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Wednesday, 31 May 2023
Taliban deploys heavy reinforcements to Iran border
Videos circulating social media on 31 May show Taliban forces heavily reinforcing the Afghan border with Iran on 31 May, after significant escalation regarding a water dispute between the two countries, which resulted in heavy border clashes between the two sides over the weekend.
The clashes broke out on 27 May between Taliban troops and Iranian border guards, resulting in the death of two Iranian border guards and a Taliban militant, despite unconfirmed reports of further Taliban casualties.
The outbreak of fighting came a week after Iranian President Ebrahim Raisi warned the Taliban to respect Iran’s rights to water from the Helmand River shared between the two countries, under the 1973 Afghan-Iranian Helmand River Treaty. Iran has long accused Afghanistan of restricting the flow of its water to Iran and causing droughts or dry spells.
Each side claimed that the other had initiated the clashes. On 29 May, Iran’s Interior Minister Ahmad Vahidi said that calm had prevailed on the border but that Tehran would respond with force if the Taliban resumed provocation.
The Taliban defense minister said on the day that the fighting broke out that the Afghan government views dialogue and negotiation as the best way to resolve issues. Other Afghan officials echoed the defense minister’s words and called for the prevention of escalation.
Other officials and Afghan figures were seen in videos on social media making inflammatory statements.
The most notable of these figures is Taliban leader Abdul Hamid Khorosani, who was seen in a video on Twitter on 28 May threateningthat “if the [religious authorities] allow us, we will seize Tehran.”
“Do not test our strength. You are behind the scenes with the Westerners,” Khorosani added, addressing the Islamic Republic. Reports suggest that Khorosani had been dismissed earlier this month over differences with Taliban leadership.
The Iranian Interior Ministry claimed on 31 May, following the release of the footage on the Afghan-Iranian border, that those who made statements against Iran were “low-ranking” members of the Taliban who have since been “dismissed” by the organization.
Iranian media outlets have also claimed that border-crossings between the two countries are now open, despite having been closed following the outbreak of clashes.
“Clashes happened based on a mistake made by the Afghan border guards. We have had several incidents like this so far. We advise Afghan authorities to justify the actions of their border guards,” the Iranian Interior Ministry added.
Despite videos showing reinforcements on the border, Iranian media reports suggested that some “elements are trying to provoke the parties involved with rumors and fake news.”
One Iranian report said that there is complete calm on the border.
However, conflicting reports continue to emerge, with some suggesting that the reinforcements are ongoing.
In December 2021, brief clashes broke out on the Afghan-Iranian border between Iran’s border guards and Taliban fighters. In June of the following year, an Iranian border guard was killed by the Taliban.
Iran urged the Afghan government at the time to “punish the perpetrators” and take action to prevent a repeat of such occurrences.
Following Washington’s chaotic withdrawal from Afghanistan in 2021, the US army left behind $7.12 billion in military equipment in the country, which immediately fell into the hands of the Taliban.
Taliban mengerahkan bala bantuan berat ke perbatasan Iran
Video yang beredar di media sosial pada 31 Mei menunjukkan pasukan Taliban sangat memperkuat perbatasan Afghanistan dengan Iran pada 31 Mei, setelah eskalasi signifikan mengenai sengketa air antara kedua negara, yang mengakibatkan bentrokan perbatasan berat antara kedua belah pihak selama akhir pekan.
Bentrokan pecah pada 27 Mei antara pasukan Taliban dan penjaga perbatasan Iran, mengakibatkan kematian dua penjaga perbatasan Iran dan seorang militan Taliban, meskipun laporan yang belum dikonfirmasi tentang korban Taliban lebih lanjut.
Wabah pertempuran terjadi seminggu setelah Presiden Iran Ebrahim Raisi memperingatkan Taliban untuk menghormati hak Iran atas air dari Sungai Helmand yang dibagi antara kedua negara, di bawah Perjanjian Sungai Helmand Afghanistan-Iran 1973. Iran telah lama menuduh Afghanistan membatasi aliran airnya ke Iran dan menyebabkan kekeringan atau musim kemarau.
Masing-masing pihak mengklaim bahwa yang lain telah memulai bentrokan. Pada 29 Mei, Menteri Dalam Negeri Iran Ahmad Vahidi mengatakan bahwa ketenangan telah berlaku di perbatasan tetapi Teheran akan merespons dengan paksa jika Taliban melanjutkan provokasi.
Menteri pertahanan Taliban mengatakan pada hari ketika pertempuran pecah bahwa pemerintah Afghanistan memandang dialog dan negosiasi sebagai cara terbaik untuk menyelesaikan masalah. Pejabat Afghanistan lainnya menggemakan kata-kata menteri pertahanan dan menyerukan pencegahan eskalasi.
Pejabat lain dan tokoh Afghanistan terlihat dalam video di media sosial yang membuat pernyataan yang menghasut.
Yang paling menonjol dari tokoh-tokoh ini adalah pemimpin Taliban Abdul Hamid Khorosani, yang terlihat dalam sebuah video di Twitter pada 28 Mei mengancam bahwa "jika [otoritas agama] mengizinkan kami, kami akan merebut Teheran."
"Jangan uji kekuatan kami. Anda berada di belakang layar dengan orang Barat,” tambah Khorosani, berbicara kepada Republik Islam. Laporan menunjukkan bahwa Khorosani telah diberhentikan awal bulan ini karena perbedaan dengan kepemimpinan Taliban.
Kementerian Dalam Negeri Iran mengklaim pada 31 Mei, setelah rilis rekaman di perbatasan Afghanistan-Iran, bahwa mereka yang membuat pernyataan terhadap Iran adalah anggota Taliban yang "berpangkat rendah" yang sejak itu telah "diberhentikan" oleh organisasi tersebut.
Outlet media Iran juga mengklaim bahwa penyeberangan perbatasan antara kedua negara sekarang terbuka, meskipun telah ditutup setelah pecahnya bentrokan.
“Kesalahan terjadi berdasarkan kesalahan yang dibuat oleh penjaga perbatasan Afghanistan. Kami telah mengalami beberapa insiden seperti ini sejauh ini. Kami menyarankan pihak berwenang Afghanistan untuk membenarkan tindakan penjaga perbatasan mereka,” tambah Kementerian Dalam Negeri Iran.
Meskipun video menunjukkan bala bantuan di perbatasan, laporan media Iran menyarankan bahwa beberapa "elemen mencoba memprovokasi pihak-pihak yang terlibat dengan rumor dan berita palsu."
Satu laporan Iran mengatakan bahwa ada ketenangan total di perbatasan.
Namun, laporan yang saling bertentangan terus muncul, dengan beberapa menyarankan bahwa bala bantuan sedang berlangsung.
Pada Desember 2021, bentrokan singkat pecah di perbatasan Afghanistan-Iran antara penjaga perbatasan Iran dan pejuang Taliban. Pada bulan Juni tahun berikutnya, seorang penjaga perbatasan Iran dibunuh oleh Taliban.
Iran mendesak pemerintah Afghanistan pada saat itu untuk "menghukum para pelaku" dan mengambil tindakan untuk mencegah terulangnya kejadian seperti itu.
Setelah penarikan kacau Washington dari Afghanistan pada tahun 2021, tentara AS meninggalkan $7.12 miliar peralatan militer di negara itu, yang segera jatuh ke tangan Taliban.
The Sultan 2.0 will heavily tilt east
The collective west was dying to bury him – yet another strategic mistake that did not take into account the mood of Turkish voters in deep Anatolia.
In the end, Recep Tayyip Erdogan did it – again. Against all his shortcomings, like an aging neo-Ottoman Sinatra, he did it “my way,” comfortably retaining Turkiye’s presidency after naysayers had all but buried him.
The first order of geopolitical priority is who will be named Minister of Foreign Affairs. The prime candidate is Ibrahim Kalin – the current all-powerful Erdogan press secretary cum top adviser.
Compared to incumbent Cavusoglu, Kalin, in theory, may be qualified as more pro-west. Yet it’s the Sultan who calls the shots. It will be fascinating to watch how Turkiye under Erdogan 2.0 will navigate the strengthening of ties with West Asia and the accelerating process of Eurasia integration.
The first immediate priority, from Erdogan’s point of view, is to get rid of the “terrorist corridor” in Syria. This means, in practice, reigning in the US-backed Kurdish YPG/PYD, who are effectively Syrian affiliates of the Kurdistan Workers’ Party (PKK) – which is also the issue at the heart of a possible normalization of relations with Damascus.
Now that Syria has been enthusiastically welcomed back to the Arab League after a 12-year freeze, a Moscow-brokered entente between the Turkish and Syrian presidents, already in progress, may represent the ultimate win-win for Erdogan: allowing control of Kurds in north Syria while facilitating the repatriation of roughly 4 million refugees (tens of thousands will stay, as a source of cheap labor).
The Sultan is at his prime when it comes to hedging his bets between east and west. He knows well how to profit from Turkiye’s status as a key NATO member – complete with one of its largest armies, veto power, and control of the entry to the uber-strategic Black Sea.
And all that while exercising real foreign policy independence, from West Asia to the Eastern Mediterranean.
So expect Erdogan 2.0 to remain an inextinguishable source of irritation for the neocons and neoliberals in charge of US foreign policy, along with their EU vassals, who will never refrain from trying to subdue Ankara to fight the Russia-China-Iran Eurasia integration entente. The Sultan, though, knows how to play this game beautifully.
How to manage Russia and China
Whatever happens next, Erdogan will not hop on board the sanctions-against-Russia sinking ship. The Kremlin bought Turkish bonds tied to the development of the Russian-built Akkuyu nuclear power plant, Turkiye’s first nuclear reactor. Moscow allowed Ankara to postpone nearly $4 billion in energy payments until 2024. Best of all, Ankara pays for Russian gas in rubles.
So an array of deals related to the supply of Russian energy trump possible secondary sanctions that might target the steady rise in Turkiye’s exports. Still, it’s a given the US will revert to its one and only “diplomatic” policy – sanctions. The 2018 sanctions did push Turkiye into recession after all.
But Erdogan can easily count on popular support across the Turkish realm. Early this year, a Gezici poll revealed that 72.8 percent of Turkish citizens privilege good relations with Russia while nearly 90 percent rate the US as a “hostile” nation. That’s what allows Interior Minister Soylu to remark, bluntly, “we will wipe out whoever is causing trouble, including American troops.”
China-Turkiye strategic cooperation falls under what Erdogan defines as “turning to the East” – and is mostly about China’s multi-continent infrastructure behemoth, the Belt and Road Initiative (BRI). The Turk Silk Road branch of the BRI focuses on what Beijing defines as the “Middle Corridor,” a prime cost-effective/secure trade route that connects Asia to Europe.
The driver is the China Railway Express, which turned the Middle Corridor arguably into BRI’s backbone. For instance, electronics parts and an array of household items routinely arriving via cargo planes from Osaka, Japan are loaded onto freight trains going to Duisburg and Hamburg in Germany, via the China Railway Express departing from Shenzhen, Wuhan, and Changsha – and crossing from Xinjiang to Kazakhstan and beyond via the Alataw Pass. Shipments from Chongqing to Germany take a maximum of 13 days.
It’s no wonder that nearly 10 years ago, when he first unveiled his ambitious, multi-trillion dollar BRI in Astana, Kazakhstan, Chinese President Xi Jinping placed the China Railway Express as a core BRI component.
Direct freight trains from Xian to Istanbul are plying the route since December 2020, using the Baku-Tblisi-Kars (BTK) railway with less than two weeks travel time – and plans afoot to increase their frequency. Beijing is well aware of Turkiye’s asset as a transportation hub and crossroads for markets in the Balkans, the Caucasus, Central Asia, West Asia, and North Africa, not to mention a customs union with the EU that allows direct access to European markets.
Moreover, Baku’s victory in the 2020 Nagorno-Karabakh war came with a ceasefire deal bonus: the Zangezur corridor, which will eventually facilitate Turkiye’s direct access to neighbors from the Caucasus to Central Asia.
A pan-Turkic offensive?
And here we enter a fascinating territory: the possible incoming interpolations between the Organization of Turkic States (OTS), the Shanghai Cooperation Organization (SCO), the BRICS+ – and all that also linked to a boost in Saudi and Emirati investments in the Turkish economy.
Sultan 2.0 wants to become a full member of both the Chinese-led SCO and multipolar BRICS+. This means a much closer entente with the Russia-China strategic partnership as well as with the Arab powerhouses, which are also hopping on the BRICS+ high-speed train.
Erdogan 2.0 is already focusing on two key players in Central Asia and South Asia: Uzbekistan and Pakistan. Both happen to be SCO members.
Ankara and Islamabad are very much in sync. They express the same judgment on the extremely delicate Kashmir question, and both backed Azerbaijan against Armenia.
But the key developments may lie in Central Asia. Ankara and Tashkent have a strategic defense agreement – including intel sharing and logistics cooperation.
The Organization of Turkic States (OTS), with a HQ in Istanbul, is the prime energizer of pan-Turkism or pan-Turanism. Turkiye, Azerbaijan, Kazakhstan, Uzbekistan, and Kyrgyzstan are full members, with Afghanistan, Turkmenistan, Hungary, and Ukraine cultivated as observers. The Turk-Azeri relationship is billed as “one nation, two states” in pan-Turkic terms.
The basic idea is a still hazy “cooperation platform” between Central Asia and the Southern Caucasus. Yet some serious proposals have already been floated. The OTS summit in Samarkand late last year advanced the idea of a TURANCEZ free trade bloc, comprising Turkiye, Kazakhstan, Kyrgyzstan, Uzbekistan, Turkmenistan, Azerbaijan, and as observers, Hungary (representing the EU) and Northern Cyprus.
Meanwhile, hard business prevails. To fully profit from the status of the energy transit hub, Turkiye needs not only Russian gas but also gas from Turkmenistan feeding the Trans-Anatolian Natural Gas Pipeline (TANAP) as well as Kazakh oil coming via the Baku-Tblisi-Ceyhan (BTC) pipeline.
The Turkish Cooperation and Coordination Agency (TIKA) is heavy on economic cooperation, active in a series of projects in transportation, construction, mining, and oil and gas. Ankara has already invested a whopping $85 billion across Central Asia, with nearly 4,000 companies scattered across all the “stans.”
Of course, when compared to Russia and China, Turkiye is not a major player in Central Asia. Moreover, the bridge to Central Asia goes via Iran. So far, rivalry between Ankara and Tehran seems to be the norm, but everything may change, lightning fast, with the simultaneous development of the Russia-Iran-India-led International North South Transportation Corridor (INSTC), which will profit both – and the fact that the Iranians and Turks may soon become full BRICS+ members.
Sultan 2.0 is bound to boost investment in Central Asia as a new geoeconomic frontier. That in itself encapsulates the possibility of Turkiye soon joining the SCO.
We will then have a “turning to the East” in full effect, in parallel to closer ties with the Russia-China strategic partnership. Take note that Turkiye’s ties with Kazakhstan, Uzbekistan, and Kyrgyzstan are also strategic partnerships.
Not bad for a neo-Ottoman who, until a few days ago, was dismissed as a has-been.
The views expressed in this article do not necessarily reflect those of The Cradle.
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"Wahai Tuhan kami! Dan masukkanlah mereka ke dalam Syurga "Adn" yang Engkau telah janjikan kepada mereka; dan (masukkanlah bersama-sama mereka): orang-orang yang layak di antara ibu bapa mereka, dan isteri-isteri mereka, serta keturunan mereka. Sesungguhnya Engkaulah jua Yang Maha Kuasa, lagi Maha Bijaksana"
"Dan peliharalah mereka dari (balasan) kejahatan-kejahatan (yang dilakukannya); dan (sebenarnya) sesiapa yang Engkau pelihara pada hari itu dari terkena (balasan) kejahatan-kejahatan (yang dilakukannya) maka sesungguhnya Engkau telah mengurniakan rahmat kepadanya; dan yang demikian itulah kemenangan yang besar (nilainya)" [Surah Ghafir 7-9]
#Inilah di antara ayat-ayat yang paling mendamaikan hati yang sedih dan berdukacita. Ayat yang menggambarkan keindahan dan keluasan Islam.
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#Makhluk-makhluk Allah di luar sana tidak terhitung banyaknya. Walaupun mereka tidak dilihat berada di sekeliling kita, bersama dengan kita, namun mereka sentiasa menyaksi dan mengambil peduli. Mereka sayang kepada kita. Mereka berdoa untuk kebaikan kita.
#Mereka tahu betapa peritnya azab neraka, lalu mereka memohon agar kita dijauhkan darinya. Mereka tahu indahnya syurga, lalu mereka berdoa agar kita dimasukkan ke dalamnya.
#Mereka tahu betapa eratnya hubungan serta kasih sayang kita terhadap ibu bapa, pasangan dan zuriat keturunan kita, lalu mereka berdoa agar kita dihimpunkan bersama-sama di dalam syurga sebagaimana kita telah dihimpunkan di dunia sementara.
#Jazakumullahu khairan kathira wahai para malaikat yang suci yang sentiasa mendoakan kami. Itulah yang Allah rakamkan dalam ayatNya diatas.
♡Ya Allah, jadikanlah kami di antara mereka yang termasuk di dalam senarai orang yang didoakan oleh makhlukMu yang suci itu. Aamiiin♡
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Health Implications of Poor COVID-19 mRNA Testing: Miscarriage, Vision Loss, Immunotoxicity
In this series, “Promise or Peril: Alarming COVID-19 mRNA Vaccine Issues,” we explore how the introduction of mRNA technology lacked an adequate regulatory framework, setting the stage for serious adverse events and other concerns related to inadequate safety testing of lipid nanoparticles, spike protein, and residual DNA and lipid-related impurities as well as truncated/modified mRNA species.
Previously: In Part 1 of this series, FDA Overhaul Needed for New Vaccines and mRNA Therapies, we introduced how the FDA relaxed the rules for mRNA vaccines compared to mRNA therapies. We also discussed the available data regarding lipid nanoparticle (LNP) distribution throughout the body based on animal testing, the fact that human testing was not done, and the lack of mRNA or spike protein biodistribution data for the COVID-19 mRNA vaccine. We now turn to the health implications of these compounds in the body.
Summary of Key Facts:
The COVID-19 mRNA vaccines were authorized for human use without going through complete animal testing on the active ingredients.
The animal testing data, which we review in detail, shows that the mRNA and LNP shell are present in tissues at high concentrations for about 72 hours, consistent with the timing of systemic reactions to vaccination within the first two to three days.
The lipids used to create the LNP shell likely stay in the body for four to five months due to their long half-life. (pdf)
Details on animal testing also show elevated adverse event rates, including joint inflammation and early pregnancy loss.
The regulatory authorities knew about these adverse events found in animals by January 2021. Nevertheless, the products were permitted to go forward in humans, assuming the benefits would outweigh the risks.
As discussed in Part 1, the U.S. Food and Drug Administration (FDA) did not require Pfizer and Moderna to do biodistribution testing on the active mRNA encoding spike protein used in the vaccines. The FDA’s relaxed biodistribution and pharmacokinetic testing essentially approved a “bioengineered egg” based on an examination of the shell only; in other words, the contents were not tested.
Reports provided by Pfizer to the FDA (pdf), Australian, and Japanese (pdf) health authorities, as well as the European Medicines Agency (EMA) (pdf) in January 2021 include identical animal data showing how the new LNP shell travels throughout the body. The reports also show how a substitute (“fake”) mRNA (encoding for luciferase) was used to visualize where the mRNA travels.
Although the compound luciferase has a sinister name, it is a harmless enzyme found in fireflies and elsewhere in nature, and it is bioluminescent—meaning, it glows in the dark. Thus, luciferase is useful for visualizing biological compounds in animal tissues.
These reports show widespread dispersal of the LNP shell. The CDC gave false reassurances about the duration of biological activity and distribution based on scant data on animals and no human data on biodistribution. People relied on these statements as truth. Thus the agency disseminated vague and misleading reassurances when data was available at the time, which contradicted these claims.
Although the CDC’s original webpage, now only available through web archives, contained a message stating that mRNA is broken down within days and that the spike protein does not persist in the body beyond a few weeks—we simply did not have this data, presumably leading them to remove the highlighted duration reference.
To understand the health implications of the new mRNA vaccine technology, we must first examine where luciferase, the spike protein, and the LNPs travel in the body and how long they persist.
What Happens to the ‘Glow-in-the-Dark’ Luciferase?
The European Medicines Agency (EMA) is the European Union’s FDA equivalent. The EMA report (pdf) gives us more detail about animal studies showing where the luciferase and LNP shell travel, as well as the concentrations of these compounds in tissues immediately after vaccination.
Pfizer conducted a study using two approaches—bioluminescence and radioactivity–to tag the mRNA for luciferase and the LNP shell for radioactivity.
The luciferase mRNA signals peaked at the injection site within six hours, at 10,000 times that of the control animals. Luciferase activity was also found in lymph nodes and the liver. The signal then decreased slowly over 72 hours. (page 46) Levels continued to decline and by day nine, the luciferase level in the experimental animals was seven times the level found in the control animals. No additional measures were taken after day nine. This elevated luciferase activity in the first 72 hours correlates with adverse symptoms people may experience after vaccination.
The radioactivity study on the LNP shell found the highest levels in most tissues within eight to 48 hours after injection. Most of the LNP was concentrated in the liver. The report goes on to describe how long the lipids stay in the liver. One of the lipids (ALC-0315) may remain in the liver for four to five months when the data is extrapolated to humans. (pages 53-54)
Together, these two animal studies show that mRNA and the LNP shell can be found in tissues at peak concentrations within 72 hours.
Figure 1. Vaccination Adverse Reactions by Days Since Last Dose
(The Lancet Infectious Diseases 2022 22802-812DOI: 10.1016/S1473-3099(22)00054-8)
What Happens to the Spike Protein?
Once the vaccine LNP enters our cells and releases the mRNA, spike protein is produced and displayed on the surface of our cells. The mRNA code contains instructions to make the full-length spike protein, containing two subunits (S1 and S2). The immune system sees these cells displaying the spike protein and responds as if the virus had infected the cell.
When these cells are destroyed by the immune system, antibodies are made that bind to the spike protein. However, the spike protein, including its S1 subunit, can be released into the blood during this messy process of cell digestion by the immune system.
For example, a study published in Circulationpoints out that “markedly elevated levels of full-length spike protein (33.9±22.4 pg/mL), unbound by antibodies, were detected in the plasma of individuals with post-vaccine myocarditis, whereas no free spike was detected in asymptomatic vaccinated control subjects (unpaired t-test; P<0.0001).” In other words, free spike protein may provide a clue about why some young people develop myocarditis following vaccination.
This study suggested that the difference was not caused by neutralizing antibodies in the myocarditis group, but was likely due to overactive innate immunity. In other words, having too many antibodies was not the cause of myocarditis. The authors suspect that another component of the immune system—innate immunity—might be involved.
Innate immunity is what helps the body fight off infection, even the first time it sees a new virus or bacteria. These innate “first responders” (inflammatory cytokines) need no training to identify foreign invaders. An overactive innate response is associated with allergies and may also be what triggers myocarditis.
Because the active mRNA and the spike protein it encodes were never tested in animals or live tissue culture, there was no way to predict these issues. The FDA essentially allowed a product to be licensed without sufficient preclinical toxicity testing.
How Toxic Is the Lipid Nanoparticle Shell?
As the EMA reiterates, “No traditional pharmacokinetic or biodistribution studies have been performed with the vaccine candidate BNT162b2.” (page 45) The biodistribution studies are important because, as the EMA continues, “ALC-0315 and ALC-0159 are novel excipients, not previously used in an approved finished product within the EU.” These two novel “excipients” (ALC-0315 and ALC-0159) are the lipid nanoparticles used to create the LNP shell. They are new compounds, different from existing data onPEGylated compounds used in a wide variety of injected medications.
The EMA report further states that the half-life of the lipid ALC-0315 is quite long. (page 46) The term half-life means the amount of time it takes for half of the compound to be removed. On page 54, the EMA report clarifies that we might expect half of the ALC-0315 to be removed from the human body in about 20 to 30 days, and 95 percent to be removed in four to five months.
A separate deliberation summary (pdf) from the Japanese government’s Pharmaceutical Safety and Environmental Health Bureau (February 2021) reviewed all of the data prior to making a determination regarding authorization. The report showed effects on the liver which were “considered to be of little toxicological significance.” (page 20) However, the report also notes that “long-term repeated-dose toxicity of Comirnaty has not been evaluated” and therefore, the dosing regimen should be limited, and the use of lipids in the vaccine should not be considered a precedent. In other words, although PEGylated compounds have been used in medicine for years, there is limited information on their use as part of an LNP carrying a vaccine, thus no existing data to support repeated doses, such as boosters, beyond the original primary series.
The EMA concurred: “This [BNT162b2] vaccine contains two new components (cationic lipid ALC-0315 and PEGylated liquid ALC-0159) in the LNP, for which there is limited experience.” Given the long half-life of the ALC-0315 lipid and the toxicity of the PEG-lipid ALC-0159, the EMA acknowledged that while there are no immediate and obvious concerns for human use, there is also very limited data and the “current evidence is not definitive.”
“Regarding PEG-related toxicity which is known to depend on the dose, dose frequency, duration of treatment, and molecular weight of the PEG protein, immunogenicity is not expected to be an issue due to the low molecular weight of this PEG (<2KDa). The scientific data available at this stage do not raise noticeable concerns regarding immunogenicity or immunotoxicity of the PEG, but current evidence is not definitive.” (page 134)
The EMA notes that serious adverse events were twice as common in the vaccine group (21 percent) as in the placebo group (13 percent). The frequency was low overall (<1 percent) but the following system/organ/class adverse events were the most frequently reported: “General disorders and administration site conditions” (11.9 percent versus 2.9 percent), “musculoskeletal reactions” (5.5 percent versus 2.1 percent), and “nervous system disorders” (4.2 percent versus 2.1 percent).
Because the active ingredient (mRNA encoding spike protein) was not tested in these animal studies, these findings likely speak to the immunotoxicity of the LNP shell itself. Nevertheless, the EMA concluded that the benefits overall were positive enough to go forward given the protection afforded to the elderly and those with comorbidities.
Inflammation and Miscarriage Rates Noted in EMA Report
In repeat dose toxicity studies among rats given one dose per week for three weeks, joint and lymph node inflammation as well as changes in the bone marrow were observed. (page 49)
In reproductive toxicity tests (page 50), the report states: “There was an increase (~2x) of pre-implantation loss (9.77%, compared to control 4.09%) although this was within historical control data range (5.1%-11.5%).” In other words, although the miscarriage rate was twice as high in the vaccinated than in control animals, the rate was within the expected range based on previous studies. The same data can be found on page 55 of the Australian report.
Interestingly, the BNT162b1 candidate—one of Pfizer’s two vaccine candidates which coded for the receptor binding domain only, not the full-length spike—had a much lower pre-implantation loss rate (4.8 percent) than the vaccine eventually brought to market. The second model (BNT162b2) was chosen for global use because it had fewer side effects.
Some Types of Vision Loss Correlate with Vaccination
A new study in Nature confirms a “strong correlation between vaccination with an mRNA vaccine and retinal vascular occlusion.” The retina is part of the eye that receives light and converts it into nerve signals which are translated into vision in the brain. The retina is covered with tiny blood vessels, and when these become occluded (blocked) due to poor cardiovascular health or diabetes, vision is lost. The blockage in the vessels can be caused by swelling, spasms, poor blood flow into the vessels, and thromboembolism (clotting). Infection with SARS-CoV-2 is also linked to retinal occlusion.
Given the mounting evidence of vaccination causing occlusion, this study used medical records for approximately 6 million people to explore the long-term association between vaccination and occlusion. The authors matched 745,041 vaccinated and 3,874,458 unvaccinated people, resulting in a final comparison group of more than 500,000 individuals in each group.
Researchers found 415 cases among vaccinated people 18 to 64 years of age and 1108 cases among the vaccinated age 65 years or older. This represented a greater than threefold higher risk of retinal occlusion following vaccination within 12 weeks and a greater than twofold risk up to two years later compared to the unvaccinated. There was no difference in risk between mRNA vaccine brands (Pfizer versus Moderna) and the risk was elevated after both doses one and two. The risk was highest for the first two weeks and persisted for 12 weeks. The risk was similarly elevated across males and females as well as across race/ethnicity.
The authors of the study surmise that the similarity between spike proteins and human proteins may cause the blockage.
To summarize, these reports raise many concerning issues which we address in this series.
The LNP capsule is dispersed throughout the body, mostly to the liver. Does it fall apart or stay in a capsule? How long does the LNP capsule persist in the body? Is the immune response to the LNP linked to post-vaccination blindness?
The lipid nanoparticle ALC-0315 has a long half-life (around six weeks in the liver). Does 95 percent of the lipid clear from the human body within four to five months as expected?
The EMA states there is known immunotoxicity associated with polyethylene glycol (PEG) (page 134). This is the first time that PEG-lipid ALC-0159 has been used as a vaccine component in humans. What immune response is provoked by the PEG-lipid ALC-0159?
How long does mRNA persist in the body? Does it stay in the capsule until it is released in cells? Does it fall out of the LNP capsule? What problems might mRNA cause if it circulates throughout the bloodstream? (Series Part 3)
Free spike was found in myocarditis patients, but not controls. How long does the spike protein stay in the body? Where does it travel? How might the spike protein or its S1 subunit cause myocarditis or other adverse events which may include neurologic issues? (Series Part 4)
What is causing effects on peripheral nerves such as Bell’s Palsy? What is the latest research describing neurologic, cardiac, autoimmune, and reproductive adverse events? Is there anything people can do to reduce the risk of a future adverse event?
The adverse events noted by the EMA in January 2021 suggest that more thorough animal testing and additional biodistribution and safety studies in humans should have been performed before licensing these products. In addition, the EMA report noted that differences in batches were found. Additional reports were requested from the manufacturer. Where is the public communication regarding updates on these issues? Why did the FDA not apply stricter mRNA “genetic therapy” standards to the regulation of mRNA vaccines? In other words, why were vaccines given a special pass when they were using the same technology platform?
Next: We look at the design of the LNPs in Part 3 and investigate how their design might predispose them to clustering or falling apart—both of which can lead to clotting.
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FDA-CBER-2021-5683-0013962 approved on: 09-Nov-2020. A Tissue Distribution Study of a [3H]-Labeled Lipid Nanoparticle-mRNA Formulation Containing ALC-0315 and ALC-0159 Following Intramuscular Administration in Wistar Han Rats. (pdf) FINAL REPORT Test Facility Study No. 185350 Sponsor Reference No. ALC-NC-0552.
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Rhea EM, Logsdon AF, Hansen KM, Williams LM, Reed MJ, Baumann KK, Holden SJ, Raber J, Banks WA, Erickson MA. The S1 protein of SARS-CoV-2 crosses the blood-brain barrier in mice. Nat Neurosci. 2021 Mar;24(3):368-378. doi: 10.1038/s41593-020-00771-8. Epub 2020 Dec 16. PMID: 33328624; PMCID: PMC8793077.
Schmeling, M, Manniche, V, Hansen, PR. Batch-dependent safety of the BNT162b2 mRNA COVID-19 vaccine. Eur J Clin Invest. 2023; 00:e13998. doi:10.1111/eci.13998
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