agency’s vaccine advisory committee recommendation to limit Pfizer’s COVID booster shot for people 65 and older, long-term care facility residents, and certain people with underlying conditions.

Instead, Walensky aligned with the U.S. Food and Drug Administration’s (FDA) authorization of a third dose of Pfizer’s vaccine for a broader population, including healthcare workers, grocery store workers, teachers, and others whose jobs put them at “high risk” of infections, plus residents of prisons and homeless shelters.

President Biden today acted on the news, announcing his administration will begin to deliver booster shots this week, Politico reported.

The CDC’s vaccine advisory panel in a meeting Thursday voted unanimously to approve booster doses of Pfizer’s COVID vaccine for people 65 and older, long-term care facility residents, and certain people with underlying conditions. The booster dose would be given at least six months after being fully vaccinated.

However, the advisers voted against recommending a booster dose for people whose jobs or situations put them at high risk of vaccine breakthrough infection.

FDA ignores the safety committee’s guidance, broadly authorizes boosters

The FDA on Wednesday amended the Emergency Use Authorization (EUA) for the Pfizer-BioNTech COVID vaccine to allow for a single booster shot to be administered to people 65 and older.

In addition to older Americans, the FDA authorized boosters for people 18 through 64 years of age at high risk of severe illness from COVID, and also those “whose frequent institutional or occupational exposure” to the virus puts them at high risk of serious complications from the disease caused by the virus, the agency said.

On Sept. 17, the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) unanimously recommended EUA for a booster dose of Pfizer’s vaccine for people 65 and older and those with compromised immune systems — but the committee voted 16 to 2 against recommending boosters for the general population, citing a lack of long-term data. The committee said the risks did not outweigh the benefits for those people.

Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said the agency considered the committee’s input, but conducted its own review of the data in reaching a decision.

Experts tell FDA vaccines ‘harm more people than they save’

During the public comment session at VRBPAC’s Sept. 17 meeting, numerous experts said data supporting Pfizer’s request for booster doses were inadequate.

Several people highlighted concerning patterns with data from VAERS — requesting more attention be given to potential signals and reported adverse events.

Dr. Jessica Rose, a viral immunologist, and virologist said there are clear risk signals emerging from VAERS data — with a 1000% increase in the total number of adverse events for 2021 so far.

Rose pointed out that as of Aug. 27, there were 1,500 adverse reactions occurring per million fully injected people, and 1 in 660 individuals reporting immunological adverse events associated with the COVID products. She said underreporting was not considered in the data.

Dr. Joseph Fraiman, an emergency medicine physician in New Orleans, said during his presentation to the FDA’s safety panel that no clinical evidence exists to disprove claims the COVID vaccines are harming more people than they save.

Steve Kirsch, founder of the COVID-19 Early Treatment Fund, using data from four different analyses, said even if the vaccines had 100% protection, it still means we kill two people to save one life.

Physician ‘horribly injured’ after Pfizer vaccine pleads with U.S. agencies for help

In an exclusive interview with The Defender, Danice Hertz, a 64-year-old physician who is “horribly ill” and “incapacitated” after getting Pfizer’s COVID vaccine, claims U.S. health agencies are ignoring thousands of adverse events.

Hertz told The Defender there are thousands of people like her — injured by COVID vaccines — who are suffering and need help, yet they’re ignored by mainstream media and U.S. health agencies.

Meanwhile, COVID vaccine mandates are being rolled out for millions of Americans, with barely any discussion of the risks, she said.

Hertz said those injured by the vaccines are struggling to get validation and medical care because these reactions are being hidden from the medical community.

She said the FDA, CDC, and National Institutes of Health have known about vaccine injuries since the clinical trials, yet are not giving informed consent — fully disclosing the possible risks associated with vaccines and allowing the individual to decide.

“This is truly shocking,” Hertz said. “Having practiced medicine for 33 years, I always had faith in our regulatory agencies. Now, having been seriously injured by this vaccine and struggling to be taken seriously and get medical assistance, I no longer have faith.”

30,000 women in the UK report menstrual problems after COVID shots

As of Sept. 2, more than 30,000 reports of menstrual irregularities and vaginal bleeding had been made to the Medicines and Healthcare Products Regulatory Agency’s (MHRA) Yellow Card Scheme — the UK system for collecting and monitoring adverse reactions following COVID vaccines.

According to an editorial published Sept. 16 in The BMJ, reports of adverse reactions include heavier-than-usual periods, delayed periods, and unexpected vaginal bleeding. Yet, none of the COVID vaccine manufacturers list any issues pertinent to menstrual health as a side effect, and no research was done to assess the effects of the vaccines on the menstrual cycle during clinical trials.

According to VAERS, between Dec. 14, 2020, and Sept. 17, 2021, there have been 9,589 total reports, including the U.S. and some foreign, of menstrual disorders after vaccination with a COVID vaccine.

Historically, VAERS has been shown to report only 1% of actual vaccine adverse events, which means the number of actual adverse events evolving menstrual disorders could be much higher.

Pfizer says COVID vaccine for 5- 1o 11-year-olds ‘safe’ and shows ‘robust’ antibody response

Pfizer said Monday a phase 2/3 trial showed its COVID vaccine was safe and generated a “robust” antibody response in children ages 5 to 11, but experts warned Pfizer’s data is misleading, and some questioned the need for kids to be vaccinated in the first place.

These are the first results released for this age group for a COVID vaccine, and the data has not yet been peer-reviewed or published.

Pfizer said it plans to request EUA from the FDA soon. FDA officials said once data is submitted, the agency could authorize a vaccine for younger children in a matter of weeks.

Dr. Elizabeth Mumper, pediatrician, president and CEO of The RIMLAND Center and member of Children’s Health Defense’s (CHD) Scientific Advisory Committee, in an email to The Defender said, Pfizer did not share specific data on efficacy or side effects and relied on measurements of antibody responses — extrapolating from adult data to imply protection. Mumper said CHD remains skeptical of “science by press release.”

New study questions need for vaccinating children against COVID

As The Defender reported this week, a new study published in Science Direct questioned the need for vaccinating children against COVID. The study found the bulk of official COVID-attributed deaths per capita occurred mostly in the elderly with high comorbidities, while COVID-attributed deaths were negligible in children.

By comparison, the study’s authors found the bulk of normalized post-vaccination deaths occurred mostly in the elderly with high comorbidities, while the normalized post-vaccination deaths were small, but not negligible, in children.

Researchers pointed out clinical trials for COVID vaccines were very short (a few months), had samples not representative of the total population, and for adolescents/children, had poor predictive power because of their small size.

Further, clinical trials for COVID vaccines did not address changes in biomarkers that could serve as early warning indicators of elevated predisposition to serious diseases, the researchers said.

“Most importantly, the clinical trials did not address long-term effects that, if serious, would be borne by children/adolescents for potentially decades.”

198 days and counting, CDC ignores The Defender’s inquiries

According to the CDC website, “the CDC follows up on any report of death to request additional information and learn more about what occurred and to determine whether the death was a result of the vaccine or unrelated.”

On March 8, The Defender contacted the CDC with a written list of questions about reported deaths and injuries related to COVID vaccines. We have made repeated attempts, by phone and email, to obtain a response to our questions.

Despite multiple phone and email communications with many people at the CDC, and despite being told that our request was in the system and that someone would respond, we have not yet received answers to any of the questions we submitted. It has been 198 days since we sent our first email to the CDC requesting information.

Children’s Health Defense asks anyone who has experienced an adverse reaction, to any vaccine, to file a report following these three steps.




Pfizer CEO Says There Will be 3 Booster Shots per Year and That Toddlers will be Included

Albert Bourla, Youtube

Source: Need To Know

Pfizer CEO Albert Bourla says a vaccine-resistant variant likely will emerge, and his company will be able to produce a vaccine to combat a new ‘variant of concern’ within 95 days after it appears. (He says nothing about knowing if it will be safe and effective, only that they will produce one.) Booster shots now are being recommended for a total of three so far this year. Pfizer released one billion doses of its Covid gene-therapy “vaccine” in the first half of 2021, and Bourla says his company will produce another two billion doses by the end of the year. (If the profit is $45 per vial, and if four-billion shots are administered four times per year, that would be $720-billion profit per year just for this one company.) Bourla says the company is currently performing a study with vaccines on children ages 5 to 11. He added that “a little bit later we are going to do for kids below five years old.” -GEG

Link for Fox News video:  https://www.thegatewaypundit.com/2021/08/pfizer-ceo-says-covid-19-vaccine-resistant-variant-likely-emerge-pharma-co-system-place-release-new-variant-specific-jab-3-months-video/

Pfizer CEO Albert Bourla on Tuesday said a vaccine-resistant variant will likely emerge.

But don’t worry because the pharma company already has a system in place to release a “variant-specific” jab within 95 days.

Two doses of the Pfizer vaccine plus a booster shot may not be enough to protect from new variants.

So we’re already talking about a fourth Covid jab.

Read the full article here…




Pfizer Fails to Convince FDA on Immediate Need for COVID Booster Shots

By Megan Redshaw | The Defender

After meeting with Pfizer executives Monday, U.S. regulators said they are still not ready to recommend COVID vaccine booster shots.

“Nothing has really changed,” Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, told CNN’s Chris Cuomo after the meeting.

Pfizer executives met privately with U.S. senior scientists and regulators Monday evening to press their case for quick authorization of COVID booster vaccines amid pushback from federal health agencies who last week said the extra doses are not needed.

Officials said after the meeting that more data — and possibly several more months — would be needed before regulators could determine whether booster shots were necessary.

During the 1-hour online virtual meeting, Pfizer’s chief scientific officer briefed top doctors in the federal government, including Fauci; Dr. Rochelle Walensky, director of the Centers for Disease Control and Prevention (CDC); Dr. Francis Collins, director of the National Institutes of Health; U.S. Surgeon General Dr. Vivek Murthy; Dr. Janet Woodcock, acting commissioner of the U.S. Food and Drug Administration (FDA); Assistant Secretary for Health Dr. Rachel Levine; and Dr. David Kessler, chief science officer of the Biden administration’s COVID response team.

The meeting was largely seen as a courtesy after Pfizer’s announcement last week that it would seek Emergency Use Authorization for its booster shot led to unusual pushback from the FDA and CDC.

The two agencies responded to Pfizer’s news in a joint statement, issued last week by the U.S. Department of Health and Human Services (HHS), in which they said fully vaccinated Americans don’t need boosters right now and the science is lacking.

“The CDC and the FDA said that based on the data that we know right now, we don’t need a boost,” Fauci told CNN Monday. “That doesn’t mean that that won’t change. We might need, as a matter of fact, at some time to give boosters either across the board or to certain select groups, such as the elderly or those with underlying conditions,” Fauci said.

Officials said any recommendations about booster shots are likely to be scaled, even within age groups. For example, if booster shots are recommended, they might go first to nursing home residents who received their vaccines in late 2020 or early 2021, while elderly people who received their first shots in the spring might have a longer wait, The New York Times reported.

Then there is the issue of what kind of booster will be needed: a third dose of the original vaccine, or a shot tailored to the Delta variant.

“It was an interesting meeting,” Fauci said. “They shared their data. There wasn’t anything resembling a decision. This is just one piece of a much bigger puzzle, and it’s one part of the data, so there isn’t a question of a convincing case one way or the other.”

Pfizer called the meeting “productive”:

“We had a productive meeting with U.S. public health officials on the elements of our research program and the preliminary booster data in our ongoing trials. Both Pfizer and the U.S. government share a sense of urgency in staying ahead of the virus that causes COVID-19, and we also agree that the scientific data will dictate next steps in the rigorous regulatory process that we always follow.”

Pfizer said it would be publishing “more definitive data in a peer-reviewed journal and continuing to work with regulatory authorities to ensure that our vaccine continues to offer the highest degree of protection possible.”

According to The New York Times, HHS, which convened the meeting, issued its own statement reiterating the administration’s stance. “At this time, fully vaccinated Americans do not need a booster shot,” the agency said.

An HHS spokesperson told CNN the CDC and FDA take laboratory data, clinical trial data, cohort data — which can include data from specific pharmaceutical companies but do “not rely on those data exclusively.”

The administration is prepared for booster doses if the science demonstrates they are needed, the spokesperson added and will continue to review any new data as it becomes available.

Prior to Monday’s meeting, Dr. Scott Gottlieb, former FDA commissioner and current board member at Pfizer, told CBS News that updated efficacy numbers from the Israeli Ministry of Health led Pfizer to seek Emergency Use Authorization for a booster dose of its COVID vaccine.

Israel’s health ministry said in a statement last week it had seen the efficacy of Pfizer’s vaccine drop from more than 90% to about 64% as the Delta variant spread.

As a result, Israel started administering a third dose of Pfizer’s COVID vaccine to immunocompromised people and heart transplant patients — despite the vaccine’s link to heart inflammation.

WHO says Pfizer should focus on improving access to vaccines, not boosters

World Health Organization (WHO) officials insisted there was not enough evidence to show the need for third doses of COVID vaccines. They said Pfizer should concentrate instead on improving vaccine access around the world, The Guardian reported.

The WHO Director-General Dr. Tedros Adhanom Ghebreyesus said grotesque vaccine disparities were driven by “greed.”

“We are making conscious choices right now not to protect those in need,” Ghebreyesus said, adding that people who have yet to receive a single dose should be prioritized. He  called on Pfizer and Moderna to “go all out to supply COVAX, the Africa Vaccine Acquisition Task Team, and low- and middle-income countries.”

Dr. Soumya Swaminathan, chief WHO scientist, said: “At this point … there is no scientific evidence to suggest that boosters are definitely needed.”

Swaminathan said the WHO would make recommendations on booster shots “based on the science and data, not on individual companies declaring that the vaccines should now be administered as a booster dose.”

Dr. Michael Ryan, WHO emergencies chief, suggested if rich countries decide to administer booster shots rather than to donate them to the developing world, “we will look back in anger and I think we will look back in shame.”

Pfizer stands to make billions from boosters

Pfizer stands to benefit financially if booster doses are needed, according to The Motley Fool which wrote: “The more COVID vaccine doses are required, the higher the companies’ sales will be and the better its vaccine stocks will likely perform.”

According to YAHOO Finance, Pfizer has recently experienced an increase in support from the world’s most elite money managers. Among these funds, Diamond Hill Capital held the most valuable stake in Pfizer — worth $407.3 million at the end of the fourth quarter.

In second place was New York-based hedge fund Two Sigma Advisors, which amassed $387.2 million worth of shares. Citadel Investment Group and AQR Capital Management — an investment management firm dedicated to delivering results for its clients — became one of the largest hedge fund holders of the company.

In terms of the portfolio weights assigned to each position, Healthcare Value Capital allocated the biggest weight to Pfizer.

Specific money managers include Marshall Wace LLP, which invested $56.1 million in the company at the end of the quarter, and Steven Boyd’s Armistice Capital, which made a $43.5 million investment in the stock during the quarter.

Other funds with brand new Pfizer positions are Charles Clough’s Clough Capital Partners, Michael Rockefeller and KarláKroeker’s Woodline Partners, and Phill Gross and Robert Atchinson’s Adage Capital Management.

As The Defender reported July 9, Pfizer CEO Albert Bourla has said for months a booster would likely be needed within a year of the initial two-dose inoculation — followed by annual vaccinations, even as public health officials and academic scientists said it wasn’t clear yet when a booster would be needed.

Booster shots for COVID are expected to serve as a key revenue driver in the years to come for Pfizer and its primary rival in the U.S., Moderna. Pfizer in May projected global sales of its COVID vaccine to reach $26 billion in 2021.

The company has also been frank that it’s current pricing — $19.50 per dose in the U.S. — is temporary. On an earnings call in February, Frank A. D’Amelio, Pfizer’s executive vice president of global supply, assured investors the company sees the vaccine market evolving as the pandemic wanes, and will likely be able to charge more per dose than it was getting under pandemic supply deals.

D’Amelio said a more typical price for vaccination was $150 or $175 per dose.

Pfizer has been working on two different booster strategies it anticipates could carry sales beyond the immediate pandemic need: a third 30 mg dose of its current vaccines and an updated vaccine that targets the South African variant.

The company said it would begin testing a booster shot specifically programmed to combat the Delta variant in August, reaffirming concerns by scientists who predicted in April that pharmaceutical companies like Pfizer, would create a vaccine treadmill with continuous booster shots targeted at emerging variants — which is music to the ears of investors.