vii https://uploads-ssl.webflow.com/5fa5866942937a4d73918723/60379523f61260115203f392_UKMFA%20_Covid-19_Vaccine_in_Children.pdf c.  Children play an insignificant role in transmission of Covid-19 [ix] [xviii] [xxix]. xxvii https://www.nrscotland.gov.uk/statistics-and-data/statistics/statistics-by-theme/vital-events/general-publications/births-deaths-and-other- vital-events-quarterly-figures/archive The tool is designed to help applicants determine the additional information required in the Cover Letters and eAFs of initial MAA and variation applications. But Moderna also reveal that the framework agreement they made with the Bill & Melinda Gates Foundation could bring the total funding up to $100 million for “follow-on projects” that are proposed to and approved by the Bill & Melinda Gates Foundation up to 2022, and the terms of this agreement stipulate that Moderna are obliged to grant the Bill & Melinda Gates Foundation certain non-exclusive licenses. lv https://www.nejm.org/doi/full/10.1056/NEJMp2030600 xxiii https://www.bbc.co.uk/news/uk-53877898 xxxviii https://pubmed.ncbi.nlm.nih.gov/32668444/ UKMFA has sent an Open Letter to the the MHRA in which we raise grave concerns about this emergency authorisation, citing evidence of known and potential harms to children that may result and the serious ethical issues this decision raises. Indeed, concerns have been raised that this approach may prolong the pandemic and risk promotion of more virulent variants [ix]. Click to share on Twitter (Opens in new window), Click to share on Facebook (Opens in new window), Click to share on Telegram (Opens in new window), Click to share on WhatsApp (Opens in new window), Click to share on Reddit (Opens in new window), Click to email this to a friend (Opens in new window), Click to share on LinkedIn (Opens in new window), Click to share on Pinterest (Opens in new window), Click to share on Tumblr (Opens in new window), Click to share on Pocket (Opens in new window), Click to share on Skype (Opens in new window), less than 9 children have died of Covid-19, Vaccine Adverse Event Reporting System (VAERS), 15 year-old female also suffered cardiac arrest, MHRA received a grant from the Bill & Melinda Gates Foundation, Freedom of Information request which the MHRA responded to in May 2021, owns major shares in both Pfizer and BioNTech, confirmed in 2016 that the Bill & Melinda Gates Foundation, Instead we rely solely on your support, so, Pandemic of the Vaccinated – Worldwide data on 188 countries proves the highest Covid-19 case rates are in the most vaccinated countries, New Legal Challenge launched against UK Gov. According to a Vaccine Adverse Event Reporting System (VAERS) report found under VAERS ID 1187918, a 15 year-old female suffered cardiac arrest and ended up in intensive care four days after having the Moderna mRNA jab. You can also use the A-Z list to find the active substance. You can use the A-Z list to find an active substance, or search for a medicine. Therefore under the terms of the agreement made with Moderna, the Bill & Melinda Gates Foundation have now been granted a non-exclusive license to the Moderna mRNA Covid-19 injection, and are therefore profiting from its use. That process is an Emergency Authorisation. Authorisation extensions involving revision of the medicinal product information (MPI), and; Type II changes involving revision of the MPI or indication extensions. The MHRA has updated its guidance on substantial amendments to a clinical trial. The UK MHRA has launched the Early Access to Medicines Scheme (EAMS) consultation. It is with the gravest of concern and utter incredulity that we assimilate the decision by the MHRA to grant regulatory approval for emergency use of the Pfizer-BioNTech Covid-19 vaccine in 12- to 15-year- old children [i]. This product has been authorised by MHRA in Great Britain (consisting of England, Scotland and Wales). On the 17th August the UK Government confirmed in a press release that the Medicine and Healthcare product Regulatory Agency (MHRA) had extended the emergency use authorisation granted to the Moderna injection to allow it to be given to children over the age of 12. In October the government made changes to the Human Medicines Regulations 2012 to allow the MHRA to grant temporary authorisation of a Covid-19 vaccine without needing to wait for the EMA. But even at this point they had not determined that an alleged new coronavirus was to blame, instead stating the pneumonia was of “unknown cause”. Rt Hon Arlene Foster – First Minister of Northern Ireland : Vaccines ARE Linked to Autism. xxv https://www.england.nhs.uk/statistics/statistical-work-areas/covid-19-daily-deaths/weekly-total-archive/ The Pfizer mRNA Covid-19 injection is in fact only temporarily authorised (see official MHRA document here) for emergency use only. The justification for the enhanced timelines and the irregular process for temporary emergency use authorization of Covid-19 vaccines has been the urgency of the ongoing pandemic. iii https://www.bmj.com/content/373/bmj.n1197 Found inside – Page 235... like Japan‟s PMDA (Pharmaceutical and Medical Devices Agency), UK‟s MHRA (Medicines and Healthcare Products Regulatory Agency), EMA (European Medicines Agency), USFDA, or those that have emergency use authorization from WHO. According … 3. It is a new route for marketing authorisation applications (MAA), where an applicant submits increments of the eCTD dossier for pre-assessment by the MHRA rather than as part of a consolidated full dossier … Vaccine- induced immunity does not cover the full spectrum of protection (mucosal immunity, IgA, and T-cell immunity to the whole virus) and may only be short-lived. This is not consistent with ethical and lawful practice of medicine and indeed constitutes a violation of Informed Consent, as required by the GMC, the NHS Constitution, and the Montgomery ruling [lxiv]. by UK Medical Medical Freedom Alliance June 8, 2021 . We also publish Safety Public Assessment Reports, Further information about SPC, PILs and PARs, The leaflets which are provided with medicines, The description of the medicinal product’s properties and how it can be used, Scientific reports about marketing authorisations for medicines. Now this of course would be fine if it were not for the fact that the Bill & Melinda Gates Foundation own shares in the Covid-19 vaccines that have been granted emergency use authorisation by the MHRA for use in children. You only need to head to Moderna’s own website to find that this is the case. Commonly known as the Orange Guide, this book is an essential reference for all involved in the manufacture or distribution of medicines in Europe. vhttps://www.americasfrontlinedoctors.org/frontline-news/americas-frontline-doctors-files-motion-for-temporary-restraining-order-against-use-of-covid-vaccine-in-children In the letter to the EMA the authors list 22 serious adverse events that were known to the FDA prior to Emergency Use Authorisation yet were not made known to the public, including vaccine-enhanced disease, stroke, myocarditis, acute multitude-system inflammatory syndrome in children, Guillain-Barré syndrome, autoimmune conditions and pregnancy and birth outcomes, as has been … This is the 5th edition of this publication and it supersedes the 4th ed. (2007) (ISBN 9780113226771). “Today’s Emergency Use Authorisation in the UK marks a historic moment in the fight against COVID-19. Medical Devices and the Public's Health examines the current 510(k) clearance process and whether it optimally protects patients and promotes innovation in support of public health. The MHRA will give a scientific opinion on the benefit/risk balance of the medicine, based on the data available; this opinion does not replace the normal licensing procedures for medicines but supports the prescriber and patient to make a decision on whether to use the medicine before its licence is determined. This book examines the rise of the direct-to-consumer genetic testing industry (DTC) and its use of 'wrap' contracts. Spike proteins appear to contribute significantly to the pathogenicity of SARS-CoV-2, and there are studies suggesting that they have the potential to cause pathology on their own [xliii] [xliv]. lxiv https://www.supremecourt.uk/cases/docs/uksc-2013-0136-judgment.pdf. This is based on the MHRA assessment report with any commercially or personally confidential information removed. At the time Dr June Raine, Chief Executive of the MHRA said that she was “pleased to confirm” its emergency use authorisation, and alleged that it is “safe and effective in this age group”. Of the 4347 events of thrombosis and embolism reported to the MHRA as of 13 May 2021, 770 occurred following the Pizer-BioNTech vaccine [xlv]. This book discusses the different regulatory pathways for gene therapy (GT) and cell therapy (CT) medicinal products implemented by national and international bodies throughout the world (e.g. North and South America, Europe, and Asia). French virologist and Nobel Prize winner Luc Montagnier recently highlighted and warned about this potential issue [x] [xi]. 30 Facts You Need to Know: Your Covid Cribsheet – A Collection of All the Arguments You’ll Ever Need. Source: Swissmedic website. The treatment was given a conditional marketing authorisation for use in Great Britain, and a temporary authorisation under regulation 174 of the Human Medicines Regulations in Northern Ireland, to allow supply across the whole of the UK. She also sadly died. Requirements regarding legal presence of the (QPPV) The Marketing Authorisation Holder (MAH) must have A QPPV permanently and continuously at its disposal. The MHRA has issued an authorisation to the Department of Health and Social Care to allow the use of the NHS Test and Trace COVID-19 Self-Test kit … But, as we recently revealed, they also granted emergency use authorisation for the Pfizer / BioNTech injection to be given to children, and a certain Mr Bill Gates, who happens to be the primary funder of the MHRA, also owns major shares in both Pfizer and BioNTech. The regulatory approval in the UK is crucial to strengthen SII's application seeking emergency use authorisation in India because the proposal here refers to trials being conducted in … xxxiv https://www.bmj.com/content/bmj/371/bmj.m4037.full.pdf Found inside – Page 164seeks. emergency. approval. in. India: In the application submitted on December 4, 2020, Pfizer has asked for permission to import the vaccine for sale as well as for distribution in India, besides waiving off clinical trials on Indian ... of any use other than the recommended or required use, or if a condition in this authorisation is breached; • The entity responsible for physically supplying the product in the United Kingdom is Pfizer Limited (incorporated in England and Wales under registered number 526209). we could not do what we do without your support. Pfizer seeks DCGI nod for emergency use of COVID-19 vaccines in India The UK on Wednesday became the first country to approve the Pfizer/BioNTech vaccine against COVID … Why has Pfizer changed the formulation of its Covid-19 Vaccine for Children to include an ingredient that stabilises people suffering a Heart Attack? The MHRA decision was made with advice from the Commission on Human Medicines, the government’s independent scientific advisory body, following a rolling review. Sorry, your blog cannot share posts by email. UKMFA Urgent Open Letter to the MHRA re Emergency Authorisation of the Pfizer Covid-19 Vaccine for Children. June 8, 2021. Found inside – Page 174February 17, 2021. https://www.cas. mhra.gov.uk/ViewandAcknowledgment/ViewAlert.aspx?AlertID=103144. [Accessed 19 February 2021]. ... Fact sheet for healthcare providers: emergency use authorization (EUA) of baricitinib. 2020. The UK Medicines and Healthcare products Regulatory Agency (MHRA) has provided authorisation for emergency supply of COVID-19 Vaccine AstraZeneca, formerly AZD1222, for the active immunisation of individuals 18 years or older. g.  Covid-19 vaccines work completely differently to established childhood vaccines. But the corruption doesn’t end there, because a confidentiality agreement shows potential coronavirus vaccine candidates were transferred from Moderna to the University of North Carolina in 2019, nineteen days prior to the emergence of the alleged Covid-19 causing virus in Wuhan, China. On the 17th August the UK Government confirmed in a press release that the Medicine and Healthcare product Regulatory Agency (MHRA) had extended the emergency use authorisation granted to the Moderna injection to allow it to be given to children over the age of 12. The MHRA has updated information regarding changes to a trial’s protocol or documentation. We thank you for taking the time to read this letter and consider its contents. A temporary use authorisation is valid for one year only and … Experts are stating that vaccinating children is neither necessary nor justified: 5. The first doses of the … The UK emergency use authorisation is temporary and only relates to a limited number of specific batches of the Covid-19 vaccine BNT162b2 supplied by Pfizer and BioNTech, in response to the increased spread of COVID-19 and loss of life. Oxford University welcomes UK regulatory emergency use authorisation of coronavirus vaccine Coronavirus The University of Oxford welcomes the news that the UK Government has today accepted the recommendation from the Medicines and Healthcare products Regulatory Agency (MHRA) to authorise the emergency use of the ChAdOx1 nCoV-19 coronavirus vaccine in the UK. This is most relevant for young people and children. In a normal world they would have been arrested and charged long time ago. Below, we set out specific issues regarding Covid-19 vaccines in children – each sufficient to justify not proceeding any further with this proposal. Conditions for authorisation for emergency supply under Regulation 174 for COVID-19 Vaccine AstraZeneca Amended on 09 September 2021 General 1. The UK Medical Freedom Alliance (UKMFA) is an alliance of UK medical professionals, scientists and lawyers campaigning for Medical Freedom, Informed Consent and Bodily Autonomy to be preserved and protected.