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H7N9 Vaccine Discussions/Preparations First Steps.

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jdljr1 View Drop Down
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    Posted: April 04 2013 at 1:20pm
     What to do, what to do???  If we commit our vaccine plants to prepare for H7N9, we might have little vaccine for next year's seasonal flu, and that kills people every year.  So wait until it is confirmed to be spreading easily between humans?  Yes, of course.  Although by then, the clock will already be ticking...
     Tic, tock.  Tic, tock...
 
 

World experts debate case for new bird flu vaccine

12:20pm EDT

By Ben Hirschler and Kate Kelland

LONDON (Reuters) - Experts from around the world are in daily talks about the threat posed by a deadly new strain of bird flu in China, including discussions on if and when to start making a vaccine.

Any decision to mass-produce vaccines against H7N9 flu will not be taken lightly, since it will mean sacrificing production of seasonal shots. And scientists warn it will take months to get any finished bird flu vaccine to the market.

But the groundwork is being laid.

The virus has been shared with World Health Organization (WHO) collaborating centers in Atlanta, Beijing, London, Melbourne and Tokyo, and these groups are analyzing samples to identify the best candidate to be used for the manufacture of vaccine - if it becomes necessary.

It is still a big "if", even assuming the continued spread of the new disease, which has killed five of the 14 people that it has infected in China.

"It is an incredibly difficult decision because once you make it you have to change from making seasonal flu vaccines and go to making a vaccine for this virus," said Jeremy Farrar, a leading expert on infectious diseases and director of Oxford University's research unit in Vietnam.

That could mean shortages of vaccine against the normal seasonal flu which, while not serious for most people, still costs thousands of lives.

Sanofi Pasteur, the world's largest flu vaccine manufacturer, said it was in continuous contact with the WHO through the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), but it was too soon to know the significance of the Chinese cases.

Other leading flu vaccine makers include GlaxoSmithKline and Novartis.

Preliminary test results suggest the new flu strain responds to treatment with Roche's drug Tamiflu and GSK's Relenza, according to the WHO.

MONEY DOWN THE DRAIN?

There is no evidence yet of person-to-person transmission of H7N9 flu, and scientists do not yet know how what the strain's potential is to develop into a human pandemic. Wendy Barclay, a flu virologist at Imperial College London, said one major argument against moving too soon would be financial.

"There is a possibility now that flu researchers will all rush to work on H7N9 and grants will be awarded for intensive research to develop vaccines ... and that could be pouring money down a drain because it could be that the barriers for this virus are high enough that we don't need to worry about it."

She said scientists should first be focused on getting "the practical biology and the sequence analysis" before they decide to move on.

Since the H1N1 swine flu pandemic of 2009, in which drugmakers took six months to develop and distribute effective vaccines, manufacturers have been stepping up efforts to produce shots faster to deal with the rapid spread of disease.

It remains a lengthy process, however.

"There is presently no technology that can quickly and cost-effectively mass-manufacture vaccine," said Anton Middelberg, a flu vaccine researcher at the University of Queensland.

"Although the WHO is sending materials for vaccine development to China, it is unlikely that vaccine will be produced quickly enough to impact this outbreak."

Still, the flu vaccine community is not starting completely from scratch.

A degree of preparedness already exists because the last WHO vaccine strain selection meeting in February had already decided to consider the broad H7 virus category as a pandemic candidate.

The European Center for Disease Prevention and Control said vaccine candidate strains had also been developed as a response to previous H7 human cases in Europe and North America.

"These candidate strains may not efficiently cross protect against the novel A(H7N9) strain, but the fact that they are moving towards development does indicate a degree of preparedness globally," the ECDC said.

(Editing by Will Waterman)

Thomson Reuters 2011.

John L
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Post Options Post Options   Thanks (0) Thanks(0)   Quote jdljr1 Quote  Post ReplyReply Direct Link To This Post Posted: April 05 2013 at 1:33am
 
It appears that someone else has percieved that the clock is already ticking too...
 
The%20New%20York%20Times

http://www.nytimes.com/2013/04/05/world/asia/cdc-has-begun-work-on-vaccine-for-new-china-flu.html?pagewanted=print&_r=0
April 4, 2013

C.D.C. Begins Work on Vaccine for China Flu

By DONALD G. McNEIL Jr. and ANDREW JACOBS

Federal health officials have begun to make a seed vaccine against the mysterious new H7N9 flu circulating in China, they said Thursday.

While it is being made “only as a precaution,” a spokesman for the Centers for Disease Control and Prevention emphasized, an agency virologist said the agency was “fairly worried” about the new virus.

China reported that it had confirmed 14 cases of the new flu, and on Friday it reported that six cases were fatal.

No cases of human-to-human transmission have been confirmed, even though China’s disease control agency has traced hundreds of people who had contact with the 14 known cases, the news agency Xinhua reported.

The flu, previously found only in wild birds, was isolated for the first time in domesticated birds on Thursday; after it was found in pigeons in a Shanghai live bird market, the authorities began culling every bird there.

It will take at least a month to create the seed vaccine, even though the agency is speeding the process by building it from synthetic DNA rather than waiting for a virus sample to arrive from China, said Michael Shaw, associate laboratory director for the C.D.C.’s influenza division.

Because China has posted the genetic sequences of the virus on public databanks, it is possible to build the genes for the virus’s outer spikes in a laboratory and attach them to a viral “backbone” that has already been proven to grow well in labs and in the sterile chicken eggs in which flu vaccines are made.

Then the seed vaccine must be tested in ferrets. They will be vaccinated and given some time to grow antibodies, then a solution of the H7N9 flu will be squirted into their noses. Doctors will then have to wait a few days to see if they get sick.

“If everything works smoothly the first time, we could theoretically have it ready to send to manufacturers within four weeks,” Dr. Shaw said. “But some things, like ferrets, you can’t speed up.”

By that time, said Tom Skinner, a spokesman for the agency, it would have a clearer idea how dangerous the new flu is.

It is still not clear how lethal it is, Dr. Shaw said, “because we may be seeing only the serious cases, the ones who go to hospitals.” How many mild cases went undetected will be known only by testing hundreds of blood samples for antibodies.

It is also not known how people are getting infected, he said. The few known cases are spread out in a wide area around Shanghai. Exposure to infected poultry is an obvious suspicion. That is the risk factor for H5N1, another bird flu that has killed 371 people since 2003 but recently has been found only in Cambodia, China and Egypt. With the new flu, only two of the 14 known cases are poultry workers; a third was a cook.

Finding it in pigeons is novel, Dr. Shaw said. “It’s clearly not making the pigeons ill, since no one’s seen large numbers of pigeons dying. Pigeons usually aren’t tested. And this could make control harder. Chickens are easy to round up.”

According to the World Health Organization, preliminary tests in China suggest the new virus is susceptible to the antiviral drugs Tamiflu and Relenza.

Several countries have acted against the flu. Vietnam banned imports of Chinese poultry. Japan posted airport notices urging people to report flu symptoms. Hong Kong banned the import of live birds from the mainland.

Donald G. McNeil Jr. reported from New York, and Andrew Jacobs from Beijing.


 
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Post Options Post Options   Thanks (0) Thanks(0)   Quote carbon20 Quote  Post ReplyReply Direct Link To This Post Posted: April 05 2013 at 3:54am
hi john i thought i read it was resistant to Tamiflu and Relenza , (will check)

by the time they get a antivirus on the market it will have recombined with h5n1 sorry

for being such a pesimist, (realist)
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Meanwhile, the ECDC today issued a risk assessment that offered some new details about the virus.

The assessment confirmed earlier reports that H7N9 is a reassortant that contains hemagglutinin (H) and neuraminidase (N) from another H7N9 strain and has six other gene segments from an H9N2 virus. Some human H9N2 infections have occurred and have usually involved uncomplicated illness, but a more severe case was seen in one immunocompromised patient.

The H7N9 virus has a specific mutation, called E627K, in its PB2 gene that was also found in an H7N7 virus that caused the death of a Dutch veterinarian in 2003, the ECDC reported. The same mutation has been linked to high virulence, host range adaptation, and airborne transmission in H5 viruses, but its significance in this setting is not yet clear.

In other comments, the ECDC said that H7 vaccine candidate strains have been developed in response to previous human H7 flu cases. "These candidate strains may not efficiently cross protect against the novel A(H7N9) strain, but the fact that they are moving towards development does indicate a degree of preparedness globally," the agency said.

The ECDC also said that one H7N9 isolate contained a neuraminidase substation that confers resistance to oseltamivir (Tamiflu) in H3N2 viruses. Despite this, the agency expects that tests will confirm that the virus is sensitive to the antiviral drug, and a WHO statement today said preliminary testing in China suggests that that's the case.

The WHO said it saw no evidence of ongoing H7N9 transmission and added that no trade or travel restrictions are currently warranted.

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Post Options Post Options   Thanks (0) Thanks(0)   Quote jdljr1 Quote  Post ReplyReply Direct Link To This Post Posted: April 05 2013 at 5:10am
     The DNA vaccine being developed at CDC utilises an advanced process and will be specific to H7N9.
     I agree that overreliance on anti-viral meds on the other hand is a mistake, as if a pandemic occurs, the virus will as usual swiftly evolve resistance to these.
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Post Options Post Options   Thanks (0) Thanks(0)   Quote carbon20 Quote  Post ReplyReply Direct Link To This Post Posted: April 06 2013 at 3:55am
WHO is in contact with national authorities and is following the event closely. The WHO-coordinated international response is also focusing on work with WHO Collaborating Centres for Reference and Research on Influenza and other partners to ensure that information is available and that materials are developed for diagnosis and treatment and vaccine development. No vaccine is currently available for this subtype of the influenza virus. Preliminary test results provided by the WHO Collaborating Centre in China suggest that the virus is susceptible to the neuraminidase inhibitors (oseltamivir and zanamivir).
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Post Options Post Options   Thanks (0) Thanks(0)   Quote jdljr1 Quote  Post ReplyReply Direct Link To This Post Posted: April 11 2013 at 3:14pm
     And so, in the second (and best)  Omega Man/I Am Legend movie, Chuck Heston is an Army doctor on the phone with a superior, with a rack of a dozen experimental vaccines in front of him.  He is watching the TV which is showing the situation in China deteriorating, when his superior asks him, "Now, look!  Are any of these really going to work?"  With typical  Heston bravado, he scowls, "How the hell would I know?"  He then hangs up, says "Well, there is only one real way to find out,"  and begins to inject himself with all twelve of them....
     Wow!  And I thought the day after I was stupid enough to get pneumovax and flu vaccine on the same day, that I had a bad vaccine hangover!
 
 
April 11, 2013

New Technology Speeding Progress on Bird Flu Vaccine

By REUTERS

CHICAGO (Reuters) - Even as U.S. officials this week awaited the arrival of a sample of the new bird flu virus from China - typically the first step in making a flu vaccine - government-backed researchers had already begun testing a "seed" strain of the virus made from the genetic code posted on the Internet.

This new, faster approach is the result of a collaboration among the U.S. government, vaccine maker Novartis and a unit of the J. Craig Venter Institute, which is using synthetic biology - in which scientists take the genetic code of the virus and use it as a recipe to build the virus from scratch.

It was an idea born in the aftermath of the 2009 H1N1 pandemic, in which production delays and poor-quality seed strain slowed delivery of the vaccine until October, late enough that people were already sick with swine flu.

The new method has shaved two weeks off the vaccine-making process. It will take five to six months to ramp up production, but even weeks could make a difference in the case of a potentially deadly flu pandemic, said Robin Robinson, director of the Biomedical Advanced Research and Development Authority, an agency that falls under the U.S. Department of Health and Human Services' Office of the Assistant Secretary for Preparedness and Response.

"We'll take it," Robinson said. "If the virus turns out to be a tough one, that could be very important."

So far, at least 33 people have been infected and 10 have died from the strain of bird flu known as H7N9 first found in humans last month.

When the genetic sequence for the virus became available on March 30, Robinson said, U.S. health officials decided to try the new synthetic biology technique to try to speed the process. That's when Novartis and Venter's company, Synthetic Genomics Vaccines Inc, went to work. By Thursday, April 4, they had synthetic DNA ready and had started to grow the virus in dog kidney cells.

Mike Shaw, director of the U.S. Centres for Disease Control and Prevention, said a sample of the virus arrived from China on Thursday afternoon.

That would normally be the starting point of making a seed vaccine. Scientists would take the sample, grow it and ensure it would grow well in chicken eggs or cells.

That involves a certain amount of guesswork, however. The new process of building the virus based on its genetic code allows "almost guaranteed success," Shaw said.

"That is because you're creating a virus that is almost tailor-made," he said.

Shaw said the CDC plans to take a vaccine candidate at least to the stage of human safety trials.

(Reporting by Julie Steenhuysen; Editing by Douglas Royalty)

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Post Options Post Options   Thanks (0) Thanks(0)   Quote Albert Quote  Post ReplyReply Direct Link To This Post Posted: April 11 2013 at 5:38pm
lol, i a agree John.   There seems to be a lot of urgency in getting that vaccine out now.  The stakes must be real high with this little flu bug if they're doing this in the first 11 days.  Time to roll the dice on a vax.
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