curious Posted September 25, 2021 Share Posted September 25, 2021 https://freewestmedia.com/2021/09/24/the-mysterious-ingredient-in-a-pfizer-vaccine-vial/ Quote Link to comment Share on other sites More sharing options...
aquaman Posted September 25, 2021 Share Posted September 25, 2021 My guess is Graphene Oxide. and yes you are right, a secret ingredient that is trade protected. 1 Quote Link to comment Share on other sites More sharing options...
Chief Stipe Posted September 25, 2021 Share Posted September 25, 2021 Quote Link to comment Share on other sites More sharing options...
Chief Stipe Posted September 25, 2021 Share Posted September 25, 2021 Interesting that it hasn't been censored by Twitter. Irrespective of informed consent how can a approval authority approve without knowing all the ingredients. It won't be graphene oxide as that isn't a patented chemical. I don't buy into the magnetic bullshit. There are enough concerns about the approval processes without going into fringe conspiracies. Quote Link to comment Share on other sites More sharing options...
Chief Stipe Posted September 25, 2021 Share Posted September 25, 2021 The Pzifer vaccine is basically mRNA encapsulated inside a lipid (fatty) nanoparticle. There is another company that produces these for Pzifer - Acuitas. It is conceivable that there is a patent pending for an ingredient. Pzifer haven't really developed the vaccine - BioNTech developed the mRNA and Acuitas the lipid nanoparticles. Pzifer is essentially just a manufacturer. The other ingredients you can buy down at the supermarket or the garden centre. Lipids – The following lipids are in the new COVID vaccine. Their main role is to protect the mRNA and provide somewhat of a “greasy” exterior that helps the mRNA slide inside the cells. ((4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis (2-hexyldecanoate), 2 [(polyethylene glycol)-2000]-N,N-ditetradecylacetamide 1,2-Distearoyl-snglycero-3- phosphocholine cholesterol Salts – The following salts are included in the Pfizer vaccine and help balance the acidity in your body. potassium chloride monobasic potassium phosphate sodium chloride dibasic sodium phosphate dihydrate Sugar – Basic table sugar, also known as sucrose, can also be found in the new COVID vaccine. This ingredient helps the molecules maintain their shape during freezing. Quote Link to comment Share on other sites More sharing options...
Chief Stipe Posted September 25, 2021 Share Posted September 25, 2021 NZ's Medsafe list of ingredients: Quote Link to comment Share on other sites More sharing options...
Chief Stipe Posted September 25, 2021 Share Posted September 25, 2021 (b) (4) seems to be a generic hiding of commercial information. Check out the full FDA document it is full of (b) (4)'s! August 23, 2021 Summary Basis for Regulatory Action - Comirnaty.pdf Quote Link to comment Share on other sites More sharing options...
Chief Stipe Posted September 26, 2021 Share Posted September 26, 2021 The two key nano-particle lipids haven't been fully tested ever. Certainly no published pharmcokinectic studies. ALC-3015 ((4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis ALC-0159 (2-hexyldecanoate), 2 [(polyethylene glycol)-2000]-N,N-ditetradecylacetamide -------------------------- https://www.bmj.com/content/372/bmj.n627/rr-1 Rapid Response: Re: The EMA covid-19 data leak, and what it tells us about mRNA instability Dear Editor Reading this important article has reminded me of a concern I had when reading what the MHRA's Public Assessment Report [1] on the Pfizer/BioNtech vaccine said about the lipid nanoparticles used as excipients - ALC-0315 and ALC-0159. They are novel excipients (at least in UK-authorised medicinal products) and the justification for not having conducted pharmacokinetic (PK) studies is that they “are generally not considered necessary to support the development and licensure of vaccine products for infectious diseases (WHO, 2005; WHO, 2014)”. But on reading WHO, 2005 - which is a reference to WHO Guidelines on nonclinical evaluation of vaccines [2]- I see that PK studies are not normally needed but should be considered on a case-by-case basis (para 4.2.6) ), and toxicity studies should be performed where new excipients (and preservatives) are used for which no toxicological data exist (para 5.2). I also note that the still extant EMA 2006 guidance [3] states “Pharmacokinetic studies are usually not required for vaccines. However, such studies might be applicable when new delivery systems are employed or when the vaccine contains novel adjuvants or excipients. The need for PK studies and their design should be considered on a case by case basis and it is recommended that applicants should obtain scientific advice from EU Competent Authorities” (para 4.1). The 2006 guidance is being revised, and this text is missing from the current draft revised version [3]. I would have expected therefore at least an explanation as to why PK studies were not considered necessary. I also see that the EMA's Public Assessment Report [4] states that in January 2021 (and April 2021) “additional information about the synthetic process and control strategy for” ALC-0315 and ALC-0159 “should” be provided by BioNTech, with final reports in July 2021, in order to “confirm the purity profile and ensure comprehensive quality control and batch-to-batch consistency throughout the lifecycle of the finished product”. I have no pharmacological expertise, but it seems to me that an explanation should be given as to why PK studies were not considered necessary, and the additional information that was due to be provided in January 2021 should be disclosed, along with the April and July updates when provided. The EMA should also explain why paragraph 4.1 of its 2006 guidance has been dropped from its draft revised guidance. Yours sincerely, Peter Roderick 1. https://assets.publishing.service.gov.uk/government/uploads/system/uploa... 2. https://www.who.int/biologicals/publications/trs/areas/vaccines/nonclini... 3. https://www.ema.europa.eu/en/clinical-evaluation-new-vaccines#current-ef... 4. https://www.ema.europa.eu/en/medicines/human/EPAR/comirnaty#product-info... Competing interests: No competing interests Quote Link to comment Share on other sites More sharing options...
Chief Stipe Posted September 26, 2021 Share Posted September 26, 2021 The EMA covid-19 data leak, and what it tells us about mRNA instability BMJ 2021; 372 doi: https://doi.org/10.1136/bmj.n627 (Published 10 March 2021)Cite this as: BMJ 2021;372:n627 Read our latest coverage of the coronavirus outbreak Article Related content Metrics Responses Serena Tinari, journalist Author affiliations serena.tinari@re-check.ch Leaked documents show that some early commercial batches of Pfizer-BioNTech’s covid-19 vaccine had lower than expected levels of intact mRNA, prompting wider questions about how to assess this novel vaccine platform, writes Serena Tinari As it conducted its analysis of the Pfizer-BioNTech covid-19 vaccine in December, the European Medicines Agency (EMA) was the victim of a cyberattack.1 More than 40 megabytes of classified information from the agency’s review were published on the dark web, and several journalists—including from The BMJ—and academics worldwide were sent copies of the leaks. They came from anonymous email accounts and most efforts to interact with the senders were unsuccessful. None of the senders revealed their identity, and the EMA says it is pursuing a criminal investigation. The BMJ has reviewed the documents, which show that regulators had major concerns over unexpectedly low quantities of intact mRNA in batches of the vaccine developed for commercial production. EMA scientists tasked with ensuring manufacturing quality—the chemistry, manufacturing, and control aspects of Pfizer’s submission to the EMA—worried about “truncated and modified mRNA species present in the finished product.” Among the many files leaked to The BMJ, an email dated 23 November by a high ranking EMA official outlined a raft of issues. In short, commercial manufacturing was not producing vaccines to the specifications expected, and regulators were unsure of the implications. EMA responded by filing two “major objections” with Pfizer, along with a host of other questions it wanted addressed. The email identified “a significant difference in % RNA integrity/truncated species” between the clinical batches and proposed commercial batches—from around 78% to 55%. The root cause was unknown and the impact of this loss of RNA integrity on safety and efficacy of the vaccine was “yet to be defined,” the email said. Ultimately, on 21 December, EMA authorised Pfizer-BioNTech’s vaccine. The agency’s public assessment report, a technical document published on its website, noted, “the quality of this medicinal product, submitted in the emergency context of the current (covid-19) pandemic, is considered to be sufficiently consistent and acceptable.”2 It’s unclear how the agency’s concerns were satisfied. According to one of the leaked emails dated 25 November, positive news had come from an undisclosed source in the US: “The latest lots indicate that % intact RNA are back at around 70-75%, which leaves us cautiously optimistic that additional data could address the issue,” the email said. A near miss? It’s also unclear whether the events in November constitute a near miss in the commercial manufacturing of mRNA vaccines. EMA says the leaked information was partially doctored, explaining in a statement that “whilst individual emails are authentic, data from different users were selected and aggregated, screenshots from multiple folders and mailboxes have been created, and additional titles were added by the perpetrators.”3 But the documents offer the broader medical community a chance to reflect on the complexities of quality assurance for novel mRNA vaccines, which include everything from the quantification and integrity of mRNA and carrier lipids to measuring the distribution of particle sizes and encapsulation efficiency. Of particular concern is RNA instability, one of the most important variables relevant to all mRNA vaccines that has thus far received scant attention in the clinical community. It is an issue relevant not just to Pfizer-BioNTech’s vaccine but also to those produced by Moderna, CureVac, and others,4 as well as a “second generation” mRNA vaccine being pursued by Imperial College London.5 RNA instability is one of the biggest hurdles for researchers developing nucleic acid based vaccines. It is the primary reason for the technology’s stringent cold chain requirements and has been addressed by encapsulating the mRNA in lipid nanoparticles (box). “The complete, intact mRNA molecule is essential to its potency as a vaccine,” professor of biopharmaceutics Daan J.A. Crommelin and colleagues wrote in a review article in The Journal of Pharmaceutical Sciences late last year. “Even a minor degradation reaction, anywhere along a mRNA strand, can severely slow or stop proper translation performance of that strand and thus result in the incomplete expression of the target antigen.”6 Crommelin and colleagues note that specific regulatory guidance for mRNA based vaccines has yet to be developed, and The BMJ’s attempts to clarify current standards were unsuccessful. Transparency and confidentiality The BMJ asked Pfizer, Moderna, and CureVac, as well as several regulators, what percentage mRNA integrity they consider acceptable for vaccines against covid-19. None offered any specifics. The Medicines and Healthcare products Regulatory Agency, the UK’s medicines regulator, acknowledged the lack of a specified percentage RNA integrity, but declined to provide further detail. “The specification limit acceptance criteria are commercially confidential,” the agency said in an email. The US Food and Drug Administration (FDA) directed The BMJ to read its guidance documents78 and its review of Pfizer’s vaccine,9 but none of these specify the percentage RNA the agency is requiring. Asked to comment, the regulator pointed to Pfizer: “information that you seek that is not addressed in the FDA Review Memorandum should be directed to Pfizer.” In subsequent correspondence, FDA, EMA, and Canadian government department Health Canada all stated that specific information related to the acceptability criteria is confidential. EMA did acknowledge, however, that vaccine efficacy depends on the presence of suitable amounts of intact mRNA. In the case of the commercial batches that first raised alarm bells, the agency told The BMJ that the levels of truncated mRNA “and the amounts of a potential protein produced by the truncated mRNA would be too low to constitute a safety risk.” EMA did not comment on how truncated mRNA might affect efficacy. The issue was satisfactorily addressed, the agency underlined, when further information was supplied by the manufacturer. Health Canada told The BMJ that Pfizer had conducted investigations into the root cause of reduced integrity in the commercial vaccine batches, and “changes were made in their processes to ensure that the integrity was improved and brought in line with what was seen for clinical trial batches.” Health Canada said the three agencies subsequently determined that “there was no concern with the RNA integrity or any other product specifications.” Correspondence in the leaked documents suggests that FDA, Health Canada, and EMA were aligned on clinically qualified specifications of percentage mRNA integrity. Health Canada has confirmed to The BMJ that regulators “have worked together to align those requirements,” but all agencies declined to share with The BMJ any specifics on grounds that such information was commercially sensitive. Pfizer also declined to comment on what percentage mRNA integrity it is aiming for, nor would it address questions about the cause of the unexpectedly low percentage mRNA integrity in certain batches, leaving open the question of whether it could happen again. Pfizer stressed: “Each batch of vaccines is tested by the official medicinal control laboratory—the Paul Ehrlich Institute in Germany—before final product release. As a result, the quality of all vaccine doses that are placed on the market in Europe has been double tested to ensure compliance with the specifications agreed upon with the regulatory authorities.” Moderna’s chief corporate affairs officer Ray Jordan declined to respond to any of The BMJ’s questions, stating: “At this point, Moderna will not be offering additional commentary on these topics.” CureVac, whose mRNA vaccine was submitted for EMA’s “rolling review” in February,10 told The BMJ that “it is too soon to give details.” The shortage of information may reflect the lack of certainty, even among regulators, about how to assess the evidence fully for this novel technology. Professor Crommelin told The BMJ that, “For small, low molecular weight products, the active pharmaceutical ingredient integrity is typically close to 100%.” But for mRNA vaccines? “Experience with mRNA integrity is limited.” Lipid nanoparticles—where do they go and what do they do? Conceived three decades ago, RNA based therapeutics11 have long inspired imaginations for their theoretical potential to transform cells of the body into “an on-demand drug factory.”12 But despite heavy investment by the biotech industry, bench-to-bedside translation was constantly hindered by the fragility of mRNA. Over the years, researchers attempted to resolve intrinsic instability by encapsulating mRNA in nanocarriers made of polymers, lipids, or inorganic materials. Lipid nanoparticles (LNPs) were chosen by Moderna, Pfizer-BioNTech, CureVac, and Imperial College London for their covid-19 vaccines. This has attracted the attention of specialists in the field of pharmaceutical biotechnology, some of whom have raised concerns about further unknowns. In a rapid response posted on bmj.com, JW Ulm, a gene therapy specialist who has published on tissue targeting of therapeutic vectors,13 raised concerns about the biodistribution of LNPs: “At present, relatively little has been reported on the tissue localisation of the LNPs used to encase the SARS-CoV-2 spike protein-encoding messenger RNA, and it is vital to have more specific information on precisely where the liposomal nanoparticles are going after injection.”14 It is an unknown that Ulm worries could have implications for vaccine safety. Ulm told The BMJ: “Pfizer-BioNTech and Moderna did a remarkable job of rapidly scaling up manufacturing of such a novel system in swift fashion, which is genuinely a landmark technological achievement. However, pharmacokinetic studies, with independent laboratory confirmation, are essential to ascertain potential cytotoxicity and macroscopic toxicity, especially given the likelihood of booster injections over months or years, since the tissue trafficking patterns of the mRNA vaccine payload will determine which cells and tissues are killed by cytotoxic T-cells in each round.” Given the variation in LNP formulations, it is unclear how relevant previous animal experiments are to answering this question. Regulators and manufacturers contacted by The BMJ for this article did not wish to address any of the questions raised by Ulm’s rapid response. Footnotes Competing interests: I have read and understood the BMJ Group policy on declaration of interests and have no relevant interests to declare. Provenance and peer review: commissioned; externally peer reviewed This article is made freely available for use in accordance with BMJ's website terms and conditions for the duration of the covid-19 pandemic or until otherwise determined by BMJ. You may use, download and print the article for any lawful, non-commercial purpose (including text and data mining) provided that all copyright notices and trade marks are retained. https://bmj.com/coronavirus/usage References ↵ European Medicines Agency. Cyberattack on the European Medicines Agency (press release). 2020. https://www.ema.europa.eu/en/news/cyberattack-european-medicines-agency ↵ European Medicines Agency. European public assessment report (EPAR) 2020. https://www.ema.europa.eu/en/documents/assessment-report/comirnaty-epar-public-assessment-report_en.pdf ↵ European Medicines Agency. Cyberattack on EMA—update 6. (press release). 2021. https://www.ema.europa.eu/en/news/cyberattack-ema-update-6 ↵ World Health Organization. The covid-19 candidate vaccine landscape. 2021. https://www.who.int/publications/m/item/draft-landscape-of-covid-19-candidate-vaccines ↵ Cormier Z. The second-generation covid vaccines are coming. Scientific American 2021. https://www.scientificamerican.com/article/the-second-generation-covid-vaccines-are-coming/ ↵ Crommelin DJA, Anchordoquy TJ, Volkin DB, Jiskoot W, Mastrobattista E . Addressing the cold reality of mRNA vaccine stability. J Pharm Sci2021;110:997-1001. doi:10.1016/j.xphs.2020.12.006 pmid:33321139 CrossRefPubMedGoogle Scholar ↵ US Food and Drug Administration. Development and licensure of vaccines to prevent covid-19/Guidance for industry. 2020. https://www.fda.gov/media/139638/download ↵ US Food and Drug Administration. Emergency use authorization for vaccines to prevent covid-19/Guidance for Industry. 2021. https://www.fda.gov/media/142749/download ↵ US Food and Drug Administration. Emergency use authorization (EUA) for an unapproved product review memorandum. 2020. https://www.fda.gov/media/144416/download ↵ European Medicines Agency. EMA starts rolling review of CureVac’s covid-19 vaccine (CVnCoV) (press release). 2021. https://www.ema.europa.eu/en/news/ema-starts-rolling-review-curevacs-covid-19-vaccine-cvncov ↵ Sahin U, Karikó K, Türeci Ö . mRNA-based therapeutics--developing a new class of drugs. Nat Rev Drug Discov2014;13:759-80. doi:10.1038/nrd4278 pmid:25233993 CrossRefPubMedGoogle Scholar ↵ Garde D. The story of mRNA: how a once-dismissed idea became a leading technology in the covid vaccine race. STAT News 2020. https://www.statnews.com/2020/11/10/the-story-of-mrna-how-a-once-dismissed-idea-became-a-leading-technology-in-the-covid-vaccine-race/ ↵ Ulm JW, Perron M, Sodroski J, Mulligan RC . Complex determinants within the Moloney murine leukemia virus capsid modulate susceptibility of the virus to Fv1 and Ref1-mediated restriction. Virology2007;363:245-55. CrossRefPubMedGoogle Scholar ↵ Ulm JW. Rapid response. Re: Will covid-19 vaccines save lives? Current trials aren’t designed to tell us. BMJ 2020. https://www.bmj.com/content/371/bmj.m4037/rr-19 Quote Link to comment Share on other sites More sharing options...
Chief Stipe Posted September 26, 2021 Share Posted September 26, 2021 I can't find any study or trial data on the two lipids included in the vaccine namely ALC-0315 and ALC-0159. The UK refers to a study which doesn't seem to exist. The study number it references is actually the main Pzifer trial of the complete vaccine. There is no mention in the latter of the two lipids. https://www.gov.uk/government/publications/regulatory-approval-of-pfizer-biontech-vaccine-for-covid-19/summary-public-assessment-report-for-pfizerbiontech-covid-19-vaccine Quote Link to comment Share on other sites More sharing options...
Chief Stipe Posted September 26, 2021 Share Posted September 26, 2021 This is from the TGA in Australia!! What the hell is "generally" and "limited" doing in a safety assessment document? TGA-Australia-Safety-Assessment-Pzifer-vaccine-foi-2389-06.pdf Quote Link to comment Share on other sites More sharing options...
Chief Stipe Posted September 26, 2021 Share Posted September 26, 2021 Quote Link to comment Share on other sites More sharing options...
Brodie Posted October 2, 2021 Share Posted October 2, 2021 Graphene Oxide has been proven by many experts around the world as well as other chemicals that the human body should not be absorbing! Unfortunately many that have been sucked into being JABBED will have major bad effects from absorbing these chemicals in the future. Government wont take any blame they are just following the socalled experts. This is the biggest con/scam in human history without doubt. The intelligent ones are actually the Maori in NZ! They do not want it in them, despite them saying just get it into you! Tell them you are all sorted! 1 1 Quote Link to comment Share on other sites More sharing options...
Recommended Posts
Join the conversation
You can post now and register later. If you have an account, sign in now to post with your account.