WHO adds LC16m8 mpox vaccine to Emergency Use Listing - "Minimally Replicating Vaccines, such as LC16m8, which should not be used during pregnancy and in people who are immunocompromised"
WHO adds LC16m8 mpox vaccine to Emergency Use Listing - Apparently it's "MINIMALLY SELF REPLICATING"... and this dear readers is PRECISELY why we are suing the W.H.O. to DELIST novel vax EUL products
Self Replicating?…
Don’t worry says WHO DG Tedros Mengele - These mPOX vaccines are only MINIMALLY self replicating! Care for a dose, or two, or ten?
Video of IoJ, Dr. Yeadon, Sasha Latypova and Dr. Janci Lindsay discussing the horrors of EUA products. The video was taken on the Nuremberg Codes 77th Anniversary, and showing you all PRECISELY how WHO waived informed consent, which violates the principles of Nuremberg Code. WHO EUL story is below!
Youtube left up our Nuremberg Hearing trailer for a week then censored it. We expect this to be censored, but we are posting it for the sole purpose of ENTRAPPING THE EVIL GOOGLE/YOUTUBE/UN Trusted News Initiative CENSORSHIP NETWORK.
UN KNOWS THEY HAVE ZERO AUTHORITY TO LIMIT OUR SPEECH & OPINION.
If youtube is down Rumble also has the video to share: https://rumble.com/v5r7v6e-ioj-discusses-with-dr.-mike-yeadon-janci-and-sasha-whos-emergency-use-listi.html
Tuesday, 19 November 2024
WHO adds LC16m8 mpox vaccine to Emergency Use Listing
The World Health Organization (WHO) has granted Emergency Use Listing (EUL) for the LC16m8 mpox vaccine, making it the second mpox vaccine to be supported by WHO following the Director-General’s declaration of an mpox public health emergency of international concern (PHEIC) on 14 August 2024.
This decision is expected to facilitate increased and timely access to vaccines in communities where mpox outbreaks are surging. In 2024, cases have been reported across 80 countries, including 19 countries in Africa, based on data as of 31 October 2024. The Democratic Republic of the Congo, the hardest-hit country, recorded a large majority of suspected cases – over 39 000 – as well as more than 1000 deaths.
Today’s move is particularly relevant as the Government of Japan has announced that it will donate 3.05 million doses of the LC16m8 vaccine, along with specialized inoculation needles, to the Democratic Republic of the Congo. This is the largest donation package announced to date in response to the current mpox emergency.
LC16m8 is a vaccine developed and manufactured by KM Biologics in Japan. The Technical Advisory Group (TAG) for EUL of vaccines convened to discuss the outcome of the LC16m8 vaccine review, including the product and programmatic suitability assessments. The TAG recommended the vaccine for use in individuals over one year of age as a single dose vaccine, via a multiple puncture technique using a bifurcated needle.
“WHO emergency use listing of the LC16m8 vaccine against mpox marks a significant step in our response to the current emergency, providing a new option to protect all populations, including children,” said Dr Yukiko Nakatani, WHO Assistant Director-General for Access to Medicines and Health Products. “Vaccines are one of the important tools to help contain the outbreak as part of a comprehensive response strategy that also includes improved testing and diagnosis, treatment and care, infection prevention control, and engagement and education within affected communities.”
WHO’s assessment for EUL is based on information submitted by the manufacturer and review by the Pharmaceuticals and Medical Devices Agency (PMDA), the Japanese regulatory agency of record for this vaccine. The LC16m8 vaccine has been used in Japan during previous mpox outbreaks and was shown to be safe and effective, including in people with well-controlled HIV.
The WHO Strategic Advisory Group of Experts (SAGE) on Immunization reviewed available evidence and recommended the use of LC16m8 vaccine in outbreak settings in children and others with a documented high-risk of exposure to mpox.
However, minimally replicating vaccines, such as LC16m8, should not be used during pregnancy and in people who are immunocompromised. Immunocompromised persons include those with active cancer, transplant recipients, immunodeficiency, and active treatment with immunosuppressive agents. They also include people living with HIV with a current CD4 cell count of <200 cells µl.
The Global Advisory Committee on Vaccine Safety reviewed the updated safety data on LC16m8 on 20 September 2024 and recommended that healthcare workers are provided with training on the use of bifurcated needles to prevent injuries and adverse effects. In light of the changing epidemiology and emergence of new virus strains, it remains important to collect as much data as possible on vaccine safety and effectiveness in different contexts.
WHO continues to work closely with manufacturers, global partners and countries to ensure the availability and administration of safe and effective life-saving products.
On 13 September 2024, WHO prequalified the Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN) vaccine and expanded its indication to include use in individuals aged 12 years and older on 8 October 2024.
Note to editors:
WHO Prequalification (PQ) and Emergency Use Listing (EUL) are mechanisms used to evaluate quality, safety and efficacy of medical products, such as vaccines, diagnostics and medicines, and product suitability for use in the contexts of low- and middle-income countries. Products receiving PQ or EUL support decision-making for international, regional and country procurement by UN and partner procurement agencies and Member States. PQ is based on the review of full set of quality, safety and efficacy data on medical products, including risk management plan and programmatic suitability. EUL is a risk benefit assessment to address urgent demands during public health emergencies based on available limited data where the benefits outweigh the risks.
*End WHO Press release*
WHY GOOD MANUFACTURING MATTERS - FROM W.H.O. IN 2014:
World Health Organization & WHO Expert Committee on Specifications for Pharmaceutical Preparations. (2014). Quality assurance of pharmaceuticals: meeting a major public health challenge. World Health Organization. https://iris.who.int/handle/10665/111108
Download below or online here: https://iris.who.int/handle/10665/111108
LETS WAIVE GOOD MANUFACTURING - FROM W.H.O. IN 2020 COVID ERA:
NOTICE TO STAKEHOLDERS FREQUENTLY ASKED QUESTIONS BY THE MANUFACTURING, TRIAL AND TESTING ORGANIZATIONS IN CONNECTION WITH SOME OF THEIR CONSTRAINTS FACED DURING THE COVID-19 OUTBREAK
INTRODUCTION AND BACKGROUND -
On 30 January 2020, WHO Director-General, Dr Tedros Ghebreyesus declared that the outbreak of COVID-19 caused by the 2019 novel coronavirus (SARS-CoV-2) had constituted a Public Health Emergency of International Concern. Since then many countries have implemented measures to combat the spread of the disease, including but not limited to travel restrictions lockdown, quarantine and social distancing. As a result, manufacturers of active pharmaceutical ingredients (APIs), finished pharmaceutical products (FPPs), vaccines, medical devices including in-vitro diagnostics (IVDs), vector control products, quality control laboratories and contract research organizations (CROs) of WHO Prequalified Products are facing several challenges during this COVID-19 pandemic.
In particular, some of them may be unable to fully meet their usual responsibilities of following Good Manufacturing Practices (GMP), Good Practice for Quality Control Laboratories (GPPQCL), Good Practice for Pharmaceutical Microbiology Laboratories (GPPML) Good Clinical Practices (GCP), Good Laboratory Practices (GLP) and Quality Management System (QMS) requirements respectively. This document was developed by WHO Prequalification Unit - Inspection Team (PQT/INS) with input from the Norms and Standards Pharmaceuticals (NSP), Health Products Policy and Standards Department, WHO.
It provides basic guidance to manufacturers/laboratories/contract research organizations (herein after referred to as organizations), on regulatory expectations and flexibility during the COVID-19 pandemic in the form of questions and answers.
It is underlined that the pandemic is affecting countries at different levels and the progress of the pandemic in each country may be at different stage; hence national measures and guidance should also be considered. The definitive aim is to ensure the quality, safety, efficacy and continuity in the supply of products and services in order to attain a high level of public health.
The document will be updated to address new questions and to include further information for organizations to the evolution of the pandemic. It will remain valid until further notice.
[Last IoJ heard this waiver by WHO of good manufacturing practices (GMP) is still valid - Throughout the document WHO flat out states they agree to waive the requirements for good manufacturing! Did you know WHO declared lowered regulatory expectations and flexibility?]
We just had a Nuremberg Hearing on 11-11 to prove EUL covid vax is unsafe and experimental. We are awaiting the governments response to find out if Costa Rica will step in to help us stop WHO EUL covid [non]vaccines. Either way we will need to have the Attorneys take over the next steps. If you want to be a REAL HERO and contribute to our case, which is probably furthest in the world to stopping these products, your support is vital and very appreciated as we try to really get out from under the Attorney fees to move full steam ahead to fix these serious problems legally!
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The Vaccinated
Did Not Have
Their Health Stolen From Them.
They Forfeited It.
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Why won't they stop?. Minimally replicating? Is that like "it stays in your arm" or "mild case of myocarditist or "you wont get covid"? How do they just barrel ahead like nothing is happening around them? It boggles the mind.