It is true that most of these studies are still on preprint servers and havent completed peer review yet to be published in a peer-reviewed journal, but the evidence thus far is strongly supportive of the conclusion that neither COVID-19 infection nor vaccination against COVID-19 has any effect on female fertility. Li G, Cappuccini F, Marchevsky NG, Aley PK, Aley R, Anslow R, Bibi S, Cathie K, Clutterbuck E, Faust SN, Feng S, Heath PT, Kerridge S, Lelliott A, Mujadidi Y, Ng KF, Rhead S, Roberts H, Robinson H, Roderick MR, Singh N, Smith D, Snape MD, Song R, Tang K, Yao A, Liu X, Lambe T, Pollard AJ; COV006 study team. 2021 Nov 25;12:779212. doi: 10.3389/fimmu.2021.779212. And that controlled follow-up is lost forever, the FDA said last October.3, At its next advisory committee in December 2020, the FDA reiterated the importance of the placebo group: Placebo controlled follow-up can be very important in showing that whatever happened in the vaccine group also happened in the placebo group. No competing interests, Copyright 2023 BMJ Publishing Group Ltd, https://www.bmj.com/content/372/bmj.n699/rr-6, https://www.bmj.com/content/372/bmj.n699/rr-20. Such biodistribution studies are a standard element of drug safety testing but are usually not required for vaccines, according to European Medicines Agency policy,21 which adds, However, such studies might be applicable when new delivery systems are employed or when the vaccine contains novel adjuvants or excipients., In the case of covid-19 vaccines, regulators accepted biodistribution data from past studies performed with related, mostly unapproved compounds that use the same platform technology.22232425, Janssen told The BMJ its covid-19 vaccine leverages the same technology as its Ebola vaccine, which received licensure last June. News-Medical. Vaccines Wont Be the Only Priority as Bidens Science Team Steps Up. This false claim originated from: viral social media post. HHS Vulnerability Disclosure, Help Some examples of these vaccines include AstraZeneca/Oxford (Chimp adenoviral vector), J&J/Janssen (Human adenoviral vector 26), CanSinoBio (Human adenoviral vector 5), and Sputnik V (Human adenoviral vectors 26 and 5). The companies challenged the feasibility, calling it onerous, and a crossover never occurred.15. On the contrary, modern genetic vaccines work on the premise of gene delivery, therefore, a detailed biodistribution and pharmacokinetic evaluation of the formulated product is invaluable in understanding the potential impact of vaccine encoding gene transfection to various body tissues beyond the site of injection. The views and opinions expressed here are those of the author and do not necessarily reflect official policy or position of the University of Maryland. The proportional tissue distribution of viral vectors in the body tissues away from the injection site was likely to increase with time, however, biodistribution beyond 24h post-dose was not studied. Vaccination at the workplace was administered to approximately 4,000 people. Adverse events following COVID-19 virus vaccination in Japanese young population: The first cross-sectional study conducted by a questionnaire survey after the first-time-injection, https://doi.org/10.1101/2021.07.23.21261029, https://www.medrxiv.org/content/10.1101/2021.07.23.21261029v1, Researchers study congenital abnormalities after COVID-19 infection and vaccination, Real-world effectiveness of the bivalent vaccine for preventing COVID-19 hospitalizations in non-hospitalized subjects, Profound immune escape by SARS-CoV-2 XBB.1 even after 4 vaccine doses, MIS-C more common and severe than previously thought, SARS-CoV-2 WA1/2020, Delta and Omicron strains found to infect human sensory neurons, Study shows booster vaccinations against SARS-CoV-2 effective but protection wanes rapidly, COVID-19 booster doses could significantly reduce the incidence of SARS-CoV-2 infection among young adults, Study explores incidence, severity, and long COVID associations of SARS-CoV-2 reinfections, Beverage fructose intake may lead to an abnormal cardiometabolic profile, Researchers explore multi-syndrome prediction of dementia syndromes, Breast milk of people vaccinated against COVID-19 provides protection to infants, study reveals, Association of aldosterone with ideal cardiovascular health in incident diabetes. DS-5670a (10, 30, 60 or 100 g) administered as an intramuscular injection into the deltoid muscle of the upper arm; 2 injections total. As countries around the world race to develop a vaccine for Covid-19 virus, the Japanese researchers have identified an effective treatment for the deadly over-activation of the inflammatory. Healthy adults participants will be randomized to receive a intramuscular injection of DS-5670a 60 g. Moderna did not respond and Janssen only confirmed it intended to apply for a BLA later in 2021. Pfizer likewise did not answer but instead quoted an FDA webpage on medical devices, which stated: Sponsors of EUA products are encouraged to follow up the EUA with a pre-market submission so that it can remain on the market once the EUA is no longer in effect.16 But EUAs have no built-in expiry datein fact, 14 EUAs for Zika diagnostic tests remain active despite the public health emergency expiring in 2017.17, Cody Meissner told The BMJ he saw some distinct advantages of a BLA over EUA. The detailed biodistribution data including pharmacokinetics of various CoViD vaccines were not conducted by the vaccine manufacturers because the studies demonstrating biodistribution of antigens were considered not required' by the regulatory authorities on the premise that vaccines work by an immunological response than the classic pharmacological approach. Has implications for blood donation. (Given the transient, infinitesimal amount of spike protein from the vaccine that gets into the circulation, Has implications for infants that are suckling. (No, spike protein made by vaccines is detectable transiently in the blood at levels that are at the lower limits of a very sensitive assay, and a, Causes gastrointestinal bleeding in infants consuming the breast milk of their vaccinated mothers, based on. Methods: An anonymous cross-sectional survey was conducted in Japan between 4 January and 5 March 2021. 2021. Yet another study has shown that vaccination against COVID-19 has no effect on immunological tolerance of the fetus by the mother. Study reports on COVID-19 vaccine-related adverse events in young Japanese population. Competing interests PD gave a public statement at the October and December FDA advisory committee meetings mentioned in this article (transcripts here: https://faculty.rx.umaryland.edu/pdoshi/#publications), and may continue to engage in public input towards regulatory decision making around covid-19 vaccines. In any event Nurse Erin appears to have gotten her information from here: Amusingly, fly tried to appear reasonable: Which brings me to Byram Bridle, who, if the above Tweets are to be believed, is the person who discovered this confidential Japanese study. Read our, ClinicalTrials.gov Identifier: NCT04821674, Interventional
For Moderna, the biodistribution of mRNA-1647 (encoding CMV genes) formulated in a similar lipid nanoparticulate delivery system confirms a biodistribution beyond the injection site, in particular, the distribution to the lymph nodes, spleen and the eye was noted [6]. 2020. 2022 Apr 12;13:836492. doi: 10.3389/fimmu.2022.836492. Less frequent were redness and itching, in up to a quarter of cases. For general information, Learn About Clinical Studies. In this nonclinical study, the biodistribution of AZD1222 was assessed in mice for 29 days following intramuscular injection. Biodistribution studies frequently use much higher doses than the human dose, the better to be able to detect distribution in low uptake organs, which, it turns out, the ovaries are. 2020;5(1) doi: 10.1038/s41541-020-00221-3. Assessment Report. The real-world effectiveness of the coronavirus disease 2019 (COVID-19) vaccines in Japan remains unclear. FOIA Epitope mapping reveals the humoral responses against the main SARS-CoV-2 structural proteins in infected patients from Africa, Mercy Medical Center secures top rank from Healthgrades for surgical care in Maryland, Investigational vaccine regimen safe but did not provide protection against HIV acquisition, Researchers use single-cell RNA-sequencing to study the aging peripheral blood in mice, Accurate information about what most other people are doing can boost vaccine uptake. I first wrote about it nearly 13 years ago! PD is also employed by a university that has mandated covid-19 vaccines for all faculty, staff, and students. Safety and immunogenicity of the ChAdOx1 nCoV-19 (AZD1222) vaccine in children aged 6-17 years: a preliminary report of COV006, a phase 2 single-blind, randomised, controlled trial. Inc. Moderna covid-19 vaccine EUA fact sheet for recipients and caregivers. It is true that some of experiments looked at the distribution of lipid nanoparticles containing an mRNA coding for Luciferase, a protein that exhibits bioluminescence allowing for visualization where the mRNA ended up. The mitigating factors include the non-serious and self-limited nature of the VAE for the most part, coupled with 94% protection against symptomatic confirmed COVID-19 after two doses of the Moderna mRNA vaccine. To date, over 4.2 million have lost their lives to the virus. He said the study shows how the. The analysis included approximately 1,900 participants, two-thirds of them being women. Competing interests:
Is it a safe assumption that it stays in the shoulder muscle? A retrospective cohort study using a self-reported questionnaire . MISSING CONTEXT: A Japanese study on the bio-distribution of Covid-19 products shows that mRNA travels to the ovaries and adrenal glands, suggesting why heartburn, blood clots, and other. Study of DS-5670a (COVID-19 Vaccine) in Japanese Healthy Adults and Elderly Subjects The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Truly, everything old is new again. Kaplan K. The FDA didnt approve Pfizers covid-19 vaccine. Why? Such data is crucial in delineating the safety and efficacy of this intervention in various age groups. And, as was pointed out by others, several female participants got pregnant during Pfizers phase 3 trial, and the only adverse pregnancy outcome was in the placebo group. FAQs on emergency use authorizations (EUAs) for medical devices during the covid-19 pandemic. Most local events occurred within a day of injection and resolved spontaneously, though redness and itching at the injection site persisted in over a quarter, and just under a fifth, of the subjects, respectively. The https:// ensures that you are connecting to the Musumeci M, Kates J. 18 January 2023. Healthy adults participants will be randomized to receive a intramuscular injection of DS-5670a 10 g. As of February 2021, Japan has 14 medical . COVID-19 Vaccine Moderna (COVID-19 mRNA Vaccine (nucleoside-modified)), EMA/15689/2021 Corr.1 2021. David H. Gorski, MD, PhD, FACS is a surgical oncologist at the Barbara Ann Karmanos Cancer Institute specializing in breast cancer surgery, where he also serves as the American College of Surgeons Committee on Cancer Liaison Physician as well as an Associate Professor of Surgery and member of the faculty of the Graduate Program in Cancer Biology at Wayne State University. Mineral samples collected from the Ryugu asteroid by the Japan's Hayabusa2 spacecraft are helping UCLA space scientists and colleagues better understand . The deadly spike protein, take two. You can view The Poynter Institutes most-recent public financial disclosure form 990. 2020. Biodistribution studies of adenovirus-based vaccines support their clinical development by evaluating their spread and persistence following in vivo administration. Pfizer and BioNTech confirm high efficacy and no serious safety concerns through up to six months following second dose in updated topline analysis of landmark COVID-19 vaccine study. Explanation: We deem this post as disinformation when it is claimed that the spike protein attacks the ovaries, the neurological system, and other organs. Support responsible news and fact-based information today! As pointed out by multiple sources, the peak accumulation in the ovaries was 0.095% (or less than 1:1,000 of the total dose of lipid nanoparticle): Antivaxxers dont even bother to look at the links they cite. We saw the spike protein was a great target antigen. I can only speculate what farcical molecular mechanism antivaxxers will think of next to blame COVID-19 vaccines for sterilizing our womenfolk. Bridle argues that unlike traditional vaccines that stay mostly in the vaccination site at the shoulder muscle, the Japanese study showed how the spike protein of the coronavirus enters the bloodstream and circulates around the body for several days after a person gets inoculated with the vaccine. The Japanese Phase 1/2/3 clinical trial1 is a clinical trial in the 5 to 11 year old pediatric population and consists of Part 1 and Part 2. The foundation runs universities and junior colleges, high schools, as well as training facilities for cooking and dental hygienists. For instance, behold Alex Berenson, the " pandemic's wrongest man ", crowing about the study: Emergency use authorizations (EUAs) versus FDA approval: implications for covid-19 and public health, A viral pandemic, vaccine safety, and compensation for adverse events. The #CoronavirusFacts database records fact-checks published since the beginning of the COVID-19 outbreak. The younger generation's hesitancy towards the COVID-19 vaccine in Japan received significant attention during the early stages of vaccination. The study 514559 was aimed to examine the biodistribution of ChAdOx1 nCoV-19 in bone marrow, brain, spinal cord, sciatic nerve, and other body tissues. Immunogenicity and safety of AZD1222 (ChAdOx1 nCoV-19) against SARS-CoV-2 in Japan: a double-blind, randomized controlled phase 1/2 trial. -, Schalk J.A.C., Mooi F.R., Berbers G.A.M., van Aerts L.A., Ovelgnne H., Kimman T.G. Background: This study aimed to survey the attitudes toward COVID-19 vaccines and their acceptability among the Japanese public as soon as the United States Food and Drug Administration (FDA) authorized vaccines and their rollouts started around the world. One of the biggest and most treacherous lies is that mRNA vaccine shots stay in the arm and dont circulate nanoparticles around the body. Now we know that is a complete lie, as new research conducted in Japan shows that Lipid NanoParticles (LNPs) containing the mRNA code are widely circulated around the body after vaccination, reaching the brain, spleen, large intestine, heart, liver, lungs and other organs. US Food and Drug Administration. You have reached the maximum number of saved studies (100). No, the Japanese biodistribution study shows nothing of the sort. Here, we report on the development of a highly efficacious mRNA vaccine, SW0123 that is composed of sequence-modified mRNA encoding the full-length SARS-CoV-2 Spike protein packaged in core-shell. European Medicines Agency. Mol Ther. The odds of local and systemic VAE were more than doubled in females relative to males. An official website of the United States government. government site. The data from this study is not yet available in the public domain but this might provide evidence of vaccine delivery in the brain. This finding is consistent with those of the Japanese Self-Defense Forces, and of the Ministry of Health, Labour, and Welfare Japan and the US Centers for Disease Control and Prevention (CDC). Healthy elderly participants will be randomized to receive a intramuscular injection of DS-5670a 30 g. As Yuri Deigin pointed out, only around 0.1% of the dose of lipid nanoparticles went to the ovaries. Evaluation of the immunogenicity of prime-boost vaccination with the replication-deficient viral vectored COVID-19 vaccine candidate ChAdOx1 nCoV-19. This is a form of antivaccine grift that goes all the way back to Andrew Wakefield, who, as you might recall, had his own measles vaccine under development at the time he published his case series linking the MMR vaccine to autism in 1998. 1 Study reports on COVID-19 vaccine-related adverse events in young Japanese population Download PDF Copy By Dr. Liji Thomas, MD Aug 6 2021 The coronavirus disease 2019 (COVID-19) pandemic. Federal government websites often end in .gov or .mil. 2020. We never knew the spike protein, itself, was a toxin and was a pathogenic protein. Leaked confidential study from Pfizer. The original report is in Japanese, but there is what appears to be a machine-translated version available. 2021. A new study from Japan, released as a medRxiv* preprint, describes the adverse effects associated with the vaccine. SARS-CoV- 2 mRNA Vaccine (BNT162, PF-07302048) 2.6.4 Yakubutsu dtai shiken no gaiy bun [summary of pharmacokinetic studies]. We also proposed that the increased circulatory levels of acute-phase proteins, as observed in the pre-clinical vaccine studies in animals, may also be a contributory factor in putting the haemostatic system at an increased thrombotic potential [3]. J Gen Virol. Have a fever of 39.0C or symptoms of suspected allergies such as systemic rash within 2 days after past vaccination, etc. In it, Ms. Olszewski claimed that people who had tested negative for COVID-19 were being diagnosed as having COVID-19 anyway, put on ventilators, and drugged up with sedatives. An approved vaccine, for one, would provide an element of assurance, increasing public trust in the vaccines, particularly for those currently sitting on the fence. Cody Meissner, a professor of paediatrics at Tufts University and member of the FDAs advisory committee, was curious. The median age was 22 years, but a quarter was below the age of 20. This site complies with the HONcode standard for trustworthy health information: verify here. Cmax of plasma MAFB-7566a and constituent lipids of lipid nanoparticle (LNP) will be assessed. In fact, this new version of the vaccines are going to sterilize our womenfolk disinformation leads me to conclude that just as aluminum became the new mercury as the science became clear that mercury in the thimerosal preservative that used to be in some childhood vaccines does not cause autism, lipid nanoparticles are the new polysorbate-80. Youll see the first part of that paragraph everywhere, usually represented as a provaccine scientist saying, We made a big mistake. Of course, the hilarious part is the huge mistake Bridle makes in the paragraph above, conflating lipid nanoparticles with the spike protein. We didnt realize it until now. Heres why. Unlike its clear articulation of two months for an EUA, the FDA has not committed to a clear minimum for approval. sharing sensitive information, make sure youre on a federal Most relevant to this post, he has made claims that the spike protein made by vaccines: One also notes, as is often the case for scientists who spread misinformation about COVID-19 vaccines, an undisclosed conflict of interest: A second emphasis of the lab is the study of host responses to viruses. New findings from the Ryugu asteroid samples indicate that carbonates were forming from water-rock reactions several million years earlier, even closer to the solar system's beginnings. They also address vaccine safety. There is very little information in the public domain to assess the biodistribution of all genetic vaccines, however, it is anticipated that if it is characteristic to the viral vector employed in the vaccine, then the other vaccines using similar technology may also lead to the same safety concerns. AstraZeneca and Oxford University's experimental COVID-19 vaccine clinical trials have resumed in Japan. Perhaps Bridles most famous quote was cited by Adams: In short, the conclusion is we made a big mistake. Misleading: The article wrongly claimed that the absolute risk reduction (ARR) from the COVID-19 vaccines indicates only "minuscule" benefit.While ARR can be a helpful measure of vaccine efficacy, interpreting it correctly requires an understanding . Yes, Dr. Bridle is trying to develop his own vaccine and treatments for COVID-19. This site needs JavaScript to work properly. It turns out that Nurse Erin is an antivaccine nurse named Erin Marie Olszewski, who caused a minor ruckus last summer after having worked as a traveling nurse during the first surge of the pandemic last spring. That would translate to a per-weight dose of ~250 g/kg. "Study reports on COVID-19 vaccine-related adverse events in young Japanese population". Coronavirus disease 2019 (COVID-19) vaccination is recommended for patients with inflammatory bowel disease (IBD). The bottom line is that there is no evidence that the lipid nanoparticles in the Pfizer vaccine (or any of the COVID-19 vaccines) accumulate at significant quantities in the ovaries, much less cause female infertility. Lancet. However, such an exemption may barely justify the conventional vaccines such as those incorporating whole inactivated virus, split virion, or the sub-unit vaccines, that directly attracts an immune response post-injection. Antivaxxers have long claimed that vaccines, particularly HPV vaccines, can damage the ovaries and cause female infertility. Front Immunol. AZD1222 (ChAdox1 nCov-19) is a replication-deficient non-human adenovirus-vectored vaccine for coronavirus disease 2019. No long-term studies. Part 1 . Would you like email updates of new search results? COVID-19 vaccine trials should seek worthwhile efficacy, Clinical endpoints for evaluating efficacy in covid-19 vaccine trials. The vaccine may therefore spur the brain cells to produce CoViD spike proteins that may lead to an immune response against brain cells, or it may spark a spike protein-induced thrombosis. Support responsible news and fact-based information today! Preclinical and clinical safety studies on DNA vaccines. At peak, only 0.02% made it to the brain. The Male Contraceptive Pill: is it possible? New study out of Harvard and published by Circulation: Free Spike Protein - Not Bound by Antibodies - Detected in the Blood of Adolescents and Young Adults Who Brian Van Hecke LinkedIn: Circulating Spike Protein Detected in Post-COVID-19 mRNA Vaccine A study with the same platform vector ChAdOx -1 (hepatitis B virus) and two studies with a similar . People with a history of allergy were also twice as likely to have local reactions, with systemic events being increased by 40%. Very often, its the fact that we have that placebo controlled follow-up over time, that gives us the ability to say that the vaccine didnt cause something at a longer period of time after vaccination, the FDAs Philip Krause explained last December.13. A World Health Organization expert group on covid-19 vaccines (which included FDA regulators) in August 2020 called for follow-up until at least month 12, or until an effective vaccine is deployed locally.10 Another group, composed of industry and academic authors, similarly wrote in October 2020: we recommend longer term follow-up of all participants for at least a year after randomisation.11. Officials have consistently emphasised that despite shaving years off traditional timelines for producing vaccines, no compromises in the process were taken.20 However one type of study, tracking the distribution of a vaccine once injected in the body, was not conducted using any of the three vaccines currently authorised in the US. Lee SW, Moon JY, Lee SK, Lee H, Moon S, Chung SJ, Yeo Y, Park TS, Park DW, Kim TH, Sohn JW, Yoon HJ, Kim SH. The purpose of this study is to evaluate the biodistribution, safety and tolerability of a single dose of [18F]GTP1 as a tau targeted radiopharmaceutical in healthy Japanese participants. The data from this study is not yet available in the public domain but this might provide evidence of vaccine delivery in the brain. Clipboard, Search History, and several other advanced features are temporarily unavailable. News-Medical. Sci Transl Med. Assessment Report. -, Tatsis N., Ertl H.C.J. How the FDA will weigh the loss of blinding and placebo controlled follow-up is unclear, but just months ago the agency said these trial properties were vital. Australian Bush Tucker Bites presents Native Mulberry (Pipturus argenteus). An area of focus is developing a better understanding of the mechanisms underlying virus-induced cytokine storms. Comirnaty (COVID-19 mRNA vaccine (nucleoside-modified)), EMA/707383/2020 Corr.1. Spike protein does not attack anything, it only aims to activate the immune response, it is not the same as coronavirus spike protein and after vaccination, it is created in a dose 100 thousand times lower than in viral infection. Have a history of anaphylaxis or severe allergies due to food, cosmetics, medicines, or vaccination. Aiming to improve scientific literacy in this age of information overload and mis/disinformation, especially on controversial and polarizing topics. As pointed out by multiple sources, the peak accumulation in the ovaries was 0.095% (or less than 1:1,000 of the total dose of lipid nanoparticle): One key difference between EUA and approval (also called licensure, and which for vaccines is known as a BLA (Biologics License Application)) was the expected length of follow-up of trial participants. A man receives a coronavirus vaccine shot at a Self-Defense Forces vaccination center in Tokyo's Chiyoda Ward on June 17, 2021. .