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.
Investigation Launched After ‘Mystery’ Surge in Deaths of Newborn Babies
By Paul Joseph Watson | Summit News | May 16, 2022
Health authorities in Scotland have launched an investigation after a mystery surge in deaths of newborn babies, the second time the phenomenon has been recorded in the space of six months.
A report by the Herald newspaper highlights the “very unusual” spike in deaths of babies, with the alarm being raised after 18 infants died within four weeks of birth in March.
That same control limit was also breached in September last year, when 21 neonatal deaths were reported, the first time this had occurred since records began.
“The neonatal mortality rate was 5.1 per 1,000 live births in September and 4.6 per 1,000 in March, against an average of 1.49 per 1000 in 2019,” reports the newspaper.
Public Health Scotland (PHS) said the deaths could not have been down to chance, while the cause behind the previous spike in September also “remained a mystery.”
The report notes that vaccination uptake has increased in expectant mothers and that COVID infections during pregnancy are associated with a higher chance of premature birth, but found no “direct link” between COVID surges and the deaths.
PHS Scotland says COVID infections “did not appear to have played a role” in the September spate of deaths.
Edinburgh University’s Dr. Sarah Stock said, “The numbers are really troubling,” but admitted she didn’t know the cause of the deaths.
Washington moves to annex north-east Syria by proxy

By Vanessa Beeley | May 14, 2022
Under cover of media focus on the NATO proxy war in Ukraine and the Zionist assassination of Al Jazeera senior correspondent Shireen AbuAkleh, Washington is making moves to annex Syrian territory.
On May 11th during the meeting of the “global coalition against Islamic State” in Marrakech, Morocco the U.S acting assistant Secretary of State, Victoria Nuland, made an extraordinary move that has largely gone under the radar of even independent media. Everyone is distracted by events in Ukraine and the Palestinian Occupied Territories.
Nuland who famously exclaimed “Fuck the EU” during recorded conversations that exposed the US State Department involvement in the 2014 coup in Ukraine and the subsequent massacre in Odessa by the Washington’s Nazi Contras is now turning her attention to Syria’s north-eastern territory.
Nuland has announced that the US will allow foreign investment in north-east Syria under the control of the Kurdish Separatists, another US Coaliton proxy in Syria. These investments will not be affected by the unprecedented sanctions that are effectively blockading Syria.
The most savage of these economic measures were introduced under the Trump administration – the Caesar sanctions that are designed to inhibit any external assistance for Syria from within the Syrian alliance, including Russia and Iran.
The Caesar Syrian Civilian Protection Act is also fraudulent by claiming to “protect civilians”. In reality, it is punishes and hurts the vast majority of 17 million persons living in Syria. It will result in thousands of civilians suffering and dying needlessly. – Rick Sterling
Needless to say that the de-facto unilateral sanctions being applied as a collective punishment for the entire Syrian population living in areas protected by the Syrian government are illegal. To extend those sanctions to sovereign nations providing assistance to rebuild Syrian infrastructure is barbaric and a deliberate attempt by the US to ensure that Syria cannot recover from the eleven year war waged against it.
The correlation between economic and military coercion in Syria was made clear by previous Secretary of State, Mike Pompeo’s point-man on Syria, Ambassador James Jeffrey, who not only described Al Qaeda as a “US asset” in Syria but also bragged openly about the misery that sanctions had brought to the Syrian people:
And of course, we’ve ratcheted up the isolation and sanctions pressure on Assad, we’ve held the line on no reconstruction assistance, and the country’s desperate for it. You see what’s happened to the Syrian pound, you see what’s happened to the entire economy. So, it’s been a very effective strategy….
Journalist Rick Sterling also pointed out the illegality and brutality of the Caesar sanctions:
The US has multiple goals. One goal is to prevent Syria from recovering. Another goal is to prolong the conflict and damage those countries who have assisted Syria. With consummate cynicism and amorality, the US Envoy for Syria James Jeffrey described his task: “My job is to make it a quagmire for the Russians.”
Nuland said Washington would issue a general licence, which frees companies from U.S. sanctions restrictions in north-east Syria.
“The United States intends in the next few days to issue a general license to facilitate private economic investment activity in non-regime held areas liberated from ISIS in Syria.”
The irony here of course is that ISIS is in reality another proxy of the US Coalition that had benefitted from the oil resource revenue prior to the occupation of the oil fields by the Kurdish Contras. There is also a degree of collaboration mired in corruption between the Kurdish Separatists and ISIS both focused on the ethnic cleansing of the north-east to make way for an “autonomous region” effectively controlled by Washington, London and Israel. As Syrian researcher, Ibrahim Wahdi, wrote back in February 2022:
We can clearly see that the largest organized smuggling and mass transfer of ISIS militants towards the Syrian Badia connected with the Iraqi border north of Al-Tanf region, which coincided with the Ukraine crisis and the negotiations of the Iranian nuclear deal, aims to trigger chaos by CIA and Israeli intelligence through reviving ISIS to keep it as a pretext for the US occupation of Syrian lands.
Nuland’s claims that investment in areas “previously held” by ISIS are “needed to prevent a resurgence of Islamic State by allowing it to recruit and exploit local grievances” is hypocrisy of the highest order. Washington and London are recruiting, arming and equipping ISIS terrorists and embedding their fighters in areas of the Badia desert (East of Homs) where they can do the most damage to Syrian Arab Army installations and convoys – this includes the disruption of the meagre oil supply to Damascus from the north-east. As Wahdi pointed out:
The danger of the ISIS card lies in the large numbers distributed among 9 prisons in the US-backed SDF-controlled areas, which are potential targets for similar attacks [to release ISIS terrorists], especially the “Kamba Al-Bulgar” prison, east of Al-Shaddadi city in the southern countryside of Hasaka, which includes 5,000 ISIS militants.
In addition to Al-Sina’a prisons, Al-Shaddadiyah, Derek/ Al-Malikiyah, Al-Kasra, Al-Raqqa Central Prison, Rmelan and Nafker in the Qamishli city, from which 60 ISIS militants were transferred to a prison in Al-Hasakah last September.
Both ISIS and the Kurdish Contras are responsible for the theft of oil from Syria. Al Qaeda has the monopoly of the processing of the stolen oil via its WATAD organisation. The US Coalition has a vested interest in bringing the Syrian population to its knees and to stir up dissent against the Syrian government that has trashed the Coalition military plans for regime change.
The war against Russia in Ukraine is also revenge for Russia’s role in genuinely fighting ISIS in Syria and forcing the terrorist entity to withdraw to the north-east and Iraq where it is equally responsible for the destruction of civilian infrastructure in particular electrical installations to further punish any Iraqi resistance to US occupation.
Nuland and Washington are deliberately enflaming local grievances and enabling ISIS recruitment and expansion.
Not only will these sanction-free licences apply to the Kurdish Contras but the Turkish backed militia occupying the northern border zones of Syria will also be included in the deal. This means that Syrian territory will be de-facto annexed by these NATO-member-state proxies including Al Qaeda (Turkey) and affiliates.
According to a diplomat who has discussed the issue extensively with U.S officials, the licence will apply to agriculture and reconstruction work but not to oil. I guess there is no need to include oil as that is already considered a U.S benefit of the war they started in 2011. After all Trump said very clearly “we’re keeping the oil – I’ve always said that — keep the oil. We want to keep the oil, $45 million a month. Keep the oil. We’ve secured the oil.”
If the licence will apply to reconstruction and agriculture, this will legitimise the building of settlements and the continued theft (by the Kurds) of Syrian agricultural produce in the region, the occupation of the wheat storage centers and the reduction in supply to Damascus of these essential resources. Essentially doubling down on the siege of the Syrian people who are already suffering severe food insecurity, poverty, fuel and energy deprivation on a terrible scale.
The act of withholding means of sustaining life to innocent civilians in order to coerce an entire nation into submission to foreign agendas in the region must surely qualify as economic terrorism. The destruction of essential civilian infrastructure is a war crime, the withholding of essential resources or occupation of those resources is also a war crime. One could argue that the US Coalition is responsible for genocide in Syria under Genocide Convention article II (e) – deliberately inflicting on the group, conditions of life calculated to bring about its physical destruction in whole or in part”.
When Washington talks about “stabilisation” activities in the areas its “allies” took from Islamic State they are lying. Its “allies” are being led to believe they will benefit from cooperation with the U.S. In reality they are useful tools to facilitate the U.S and Israeli agenda in the region – to balkanise Syria and above all to secure the illegal US Al Tanf military base in the south-east (bordering Jordan) to prevent the linking of the Resistance Axis from Iran to Lebanon and ultimately Palestine. To protect “Israeli security” in the region.
The organised smuggling and transfer of ISIS terrorists towards the Syrian Badia connected with the Iraqi border north of Al Tanf is to maintain the CIA/MI6/Israeli chaos strategy in Syria and to justify US occupation of Syrian territory under the faux ISIS pretext.
What Nuland is proposing is a step forward for Washington in the annexation of Syria’s most resource rich territory. It is annexation by proxy. Turkey will also benefit from these licence schemes and will further embed its Al Qaeda-led militia in the northern border areas thus ensuring permanent insecurity for Syria to the north.
Arabs, Assyrians and Armenians will necessarily be ethnically cleansed from these zones to make way for these US-sanctioned settlements and it is common knowledge that the Kurdish Contras have been preparing for this for some time – banning the Syrian curriculum in schools and razing Arab houses in the area while forcing conscription onto local communities, running campaigns of kidnapping and detention.
Nuland informed coalition members in Marrakech that “Washington wanted to raise $350 million for these alleged “stabilisation” activities in north-east Syria during 2022. Iraq is also the target of the same “stabilisation” campaign. What Nuland really means is that Washington under cover of Ukraine will move to secure permanent violation of Syria’s territorial integrity while feigning outrage that Russia is violating the sovereignty of Ukraine already occupied by NATO and little more than Washington’s satellite vassal state on the border with its arch enemy Russia.
Nearly 30,000 Deaths After COVID Vaccines Reported to VAERS, CDC Data Show
By Megan Redshaw | The Defender | May 13, 2022
The Centers for Disease Control and Prevention (CDC) today released new data showing a total of 1,261,149 reports of adverse events following COVID-19 vaccines were submitted between Dec. 14, 2020, and May 6, 2022, to the Vaccine Adverse Event Reporting System (VAERS). VAERS is the primary government-funded system for reporting adverse vaccine reactions in the U.S.
The data included a total of 27,968 reports of deaths — an increase of 210 over the previous week — and 228,477 serious injuries, including deaths, during the same time period — up 1,774 compared with the previous week. There were 5,794 additional total adverse events reported to VAERS over the previous week.
Excluding “foreign reports” to VAERS, 815,384 adverse events, including 12,899 deaths and 81,830 serious injuries, were reported in the U.S. between Dec. 14, 2020, and May 6, 2022.
Foreign reports are reports foreign subsidiaries send to U.S. vaccine manufacturers. Under U.S. Food and Drug Administration (FDA) regulations, if a manufacturer is notified of a foreign case report that describes an event that is both serious and does not appear on the product’s labeling, the manufacturer is required to submit the report to VAERS.
Of the 12,899 U.S. deaths reported as of May 6, 16% occurred within 24 hours of vaccination, 20% occurred within 48 hours of vaccination and 59% occurred in people who experienced an onset of symptoms within 48 hours of being vaccinated.
In the U.S., 578 million COVID-19 vaccine doses had been administered as of May 6, including 341 million doses of Pfizer, 218 million doses of Moderna and 19 million doses of Johnson & Johnson (J&J).

Every Friday, VAERS publishes vaccine injury reports received as of a specified date. Reports submitted to VAERS require further investigation before a causal relationship can be confirmed.
Historically, VAERS has been shown to report only 1% of actual vaccine adverse events.
U.S. VAERS data from Dec. 14, 2020, to May 6, 2022, for 5- to 11-year-olds show:
- 10,560 adverse events, including 272 rated as serious and 5 reported deaths.
- 20 reports of myocarditis and pericarditis (heart inflammation).
The CDC uses a narrowed case definition of “myocarditis,” which excludes cases of cardiac arrest, ischemic strokes and deaths due to heart problems that occur before one has the chance to go to the emergency department.
The Defender has noticed over previous weeks that reports of myocarditis and pericarditis have been removed by the CDC from the VAERS system in this age group. No explanation was provided. - 43 reports of blood clotting disorders.
U.S. VAERS data from Dec. 14, 2020, to May 6, 2022, for 12- to 17-year-olds show:
- 31,504 adverse events, including 1,812 rated as serious and 43 reported deaths. VAERS reported 44 deaths in the 12- to 17-year-old age group last week.
- 65 reports of anaphylaxis among 12- to 17-year-olds where the reaction was life-threatening, required treatment or resulted in death — with 96% of cases attributed to Pfizer’s vaccine.
- 650 reports of myocarditis and pericarditis with 638 cases attributed to Pfizer’s vaccine.
- 166 reports of blood clotting disorders with all cases attributed to Pfizer.
U.S. VAERS data from Dec. 14, 2020, to May 6, 2022, for all age groups combined, show:
- 20% of deaths were related to cardiac disorders.
- 54% of those who died were male, 41% were female and the remaining death reports did not include the gender of the deceased.
- The average age of death was 73.
- As of May 6, 5,503 pregnant women reported adverse events related to COVID-19 vaccines, including 1,720 reports of miscarriage or premature birth.
- Of the 3,629 cases of Bell’s Palsy reported, 51% were attributed to Pfizer vaccinations, 40% to Moderna and 8% to J&J.
- 873 reports of Guillain-Barré syndrome, with 42% of cases attributed to Pfizer, 30% to Moderna and 29% to J&J.
- 2,331 reports of anaphylaxis where the reaction was life-threatening, required treatment or resulted in death.
- 1,698 reports of myocardial infarction.
- 13,922 reports of blood-clotting disorders in the U.S. Of those, 6,248 reports were attributed to Pfizer, 4,972 reports to Moderna and 2,661 reports to J&J.
- 4,183 cases of myocarditis and pericarditis with 2,562 cases attributed to Pfizer’s, 1,424 cases to Moderna’s and 184 cases to J&J’s COVID-19 vaccines.
Pfizer’s COVID efficacy fades rapidly just weeks after second and third doses
Second and third doses of Pfizer’s COVID-19 vaccine provide protection against the Omicron variant for only a few weeks, according to peer-reviewed research published today in JAMA Network Open.
“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 of the research letter wrote.
The authors said their findings “could support rolling out additional booster shots to vulnerable people as the variant drives an uptick in new cases across the country,” Forbes reported.
Danish researchers studied adults who received two or three doses of BNT162b2 between January 2021 and October 2021, or were previously infected prior to February 2021 and then vaccinated.
They found that after an initial increase in Omicron-specific antibodies after the second Pfizer shot, levels dropped rapidly, from 76.2% at week 4, to 53.3% at weeks 8 to 10, and 18.9% at weeks 12 to 14.
After the third shot, neutralizing antibodies against Omicron fell 5.4-fold between week 3 and week 8.
Megan Redshaw is a staff attorney for Children’s Health Defense and a reporter for The Defender.
UN Urges Israel to Protect Freedom of Assembly After Video Emerges of Journalist Funeral
Samizdat – 13.05.2022
The United Nations is aware of “shocking” video showing violence during the funeral of Al Jazeera journalist Shireen Abu Akleh in Jerusalem and calls on the Israeli government to protect freedom of peaceful assembly, UN spokesperson Farhan Haq said on Friday.
“We have just seen the video coming from this, and this is very shocking to us,” Haq said in a press briefing.
Israeli forces fatally shot reporter Shireen Abu Akleh and injured another employee as the two were covering the government forces’ raids in the West Bank city of Jenin, media reported on Wednesday.
The video showed violence erupting during Akleh’s funeral in Jerusalem when the Israeli police charged the crowd carrying her coffin.
Haq said the United Nations will try to gather more information about the incident.
“Clearly, as in all cases, we want to make sure that the basic rights to freedom of assembly, and of course the right to freedom of peaceful demonstration are protected and upheld,” he said.
No country can attack or kill journalists and those who are responsible for such actions need to be brought to account, Haq added.
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!
Israel shoots dead Al Jazeera journalist during invasion of Jenin

MEMO | May 11, 2022
Israeli occupation forces shot dead Al Jazeera correspondent Shireen Abu Akleh this morning during an invasion of the northern occupied West Bank city of Jenin.
The Palestinian Ministry of Health said Abu Akleh was shot by a live bullet in the head and rushed to hospital where she was declared dead.
Another reporter, Ali Al-Samudi, was also shot by a live bullet in the back, the ministry said. He was reported to be in a stable condition.
Waleed Al-Omari, Al Jazeera‘s bureau chief in Ramallah, said: “It seems that she was shot by an Israeli sniper.” He added that Abu Akleh had been standing in an area away from Palestinians who were protesting against Israel’s deadly raid of Jenin.
Al-Omari’s account negates Israel’s claim that there had been gunfire in the area to which occupation forces responded.
“During the operation in Jenin refugee camp, suspects fired an enormous amount of gunfire at troops and hurled explosive devices. [Israeli] forces fired back. Hits were identified,” the Israeli army said in a statement.
The army also said it was “looking into the possibility that journalists were injured, potentially by Palestinian gunfire.”
A Palestinian paramedic denied the Israeli army’s claims.
In a statement, Al Jazeera said Israeli occupation forces “assassinated in cold blood” its correspondent. This, it added, was “a blatant murder, violating international laws and norms. Al Jazeera Media Network condemns this heinous crime, which intends to only prevent the media from conducting their duty.”



