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Global Agreement to share flu virus genetic data and vaccines

Shiloh

Editor, Senior Moderator
http://www.cidrap.umn.edu/cidrap/content/influenza/general/news/apr1211sharing-br.html

WHO group renews push for pact on virus-sharing, pandemic vaccine access

Lisa Schnirring * Staff Writer

Apr 12, 2011 (CIDRAP News) ? Leaders from a World Health Organization (WHO) working group on virus sharing and vaccine issues related to pandemic preparedness today said they hope to reach an agreement by Friday (Apr 15) so that it could go to the World Health Assembly (WHA) for a vote in May.

The group's cochairs, ambassadors Bente Angell-Hansen from Norway and Juan Jose Gomez-Camacho from Mexico, briefed reporters today in Geneva, where the working group is meeting this week to finish what they hope is the final draft of the agreement.

In late 2006, virus sharing became an international flash point when Indonesia broke a long tradition of free international sharing of flu virus specimens by withholding its H5N1 virus samples as a protest against the high cost of commercial vaccines derived from such samples. The controversy has drawn attention to the problem of equitably distributing vaccines in the event of a pandemic.

In 2007 the WHO appointed a working group to hammer out an agreement to ease global virus-sharing issues, but so far problems such as intellectual-property rights and mechanisms for sharing the viruses and ensuring benefits for developing countries have stalled the group's progress.

Gomez-Camacho told reporters that the WHO asked him and Angell-Hansen to take over leadership to get momentum going again. He said that over the past year he and Angell-Hansen have conducted thorough consultations with governments, the pharmaceutical industry, and nongovernmental organizations (NGOs).

He said two major lessons of the 2009 H1N1 pandemic were that the world wasn't prepared for a severe pandemic and that the global community had a difficult time getting vaccine to developing countries. Gomez-Camacho said in some instances, developing countries lacked policies and infrastructure needed to accept donated vaccine.

The working group met with NGOs in February and sought written input from other such groups. Gomez-Camacho said the panel has had talks with pharmaceutical organizations from developing countries, and on Apr 7 held a private consultation with about 30 large companies. "These meetings are taking place within the context of complex negotiations," he said, adding that the talks were sensitive, because of pricing and intellectual property issues.

"We hope to wrap up the package by Friday in our last round of negotiations," he said. Ideally the framework, if adopted by the WHA, would serve as a guidepost for pandemic virus-sharing and vaccine issues for the next 5 years, after which technology advancements will likely require a review of the agreement and possible changes.

Angell-Hansen said the group is trying to build a flexible system that also shoots for more predictable vaccine production and sharing with developing countries. A major goal is to ensure a basic supply of pandemic vaccine for all countries, especially to protect healthcare workers and other key personnel. "We don't want states crumbling if there's a pandemic with a high mortality rate," she said, adding that she hopes the pact produces a "push button" system that funnels vaccine to areas in need.

Such a system will require monitoring of where the world stands in terms of production, lab capacity, and adjuvant availability, she said. Industry officials project that the global pandemic vaccine capacity has grown to 1.1 billion doses, which will expand to 1.8 billion doses as new companies in developing countries start producing vaccine through their collaborations with major producers, according to Angell-Hansen.

See also:

WHO virus sharing working group background materials

Apr 12 WHO press conference audio file
 
Re: CIDRAP: WHO group renews push for pact on virus-sharing, pandemic vaccine access

Re: CIDRAP: WHO group renews push for pact on virus-sharing, pandemic vaccine access

Source: http://in.reuters.com/article/2011/04/14/us-pandemic-vaccines-idINTRE73D8I720110414

Deal in reach on flu virus-sharing, vaccine access
By Stephanie Nebehay

GENEVA | Fri Apr 15, 2011 3:50am IST

GENEVA (Reuters) - A global deal is tantalizingly close under which countries would share flu virus samples in exchange for access to affordable vaccines derived from them, thus saving lives in a pandemic, senior diplomats said...
 
Re: CIDRAP: WHO group renews push for pact on virus-sharing, pandemic vaccine access

Re: CIDRAP: WHO group renews push for pact on virus-sharing, pandemic vaccine access

US agrees to global vaccine-sharing deal

Countries would share virus samples in return for affordable vaccines derived from them under plan


snip

Negotiators ended an all-night session with a draft agreement accepted by all countries, including the United States, which was the last to join the consensus, they said.

snip

Under the deal, 10 percent of production would be earmarked for developing countries, diplomats said.

more...

http://www.msnbc.msn.com/id/42619573/ns/health/
 
Re: Global Agreement to share flu virus genetic data and vaccines

This could be really great news.

...a long tradition of free international sharing of flu virus specimens...

Please go back to this so we can openly post the sequences and discuss our findings.
 
Re: Global Agreement to share flu virus genetic data and vaccines

> complex negotiations," he said, adding that the talks were sensitive,
> because of pricing and intellectual property issues.

sounds like a gisaid-like system to me, though
 
Re: Global Agreement to share flu virus genetic data and vaccines

Basically the developing countries want a guaranteed percentage of flu vaccines at an affordable price (or free) in exchange for their genetic samples.
 
Re: Global Agreement to share flu virus genetic data and vaccines

will they be published or not
 
Re: Global Agreement to share flu virus genetic data and vaccines

From gs's link:

Two kinds of SMTAs (standard material transfer agreements) were discussed. The first one concerned sharing of viruses within the WHO Global Influenza Surveillance Network (SMTA 1), and the second dealt with the sharing of viruses outside this network (SMTA 2).

All I can see from the article and the SMTA 2 .pdf is: You give this and you will recieve that in return.

So far, I don't see anything about openly sharing the sequences.
 
Re: Global Agreement to share flu virus genetic data and vaccines

> sharing of viruses within the WHO Global Influenza Surveillance Network

WHO is usually public, that's their mission, as a sub-organisation
of UNO.
I also remember Fukuda repeatedly advocating free data-availability


they can hardly keep vaccine-info secret, see the half-yearly WHO
vaccine-recommendations and the ferret antisera-tables,
testing the current viruses.

And for the non-vaccine data, bird viruses, segments other than HA,
what's the argument to claim for IP on those ?
 
Re: Global Agreement to share flu virus genetic data and vaccines

member-countries of the world medical body have agreed to share flu virus samples
in exchange for vaccines produced from them.
enable countries to sharing virus samples with the WHO?s network of laboratories, and will, in return, get affordable vaccines from these labs.
reaching the final accord, will be presented to the next WHO general assembly in May.
 
Re: Global Agreement to share flu virus genetic data and vaccines

News Release WHO/6
17 April 2011

Landmark agreement improves global preparedness for influenza pandemics

GENEVA, 17 April 2011 – After a week of negotiations continued through Friday night and into Saturday morning, an open-ended working-group meeting of Member States successfully agreed upon a Framework that ensures that in a pandemic, influenza virus samples will be shared with partners who need the information to take steps to protect public health.

The working-group meeting was convened under the authority of the World Health Assembly and coordinated by the World Health Organization (WHO).
The new Framework includes certain binding legal regimes for WHO, national influenza laboratories around the world and industry partners in both developed and developing countries that will strengthen how the world responds more effectively with the next flu pandemic. By making sure that the roles and obligations among key players are better established than in the past -- including through the use of contracts -- the Framework will help increase and expedite access to essential vaccines, antivirals and diagnostic kits, especially for lower-income countries.

In addition, the Framework will also put the world in a better position for seasonal influenza and potential pandemic threats such as the H5N1 virus, because some key activities will begin before the next pandemic, such as greater support for strengthening laboratories and surveillance, and partnership contributions from the industry.
During an influenza outbreak, knowing the exact makeup of the virus is critical for monitoring the spread of the disease, for knowing the potential of the virus to cause a pandemic and for creating the life-saving vaccines as well as other technological benefits. However, developing countries often have limited access to these vaccines for several reasons: they often do not have their own manufacturing capacity, global supplies can be limited when there is a surge in demand as is seen during pandemics, and vaccines can often be priced out of the reach of some countries.

The new Framework will help ensure more equitable access to affordable vaccines and at the same time, also guarantee the flow of virus samples into the WHO system so that the critical information and analyses needed to assess public health risks and develop vaccines are available.

“This has been a long journey to come to this agreement, but the end result is a very significant victory for public health,” says Dr Margaret Chan, Director-General of the World Health Organization. “It has reinforced my belief that global health in the 21<sup>st</sup> century hinges on bringing governments and key stakeholders like civil society and industry together to find solutions.”

The legal regimes will address clear roles and responsibilities of WHO, national labs and vaccine and pharmaceutical manufacturers.

“The framework provides a much more coherent and unified global approach for ensuring that influenza viruses are available to the WHO system for monitoring and development of critical benefits such as vaccines, antiviral drugs and scientific information while, at the same time, ensuring more equitable access to these benefits by developing countries,” says Dr Keiji Fukuda, Assistant Director-General of Health Security and Environment at WHO.

The working group was co-chaired by Ambassador Juan José Gomez-Camacho (Mexico) and Ambassador Bente Angell-Hansen (Norway) and included the participation of WHO Member States, industry representatives, civil society and other organizations involved in influenza pandemic preparedness.

“It was a historic negotiation that proved that when governments show statesmanship, stature, responsibility and fine diplomacy, they can successfully meet the most pressing global challenges,” says Gomez-Camacho. “It also helped us realize that public and private partnerships that bring together governments, corporations and civil society are extraordinarily powerful tools that, in the future, I believe will be the only possible way for the world to face these incredibly complex challenges.”

“This agreement promotes global health security and solidarity in pandemic times. It reflects also a unique partnership with industry, and contains concrete measures of cooperation with both industry and civil society,” says Angell-Hansen. “I am grateful to the very many who contributed to this positive outcome. It demonstrates what we can achieve through health diplomacy in WHO.”

The agreed upon framework will be presented to the World Health Assembly in May this year for its consideration and approval.

The negotiations by 193 WHO Member States began in November 2007 amid concerns that the avian influenza (H5N1) virus in South-East Asia could become a human pandemic.

Additional link:
Please note that when available the documents will be posted on www.who.int/gb and http://apps.who.int/gb/pip
 
Re: Global Agreement to share flu virus genetic data and vaccines

can we have the comments from Chang and Supari, please
 
Re: Global Agreement to share flu virus genetic data and vaccines

Again a major opportunity has been missed to address the real problem.
I will not go through the reasoning again here as I have already posted it in anticipation of this outcome (first post in linked thread). While a return to sharing, improved testing, more equitable vaccine distribution and the dropping of some of the more absurd attempts to patent Mother Nature’s inventions are all laudable it does not get us any closer to being able to produce a vaccine for a flu pandemic.

The vaccine appeared in the needed volumes after the pandemic had largely finished and this agreement will not help change that fact. In this case the timing could not have been kinder in that it started in the N-Hem. (much the larger in population terms) just at the end of its flu season giving the longest possible lead times to get our act together, but it still was not enough. Both hemispheres had complete flu seasons with no vaccine. This time large numbers did not die because the virus had a low Case Fatality Rate but that was luck, had it been H1N1(1918) like or - heaven forefend - H5N1 like then we would just have watched everyone die and would now be having a blood-letting of the politicians who left us completely unprotected - which we still are.
 
Re: Global Agreement to share flu virus genetic data and vaccines

Good point. The vaccine was not widely available until November of 2009 and the pandemic started approximately in April of 2009.

It gets back to the same ole thing.

1) Get yourself in good physical shape i.e. lose weight and stop smoking,
2) Get some preparations i.e 90 days of medical prescriptions and 2 weeks, at least, of food and other essentials,
3) Find some "flu buddies" to help you during a flu epidemic or pandemic,
4) Stay home from work if you are sick. Keep your children out of school as necessary. Stay away from crowds.
5) Wear face masks and wash your hands frequently to lessen the chances of other illnesses and infections that might wear down your overall physical condition,
6) Consult your medical practitioner about natural medicines and over-the-counter medicines to use for flu.
7) Stay away from your pets so that you do not give the flu to them. :(
 
Re: Global Agreement to share flu virus genetic data and vaccines

we did not implement methods of delaying, because the flu
was not so virulent.
In a severe pandemic we would have closed airports etc.
and people would just have been more careful
(in some countries)
 
Re: Global Agreement to share flu virus genetic data and vaccines

we did not implement methods of delaying, because the flu
was not so virulent.
In a severe pandemic we would have closed airports etc.
and people would just have been more careful
(in some countries)


I disagree with your assessment, gsgs. The world was exceptionally lucky as pointed out by JJackson that pH1N1 was not a high CFR, high morbidity, novel influenza virus.

I don't think that the governments of developed nations have a contingency plan for an actual high CFR influenza strain, especially one that is easily transmissible. They do not seem to have nationwide plans of NPI that can stop the spread of an easily transmissible, virulent novel virus. Also, I think that strong corporate interests will delay public health officials from implementing measures that would stop transmission because of the economic losses. So I don't think airports will close until it is too late.

Finally, most people only have a fuzzy idea of how to prevent disease infection. By the time individuals start to understand NPI at the individual and family level, it will be too late to stop the spread of the new virulent virus.
 
Re: Global Agreement to share flu virus genetic data and vaccines

they will close even without order in a severe pandemic.
Remember SARS

"too late" for one place is not "too late" for another

why was there a summer wave in 2009 in NYC but not
e.g. Philadelphia ?
Cancun-->air-->St.Francis

we can maybe start a mild counterpandemic
(create a suitable virus now)


I remember that one study from UK , estimating how much time
could be gained

http://www.advisorybodies.doh.gov.uk/spi/minutes/modelling-implications-summary-jan07.pdf

estimated delay:
90% travel restriction from all countries : 3-4 weeks
99.9% travel restriction (very hard)from all countries : 3-4 months
 
Re: Global Agreement to share flu virus genetic data and vaccines

they will close even without order in a severe pandemic.
Remember SARS

"too late" for one place is not "too late" for another

why was there a summer wave in 2009 in NYC but not
e.g. Philadelphia ?
Cancun-->air-->St.Francis

we can maybe start a mild counterpandemic
(create a suitable virus now)

H3N2?

H5N1?

H9N2?

H1N1?

Tinkering with potential reassortment for an unknown future pandemic is irresponsible. A search for a universal vaccine would be a better investment of effort.
 
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