FDA Dumps More Pfizer Documents: Why Were So Many Adverse Events Reported as ‘Unrelated’ to Vaccine?
By Michael Nevradakis, Ph.D. | The Defender | May 17, 2022
The latest release of Pfizer-BioNTech COVID-19 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 by the U.S. Food and Drug Administration (FDA) includes an extensive set of Case Report Forms (CRFs) from Pfizer trials conducted at various locations in the U.S.
The documents also include the “third interim report” from BioNTech’s trials conducted in Germany (accompanied by a synopsis of this report and a database of adverse events from this particular set of trials).
The FDA released the documents, which pertain to the Emergency Use Authorization (EUA) of the vaccine, as part of a court-ordered disclosure schedule stemming from an expedited Freedom of Information Act (FOIA) request filed in August 2021.
Public Health and Medical Professionals for Transparency, a group of doctors and public health professionals, submitted the FOIA request.
Adverse events during Pfizer vaccine trials in the U.S. usually reported as ‘unrelated’ to vaccination
Pfizer conducted a series of vaccine trials at various locations in the U.S., including the New York University Langone Health Center, Rochester Clinical Research and Rochester General Hospital (Rochester, New York) and the J. Lewis Research, Inc. Foothill Family Clinic (Salt Lake City, Utah).
The Pfizer documents released this month by the FDA included a series of CRFs for patients who suffered some type of adverse event during their participation in the COVID-19 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.
Such serious yet “unrelated” adverse events included:
- Acute asthma exacerbation
- Aortic aneurysm (listed as a pre-existing condition)
- Appendicitis (requiring hospitalization)
- Atrial defibrillation
- Cardiac arrest and acute respiratory failure, requiring hospitalization, sustained by a patient who then was “lost” (could not be located for continued participation in the trial)
- Chest pain (requiring hospitalization, later listed as cardiac ischemia)
- Coronary artery occlusion (listed as both serious and life-threatening)
- Injuries sustained from a fall
- Intermittent non-cardiac chest pain (requiring hospitalization)
- Left breast cancer (listed as a pre-existing occult malignancy)
- Neuritis (peripheral nerve Injury), listed as “unrelated” to the vaccine but related to the blood draw during vaccination
- Pulmonary embolism and bilateral deep venous thrombosis
- Respiratory failure (requiring hospitalization)
- Right ureteropelvic junction obstruction (requiring hospitalization, listed as congenital)
- Small bowel obstruction, listed as “unplanned,” and a panic attack
Of the CRFs found in the documents released this month, 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 (see here and here), or during a partner’s pregnancy (see here and here). 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 not related 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 SAEs (severe adverse events) in question.
Did Pfizer hide critical information from regulators?
It is difficult to draw concrete conclusions about any specific case from the data provided by CRFs and vaccine trial summaries.
However, what raises eyebrows is the very large number of adverse events — often serious and often requiring the hospitalization of the patients involved — that were determined to be “unrelated” to the administration of the COVID vaccine.
Previously released Pfizer documents also included discrepancies in the recording of adverse events.
According to investigative journalist Sonia Elijah, these discrepancies include:
- Trial participants were entered into the “healthy population” but were, in actuality, far from healthy.
- SAE numbers were left blank.
- Barcodes were missing from samples collected from trial participants.
- The second vaccine dose was administered outside the three-week protocol window.
- New health problems were dismissed as “unrelated” to the vaccination.
- A remarkable number of patients with an observation period of exactly the same duration — 30 minutes, with very little variety in observation times and raising questions as to whether patients were adequately observed or were put at risk.
- Oddities pertaining to the start and end dates of SAEs – for instance, a “healthy” diabetic suffered a “serious” heart attack on October 27, 2020, but the “end” date for this SAE is listed as the very next day, even though the patient was diagnosed with pneumonia that same day.
- Impossible dating: in the aforementioned example of the patient who sustained a heart attack and pneumonia, the individual in question later died, but the date of death is indicated as the day before the patient was recorded as having gone to a “COVID ill” visit.
- Unblinded teams, who were aware of which patients received the actual vaccine or a placebo, were responsible for reviewing adverse event reports, potentially leading to pressure to downplay COVID-related events in the vaccinated, or to indicate that adverse events were related to the vaccine.
- Other adverse events were indicated as “not serious” despite extensive hospital stays, of up to at least 26 days in the case of one patient who suffered a fall which was classified as “not serious,” yet facial lacerations sustained as a result of the fall were attributed to hypotension (low blood pressure).
Many of these practices seem to appear in the trial-related documents released this month.
Medical and scientific experts who spoke to The Defender expressed similar concerns about what this month’s tranche of documents reveals, and addressed cases of “disappearing” adverse events.
Brian Hooker, chief scientific officer for Children’s Health Defense, remarked:
“I’m most concerned about ‘disappearing’ patients. One cannot conduct a valid trial and simply omit the results that they don’t like!
“With the stories about Maddie de Garay and Augusto Roux surfacing, I have to wonder how many other participants were dropped in order to hide vaccine adverse events/effects.
“If you look at the data in VAERS [Vaccine Adverse Event Reporting System], COVID-19 vaccines are the most dangerous ever introduced into the population.”
Dr. Madhava Setty, a board-certified anesthesiologist and senior science editor for The Defender, said:
“The ‘unrelated’ label the investigators use to divert attention from AEs [adverse events] is a powerful point that stands on its own. We haven’t pushed back on this enough.
“Equivalently, we can say that the meager and short-lived benefit of these shots is also ‘unrelated’ using their ‘standards.’ On what grounds can they say that their product is preventing infection (which it isn’t anymore), or death (marginally)?
“They cannot have it both ways. They cannot claim a benefit through short-term outcomes while denying that side effects of any kind are related to their product.
“That’s the whole point of doing a trial. You cannot prove causation, only statistically significant correlation.”
Setty provided further context for his remarks in an April 2022 article for The Defender and in a March 2022 presentation, in which he discussed the number of these adverse events and how Pfizer swept them away (timestamp 24:00).
In Setty‘s view:
“There’s a high likelihood of malfeasance going on. [Pfizer whistleblower] Brook Jackson says the PIs [principal investigators] were unblinded. If true, it would make it very easy for the investigators to bump up the AEs in the placebo group while ignoring some of the AEs in the vaccine group.
“Pfizer claims that 0.5% of placebo recipients suffered a serious adverse event compared to 0.6% in the vaccine group. This is how these events were obscured.”
The extant body of evidence indicates Pfizer “is hiding critical information from regulators,” Setty said:
“The clincher is in the memorandum to the VRBPAC [Vaccines and Related Biological Products Advisory Committee] (Table 2, efficacy populations), where they show us that five times more people in the vaccine group were pulled out of the trial than the placebo within seven days of their second shot for ‘important protocol deviations.’
“In a trial that big the chances that could have happened coincidentally is infinitesimally small (less than 1 in 100,000).
“Moreover, months later, the same thing happened in the pediatric trial (Table 12). This time, six times more children were pulled from the trial after their second dose.
“There are, of course, procedural differences when administering a placebo versus the mRNA vaccine, but why didn’t it happen after the first dose as well?
“Mathematically, that is about as close as you can get to eliminating any ‘shadow of doubt.’ With a formal allegation by a trial coordinator that states the same thing [referring to whistleblower Brook Jackson], we can be assured Pfizer is hiding critical information from regulators.”
BioNTech trials in Germany claim few adverse events ‘related’ to vaccine
The BioNTech trial in Germany tested various dosages of two COVID-19 vaccine formulas, labeled BNT162b1 and BNT162b2 — the latter granted EUA by the FDA.
The latest cache of Pfizer documents suggests a pattern, similar to the one in the U.S. trials, of not reporting adverse events as related to the vaccine.
According to the third interim report, dated March 20, 2021, among trial participants who were administered the BNT162b2 candidate vaccine granted EUA in the U.S.:
- 87% of younger participants reported solicited local reactions, and 88% reported solicited systemic reactions, with 10% reporting solicited systemic reactions of Grade 3 or higher.
- 87% of younger participants experienced “mild” solicited local reactions, and 35% experienced “moderate” solicited local reactions.
- 88% of younger participants experienced “mild” solicited systemic reactions, and 38% experienced “moderate” solicited systemic reactions. As stated in the report:
“The most frequently reported solicited systemic reactions of any severity were fatigue (n=40, 67%), followed by headache (n=32, 53%), malaise (n=24, 40%), and myalgia (n=23, 38%). The remaining symptom terms were less frequent.
“For nausea, headache, fatigue, myalgia, chills, arthralgia and malaise each symptom was assessed as severe in <10% of participants.”
- 43% of younger participants reported a total of 51 unsolicited TEAEs (treatment-emergent adverse events, referring to conditions not present prior to treatment or that worsened in intensity after treatment) within 28 days of the first or second dose, nine of which were deemed to be “related” to the vaccination. One participant in this category sustained a TEAE assessed as Grade 3 or higher, but “which was assessed as not related by the investigator.”
- TEAEs among younger participants included hypoaesthesia, lymphadenopathy, heart palpitations, external ear inflammation, blepharitis, toothache, non-cardiac chest pain, cestode infection, oral herpes, tonsillitis, neck pain, insomnia, anosmia and dysmenorrhea.
- No unsolicited treatment-emergent serious adverse events (TESAEs) or deaths were reported among younger participants, but one discontinued participation due to moderate nasopharyngitis.
- One younger participant “discontinued due to a moderate AE (nasopharyngitis).”
- 86% of older participants reported solicited local reactions, with 6% reporting solicited local reactions of Grade 3 or higher, 78% reporting “mild” solicited local reactions and 36% reporting “moderate” solicited local reactions.
- 72% of older participants reported solicited systemic reactions, with 11% of these participants sustaining solicited systemic reactions of Grade 3 or higher, 69% sustaining “mild” solicited reactions and 36% sustaining “moderate” solicited reactions.
- 33% of older participants reported a total of 20 unsolicited TEAEs, four of which were determined to be “related” to the vaccination. Among older participants, 8% reported a TESAE of Grade 3 or higher, with “one event assessed as related by the investigator.”
- One older participant was reported to have sustained a “not related TESAE” (an ankle fracture).
- TESAEs among older participants included back pain, chest pain, facial injury, increased lipase, increased amylase, muscle spasms, musculoskeletal pain, tendon pain, orthostatic intolerance, renal colic, seborrhoeic dermatitis and “painful respiration.”
Among trial participants who received the BNT162b1 candidate vaccine (not granted EUA):
- 86% of “younger participants” reported solicited (expected) localized reactions (remaining in one part of the body), with 18% reporting Grade 3 or higher solicited local reactions, 86% of younger participants reporting “mild” solicited local reactions and 54% reporting “moderate” solicited local reactions.
- 92% of younger participants reported solicited systemic reactions (spreading to other parts of the body), with 44% reporting Grade 3 or higher solicited systemic reactions, 90% reporting “mild” solicited systemic reactions and 74% experiencing “moderate” solicited systemic reactions.
The report states:
“The most frequently reported solicited systemic reactions of any severity were fatigue (n=68, 81%), headache (n=66, 79%), myalgia (n=51, 61%), malaise (n=50, 60%), and chills (n=47, 56%). The remaining symptom terms were less frequent.
“For nausea, vomiting, diarrhea, myalgia, arthralgia and fever each symptom was assessed as severe in ≤10% of participants.”
- 45% of younger participants reported a total of 83 unsolicited (unexpected) TEAEs within 28 days of receiving the first or second dose.
A total of 51 of these unsolicited TEAEs were reported as “related” to the vaccination, while 2% of participants sustained Grade 3 or higher TEAEs (four in total), “of which three events were assessed as related by the investigator.”
No unsolicited TESAEs or deaths were reported in this category.
- According to the report, among younger participants, TEAEs included:
“‘General disorders and administration site conditions’ reported by 9 participants (11%),” including influenza-like illness and injection site hematoma.
“‘Nervous system disorders’ reported by 10 participants (12%),” including presyncope, hyperaesthesia, paraesthesia, and headache.
“‘Respiratory, thoracic and mediastinal disorders’ reported by 9 participants (11%),” including cough and oropharyngeal pain.”
Other symptoms included back pain, musculoskeletal chest pain, cervicobrachial syndrome, taste disorder, sleep disorder, depression, hallucination, dysmenorrhoea, pruritus and pityriasis rosea, while one participant required the excision (removal) of a papilloma.
- One younger participant discontinued participation in the trial, “due to a moderate AE (malaise),” while another participant discontinued participation “due to dose-limiting toxicity.”
- 83% of “older participants” reported solicited local reactions, but none were reported as Grade 3 or higher, while 83% of solicited local reactions were “mild” and 42% were “moderate.”
- 92% of older participants reported solicited systemic reactions, with 28% of participants experiencing Grade 3 or higher solicited systemic reactions, 89% experiencing “mild” solicited systemic reactions, and 61% experiencing “moderate” solicited systemic reactions.
According to the report:
“The most frequently reported solicited systemic reactions of any severity were headache (n=29, 81%), fatigue (n=27, 75%), myalgia (n=18, 50%), and malaise (n=18, 50%). The remaining symptom terms were less frequent.”
- 36% of participants reported a total of 24 unsolicited TEAEs within 28 days of the first or second dose, nine of which were assessed as “related” to the vaccination.
Of the participants in this category, 11% reported TEAEs of Grade 3 or higher (four events in total), with one of these events assessed as “related” to the vaccination.
- TEAEs reported by older participants included oropharyngeal pain, nasopharyngitis, bladder dysfunction, sleep disorder, musculoskeletal pain and musculoskeletal chest pain, pollakiuria, migraine, syncope and alopecia.
- One older participant receiving the BNT162b1 candidate sustained a TESAE (syncope), and there were no deaths in this category.
Of note, none of the participants for either vaccine candidate were pregnant, which raises questions about recommending and administering the vaccine to pregnant women despite the absence of any clinical trial data.
As the documents show, a wide range of adverse effects were reported, including cardiovascular and nervous system conditions, most of which were determined to be unrelated to the vaccination itself.
Michael Nevradakis, Ph.D., is an independent journalist and researcher based in Athens, Greece.
© 2022 Children’s Health Defense, Inc. This work is reproduced and distributed with the permission of Children’s Health Defense, Inc. Want to learn more from Children’s Health Defense? Sign up for free news and updates from Robert F. Kennedy, Jr. and the Children’s Health Defense. Your donation will help to support us in our efforts.
FDA Authorizes Pfizer Booster for Kids 5 to 11, Bypasses Advisory Panel
By Megan Redshaw | The Defender | May 17, 2022
The U.S. Food and Drug Administration (FDA) today authorized a booster dose of the Pfizer-BioNTech COVID-19 vaccine for children ages 5 to 11, without convening its vaccine advisory panel of independent experts to discuss Pfizer’s data on 5- to 11-year-olds — and based on a study subset of only 67 children, CNBC reported.
The FDA granted Emergency Use Authorization (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 vaccine advisory panel for the Centers for Disease Control and Prevention (CDC) is scheduled to meet Thursday. The agency and its director, Dr. Rochelle Walensky, are expected to sign off on the boosters, The Washington Post reported.
Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said data increasingly show protection provided by two shots wanes over time, but the agency determined a third shot could help boost protection for children in the 5 to 11 age group and the “benefits outweigh the risks.”
The FDA authorized the third shot after analyzing data from an ongoing Pfizer clinical trial in which a small subset of only 67 children in the age group had higher antibody levels one month after receiving a booster dose.
As The Defender reported, antibody levels alone are not indicative of immune protection. When it comes to COVID-19, T cell and natural killer cell responses are the crucial part of immune protection.
Pfizer has not published its actual data, precluding experts from conducting this analysis.
The authorized booster dose, the same strength as the first two doses, generated neutralizing antibodies to Omicron and the ancestral Wuhan version of the virus, according to The New York Times.
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.
About 8.1 million, or 28%, of children ages 5 to 11, received their primary series of two COVID-19 vaccine doses as of May 11, according to data from the American Academy of Pediatrics.
Those children will now be eligible for a third dose five months after their second dose based on data obtained from the 67 children who were followed for only one month.
COVID cases higher in vaccinated children aged 5 to 11, CDC data show
According to the latest CDC data, since February, higher COVID-19 case rates were recorded among fully vaccinated children compared to unvaccinated children in the 5 to 11 age group.
The CDC on Feb. 12 reported a weekly case rate of 250.02 per 10,000 population in fully vaccinated children ages 5 to 11, compared to 245.82 for unvaccinated children in the same age group.
The trend continued through the third week of March, which is the latest week of available data.
“Several factors likely affect crude case rates by vaccination and booster dose status, making interpretation of recent trends difficult,” CDC spokesperson Jasmine Reed told The Epoch Times in an email.
“Limitations include higher prevalence of previous infection among the unvaccinated and unboosted groups, difficulty in accounting for time since vaccination and waning protection, and possible differences in testing practices (such as at-home tests) and prevention behaviors by age and vaccination status,” Reed said. “These limitations appear to have less impact on the death rates presented here.”
According to CDC data, the gap between fully vaccinated and unvaccinated individuals in all age groups has grown increasingly smaller, with the death rate showing the same trend for people over age 50.
For people under age 50, death rates are almost identical between the vaccinated and unvaccinated since the beginning of the vaccine rollout.
Data show COVID-19 vaccines have a “negligible effect” on people, said Dr. Peter McCullough, a prominent cardiologist and epidemiologist.
“With these results in hand, it is clear the vaccines are having a negligible effect in populations,” McCullough told The Epoch Times in an email.
“Given the overall poor safety profile and lack of any assurances on long-term safety, Americans should be cautious in considering additional injections of these products.”
Having COVID may be more effective than getting a booster, studies show
Two new studies show, for people who are vaccinated against COVID-19, getting a breakthrough Omicron infection may provide better protection than receiving a second booster, Fortune reported.
One study conducted by German biotechnology company BioNTech SE assessed vaccinated individuals who had breakthrough COVID-19 infection associated with the Omicron variant.
BioNTech found these individuals had a better B-cell response than individuals who had received a booster but had not been infected.
According to MD Anderson Center, B cells are a type of white blood cell that create antibodies that bind to pathogens or foreign substances and neutralize them. B cells bind to a virus and prevent it from entering a normal cell causing infection. They also recruit other cells to help destroy infected cells.
A second study by the University of Washington and Vir Biotechnology investigated the immune responses of various groups based on vaccination and infection status.
The study analyzed blood samples of individuals who had been vaccinated and then caught the Delta or Omicron variants and compared them with those who had COVID-19 first and were then vaccinated, those who had been vaccinated but were not previously infected and those who were infected but had never received a COVID-19 vaccine.
The study found vaccinated individuals with breakthrough Omicron infection produced antibodies that formed a strong defense against other variants of the virus. Unvaccinated people who caught Omicron did not have a similarly robust immune response.
Efficacy of Pfizer’s COVID vaccine wanes rapidly
A study published May 13 in the Journal of the American Medical Association (JAMA) found protection from Pfizer’s COVID-19 vaccine turned negatively effective among children and adolescents five months after receiving a second dose — meaning recipients were more likely to get COVID-19 five months after being vaccinated.
Vaccine effectiveness “was no longer significantly different from 0 during month 3 after the second dose,” the researchers wrote. They also found protection against hospitalization waned significantly over time.
In adolescents, the authors said, efficacy increased again with boosters.
Most non-randomized studies attempting to determine vaccine efficacy (VE) had “common flaws,” including no accounting for baseline prior COVID-19 infection, no reporting for those who received a booster within a six-month time window and no adjudication of hospitalization or death due to COVID-19 or other conditions, McCullough told The Epoch Times.
“As a result, most studies of COVID-19 VE have biases towards overestimating any clinical benefit of vaccination,” McCullough said.
As The Defender reported on May 13, a different study published in JAMA showed second and third doses of Pfizer’s COVID-19 vaccine provided protection against the Omicron variant for only a few weeks.
“Our study found a rapid decline in Omicron-specific serum neutralizing antibody titers only a few weeks after the second and third doses of [the Pfizer-BioNTech] BNT162b2,” the authors wrote.
A preprint study released in February showed Pfizer’s two-dose regimen of its COVID-19 vaccine for children was only 12% effective against Omicron in children ages 9 to 11, and the effectiveness of the vaccine “declined rapidly” for children 5 to 11.
Researchers at the New York State Department of Health and the University at Albany School of Public Health examined the effectiveness of the vaccine in children 5 to 11 and adolescents 12 to 17 from Dec. 13, 2021, to Jan. 30, 2022, and determined the effectiveness of Pfizer’s COVID-19 vaccine declined rapidly for children, particularly those 5-11 years.
According to a Danish study of 128 people who had received two or three doses of Pfizer’s COVID-19 vaccine, levels of Omicron-specific “neutralizing” antibodies decline rapidly after a second and third dose of Pfizer’s shot.
Compared to original and Delta variants, researchers found the proportion of Omicron-specific antibodies detected in participants’ blood dropped “rapidly” from 76% four weeks after the second dose to 53% at weeks 8 to 10 and 19% at weeks 12 to 14.
After the third shot, neutralizing antibodies against Omicron fell 5.4-fold between week 3 and week 8.
Last month, Moderna requested EUA for its COVID-19 vaccine for children aged 6 months to 6 years. Pfizer plans to seek EUA for a three-dose regimen for the same age group.
The FDA’s top vaccine official told a congressional committee on May 6 COVID-19 vaccines for children under 6 will not have to meet the agency’s 50% efficacy threshold required to obtain EUA.
Megan Redshaw is a staff attorney for Children’s Health Defense and a reporter for The Defender.
© 2022 Children’s Health Defense, Inc. This work is reproduced and distributed with the permission of Children’s Health Defense, Inc. Want to learn more from Children’s Health Defense? Sign up for free news and updates from Robert F. Kennedy, Jr. and the Children’s Health Defense. Your donation will help to support us in our efforts.
FDA announces FIVE meetings in June to push Novavax in adults, Moderna in kids 0-17, and Pfizer in kids under 5
The blitzkrieg culminates with a “Future Framework” to automatically deem all reformulated Covid-19 shots as “safe and effective” WITHOUT further clinical trials
By Toby Rogers | May 11, 2022
I. FDA goes full Shock & Awe in the attempt to get several toxic shots authorized in quick succession
In a little noticed article in the Washington Post, the FDA revealed that they are going to hold FIVE meetings of the Vaccines and Related Biological Products Advisory Committee (VRBPAC) in June. FIVE! The meetings have not been officially announced on the FDA website yet but the best guess at this point is as follows:
June 7, Novavax in adults
June 8, Moderna in adolescents (delayed for a year because of myocarditis concerns)
June 21, Moderna in kids <6
June 22, Pfizer in kids <5
June 28, “Future Framework” for Covid-19 shots
This is very troubling. It means that the FDA is shifting into Shock & Awe military strategy to try to push through five authorizations in quick succession — so that the public does not have time to think and react. This is not the proper way to do science, it is an attack on democracy, and if they succeed, the FDA will kill and injure millions of American for years to come.
Let’s talk about what we know about each of these shots and then talk about what we can do to stop the FDA from destroying our country.
II. Novavax is terrible and useless
Novavax is a protein subunit vaccine. Fellow Substacker Robyn Chuter has done the best deep dive that I’ve seen on Novavax:
Robyn reviewed 3 Novavax clinical trials and the results are always terrible:
• No reductions in hospitalizations.
• No reductions in deaths.
• Tiny absolute risk reduction for a couple months (and then, after six months, the control group gets injected too so there is no long term data).
• Significant risk of adverse events in the vaccinated group.
This is not a surprise. The SARS-CoV-2 virus was never a good candidate for a vaccine (in the same way that HIV and the common cold have never had a successful vaccine in spite of decades of efforts). Recombinant proteins are not safer nor more effective than mRNA — they just fails in different ways. Novavax also uses a proprietary new adjuvant, “Matrix M”, that is not well studied.
III. Moderna mRNA shots in adolescents and kids are useless and terrible
A few days ago, I did a deep dive into the problems with the Moderna mRNA shot in kids. To summarize briefly:
• The Moderna application to inject adolescents has been held up since June 2021, because the Moderna shot increases the risk of myocarditis.
• Finland, Sweden, Denmark, and Norway have all suspended the use of the Moderna mRNA shot in teenagers because it leads to myocarditis. Finland and Sweden even suspended its use in men under 30 years old.
• We have no data from the Moderna clinical trial in kids younger than 12 other than selective leaks to the NY Times. But we know that even with Moderna rigging the trials, the shot made no difference on clinically significant outcomes including infection, hospitalization, ICU visits, or death.
However the Moderna shot did cause fevers in 15% to 17% of kids and fevers over 104 degrees in 0.2% of kids (which, if you multiply that by the 18 million kids they want to inject = 36,000 kids with potentially permanent neurological injury from a shot that provides no benefit).
IV. Pfizer mRNA shots in kids under 5 are useless and terrible
I’ve done several articles on the dangers of Pfizer mRNA shots in kids under 5. To summarize briefly:
• There is no Covid emergency for children under five years old. The CDC’s own research shows that 74.2% of kids 0-11 already had natural immunity. That was as of February 2022 — by now the number is probably closer to 100%.
• The Pfizer mRNA shot does not work very well in kids. The Pfizer clinical trial in kids 6 months to four years old failed in December 2021 and failed again in February 2022. A study by the NY State Department of Health shows that against the Omicron variant, after one month the Pfizer shot was only 12% effective in kids 5 to 11. After 6 weeks, vaccine effectiveness was a shocking MINUS 41% (vaccinated children were significantly more likely to catch Covid than the unvaccinated).
• The harms from the Pfizer mRNA shot in children are catastrophic. There are now 47,736 VAERS reports of adverse events in children following Covid-19 shots. These reports likely understate harms by a factor of 41 to 100. There are numerous reports of fatalities in children following Covid-19 shots (including reports that mysteriously disappear).
For those who want more details, Michael Palmer, MD; Sucharit Bhakdi, MD; and Wolfgang Wodarg, MD produced a 50 page guide, “On the use of the Pfizer and the Moderna COVID-19 mRNA vaccines in children and adolescents.”
V. The FDA’s proposed “Future Framework” for Covid-19 Vaccines is the worst idea in the history of public health
The “Future Framework” is how the FDA plans to rig the process in perpetuity. The “Future Framework” will take the” “flu strain selection process” that is used every year — and apply it to future (reformulated) Covid-19 shots.
Manufacturers love this because then all future Covid-19 shots will be deemed automatically “safe and effective” WITHOUT FURTHER CLINICAL TRIALS because they are “biologically similar” to existing Covid-19 shots.
This approach does not work with the flu shot (last year the flu shot was somewhere between 0% and 14% effective) and it will not work with Covid-19 shots either.
Moderna is already signaling that they want to manufacture a Covid-19 shot with Wuhan and Beta strains — even though neither strain is still in widespread circulation.
If the “Future Framework” is approved, there will be no future clinical trial data submitted to the FDA in connection with Covid-19 shots in perpetuity.
VI. What is to be done. Talking points.
I imagine we are all tempted to just say/write:
• No Novavax in adults.
• No Moderna in adolescents.
• No Moderna in little kids.
• No Pfizer in little kids.
• No “Future Framework”.
The problem with that approach is that negating a frame reinforces a frame. So the more we just say NO, the more we reinforce the very thing we are trying to stop.
Furthermore, we do not want to leave the bougiecrats in an existential abyss because they are incapable of original thought. So if we just say no, they will not know what to do with themselves and will become panicked and vengeful and start lashing out.
So let’s find a way to reframe and give our country a path out of this valley of misery. My proposed talking points are as follows.
1. The FDA must revoke the existing authorizations for Moderna, Pfizer, and J&J Covid-19 shots and withdraw them from the market immediately. SARS-CoV-2 was never a good candidate for a vaccine. These shots do not stop infection, transmission, hospitalization, nor death. They appear to have negative efficacy and are driving the evolution of variants that evade vaccines. The pandemic will never stop as long as the FDA and CDC are promoting shots that lack sterilizing immunity.
2. The FDA and CDC must pivot to therapeutics. This was always the answer. The CDC’s own research showed that chloroquine is safe and effective for prophylaxis and early treatment of SARS coronaviruses (hydroxychloroquine is even safer than chloroquine). The best frontline doctors have found that ivermectin is a life saver if used early. About twenty off-the-shelf treatments are more effective than vaccines. Get these safe and effective medicines to people who need them and let doctors be doctors again and treat patients based on their own best clinical judgment.
3. Vaccine safety assessments must be based on actual science. That means:
• Large (50,000+ person) double blind randomized controlled trials with inert saline placebos conducted by an independent third party.
• Safety and efficacy studies for two years prior to any application followed by 20 years of follow up (with the control group intact).
• Greater than 90% efficacy with less than 1% Grade 3 Adverse Events.
• Proper monitoring for carcinogenesis, mutagenesis, and impairment of fertility.
VII. What is to be done. Whom to contact:
Please reach out and find a way to awaken the moral core of these 36 people:
You can use the talking points from above or share your own story and insights.
Political appointees:
Xavier Becerra
Secretary, Health & Human Services
200 Independence Avenue S.W.
Washington, D.C. 20201
c/o Sean McCluskie
sean.mccluskie@hhs.gov
https://twitter.com/XavierBecerra
Robert Califf
FDA Commissioner
Food and Drug Administration
Mail stop: HF-1
10903 New Hampshire Ave.
Silver Spring MD 20993-0002
phone: (301) 796-5400
fax: (301) 847-8752
commissioner@fda.hhs.gov
https://twitter.com/DrCaliff_FDA
Ashish K. Jha, MD, MPH
White House Covid Czar
Brown University School of Public Health
121 South Main Street
Providence RI 02903
DeanofPublicHealth@brown.edu
https://twitter.com/ashishkjha
Rochelle Walensky
Director, Centers for Disease Control and Prevention
Roybal Building 21, Rm 12000
1600 Clifton Rd
Atlanta, GA 30333
phone: (404) 639-7000
Aux7@cdc.gov
https://twitter.com/CDCDirector
FDA staff:
Peter Marks
Director, Center for Biologics Evaluation and Research
FDA, Mail stop: HFM-2
10903 New Hampshire Ave., WO71-7232
Silver Spring MD 20993-0002
phone: (240) 402-8116
fax: (301) 595-1310
Peter.Marks@fda.hhs.gov
Hong Yang
Biologist, FDA/CBER/OBE
Building WO71, Room 5338
Mail stop: HFM-210
Silver Spring MD 20993-0002
phone: (240) 402-8836
fax: (301) 595-1240
Hong.Yang@fda.hhs.gov
Richard Forshee
Associate Director, FDA/CBER/OBE
Building, WO71, Room 5342
Silver Spring MD 20993-0002
phone: (240) 402-8631
fax: (301) 595-1240
Richard.Forshee@fda.hhs.gov
Hui-Lee Wong
Associate Director for Innovation and Development,
Office of Biostatistics and Epidemiology,
Center for Biologics Evaluation and Research
White Oak Building 71, Room 5222
Silver Spring MD 20993-0002
phone: (240) 402-0473
Huilee.Wong@fda.hhs.gov
Leslie Ball
Office of Vaccines Research and Review
Division of Vaccines and Related Products Applications,
Center for Biologics Evaluation and Research
Building WO22, Room 6156
Silver Spring MD 20993-0002
phone: (301) 796-3399
Leslie.Ball@fda.hhs.gov
Doran L. Fink
Deputy Director – Clinical
Division of Vaccines and Related Products Applications
Office of Vaccines Research and Review, CBER
Mail stop HFM-475
Building WO71, Room 3314
Silver Spring MD 20993-0002
phone: (301) 796-1159
Doran.Fink@fda.hhs.gov
Hana El Sahly, M.D., Chair VRBPAC
Associate Professor
Department of Molecular Virology and Microbiology
Department of Medicine
Section of Infectious Diseases
Baylor College of Medicine
Houston, TX 77030
713-798-2058
hanae@bcm.edu
Paula Annunziato, M.D.
Vice President and Therapeutic Area Head
Vaccines Clinical Research
Merck
North Wales, PA 19454
paula.annunziato@merck.com
Adam C. Berger, Ph.D.
Director, Division of Clinical and Healthcare Research Policy
Office of Science Policy
Office of the Director
National Instituters of Health
6705 Rockledge Drive, Suite 630
Bethesda, MD 20892
(301) 827-9676
adam.berger@nih.gov
Henry H. Bernstein, D.O.
Professor of Pediatrics
Zucker School of Medicine at Hofstra/Northwell
Department of Pediatrics
Cohen Children’s Medical Center
New Hyde Park, NY 11042
phone: (516) 838-6415 (office)
fax: (516) 465-5399
hbernstein@northwell.edu
Captain Amanda Cohn
Chief Medical Officer
National Center for Immunizations and Respiratory Diseases
Centers for Disease Control and Prevention
1600 Clifton Rd
Atlanta, GA 30333 MS C-09
phone: (404) 639-6039
fax: (404) 315-4679
acohn@cdc.gov
anc0@cdc.gov
Holly Janes, Ph.D.
Fred Hutchinson Cancer Research Center •
Vaccine and Infectious Disease Division
1100 Fairview Avenue North,
M2-C200
P.O. Box 19024
Seattle, Washington 98109 U.S.A.
phone: (206) 667.6353
hjanes@fredhutch.org
Hayley Gans, M.D.
Professor of Pediatrics
Department of Pediatrics
Stanford University Medical Center
Stanford, CA 94305
phone: (650) 723-5682
fax: (650) 725-8040
hgans@stanford.edu
David Kim, M.D.
CAPT, U.S. Public Health Services
Office of Infectious Disease and HIV/AIDS Policy
Office of the Assistant Secretary for Health
U.S. Department of Health and Human Services
330 C Street SW, Suite L600
Washington, DC 20024
phone: (202) 795-7636
david.kim@hhs.gov
Arnold Monto, M.D.
Professor Emeritus
Department of Epidemiology
University of Michigan School of Public Health
Ann Arbor, MI 48109
phone: (734) 764-5453
fax: (734) 764-3192
asmonto@umich.edu
Paul Offit, M.D.
Professor of Pediatrics
Division of Infectious Diseases
Abramson Research Building
The Children’s Hospital of Philadelphia
Philadelphia, PA 19104
phone: (215) 590-2020
offit@chop.edu
https://twitter.com/DrPaulOffit
Steven Pergam, M.D.
Medical Director
Infection Prevention
Seattle Cancer Care Alliance
Seattle, WA 98109
phone: (206) 667-7126
spergam@fredhutch.org
https://twitter.com/PergamIC
Jay Portnoy, M.D.
Director, Division of Allergy, Asthma & Immunology
Children’s Mercy Hospitals & Clinics
2401 Gillham Road
Kansas City, MO 64108
phone: (816) 960-8885
fax: (816) 960-8888
Jportnoy@cmh.edu
Eric Rubin, M.D., Ph.D.
Editor-in-Chief
New England Journal of Medicine
Adjunct Professor
Harvard TH Chan School of Public Health
665 Huntington Ave
Building 1, Room 811
Boston, MA 02115
phone: (617) 432-3335
erubin@hsph.harvard.edu
erubin@nejm.org
Andrea Shane, M.D.
Professor of Pediatrics
Emory University School of Medicine
2015 Uppergate Drive NE, Rm. 504A
Atlanta, GA 30322
phone: (404) 727-9880 (direct)
(404) 727-5642 (main)
fax: (404) 727-8249
ashane@emory.edu
Geeta K. Swamy, M.D.
Senior Associate Dean
Vice Chair for Research & Faculty Development
Associate Professor, Department of Obstetrics & Gynecology
Division of Maternal-Fetal Medicine
Duke University
Box 3967 Med Ctr,
Durham, NC 27710
phone: (919) 681-5220
swamy002@mc.duke.edu
Temporary VRBPAC members (but their votes count just the same):
A. Oveta Fuller, Ph.D.
Associate Professor of Microbiology and Immunology,
University of Michigan Medical School
Ann Arbor, MI 48109
phone: (734) 647-3830
fullerao@umich.edu
Randy Hawkins, M.D.
Charles Drew University
1731 E. 120th St.
Los Angeles, CA 90059
(323) 563-4800
RandyHawkins@cdrewu.edu
James Hildreth, Sr., Ph.D., M.D.
Professor
Department of Internal Medicine
School of Medicine
President and Chief Executive Officer
Meharry Medical College
Nashville, TN 37205
officeofthepresident@mmc.edu
Jeannette Lee, Ph.D.
Professor Department of Biostatistics
University of Arkansas for Medical Sciences
Little Rock, AR 72701
phone: (501) 526-6712
JYLee@uams.edu
Ofer Levy, M.D., Ph.D.
Staff Physician & Principal Investigator
Director, Precision Vaccines Program
Division of Infectious Diseases
Boston Children’s Hospital
Professor,
Harvard Medical School Associate Member
phone: (617) 919-2900
fax: (617) 730-0254
ofer.levy@childrens.harvard.edu
Wayne Marasco
Dana-Farber Cancer Institute
450 Brookline Avenue
Jimmy Fund 824
Boston, MA 02215
Phone: (617) 632-2153
fax: (617) 632-3889
wayne_marasco@dfci.harvard.edu
H. Cody Meissner, M.D.
Professor of Pediatrics
Tufts University School of Medicine
Director, Pediatric Infectious Disease
Tufts Medical Center
Boston, MA 02111
phone: (617) 636-5227
fax: (617) 636-4300
cmeissner@tuftsmedicalcenter.org
Michael Nelson, M.D., Ph.D.
Professor of Medicine
Asthma, Allergy and Immunology Division
UVA Division of Asthma, Allergy & Immunology
PO Box 801355
Charlottesville, VA 22908
phone: (434) 297-8399
fax: (434) 924-5779
mrn8d@virginia.edu
Stanley Perlman, M.D., Ph.D.
Professor of Pediatrics
University of Iowa
3-712 Bowen Science Building (BSB)
51 Newton Rd
Iowa City, IA 52242
phone: (319) 335-8549
stanley-perlman@uiowa.edu
Mark Sawyer, M.D.
Professor of Clinical Pediatrics
8110 Birmingham Way
Bldg. 28, 1st Floor
San Diego, CA 92123
phone: (858) 966-7785
fax: (858) 966-8658
mhsawyer@ucsd.edu
Melinda Wharton, M.D., MPH
Associate Director for Vaccine Policy
National Center for Immunization and Respiratory Diseases,
Centers for Disease Control and Prevention,
1600 Clifton Road, Mailstop E05,
Atlanta, GA 30333
phone: (404) 639.8755
fax: (404) 639.8626
mew2@cdc.gov
I know that we’re all weary. We’ve been battling Pharma fascism for the last two years and battling against the FDA every day for the last few months. I imagine it’ll take about an hour to call or write to all 36 people on this list. It’s a heavy lift. But that’s the price of liberty. This is what it’s going to take to save our Republic. So let’s fire up our computers and get out our phones and generate the largest response in the history of the movement. Let’s make history together!
FDA Chief Claims “Misinformation” is Leading Cause of Death in the United States
By Paul Joseph Watson | Summit News | May 9, 2022
During an appearance on CNN, FDA chief Dr. Robert Califf asserted that the leading cause of death in the United States is online “misinformation.”
Yes, really.
Califf spoke about his remarks during an interview with CNN’s Pamela Brown, which were originally made at a health conference in Texas last month when he said online misinformation was “now our leading cause of death.”
After admitting that there was “no way to quantify this,” before mentioning heart disease and cancer (actual killers), Califf went on to bolster the claim anyway.
Claiming that there has been “an erosion of life expectancy,” Califf went on to say that Americans were living an average of 5 years shorter than people in other high income countries.
Califf said that anti-virals and vaccinations meant “almost no one in this country should be dying from COVID,” before going on to explain that there was also a “reduction in life expectancy from common diseases like heart disease.”
“But somehow … the reliable, truthful messages are not getting across,” he said, adding, “And it’s being washed down by a lot of misinformation, which is leading people to make bad choices that are unfortunate for their health.”
The FDA chief did not explain how ‘online misinformation’ was causing more deaths from heart disease, but went ahead and made the claim anyway without being challenged by the host.
As we have exhaustively highlighted, “online misinformation” is indistinguishable from information the regime doesn’t like.
As we previously noted, the woman picked to head up the Department of Homeland Security’s ‘Ministry of Truth’ said free speech makes her “shudder” while also promoting the lie that the Hunter Biden laptop story was Russian disinformation.
Nina Jankowicz also ludicrously cited Christopher Steele as an expert on disinformation. Steele was the author of the infamous Clinton campaign-funded Trump ‘peegate’ dossier’ that turned out to be an actual product of disinformation.
The contrived moral panic over “misinformation” has become more pronounced following Elon Musk’s purchase of Twitter, with CNN guests recently complaining about how it might impact their monopoly on controlling “the channels of communications.”
Pfizer and FDA reveal Paxlovid fails clinical trial, as FDA tries to evade its responsibility
FDA emphasizes the drug is not approved, not even for COVID
By Meryl Nass, MD | May 2, 2022
Suddenly Pfizer’s website and the FDA want to emphasize all the problems with Paxlovid. So in the case of this drug, these two co-conspirators apparently think that disclosures will save them from something.
Just look at this language! Compare to the lack of disclosure of adverse effects long known to be due to the COVID vaccines. Have you EVER heard FDA refer to the vaccines for children as unapproved?
U.S. FDA Emergency Use Authorization Statement
PAXLOVID has not been approved, but has been authorized for emergency use by FDA under an EUA, for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS CoV-2 viral testing, and who are at high-risk for progression to severe COVID-19, including hospitalization or death.
The emergency use of PAXLOVID is only authorized for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of drugs and biological products during the COVID-19 pandemic under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization revoked sooner.
AUTHORIZED USE
The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for the emergency use of the unapproved product PAXLOVID for the treatment of mild-to-moderate coronavirus disease 2019 (COVID-19) in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death.
LIMITATIONS OF AUTHORIZED USE
• PAXLOVID is not authorized for initiation of treatment in patients requiring hospitalization due to severe or critical COVID-19
• PAXLOVID is not authorized for use as pre-exposure or post-exposure prophylaxis for prevention of COVID-19
• PAXLOVID is not authorized for use for longer than 5 consecutive daysPAXLOVID may only be prescribed for an individual patient by physicians, advanced practice registered nurses, and physician assistants that are licensed or authorized under state law to prescribe drugs in the therapeutic class to which PAXLOVID belongs (i.e., anti-infectives).
PAXLOVID is not approved for any use, including for use for the treatment of COVID-19.
PAXLOVID is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of PAXLOVID under 564(b)(1) of the Food Drug and Cosmetic Act unless the authorization is terminated or revoked sooner.
IMPORTANT SAFETY INFORMATION … continue
Parsing the “data” from Moderna’s selective leaks to the press about its failed clinical trial in kids under 6
The shot made no difference against Covid but it does cause myocarditis and came with a 15% to 17% adverse event rate. Meanwhile the CDC admits that 74.2% of kids already have natural immunity.
By Toby Rogers | April 30, 2022
On Friday, the NY Times and other stenographers for the cartel breathlessly announced that Moderna has asked the FDA to authorize its junk science mRNA shot in kids under 6. Oh, so that means Moderna submitted an application to the FDA? Well, not exactly. From the article:
“A top official at the company said it would finish submitting data to regulators by May 9.”
Wait, so Moderna is “asking” the FDA to authorize its product but Moderna will not even finish its application for another 10 days!? That’s weird. It’s like a kid asking his teacher for a A+ while his homework assignment is half-finished.
So already we’re seeing serious red flags and we’re not even out of the first paragraph.
Of course it gets worse.
To be clear, there is no data because Moderna has not even finished its application. But Moderna and the White House have been selectively leaking numbers to the press that dutifully prints them without question — and those numbers tell us that Moderna’s clinical trial was a disaster.
I need to provide some background and context and then I’ll get into the particular details about this failed clinical trial in kids.
Moderna applied for Emergency Use Authorization to administer its mRNA shot to adolescents 12 to 17 years old back on June 10, of 2021. But the application has been held up ever since. Why? Myocarditis. From the Wall Street Journal :
The Food and Drug Administration is delaying a decision on authorizing Moderna Inc.’s mRNA Covid-19 vaccine for adolescents to assess whether the shot may lead to heightened risk of a rare inflammatory heart condition, according to people familiar with the matter.
Moderna has at least two big problems in giving this shot to teenagers:
1) The dose they are giving to teenagers is the same dose as that given to adults — 100 mcg of mRNA — which is four times the amount in the Pfizer shot given to adults (25 mcg). So the Moderna shot is great at generating antibodies that target the spike protein of the original Wuhan lab leak strain. But some of that mRNA can migrate to the heart and generate myocarditis as well. Remember, Pharma’s capture of the FDA is so extreme, they should just be able to write “Iz Gud!” on a paper napkin and the FDA will approve it — as they did with Pfizer’s application to inject kids 5 to 11 — in spite of ZERO evidence supporting this use. So if the FDA has held up Moderna’s application in teens for nearly a year, the myocarditis signal must be truly terrifying.
2) Nordic countries are slightly less corrupt than the United States. Finland, Sweden, Denmark, and Norway have all suspended the use of the Moderna mRNA shot in teenagers because its leads to myocarditis. (Finland and Sweden even suspended its use in men under 30 years old.) Even the criminally corrupt European Medicines Agency acknowledged that both Pfizer and Moderna mRNA shots lead to myo- and pericarditis and added a warning to the product insert.
Okay what do we know about Moderna’s clinical trial in kids under 6?
Back on March 23, Moderna put out a press release claiming that:
vaccine efficacy in children 6 months to 2 years was 43.7% and vaccine efficacy was 37.5% in the 2 to under 6 years age group.
The NY Times of course printed that like it was a clay tablet handed directly from God to Moses just as they printed the “90% to 100% effective(TM)” lie in connection with the clinical trial in adults. By now everyone knows that the actual vaccine effectiveness is zero or even negative after 6 months.
Sane people pointed out that vaccine efficacy of 43% and 37% are BELOW the 50% threshold required for FDA authorization. It’s not clear why the geniuses at Moderna did not realize this — perhaps they just wanted to rub everyone’s noses in the sheer criminality of their enterprise?
But somewhere between March 23 and last Friday, Moderna staff got the message so they did what they always do, they just manipulated the data. From the NY Times :
Moderna said Thursday the vaccine appeared to be 51 percent effective against symptomatic infection among those younger than 2, and 37 percent effective among those 2 to 5.
Okay first off, lol that they still cannot get the number above 50% in kids 2 to 5 even when they are just straight up lying about the numbers. But how did they convert 43% to the magical 51% in kids 0 to 2? They simply deleted data that they did not like:
Those results were slightly better than the ones Moderna previously released for children under 2. The company said that was because the second time, the firm excluded infections that had not been confirmed with a P.C.R. test analyzed in a laboratory.
Let’s be clear — this is Moderna’s clinical trial. They control the whole process. If you’re a study participant who is having a heart attack in the middle of the night and call 911 and go to the hospital — they kick you out of the clinical trial for not seeing their doctors and following their protocol. So Moderna is the one who makes the decision as to whether to use “a P.C.R. test analyzed by a laboratory.” To now exclude (without any valid justification) infections that made their clinical trial look bad is gross scientific misconduct. The Moderna application, when/if it is submitted 10 days from now, should be rejected immediately because of this misconduct.
While the clinical trials in kids were failing, Pfizer and Moderna were running a half-hearted campaign to pressure the FDA to approve these shots in kids under 5 — in spite of zero data showing benefit and considerable evidence showing harms. The attempts were pathetic and included hashtags on social media like #immunizeunder5 that were likely only used by people taking money from these monsters. But of course the stenographers eagerly reported on this milquetoast effort and one of the talking points is, ‘well, okay, the shots do not meet the required 50% FDA threshold but some protection is better than none(TM) so please authorize my right to genocide my kids.’
Well, it turns out, these shots do NOT even offer “some protection”:
Moderna’s clinical trial data showed that the antibody response of the youngest children compared favorably with that of adults ages 18 to 25, meeting the trial’s primary criterion for success. Although the trial was not big enough to measure vaccine effectiveness…
What!? “The trial was not big enough to measure vaccine effectiveness.” Isn’t that the whole point of a clinical trial!? So Moderna (and the NY Times ) are saying that the clinical trial made ZERO difference on Covid-related health outcomes including infection, hospitalization, ICU visits, or deaths, because the SARS-CoV-2 virus is not a threat to healthy children in this age group — which we have been pointing out for months.
So how does Moderna try to finesse it? They look at antibodies in the blood, not health outcomes in the real world. They call it “immunobridging”. As I explained at length back in October, this is NOT a scientifically valid way to use immunobridging (claiming likely future health outcomes from antibodies alone when the trial showed no such thing). Immunobriding is only valid if one has clinically validated correlates of protection and conditions prevent one from conducting a proper RCT (neither of which apply in this case).
Even the hand-picked yes-men and women on the CDC’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) acknowledged at their last meeting that they do NOT have “correlates of protection” that would enable them to estimate health outcomes from antibody measures. Eric Rubin (Editor-in-Chief of the NEJM ) even stated, “We know what kind of antibody response can be generated, we just don’t know if it works.”
So Moderna is asking the FDA to authorize its mRNA shot in kids under 6 based on antibodies alone even though every member of the FDA’s VRBPAC acknowledges that antibodies tell you absolutely nothing about likely health outcomes.
(In fact, new evidence suggests that mRNA shots suppress the body’s innate ability to generate anti-N antibodies.)
What about side effects?
Side effects were at a similar level as those from previously approved pediatric vaccines, with fevers in 15 percent to 17 percent of the children, Moderna said.
Any shot with an adverse event rate over 1% should not be authorized. To authorize a shot with a 15 to 17% adverse event would be batsh*t insane.
Furthermore, we know that Moderna and Pfizer make cases of disability and death in their clinical trials disappear — so the actual adverse event rate is surely even higher than 15% to 17%.
Making this nightmare complete, the CDC acknowledged on April 26, 2022, that 74.2% of children ages 0 to 11 are already naturally immune to Covid-19 because of prior exposure. The 74.2% number came from February, so given the rate of increase at the time, by now nearly 100% of children ages 0 to 11 likely already have natural immunity which is superior to artificial vaccine immunity. There is no emergency in this population that would justify an emergency use authorization of this useless toxic product.
So to recap this painful saga:
• Moderna shots cause myocarditis and pericarditis which is why Moderna has not been able to get authorization to inject mRNA into teenagers.
• Moderna shots make no difference in connection with Covid-19 in this age group.
• Moderna shots come with at least a 15% to 17% adverse event rate.
• Nearly all children in this age group are already naturally immune so there is no emergency that would justify an emergency use authorization.
This is not hard to figure out. In a sane world this application would be dead on arrival, whenever Moderna gets around to actually turning in its application. Any reporter worth his/her salt should be ridiculing Moderna’s weird mix of hubris, incompetence, bad “data”, and malevolence. But our country, its “public health” agencies, and the mainstream media are run by Insane Nazi Clowns. I imagine many bougiecrats will drown in their own tears if they are not allowed to genocide their own kids with this shot (and then they’ll celebrate their sacrifice and take selfies with their kids in the ICU when the myocarditis kicks in, proclaiming #getvaccinated). Of course bougiecrats can already get this shot for their kid off label, so my hunch is that it’s really your kids who they want to genocide.
In future articles I’ll have additional thoughts about how we push back. In the meantime, this continues to be our best play and I encourage all of us to just get into the habit of contacting 25 people at the FDA every day to tell them to REJECT both the Moderna and Pfizer applications to inject mRNA into little kids.
FDA Rubber-Stamps Remdesivir for Infants Without Evidence of Safety, Efficacy
By Madhava Setty, M.D. | The Defender | April 27, 2022
The U.S. Food and Drug Administration (FDA) on Monday approved the use of the antiviral therapy, remdesivir, to treat COVID-19 in infants four weeks and older.
Dr. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, said in a press release:
“As COVID-19 can cause severe illness in children, some of whom do not currently have a vaccination option, there continues to be a need for safe and effective COVID-19 treatment options for this population.
“Today’s approval of the first COVID-19 therapeutic for this population demonstrates the agency’s commitment to that need.”
According to the press release, the FDA’s decision to approve the therapy, marketed under the name Veklury, is supported by a clinical study conducted on infants 4 weeks and older weighing a minimum of 6.6 pounds.
The study is underway and will not be completed until February 2023. There are no published results.
However, Gilead Sciences, maker of remdesivir and sponsor of the study, provided the following details in a company press release:
- A total of 53 hospitalized pediatric patients were enrolled in the clinical study.
- 72% suffered adverse events.
- 21% suffered serious adverse events determined to be unrelated to the drug.
- Three children died from either underlying conditions or COVID-19.
Nevertheless, Gilead Science assured that “no new safety signals were apparent for patients treated with Veklury.”
The study was of single-arm, open-label design.
A single-arm study has no control group, making it impossible to compare its effectiveness against standard of care.
Open-label means participants and investigators were aware they were receiving the drug, making it impossible to separate placebo from drug effect.
Studies show little or no benefit
Beyond the absence of any publicly available data on the efficacy and safety of this drug in humans of this age, available studies on older subjects indicate remdesivir offers no more than a meager benefit to those who survive its use.
In fact, this is why the World Health Organization (WHO) in November 2020 recommended against the use of remdesivir to treat COVID-19. The WHO only recently (April 22, 2022) updated its recommendation to support the drug’s use in patients who are at high risk for hospitalization.
Nevertheless, the FDA explains its long-standing support of remdesivir use in adults here, citing six studies that had the greatest impact on the agency’s position.
Here is a summary of the findings of each study from the FDA’s webpage:
- ACTT-1 Trial: Time to clinical recovery was shortened from 15 days to 10 through the use of remdesivir. There was no difference in mortality. The drug was no better than placebo when administered to patients who required high-flow oxygen, non-invasive respiratory support, mechanical ventilation or extracorporeal membrane oxygenation at baseline. A benefit was seen only in patients who required low levels of supplemental oxygen.
- Discovery Trial: There was no clinical benefit of remdesivir in hospitalized patients who were symptomatic for >7 days and who required supplemental oxygen. There was no difference in mortality between remdesivir and standard of care. Investigators judged three of 429 participants who received remdesivir died from the drug.
- WHO Solidarity Trial: Remdesivir did not decrease in-hospital mortality or the need for mechanical ventilation compared to standard of care. Four hundred and forty patients in this study were also enrolled in the Discovery trial above.
- Journal of the American Medical Association (moderate disease): After 10 days of treatment with remdesivir, clinical status was not significantly different from standard of care.
- New England Journal of Medicine (severe disease): No difference between five and 10 days of remdesivir treatment. No placebo group, thus “the magnitude of benefit cannot be determined.”
- PINETREE study: Three consecutive days of IV remdesivir resulted in an 87% relative reduction in the risk of hospitalization or death when compared to placebo.
As demonstrated, the first five studies used to justify the FDA’s approval of remdesivir showed little, if any, benefit to hospitalized patients with moderate or severe disease.
This is in contrast to the sufficiently proven benefit of off-label use of the previously licensed medications hydroxychloroquine and ivermectin.
Only the PINETREE study investigated the benefit of remdesivir for outpatient use. In that study, the drug provided a substantial benefit in preventing hospitalization when given in three separate doses over three days.
However, only eight individuals under the age of 18 were enrolled in the study, and none were younger than 12.
The primary endpoint, a composite of COVID-19-related hospitalization or death from any cause, did not occur in the under-18 group.
In other words, the study — funded by Gilead Sciences — showed the drug offered no benefit in this cohort.
Nevertheless, in reporting on the FDA’s approval of remdesivir for infants and young children, CNN found someone to support the FDA’s decision.
CNN wrote:
“The FDA’s approval of remdesivir for young children is ‘great,’ said Dr. Daniel Griffin, an instructor in clinical medicine and associate research scientist in the Department of Biochemistry and Molecular Biophysics at Columbia University.”
Safety ‘not established’ in pediatric patients
Not only is there scant evidence that remdesivir is an effective treatment for COVID-19, the drug’s safety is debatable.
With regard to its use in infants, even the FDA must acknowledge nobody knows how safe it is.
After all, the manufacturer’s label states:
“The safety and effectiveness of VEKLURY (remdesivir) have not been established in pediatric patients younger than 12 years of age or weighing less than 40 kg.”
With regard to pharmacokinetics (where the drug distributes in the body) the label states:
“The pharmacokinetics of VEKLURY in pediatric patients have not been evaluated.”
An indictment of the drug regulatory process
Let’s reflect on what the director of the FDA’s Center for Drug Evaluation and Research said regarding the approval of remdesivir for treating COVID-19 in infants 4 weeks and older:
“As COVID-19 can cause severe illness in children, some of whom do not currently have a vaccination option, there continues to be a need for safe and effective COVID-19 treatment options for this population. Today’s approval of the first COVID-19 therapeutic for this population demonstrates the agency’s commitment to that need.”
To summarize:
- Some children do not have a vaccination option.
- They need a safe and effective treatment.
- The FDA meets that need by approving a drug with no safety and efficacy record in children.
Safety and efficacy apparently can be conveniently established by fiat, not evidence.
In the end, the FDA’s approval of remdesivir is not an assurance of the drug’s safety and efficacy but an indication the agency is no longer interested in protecting the public from potentially harmful and ineffective therapies — or, in other words, in doing its job.
There will undoubtedly be doctors like Griffin who welcome this approval.
However, I don’t believe every pediatrician will accept the FDA’s guidance so readily.
It’s not easy to place an intravenous line to administer remdesivir in the tiny vein of an irritable baby coming from home with a positive rapid test. And then do it again the next day. And the day after that.
At some point, clinicians’ sensibilities will be challenged enough to compel them to actually examine how the FDA arrived at its conclusions.
Guidelines are meaningless if doctors choose not to abide by them.
Madhava Setty, M.D. is senior science editor for The Defender.
© 2022 Children’s Health Defense, Inc. This work is reproduced and distributed with the permission of Children’s Health Defense, Inc. Want to learn more from Children’s Health Defense? Sign up for free news and updates from Robert F. Kennedy, Jr. and the Children’s Health Defense. Your donation will help to support us in our efforts.
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From the Archives
A short history of British torture
ICC | December 2005
When the House of Commons was debating how much to increase the time limit for detention without trial the question of torture came up. Officially this was limited to the nice considerations of whether it was all right to send people to places where torture is used and whether Britain can use information collected by the use of torture in other countries. This discussion gave an impression of democratic Britain as the home of civilised behaviour where the very idea of torture is repugnant to our legislators – unlike, say, the US with its secret CIA jails… In reality, the British state has a long history of using and developing a whole range of torture techniques. … continue
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