The long nightmare of oppression of Palestinians is not a tangential issue. It is a black and white issue of a settler-colonial state imposing a military occupation, horrific violence and apartheid, backed by billions of U.S. dollars, on the indigenous population of Palestine. It is the all powerful against the all powerless.
Israel uses its modern weaponry against a captive population that has no army, no navy, no air force, no mechanized military units, no command and control and no heavy artillery, while pretending intermittent acts of wholesale slaughter are wars. The crude rockets fired at Israel by Hamas and other Palestinian resistance organizations — a war crime because they target civilians — are not remotely comparable to the 2,000 pound “bunker-buster” Mark-84 bombs with a “kill radius” of over 32 yards and which “create a supersonic wave of pressure when they explode” that have been dropped by Israel on crowded Palestinian neighborhoods, the thousands of Palestinian killed and wounded and the targeted destruction of basic infrastructure, including electrical grids and water purification plants.
Palestinians in Gaza live in an open air prison that is one of the most densely populated spots on the planet. They are denied passports and travel documents.
Malnutrition is endemic in the Occupied Territories. “High proportions” of the Palestinian population are “deficient in vitamins A, D, and E, which play key roles in vision, bone health, and immune function,” according to a 2022 World Bank report. The report also notes that over 50 percent of those aged six to 23 in Gaza and over half of its pregnant women are anemic and “more than a quarter of pregnant women and more than a quarter of children aged 6–23 months [in the West Bank are] anemic.”
Eighty-eight percent of Gaza’s children suffer from depression, following 15 years of the Israeli blockade, according to a 2022 report from Save the Children and over 51 percent of children were diagnosed with PTSD following the third major war on Gaza in 2014. Only 4.3 percent of the water in Gaza is considered fit for human consumption. Palestinians in Gaza are crammed into unsanitary and overcrowded hovels. They often lack basic medical care. Unemployment rates are among the highest in the world at 46.6 percent.
Zionism’s goal, since before Israel’s inception, has been to displace Palestinians from their land and reduce those who remain to a struggle for basic subsistence, as Israeli historian Professor Ilan Pappe, notes:
10 March 1948, a group of eleven men, veteran Zionist leaders together with young military Jewish officers, put the final touches on a plan for the ethnic cleansing of Palestine. That same evening, military orders were dispatched to units on the ground to prepare for the systematic expulsion of Palestinians from vast areas of the country. The orders came with a detailed description of the methods to be used to forcibly evict the people: large-scale intimidation; laying siege to and bombarding villages and population centers; setting fire to homes, properties, and goods; expelling residents; demolishing homes; and, finally, planting mines in the rubble to prevent the expelled inhabitants from returning. Each unit was issued its own list of villages and neighborhoods to target in keeping with the master plan. Code-named Plan D (Dalet in Hebrew)…
Once the plan was finalized, it took six months to complete the mission. When it was over, more than half of Palestine’s native population, over 750,000 people, had been uprooted, 531 villages had been destroyed, and 11 urban neighborhoods had been emptied of their inhabitants.
These political and historical facts, which I reported on as an Arabic speaker for seven years, four of them as The Middle East Bureau Chief for The New York Times, are hard to ignore. Even from a distance.
I watched Israeli soldiers taunt boys in Arabic over the loudspeakers of their armored jeep in the Khan Younis refugee camp in Gaza. The boys, about 10 years old, then threw stones at an Israeli vehicle. The soldiers opened fire, killing some, wounding others. In the Israeli lexicon this becomes children caught in crossfire. I was in Gaza when F-16 attack jets dropped 1,000-pound iron fragmentation bombs on densely packed neighborhoods. I saw the corpses of the victims, including children, lined up in neat rows. This became a surgical strike on a bomb-making factory. I watched Israel demolish homes and apartment blocks to create buffer zones between the Palestinians and Israeli troops. I interviewed destitute families camped in the rubble of their homes. The destruction becomes the demolition of the homes of terrorists. I stood in the bombed remains of schools as well as medical clinics and mosques. I heard Israel claim that errant rockets or mortar fire from the Palestinians caused these and other deaths, or that the attacked spots were being used as arms depots or launching sites. I, along with every other reporter I know who has worked in Gaza, have never seen any evidence that Hamas uses civilians as “human shields.” Ironically, there is evidence of the Israeli military using Palestinians as human shields, which Israel’s High Court deemed illegal in 2005.
There is a perverted logic to Israel’s use of the Big Lie — Große Lüge. The Big Lie feeds the two reactions Israel seeks to elicit — racism among its supporters and terror among its victims.
There is a heavy political price to pay for defying Israel, whose overt interference in our political process makes the most tepid protests about Israeli policy a political death wish. The Palestinians are poor, forgotten and alone. And this is why the defiance of Israel’s treatment of the Palestinians is the central issue facing any politician who claims to speak on behalf of the vulnerable and the marginalized. To stand up to Israel has a political cost few, including Robert F. Kennedy Jr., are willing to pay. But if you do stand up, it singles you out as someone who puts principles before expediency, who is willing to fight for the wretched of the earth and, if necessary, sacrifice your political future to retain your integrity. Kennedy fails this crucial test of political and moral courage.
Kennedy, instead, regurgitates every lie, every racist trope, every distortion of history and every demeaning comment about the backwardness of the Palestinian people peddled by the most retrograde and far-right elements of Israeli society. He peddles the myth of what Pappe calls “Fantasy Israel.” This alone discredits him as a progressive candidate. It calls into question his judgment and sincerity. It makes him another Democratic Party hack who dances to the macabre tune the Israeli government plays.
Kennedy has vowed to make “the moral case for Israel,” which is the equivalent of making the moral case for apartheid South Africa. He repeats, almost verbatim, talking points from the Israeli propaganda playbook put together by the Republican pollster and political strategist, Frank Luntz. The 112-page study, marked “not for distribution or publication,” which was leaked to Newsweek, was commissioned by The Israel Project. It was written in the aftermath of Operation Cast Lead in December 2008 and January 2009 — when 1,387 Palestinians and nine Israelis were killed.
The strategy document is the blueprint for how Israeli politicians and lobbyists sell Israel. It exposes the wide gap between what Israeli politicians say and what they know to be the truth. It is tailored to tell the outside world, especially Americans, what they want to hear. The report is required reading for anyone attempting to deal with the Israeli propaganda machine.
The document, for example, suggests telling the outside world that Israel “has a right to defensible borders,” but advises Israelis to refuse to define what the borders should be. It advises Israeli politicians to justify the refusal by Israel to allow 750,000 Palestinians and their descendants, who were expelled from their country during the 1948 war, to return home, although the right of return is guaranteed under international law, by referring to this right as a “demand.” It also recommends arguing that Palestinians are seeking mass migrations to seize land inside Israel. It suggests mentioning the hundreds of thousands of Jewish refugees from Iraq, Syria and Egypt, who fled anti-Semitism and violence in the Arab world after the creation of the Jewish state. The document recommends saying these refugees also “left property behind,” in essence justifying the Israeli pogrom by the pogrom Arab states carried out after 1948. It recommends blaming the poverty among Palestinians on “Arab nations” that have not provided “a better life for Palestinians.”
What is most cynical about the report is the tactic of expressing a faux sympathy for the Palestinians, who are blamed for their own oppression.
“Show Empathy for BOTH sides!” the document reads. “The goal of pro-Israel communications is not simply to make people who already love Israel feel good about that decision. The goal is to win new hearts and minds for Israel without losing the support Israel already has.” It says that this tactic will “disarm” audiences.
I doubt Kennedy has read or heard of Luntz’s report. But he has been spoon-fed its talking points and naively spits them back. Israel only wants peace. Israel does not engage in torture. Israel is not an apartheid state. Israel gives Israeli Arabs political and civic rights they do not have in other parts of the Middle East. Palestinians are not deliberately targeted by the Israeli Defense Forces (IDF). Israel respects civil liberties and gender and marriage rights. Israel has “the best judiciary in the world.”
Kennedy makes other claims, such as his bizarre statement that the Palestinian Authority pays Palestinians to kill Jews anywhere in the world along with falsifications of elemental Middle Eastern history, which are so absurd I will ignore them. But I list below examples from the volumes of evidence that implode the Luntz-inspired talking points Kennedy repeats on behalf of the Israel lobby, not that any evidence can probably puncture his self-serving attachment to “Fantasy Israel.”
Apartheid
The 2017 U.N. report: “Israeli Practices towards the Palestinian People and the Question of Apartheid” concludes that Israel has established an apartheid regime that dominates the Palestinian people as a whole.” Since 1967, Palestinians as a people have lived in what the report refers to as four “domains,” in which the fragments of the Palestinian population are ostensibly treated differently but share in common the racial oppression that results from the apartheid regime.
Those domains are:
Civil law, with special restrictions, governing Palestinians who live as citizens of Israel;
Permanent residency law governing Palestinians living in the city of Jerusalem;
Military law governing Palestinians, including those in refugee camps, living since 1967 under conditions of belligerent occupation in the West Bank and Gaza Strip;
Policy to preclude the return of Palestinians, whether refugees or exiles, living outside territory under Israel’s control.
On 19 July 2018, the Israeli Knesset voted “to approve the Jewish Nation-State Basic Law, constitutionally enshrining Jewish supremacy and the identity of the State of Israel as the nation-state of the Jewish people,” the Haifa-based civil liberties group Adalah explained. It is the supreme law in Israel “capable of overriding any ordinary legislation.”
In 2021 Israeli human rights group B’Tselem published its report “A regime of Jewish supremacy from the Jordan River to the Mediterranean Sea: This is apartheid.” The report reads:
In the entire area between the Mediterranean Sea and the Jordan River, the Israeli regime implements laws, practices and state violence designed to cement the supremacy of one group — Jews — over another — Palestinians. A key method in pursuing this goal is engineering space differently for each group.
Jewish citizens live as though the entire area were a single space (excluding the Gaza Strip). The Green Line means next to nothing for them: whether they live west of it, within Israel’s sovereign territory, or east of it, in settlements not formally annexed to Israel, is irrelevant to their rights or status.
Where Palestinians live, on the other hand, is crucial. The Israeli regime has divided the area into several units that it defines and governs differently, according Palestinians different rights in each. This division is relevant to Palestinians only…Israel accords Palestinians a different package of rights in every one of these units — all of which are inferior compared to the rights afforded to Jewish citizens.
“Since 1948,” the reports continues, “Israel has taken over 90% of land within its sovereign territory and built hundreds of Jewish communities, yet not one for Palestinians (with the exception of several communities built to concentrate the Bedouin population, after dispossessing them of most of their property rights),” the report reads.
“Since 1967, Israel has also enacted this policy in the Occupied Territories, dispossessing Palestinians of more than 2,000 km2 on various pretexts. In violation of international law, it has built over 280 settlements in the West Bank (including East Jerusalem) for more than 600,000 Jewish citizens. It has devised a separate planning system for Palestinians, designated primarily to prevent construction and development, and has not established a single new Palestinian community.”
Targeting Civilians
Contrary to Kennedy’s claims that “the policy of the Israeli military is to always only attack military targets,” the deliberatetargeting of civilians and civilian infrastructure by the Israeli military, and other branches of the Israeli security apparatus, has been extensively documented by Israeli and international organizations.
The 2010 Goldstone report, which is over 500 pages, investigated Israel’s 22-day air and ground assault on Gaza that took place from Dec. 27, 2008, to Jan. 18, 2009. The United Nations Human Rights Council and the European Parliament endorsed the report.
The Israeli attack killed 1,434 people, including 960 civilians, according to the Palestinian Center for Human Rights. More than 6,000 homes were destroyed or damaged, leaving behind some $3 billion in destruction in one of the poorest areas on Earth. Three Israeli civilians were killed by rockets fired into Israel during the assault.
The report’s key findings include that:
Numerous instances of Israeli lethal attacks on civilians and civilian objects were intentional, including with the aim of spreading terror, that Israeli forces used Palestinian civilians as human shields and that such tactics had no justifiable military objective.
Israeli forces engaged in the deliberate killing, torture and other inhuman treatment of civilians and deliberately caused extensive destruction of property, outside any military necessity, carried out wantonly and unlawfully.
Israel violated its duty to respect the right of Gaza’s population to an adequate standard of living, including access to adequate food, water and housing.
On 14 June of this year, B’Tselem reported that “Top Israeli officials” are “criminally liable for knowingly” ordering airstrikes which were “expected to harm civilians, including children, in the Gaza Strip.”
Contrary to the myth propagated by Kennedy, reports and investigations, both by the U.N. as well as by rights groups, domestic and international, routinely cover suspected or known violations by Palestinian militants when they investigate alleged war crimes. As B’Tselem noted in the same 2019 report, in total, four Israelis were killed and 123 wounded.
Last month, the U.N.’s expert on the situation of human rights in the Palestinian territories occupied since 1967, Italian international lawyer and academic Francesca Albanese, presented her report to the U.N. Human Rights Council. It makes for very grim reading.
Deprivation of liberty has been a central element of Israel’s occupation since its inception. Between 1967-2006 Israel has incarcerated over 800,000 Palestinians in the occupied territory. Although spiking during Palestinian uprisings, incarceration has become a quotidian reality. Over 100,000 Palestinians were detained during the First Intifada (1987-1993), 70,000 during the Second Intifada (2000-2006), and over 6,000 during the ‘Unity Intifada’ (2021). Approximately 7,000 Palestinians, including 882 children, were arrested in 2022. Currently, almost 5,000 Palestinians, including 155 children, are detained by Israel, 1,014 of them without charge or trial.
Torture
Around 1,200 complaints “alleging violence in Shin Bet [The Israeli Security Agency] interrogations” were filed between 2001 and 2019, according to the Public Committee Against Torture in Israel.
“Zero indictments have been brought,” the committee reports. “This is yet another illustration of the complete systemic impunity enjoyed by the Shin Bet’s interrogators.”
Coercive methods include sexual harassment and humiliation, beatings, stress positions imposed for hours and interrogations that lasted as long as 19 hours as well as threats of violence against family members.
“They said they would kill my wife and children. They said they would cancel my mother’s and sister’s permits for medical treatments,” one survivor said in 2016. “I couldn’t sleep because even when I was in my cell, they would wake me up every 15 minutes… I couldn’t tell the difference between day and night… I still scream in my sleep,” another said in 2017.
The U.N. Special Rapporteur on Torture, Nils Melzer, expressed “his utmost concern” after a December 2017 ruling by Israel’s Supreme Court exempting security agents from criminal investigation despite their undisputed use of coercive “pressure techniques” against a Palestinian detainee, Assad Abu Gosh. He called the ruling a “license to torture.”
Abu Gosh “was reportedly subjected to ill-treatment including beatings, being slammed against walls, having his body and fingers bent and tied into painful stress positions and sleep deprivation, as well as threats, verbal abuse, and humiliation. Medical examinations confirm that Mr. Abu Gosh suffers from various neurologic injuries resulting from the torture he suffered.”
Civil Liberties
In the November 2022 elections in Israel, a far-right theocratic, nationalist and openly racist coalition took power. Itamar Ben-Gvir, from the ultra-nationalist Otzma Yehudit, “Jewish Power,” party, is the Minister of National Security. Otzma Yehudit is populated with former members of Rabbi Meir Kahane’s Kach party, which was banned from running for the Knesset in 1988 for espousing a “Nazi-like ideology” that included advocating the ethnic cleansing of all Palestinian citizens of Israel, as well as all Palestinians living under Israeli military occupation. His appointment, along with that of other far-right ideologues, including Bezalel Smotrich, the Minister of Finance, effectively jettisons the old tropes liberal Zionists used to defend Israel — that it is the only democracy in the Middle East, that it seeks a peaceful settlement with the Palestinians in a two-state solution, that extremism and racism have no place in Israeli society and that Israel must impose draconian forms of control on the Palestinians to prevent terrorism.
The new coalition government is reportedly preparing legislation that would be used to disqualify almost all Palestinian/Arab Knesset members from serving in the Israeli parliament, as well as ban their parties from standing in elections. The recent judicial “reforms” gut the independence and oversight of the Israeli courts. The government has also proposed shutting down Kan, the public broadcasting network, although that has been amended to fixing its “flaws”. Smotrich, who opposes LGBTQ rights and refers to himself as a “fascist homophobe,” said on Tuesday he would freeze all funds to Israel’s Palestinian communities and East Jerusalem.
Israel has promulgated a series of laws to curtail public freedoms, brand all forms of Palestinian resistance as terrorism, and label supporters of Palestinian rights, even if they are Jewish, as anti-Semites. The amendment of one of Israel’s principle apartheid laws, the 2010 “Village Committees Law,” grants neighborhoods with up to 700 households the right to reject people from moving in to “preserve the fabric” of the community. Israel has over 65 laws that are used to discriminate directly or indirectly against Palestinian citizens of Israel and those in the Occupied Territories.
Israel’s Citizenship and Entry into Israel Law prevents Palestinian citizens of Israel from marrying Palestinians in the West Bank and Gaza.
Interreligious marriage in Israel is also prohibited.
As explained by Jacob N. Simon, who served as the President of the Jewish Legal Society at the Michigan State University College of Law:
The combination of the blood line related requirements to be considered Jewish by the Orthodox Rabbinical Court and the restriction of marriage requiring religious ceremonies shows an intent to maintain race purity. At its core, this is no different than the desire for pure blooded Aryans in Nazi Germany or pure blooded whites in the Jim Crow Southern United States.
Those who support these discriminatory laws and embrace Israeli apartheid are blinded by willful ignorance, racism or cynicism. Their goal is to dehumanize Palestinians, champion an intolerant Jewish chauvinism and entice the naïve and the gullible into justifying the unjustifiable. Kennedy, bereft of a moral compass and a belief system rooted in verifiable fact, has not only failed the Palestinians, he has failed us.
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On Dec. 4, Robert F. Kennedy, Jr., chairman and chief legal counsel for Children’s Health Defense, sent the below letter to Peter Marks, director of the Center for Biologics Evaluation and Research (CBER), asking the U.S. Food and Drug Administration to take a cautious approach in approving COVID-19 vaccines that have been developed at “warp speed.”
TAKE ACTION: On Dec. 10, CBER’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) will meet in open session to discuss Emergency Use Authorization of the Pfizer-BioNTech COVID vaccine for the prevention of COVID-19 in individuals 16 years of age and older. Take action below by urging VRBPAC to make safety the chief concern in its considerations:
- Send RFK, Jr.’s letter (see below) to CBER Director Peter Marks and Senator Ron Johnson of Wisconsin, chair of the Senate Homeland Security and Governmental Affairs Committee, who has expressed similar COVID vaccine safety concerns.
- Send the letter in the action alert below to your representatives in the House and Senate letting them know that you support Kennedy’s call for caution in making decisions regarding Emergency Use Authorization of Pfizer’s COVID vaccine as well as any other COVID vaccine in development.
With the VRBPAC meeting coming up so quickly, the time to act is now!
Letter to Congressional Representatives and Senators
If the form does not load for you go to this page.
Here’s Robert F. Kennedy, Jr.’s letter:
Dear Dr. Marks,
Transparency and accountability are essential ingredients in the public policy process, helping to engender public trust and promote sound decision-making. As you are undoubtedly aware, many Americans are expressing worries about the lack of transparency and abbreviated timeline governing the experimental COVID-19 vaccines currently under development. Children’s Health Defense shares the public’s concern that the government’s single-minded—and perhaps unrealistic—preoccupation with a vaccine as the only way to end the COVID crisis has given the vaccine enterprise a dangerous urgency that could prompt health officials to take reckless steps to speed one or more vaccines to approval. Children’s Health Defense is writing to respectfully request that you and the FDA slow down the approval process to meet the public’s expectations for deliberations of the utmost rigor and integrity.
Without having to provide “the full data to back up their claims,” executives at Pfizer and Moderna “have made significant amounts of money off their early announcements of [vaccine] success.” In addition, through Operation Warp Speed, Pfizer (in partnership with German company BioNTech) has received $1.95 billion in taxpayer funds for the manufacture and distribution (though not R&D) of 100 million doses of its BNT162b2 mRNA vaccine; Operation Warp Speed has also awarded over $2.4 billion to support the clinical trials, manufacturing and distribution of 100 million doses of Moderna’s mRNA-1273 vaccine developed in partnership with the National Institute of Allergy and Infectious Diseases (NIAID).
Both Pfizer and Moderna have now submitted Emergency Use Authorization (EUA) applications (on November 20 and November 30, respectively) for their vaccines, and Moderna has also directed an application to the European Medicines Agency. News reports indicate that the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) will meet on December 10 to review Pfizer’s application and are speculating that FDA could authorize the company’s vaccine as soon as mid-December. VRBPAC is also apparently hurrying to review Moderna’s vaccine on December 17.
At an October 22 meeting of outside experts convened by VRBPAC to discuss COVID-19 vaccines, one of the attendees described the difficulty—particularly when making a less stringent EUA decision—of striking the proper “balance between looking at people’s rights to take something where it’s determined that the benefit might exceed the risk, while also making sure that. . . people are not taking vaccines that might actually harm them” (p. 348). Recognizing the innumerable uncertainties that surround these novel vaccines, Children’s Health Defense believes that, at a minimum, the American public deserves to have the FDA’s thorough and thoughtful answers to the following questions:
How will the FDA account for potentially biased conclusions about COVID-19 vaccine efficacy?
Both Pfizer and Moderna recently issued press releases citing preliminary evidence that their COVID-19 vaccines are 95% effective in preventing symptoms of mild coronavirus infection; they are banking on these early results to obtain the FDA’s emergency use authorization. However, the clinical trials’ reliance on PCR testing to ascertain study participants’ SARS-CoV-2 infection status raises important questions. These prompted world-renowned diagnostics expert Dr. Sin Hang Lee, founder of the Connecticut-based Milford Molecular Diagnostics Laboratory, to file an Administrative Stay of Action petition with the FDA (Docket No. FDA-2020-P-2225) on November 25. The petition focuses on the Pfizer study but is just as relevant to the Moderna study. In the petition, Dr. Lee asserts that Pfizer’s study design is “inadequate to accurately assess efficacy” and asks the FDA to conduct a more appropriate efficacy review before proceeding to an EUA determination, stating that PCR testing—prone to generating a high rate of false-positives—should not serve as the primary evidence of SARS-CoV-2 infection in trial participants. As Dr. Lee spells out, “a higher number of false-positive test results in the participants receiving placebo will artificially raise the efficacy of the vaccine.” He argues that it is “absolutely necessary” that all positive test results be verified using gold-standard DNA sequencing.
Will the FDA factor into its EUA deliberations the fact that neither clinical trial has a primary objective of assessing whether the vaccines prevent severe outcomes?
The pre-specified endpoints forming the basis of Pfizer’s and Moderna’s preliminary conclusions about effectiveness—the endpoints upon which the FDA’s potentially momentous decision to grant EUA rests—focus on a trivial difference in COVID-19 symptomatology between a tiny subset of 164 or fewer trial participants in the vaccinated and control groups. In late October, internationally esteemed British Medical Journal (BMJ) Associate Editor Dr. Peter Doshi, who is also a University of Maryland professor, wrote in the BMJ, “The world has bet the farm on vaccines as the solution to the pandemic, but the trials are not focused on answering the questions many might assume they are.” Dr. Doshi continued, “None of the trials currently under way are designed to detect a reduction in any serious outcome such as hospital admissions, use of intensive care, or deaths.” According to Dr. Doshi, Moderna’s chief medical officer is well aware of this design shortcoming, having explained that to capture endpoints such as hospitalization or death, the trials would need to be “10 times the size” and run for a much longer time frame. Scientist and former Harvard Medical School professor Dr. William A. Haseltine agrees that the trials’ narrow focus on mild cold-like symptoms makes the study protocols “far from adequate”; Dr. Haseltine has argued that the trials seem “intended to pass the lowest possible barrier of success,” allowing manufacturers to quickly petition for vaccine approval.
Experts at the late-October VRBPAC meeting made similar remarks about the limitations of using mild infection as the primary endpoint. Noting that there could be “limited and, in some instances, no information about some of the secondary endpoints” (such as more severe illness), one panelist stated that “This would be particularly true in the instance of an early EUA” (p. 100). Another attendee pointed out that a vaccine could be “effective in avoiding mild cases but actually [do] very little to address what we really care about, which is serious disease and deaths” (p. 308). A third participant made the critical point that “many of the groups at risk for severe disease don’t respond well to vaccines in the first place” (pp. 346-347).
Messenger RNA technology has previously faced significant safety hurdles; what evidence can the FDA share with the public supporting the short-term and long-term safety of mRNA vaccines?
Until very recently, concerns about mRNA instability bedeviled efforts to develop mRNA vaccines. The apparent technological solutions for overcoming these challenges—including nanoparticle carrier systems and, in the case of the Pfizer vaccine, extreme freezing—remain unproven. To our knowledge, Pfizer has not provided detailed information about the reasons for its mRNA vaccine’s unprecedented minus-94-degree freezing requirements, which specify that the cool boxes may only be opened briefly twice a day, must have their dry ice replenished every five days, and that the vaccine can only be stored at refrigerator temperatures for 24 hours. Why are the Pfizer vaccine’s storage conditions so different from those of the Moderna mRNA vaccine, which apparently can be refrigerated for 30 days? Many members of the public and scientific community would like to know more about the two vaccines’ real-world stability and safety.
Discussing Pfizer’s vaccine, Professor Allan Cheng, acting chief health officer in the Australian state of Victoria, describes safety as a “key unknown,” characterizing mRNA vaccines as “pretty reactogenic” and prone to “lots of side effects.” During the Phase II/III trials, 50% of Pfizer participants aged 18-55 experienced systemic adverse events within a month of their second dose of vaccine, as did 100% of those injected with two doses of Moderna’s vaccine.
Because mRNA vaccines rely on synthetic RNA, they represent a significant departure from other biologically based vaccine technologies. Virologist, Dr. Luc Montagnier (who won the 2008 Nobel Prize for his discovery of HIV) and other scientists even dispute the label of “vaccine,” arguing that these products represent a new form of gene therapy. It is debatable whether a fast-tracked approval schedule is appropriate for an entirely new vaccine technology that, essentially, is intended to turn the body’s cells into viral-protein-making factories. Professor Montagnier, who opposes the use of mRNA vaccines in humans, stated in an interview with Children’s Health Defense, “The human genome contains 7% to 9% of endogenous retrovirus sequences. Some of these sequences code for reverse transcription of RNA into DNA. Therefore, it is possible that the spike protein mRNA of the vaccine could be absorbed by human cells, reverse transcribed, and integrated as a human gene in these cells. This could be a beneficial event protecting the human host from further infection by coronavirus or it could induce a long-term deleterious effect such as cancer. Even if animal testing showed protection, nobody could predict long-term pathologic effects in a human population and the precautionary principle should apply.”
Messenger RNA vaccines will not work without an in-built delivery mechanism that enables the mRNA to make its way into a cell’s cytoplasm. Moderna’s and Pfizer’s chosen solution is to use lipid nanoparticle (LNP) carrier systems. The two mRNA vaccine manufacturers are using LNPs to “encapsulate the mRNA constructs to protect them from degradation and promote cellular uptake,” in addition to taking advantage of what vaccine scientists describe as LNPs’ “inherent adjuvant properties.” However, the LNP formulations in both COVID-19 vaccines are PEGylated, meaning that the vaccine nanoparticles are coated with the synthetic, nondegradable and controversial polyethylene glycol (PEG) polymer. PEG is a potential allergen as well as a suspected carcinogen. Moderna’s 2018 corporate prospectus acknowledges that “there can be no assurance that our LNPs will not have undesired effects,” including reactions that “could lead to significant adverse events.”
How will the FDA evaluate possible risks of pathogenic priming and antibody-dependent enhancement?
Although Pfizer and Moderna have conducted some experimental animal trials alongside their clinical trials in humans, neither company has released any data addressing the possibility of pathogenic priming. In individuals vaccinated against the SARS-CoV-2 virus, pathogenic priming could potentially trigger autoimmunity against critical human immune system proteins as a result of molecular similarities between SARS-CoV-2 protein components and human protein components (epitopes). A 2020 paper on pathogenic priming discusses these risks, pointing out that “All SARS-CoV-2 immunogenic epitopes have similarity to human proteins except one.” The paper’s author cautions, “These epitopes should be excluded from vaccines under development to minimize autoimmunity due to risk of pathogenic priming.”
Another issue, as yet undiscussed by Pfizer and Moderna, concerns the potential for antibody-dependent enhancement (ADE), a phenomenon documented in humans, non-human primates, and ferrets in connection with the coronaviruses linked to SARS and MERS. In ADE, vaccines can cause idiopathic antibodies to act like a Trojan horse for wild viruses. In the case of individuals receiving COVID-19 vaccines, ADE could not only end up enhancing disease severity but could also lead to organ damage. Of concern, COVID-19 vaccine trials are not designed to detect ADE. It is not known what proportion of the U.S. population might suffer pathogenic priming or ADE after receiving a COVID-19 vaccine, but the estimated 15 to 24 million Americans who already have an autoimmune disease could be particularly susceptible. The CDC has indicated that individuals with high-risk medical conditions—individuals excluded from the Phase I trials—are one of the proposed groups for early vaccination.
What are the FDA’s plans for ensuring transparency of data describing rates and types of adverse events, including information about susceptible subgroups? And how does the FDA plan to monitor adverse events and long-term health outcomes once the clinical trials are unblinded and vaccines are offered to those in the placebo arm?
The National Vaccine Injury Compensation Program has awarded over $4.4 billion for vaccine injuries and deaths since 1990. These awards, along with the scientific literature, the Vaccine Adverse Event Reporting System (VAERS), and the data compiled in vaccine package inserts, all illustrate that vaccines cause a multitude of serious injuries, many of which have long diagnostic horizons. Unfortunately, conditions such as allergies, autoimmune diseases, neurodevelopmental problems, and cancers are unlikely to be detectable within the short clinical trial follow-up windows. The appallingly low rate of reporting of vaccine injuries (an estimated 1%, according to Harvard researchers) also suggests that, without fully transparent access to data and information, few vaccine recipients or health care providers are likely to connect the dots between vaccination and subsequent adverse events.
The unpredictable outcomes that may arise from population-wide coronavirus vaccination are a disturbing unknown. Although FDA often requires medicines to continue active monitoring of injuries for up to five years, Pfizer’s approved Phase 3 protocol calls for the company to “actively” collect information about adverse events and serious adverse events only through the second month—the point at which the FDA could decide to award EUA. Although the protocol states that researchers will also collect serious adverse event data “approximately 6 months after the last dose of study intervention,” it implies that it will rely on voluntary rather than “active” reporting of these injuries and illnesses. Moreover, from 24 months on (after the last follow-up visit), Pfizer’s investigators will no longer be “obligated” to pay attention to adverse events.
Following the close of their studies—or even sooner—both Pfizer and Moderna have indicated that they plan to offer their vaccine to every member of the placebo group. This scheme will have the obvious effect of erasing opportunities for long-term comparisons and making future vaccine injuries invisible and deniable. Industry and health officials argue that they will take this action “for ethical reasons,” stating that it would be unethical to deny placebo group members the advantage of an approved vaccine. It would, however, also be highly unethical to give millions of Americans a vaccine with potential long-term adverse effects that have not been properly researched, characterized, and documented.
How will the FDA assess vaccine safety in different age groups, including the elderly and children?
In a recent press release, Pfizer stated that 45% of the participants in the U.S. portion of its vaccine clinical trials were between the ages of 56 and 85. This lumping together of working-age adults and seniors will make it difficult to evaluate subsequent claims about COVID-19 vaccine safety and efficacy specifically in the elderly. This is concerning, given that older adults in assisted living and nursing home populations are one of the proposed groups for early phase vaccination. The elderly and the general public have a right to full transparency concerning the number of seniors, broken down by smaller age ranges and underlying health conditions, who participated in the clinical trials and the rates of infection and adverse events experienced by those trial participants. The published data to date in the Phase I and II trials of both vaccines (Pfizer and Moderna) included only 22 healthy, community-living white seniors (the oldest was 74); none of them were representative of the frail elderly populations in long-term care facilities. Almost two out of five nursing home residents are over age 85 (39%), and Pfizer’s Phase III trial excluded people who were over 85. Many comorbidities found in frail seniors would also have excluded them from both of the Phase III trials. The well-known phenomenon of immunosenescence—the “age-related dysregulation and decline of the immune system”—is linked to poor vaccine responses in older adults. No one, and especially not seniors, will be able to make informed risk-benefit decisions without access to full information and clinical trial data.
At the October 22 expert meeting convened by VRBPAC, participants expressed caution about giving COVID-19 vaccines to children, arguing that the risks could well outweigh the benefits. Leading NIH researcher Dr. Luigi Notarangelo went further, frankly stating that coronavirus vaccines “should not be considered for use” in children “at this point” and adding that the evidence presented at the meeting had been insufficient to answer pressing questions about safety in children (p. 337). Although FDA requires institutions that test drugs and biologics in children to have a pediatric plan in place, in early November, the principal investigator leading Pfizer’s vaccine trials in 12-17-year-olds made the scarcely comforting disclosure to TIME magazine that “The plan can be simply ‘We don’t have a plan,’” stating that the rule “is lenient to the point of being no rule at all.” Bafflingly, these remarks—which one hopes are a mischaracterization of the FDA’s willingness to exercise pediatric oversight—appear to have been intended to reassure parents pondering whether to sign up their children for the trials.
How will the FDA earn the public’s trust?
While all vaccines require due deliberation about safety and efficacy, the candidate vaccines’ accelerated development and the experimental nature of the never-before-approved mRNA technologies upon which they rely clearly raise even more questions than usual. The fact that racial/ethnic minorities are disproportionately represented among the groups targeted for early phase vaccination (including essential health care workers and individuals with high-risk medical conditions) has also prompted concerns. Focus groups indicate that communities of color do not want to be “first in line,” are reluctant to be “guinea pigs,” and “want to see some data”; vaccine experts concede that ethnic minority groups’ extremely low levels of trust in the vaccines’ safety are “quite rooted in historical reality.”
There are significant differences between the FDA’s standard drug and biologic approval process and the expedited EUA process; as those familiar with drug development procedures acknowledge, an EUA “is not an accepted endpoint for product development.” We urge you, therefore, to take all the time required to carefully assess the full range of unknowns pertaining to the Pfizer and Moderna vaccines. The FDA’s eventual decisions about these vaccines will have major implications not just for 328 million Americans, but potentially for billions worldwide.
Sincerely,
Robert Kennedy, Jr., Chairman, Children’s Health Defense