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Publications

Interim Laboratory Biosafety Guidelines for Handling and Processing Specimens Associated with Coronavirus Disease 2019 (COVID-19) – CDC

This guidance is intended for clinical laboratory and support staff who handle or process specimens associated with COVID-19. Guidance for Point-Of-Care Testing can be found here.

All laboratories should perform a site-specific and activity-specific risk assessment and follow Standard Precautions when handling clinical specimens. See Biological Risk Assessment: General Considerations for Laboratories

Refer to List Nexternal icon on the Environmental Protection Agency (EPA) website for EPA-registered disinfectants that have qualified under EPA’s emerging viral pathogens program for use against SARS-CoV-2.

Cultures of SARS-CoV-2 should be handled in a Biosafety Level 3 (BSL-3) laboratory using BSL-3 practices, and inoculation of animals with infectious wild-type SARS-CoV-2 should be conducted in an Animal Biosafety Level 3 (ABSL-3) facility using ABSL-3 practices and respiratory protection.

Suspected and confirmed SARS-CoV-2 positive clinical specimens, cultures, or isolates should be packed and shipped as UN 3373 Biological Substance, Category B.

https://www.cdc.gov/coronavirus/2019-ncov/lab/lab-biosafety-guidelines.html

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News

Cells from human foetuses are important for developing vaccines – but they’re not an ingredient – The Conversation

Two embryonic cell lines have been used to develop COVID-19 vaccines: human embryonic kidney cells called HEK 293 and human embryonic retinal cells called PER.C6. The PER.C6 cell line is from an elective abortion in the Netherlands in 1985, and the HEK 293 cell line comes from an undisclosed source (either spontaneous miscarriage or elective abortion) in the Netherlands in about 1972.

Johnson & Johnson used PER.C6 cells in their COVID-19 vaccine development, and the Oxford/AstraZeneca vaccine used HEK 293 cells. CanSino Biologics and Gamaleya Research Institute’s Sputnik V vaccines have also used HEK 293 cells.

Moderna and Pfizer/BioNTech used HEK 293 cells in their proof-of-concept tests to see effectively take up the genetic instructions contained in these vaccines and produce the required spike protein. But human embryonic cell lines were not used to make either company’s final vaccine.

HEK 293 and PER.C6 cell lines have been genetically altered to include the part of the adenovirus instructions that trigger replication of adenoviruses. This allows the production of a large amount of the final vaccination product and allows the removal of the adenoviral replication instructions in the vaccine.

http://archive.today/2022.10.02-145609/https://theconversation.com/cells-from-human-foetuses-are-important-for-developing-vaccines-but-theyre-not-an-ingredient-157484

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Opinion

The ex-Pfizer scientist who became an anti-vax hero – Reuters

Michael Yeadon was a scientific researcher and vice president at drugs giant Pfizer Inc. He co-founded a successful biotech. Then his career took an unexpected turn.

https://www.reuters.com/investigates/special-report/health-coronavirus-vaccines-s

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News

How the British Government subjected thousands of people to chemical and biological warfare trials during Cold War – The Independent (2015)

During the Cold War, the British Government used the general public as unwitting biological and chemical warfare guinea pigs on a much greater scale than previously thought, according to new historical research.

In more than 750 secret operations, hundreds of thousands of ordinary Britons were subjected to ‘mock’ biological and chemical warfare attacks launched from aircraft, ships and road vehicles.

Up until now historians had thought that such operations had been much less extensive. The new research, carried out by Ulf Schmidt, Professor of Modern History at the University of Kent, has revealed that British military aircraft dropped thousands of kilos of a chemical of ‘largely unknown toxic potential’ on British civilian populations in and around Salisbury in Wiltshire, Cardington in Bedfordshire and Norwich in Norfolk.

https://www.independent.co.uk/news/uk/politics/how-british-government-subjected-thousands-people-chemical-and-biological-warfare-trials-during-cold-war-10376411.html

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Publications

Why Most Clinical Research Is Not Useful – Prof. John Ioannidis

Many clinical research studies, even in the major general medical journals, do not satisfy the identifiable features that make them useful. These features include:

  • problem base;
  • context placement;
  • information gain;
  • pragmatism;
  • patient centeredness;
  • value for money;
  • feasibility;
  • transparency.

Most clinical research findings false. Further, most of the true findings do not result in huge human benefit. Reform and improvement in the clinical research are overdue.

See also: Peer review: a flawed process at the heart of science and journals by Richard Smith at the Journal of the Royal Society of Medicine

Quoted summary points

Blue-sky research cannot be easily judged on the basis of practical impact, but clinical research is different and should be useful. It should make a difference for health and disease outcomes or should be undertaken with that as a realistic prospect.

Many of the features that make clinical research useful can be identified, including those relating to problem base, context placement, information gain, pragmatism, patient centeredness, value for money, feasibility, and transparency.

Many studies, even in the major general medical journals, do not satisfy these features, and very few studies satisfy most or all of them. Most clinical research therefore fails to be useful not because of its findings but because of its design.

The forces driving the production and dissemination of nonuseful clinical research are largely identifiable and modifiable.

Reform is needed. Altering our approach could easily produce more clinical research that is useful, at the same or even at a massively reduced cost.

https://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.1002049

Categories
News

Neil Ferguson, the scientist who convinced Boris Johnson of UK coronavirus lockdown, criticised in past for flawed research – The Telegraph

https://www.telegraph.co.uk/news/2020/03/28/neil-ferguson-scientist-convinced-boris-johnson-uk-coronavirus-lockdown-criticised/