Ensuring the Safety and Integrity of the World’s Drug, Vaccine, and Medicines Supply – Council on Foreign Relations – 14 May 2012

Posted on May 21, 2012. Filed under: Patient Safety, Pharmacy | Tags: , |

Ensuring the Safety and Integrity of the World’s Drug, Vaccine, and Medicines Supply – Council on Foreign Relations – 14 May 2012

Policy Innovation Memorandum No. 21

“The world is facing two immediate health crises concerning drugs and vaccines: affordable and reliable access to life-sparing medicines and the safety and reliability of those medicines. Regulation and distribution systems to ensure access and protect public safety, where they exist, are outdated. And over the past decade all aspects of raw materials extraction, ingredients synthesis, formulation, packaging, and distribution have globalized to such an extent that nearly every pill, injection, and salve contains elements derived from multiple countries. The supply chain of production is compromised: hundreds of thousands of people are dying annually from false, poisonous, or substandard medicines. Unless this issue is addressed, millions more lives and the credibility of medicines and vaccines will be lost. The Groups of Eight (G8) and Twenty (G20) countries should take the lead, as a matter of urgency, in promoting cooperation among national safety regulators, tougher legal frameworks, and regional networks of surveillance and prosecution.”

… continues on the site

Media on this – Drug Safety Crisis – ABC RN – 19 May 2012

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Ranking Vaccines: A Prioritization Framework – Phase I: Demonstration of Concept and a Software Blueprint – Institute of Medicine – 10 May 2012

Posted on May 11, 2012. Filed under: Infectious Diseases | Tags: , , |

Ranking Vaccines: A Prioritization Framework – Phase I: Demonstration of Concept and a Software Blueprint – Institute of Medicine – 10 May 2012

Full text

“As a number of diseases emerge or reemerge, thus stimulating new vaccine development opportunities to help prevent those diseases, it can be especially difficult for decision makers to know where to invest their limited resources. Therefore, it is increasingly important for decision makers to have the tools that can assist and inform their vaccine prioritization efforts.

In this first phase report, the IOM offers a framework and proof of concept to account for various factors influencing vaccine prioritization—demographic, economic, health, scientific, business, programmatic, social, policy factors and public concerns. Ranking Vaccines: A Prioritization Framework describes a decision-support model and the blueprint of software—called Strategic Multi-Attribute Ranking Tool for Vaccines or SMART Vaccines. SMART Vaccines should be of help to decision makers. SMART Vaccines Beta is not available for public use, but SMART Vaccines 1.0 is expected to be released at the end of the second phase of this study, when it will be fully operational and capable of guiding discussions about prioritizing the development and introduction of new vaccines.”

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Pandemic Vaccine Distribution Policy for the Twenty-First Century – Homeland Security Affairs – 2012

Posted on February 29, 2012. Filed under: Infectious Diseases | Tags: , , |

Pandemic Vacscine Distribution Policy for the Twenty-First Century – Homeland Security Affairs – 2012

“Introduction

The nation’s response to the 2009 H1N1 Pandemic has been met with scrutiny, candor, and a collaborative effort among federal and state agencies, local public health authorities, associations, and experienced practitioners. The Institutes of Medicine and Center for Biosecurity have held conferences that have paved the way toward improving pandemic response.1 The workshop format used at these conferences resulted in the identification and exploration of issues relating to vaccine supply, administration, and distribution by both attendees and panelists. However, after-action vaccine distribution discussions failed to result in an overarching implementation strategy that could be linked to many elements of a coherent vaccine distribution strategy. This article presents a model that could serve as a conceptual framework for designing a pandemic vaccine distribution policy.”

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National Partnership Agreement on Essential Vaccines: Performance report for April 2010–March 2011 – COAG Reform Council – released 6 September 2011

Posted on September 6, 2011. Filed under: Infectious Diseases | Tags: , , |

National Partnership Agreement on Essential Vaccines: Performance report for April 2010–March 2011 – COAG Reform Council – released 6 September 2011

“This is the council’s second report on the National Partnership Agreement on Essential Vaccines. The council has assessed the performance of all States and Territories against four benchmarks based on maintaining, and, where possible, improving immunisation coverage rates.

This report was submitted to COAG on 10 August 2011, and publicly released on 6 September 2011.”

Executive summary –  PDF 108KB
Full report – PDF 498KB

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Adverse Effects of Vaccines: Evidence and Causality – Institute of Medicine – report to be released 25 August 2011

Posted on August 24, 2011. Filed under: Infectious Diseases | Tags: , , , |

Adverse Effects of Vaccines: Evidence and Causality – Institute of Medicine – to be released 25 August 2011

The Institute of Medicine will release the report Adverse Effects of Vaccines: Evidence and Causality on Thursday, August 25, 2011 at 11:00 am EDT. Committee chair, Ellen Wright Clayton, and two members of the committee, S. Claiborne Johnston and Douglas Barrett, will host an audio webcast at 1:00 pm EDT on August 25th.

A link to the webcast will be available shortly before the 1:00 pm start at http://www.iom.edu/vaccineadverseeffects or http://www.nationalacademies.org . Listeners will be able to email questions to the committee during the audio webcast via a link on the same webpage.

The report and summary material will be available for free download at 11:00 am at http://www.iom.edu/vaccineadverseeffects .

Please use the registration link ( HERE). Registered participants will receive an email reminder 15 minutes prior to the start of the audio webcast on August 25th.

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Review of the management of adverse effects associated with Panvax and Fluvax: Final Report – 10 March 2011 – report released 26 May 2011

Posted on May 31, 2011. Filed under: Infectious Diseases | Tags: , , |

Review of the management of adverse effects associated with Panvax and Fluvax: Final Report – 10 March 2011 – report released 26 May 2011

Professor John Horvath

Print ISBN 978-1-74241-463-8
Online: 978-1-74241-464-5
Publications Number: D0371

Media Release

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Universal flu vaccine successfully tested – ABC – 7 February 2011

Posted on February 7, 2011. Filed under: Infectious Diseases, Influenza A(H1N1) / Swine Flu | Tags: |

Universal flu vaccine successfully tested: report

Copied from the ABC website:
“Scientists in Britain have successfully tested a vaccine which could work against all known flu strains, the Guardian newspaper reports.

The new vaccine, developed by scientists at Oxford University, differs from traditional treatments by targeting proteins inside the flu virus rather than proteins on the flu’s external coat.

The two proteins within the virus are similar across strains and less likely to mutate, meaning new vaccines would not have to be developed for each new strain of the illness.”  … continues on the ABC site

About Dr Sarah Gilbert

More

News report on the research

Google news on the research

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Report to the President on Reengineering the Influenza Vaccine Production Enterprise to Meet the Challenges of Pandemic Influenza – White House – 19 August 2010

Posted on August 25, 2010. Filed under: Infectious Diseases | Tags: , , |

Report to the President on Reengineering the Influenza Vaccine Production Enterprise to Meet the Challenges of Pandemic Influenza – White House – 19 August 2010

Press release

President’s Council of Advisors on Science and Technology Releases Plan to Improve Nation’s Vaccine Response Against Pandemic Influenza and Other Outbreaks Improvements Could Cut Several Weeks Off Vaccine Production, Save Thousands of Lives.

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Ministerial Review into the Public Health Response into the Adverse Events to the Seasonal Influenza Vaccine – WA – released 11 August 2010

Posted on August 13, 2010. Filed under: Infectious Diseases, Influenza A(H1N1) / Swine Flu | Tags: , |

11 August 2010
Ministerial Review into the Public Health Response into the Adverse Events to the Seasonal Influenza Vaccine – Final Report to the Minister for Health (PDF 2.52MB) – Western Australia

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TGA approves Pandemic (H1N1) 2009 influenza vaccine for use in children aged from 6 months of age – 3 December 2009

Posted on December 3, 2009. Filed under: Influenza A(H1N1) / Swine Flu | Tags: , , , |

TGA approves Pandemic (H1N1) 2009 influenza vaccine for use in children aged from 6 months of age
3 December 2009

“Australia’s medicines regulator, the Therapeutic Goods Administration (TGA), has today approved the use of Panvax® H1N1 influenza vaccine to include children aged from 6 months of age.

In addition, the TGA has also approved Panvax H1N1 Junior® influenza vaccine specifically for use in children aged from 6 months up to 3 years of age.

The TGA approved the use of Panvax® H1N1 influenza vaccine in children, and Panvax H1N1 Junior®, following analysis of paediatric clinical trial data.

The TGA approved Panvax® H1N1 influenza vaccine on 18 September 2009 for use in adults and children over 10 years of age.

Panvax® H1N1 influenza vaccine and Panvax H1N1 Junior® are manufactured by the Australian company, CSL Limited, using the same processes as those used to manufacture seasonal influenza vaccines.

Information on the vaccination dosage and planned roll-out of the vaccine programme can be found at http://www.healthemergency.gov.au.

Healthcare practitioners and consumers are encouraged to report any side effects by telephoning 18 02 007 or by using the online reporting form available from the TGA website at http://www.tga.gov.au/problem/panvaxh1n1.htm.

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Pandemic vaccine priority for most at risk – UK – 13 August 2009

Posted on August 14, 2009. Filed under: Infectious Diseases, Influenza A(H1N1) / Swine Flu | Tags: , , |

Pandemic vaccine priority for most at risk
13 August 2009 17:25
UK  Department of Health   (National)

“More than 11 million people in England will be targeted first

The priority groups who will be first in line for vaccination against swine flu will include pregnant women, frontline health and social care workers, and everyone in at-risk groups aged over six months, Health Secretary Andy Burnham announced today.

This follows advice from independent experts on who should be first in line for vaccination.

The Joint Committee on Vaccination and Immunisation reviewed the evidence and advised the Department of Health on the crucial risk groups to be offered vaccination in order to reduce the rate or possibility of serious illness.

This advice was also scrutinised and endorsed by the Scientific Advisory Group for Emergencies (SAGE).”

… continues on the website

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New swine flu vaccine developed – ABC News report – 29 June 2009

Posted on June 29, 2009. Filed under: Influenza A(H1N1) / Swine Flu | Tags: |

New swine flu vaccine developed Monday, 29 June 2009 Dani Cooper

“An egg-free vaccine for swine flu that can be produced from scratch within weeks has been made by Australian researchers.

The vaccine, which is currently not registered for use in Australia, matches the virus found in the 10-year-old boy from San Diego who was the first US case of the illness.

Professor Anton Middelberg, of the Australian Institute for Bioengineering and Nanotechnology at the University of Queensland in Brisbane, says it is different from conventionally produced vaccines because it is made in cell cultures instead of in eggs.

Middelberg says the advantage of the new technology, developed by US company Protein Sciences Corporation (PSC), is the speed and potency of the vaccine.
Pure protein

He says while the vaccine contains the same amount of protein as conventionally produced vaccines, it contains virus protein rather than a combination from egg and virus.

This means a single dose delivers three times as much of the virus protein as a conventional vaccine.

For those people considered at high risk this will generate a higher immune response in the body and therefore greater protection, he says.

Another advantage is because the vaccine is only made up of virus protein it opens up a variety of methods of delivery apart from injection.”  … continues on the ABC website

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Trial of Novel H1N1 ‘Swine’ Flu candidate vaccine to take place in Adelaide – 29 June 2009

Posted on June 29, 2009. Filed under: Influenza A(H1N1) / Swine Flu | Tags: , |

Trial of Novel H1N1 ‘Swine’ Flu candidate vaccine to take place in Adelaide Melbourne, Australia — 29/06/2009

“CSL Limited, Australia’s leading biopharmaceutical company, will shortly be commencing a clinical trial of a candidate vaccine against Novel H1N1 ‘Swine’ Flu. The trial will be undertaken in partnership with Clinical Research Organisation CMAX and the Royal Adelaide Hospital in South Australia. ” … continues on the website

Download the Release:
Trial of Novel H1N1 ‘Swine’ Flu candidate vaccine to take place in Adelaide (0.22Mb)

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