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News

FDA report finds all-cause mortality higher among vaccinated – Israel Nation News

FDA report shows Pfizer’s clinical trials found 24% higher all-cause mortality rate among the vaccinated compared to placebo group.

The clinical trials of Pfizer’s coronavirus vaccine found that the all-cause mortality rate of the vaccinated group was higher than that of the control group, months after the trials were launched, according to a recently released FDA report.

According to the report, which was released by the US Food and Drug Administration to provide background information on its August 2021 decision to grant full approval for the Pfizer-BioNTech coronavirus vaccine after offering limited emergency authorization of use in last December, six months after the vaccine’s clinical trial began, the total number of deaths reported in the vaccinated group was nearly one-quarter higher than the number of deaths in the placebo group.

http://archive.today/2021.11.19-040650/https://www.israelnationalnews.com/News/News.aspx/317091

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Videos

Dr. Robert Malone: “This is the Largest Experiment Performed on Human Beings in the History of the World.” – The New American

In an exclusive and explosive one-hour interview with Veronika Kyrylenko of The New American, pioneering mRNA scientist Dr. Robert Malone explains the intensely corrupt workings of the government regulatory bodies that have mismanaged the pandemic, discusses the problems with the vaccine program and delves into potentially explosive and game-changing revelations about the shady origins of the Covid-19 pandemic in Wuhan, China.

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Publications

November 8, 2021 Summary Basis for Regulatory Action – Comirnaty – FDA

Introduction

BioNTech Manufacturing GmbH (in partnership with Pfizer Inc.) submitted a Biologics License Application (BLA) STN BL 125742 for licensure of COVID-19 Vaccine, mRNA. The proprietary name of the vaccine is COMIRNATY. COMIRNATY is a vaccine indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 16 years of age and older. The vaccine is administered intramuscularly (IM) as a series of two 30 μg doses (0.3 mL each) 3 weeks apart.

For commentary, see FDA report finds all-cause mortality higher among vaccinated – Israel Nation News.

http://archive.today/2021.10.11-032110/https://www.fda.gov/media/151733/download

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Videos

AstraZeneca shots should be halted for over-60s- EMA official – Reuters

Countries should also avoid giving the Astrazeneca coronavirus vaccine to people over 60, the head of the EU drug regulator’s COVID-19 task force was quoted on Sunday as saying, amid fears over rare blood clotting and as more vaccines become available. Emer McCarthy reports.

https://www.reuters.com/video/watch/idRCV009UM3

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Publications

MHRA awarded over £980,000 for collaboration with the Bill and Melinda Gates Foundation and the World Health Organisation – Gov.uk

Published 15 December 2017

MHRA today announced a partnership worth over £980,000 to improve the safety monitoring of medicines in low and middle-income countries.

https://www.gov.uk/government/news/mhra-awarded-over-980000-for-collaboration-with-the-bill-and-melinda-gates-foundation-and-the-world-health-organisation

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News

EU Approves Sale of Mealworm for Human Consumption – Bloomberg

Frog legs rolled in worm flour could be the next culinary delight for European haute cuisine after the European Union gave its blessing for the first time for an insect food.

Dried yellow mealworm can now be sold across the 27-nation bloc after a Monday decision from EU governments and a food safety assessment, the European Commission said on Tuesday.

EU officials suggest it could be used as a protein boost for cookies, pasta or baked goods, as they try to reassure fussy eaters that millions of people around the world already eat insects. It’s also a more environmentally friendly alternative to rearing cattle and other larger sources of protein. The market for edible insects is set to reach $4.6 billion by 2027, according to one report earlier this year.

https://www.bloomberg.com/news/articles/2021-05-04/worm-cuisine-set-to-hit-europe-s-dinner-tables-as-eu-gives-nod

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Publications

Vaccine Development, Testing, and Regulation – The History of Vaccines

Vaccine development is a long, complex process, often lasting 10-15 years and involving a combination of public and private involvement.

https://www.historyofvaccines.org/content/articles/vaccine-development-testing-and-regulation

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News

COVID-19: Human Medicine Regulations amended to support vaccine rollout – Thomson Reuters Practical Law

On 16 October, the Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2020 (SI 2020/1125) entered into force. The Regulations cover temporary authorisations for vaccines, civil liability and immunity for participants in vaccination programmes, expansion of the healthcare workforce who can administer vaccines, promotion of vaccines and an exemption to wholesale licensing requirement.

https://uk.practicallaw.thomsonreuters.com/w-027-9751?transitionType=Default&contextData=(sc.Default)&firstPage=true

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Opinion

Concern about powers in new UK Coronavirus laws – may include compulsory detention of children

Lawyers at the Russell Cooke law firm express concerns about new Coronavirus Regulations.

Background:

  • The Health Protection (Coronavirus) Regulations 2020 passed 10 Feb 2020
  • Regulations were made without a draft being laid and approved by Parliament and came into effect immediately.
  • This was permitted under the claim that it was necessary due to threat to human health from COVID-19.

Regulations:

  • Allow the Secretary of State or a registered public health consultant to impose compulsory detention and isolation of people suspected of having COVID-19.
  • Allow forced testing and screening for 48 hours.
  • Power to restrict a person’s travel and other activities and to restrict a person’s contact with specified people.
  • The police are given power under to enforce the regulations where a person is not willing to be isolated voluntarily using ‘reasonable force’.
  • An isolated or detained individual will not be free to leave.
  • Refusal to comply is a criminal offence punishable by a fine of up to £1,000.
  • There are also powers in the regulations which envisage the detention of children, which could present its own issues.

Source:

https://www.russell-cooke.co.uk/insight/briefings/2020/new-coronavirus-regulations-quarantine-measures-to-contain-the-virus/