Thursday, April 04, 2013

H7N9 Vaccine Realities

 

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# 7073

 


While we are far from knowing how serious this H7N9 bird flu virus outbreak in China will ultimately become, there are people in the world who’s job it is to plan for a variety of `worst case pandemic scenarios.  

 

So it should come as little surprise that discussions over the possibility of developing an emergency pandemic vaccine for this virus are already underway around the globe.

 

The CDC has acknowledged their intention to pursue the development of a seed vaccine, as part of a series of `routine preparedness measures’ that are taken whenever a new virus threatens.

 

We’ve seen these sorts of precautionary steps before, with the H5N1, H3N2v and H7N9 viruses (see H3N2v Vaccine Trials & Bangladesh To Share H9N2 Bird Flu Virus).

 

This report from Reuters.

 

CDC to prepare bird flu vaccine just in case

By Reuters staff

The U.S. Centers for Disease Control and Prevention (CDC) said on Thursday it was monitoring a new strain of bird flu and has started work on a vaccine just in case it is needed.

 

So far, the strain known as avian influenza A (H7N9) is only in China and has not yet been found to be capable of being transmitted from person to person.

 

The strain has killed five people, and global health officials are debating whether to start mass-producing a vaccine.

 

(Continue . . . )

 

Via Japan’s NHK network, we get a report on an analysis released today by Japan’s National Institute of Infectious Diseases of the  H7N9 virus.

 

While we’ve yet to see direct evidence of human-to-human transmission  - this reassortant H7 virus is said likely able to replicate in the nose and upper airway - a trait that has long been suspected as needed to make avian flu viruses transmit more efficiently in humans.

 

The research team leader, Takato Odagiri, is calling for the development of a vaccine. Follow the link to read:

 

H7N9 flu virus differs from other viruses

 

Japanese researchers say the new strain of influenza virus spreading in China has different characteristics than other avian viruses. They are calling for the development of a new vaccine.

 

Experts at the National Institute of Infectious Diseases released their findings on Thursday. Their findings are based on gene sequences obtained from China of 2 Shanghai men who died from the infection and an Anhui Province woman in serious condition.

 

(Continue . . .)

 

 

And my thanks to Helen Branswell for tweeting this Reuters story earlier today on the complexities involved in switching from a seasonal flu vaccine run (already in progress) to a pandemic vaccine production schedule.

  

 

World experts debate case for new bird flu vaccine

Thu Apr 4, 2013 12:12pm EDT

  • Experts in daily talks on risks posed by new China virus
  • Researchers analysing samples to find vaccine candidate
  • Decision to make vaccine depends on whether H7N9 spreads

By Ben Hirschler and Kate Kelland

LONDON, April 4 (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.

(Continue . . .)


 

We do have some recent experience with rolling out an emergency pandemic vaccine. 

 

Even though the first H1N1 vaccines came off the production line in the fall of 2009, it proved too little & too late to have much of an impact on the second pandemic wave. 


Estimates made In May of 2009 by Dr. Marie-Paule Kieny, director of the WHO's Initiative for Vaccine Research, (see CIDRAP Experts to discuss swine flu vaccine decision May 14) gave our global vaccine production capacity as:

 

. . . .  somewhere between 1 billion and 2 billion doses in a year, based on an estimated seasonal vaccine capacity of about 900 million doses. Current world population is more than 6 billion.

 

"Being conservative, we think there'll be at least between 1 and 2 billion doses," she said.

 

But at the end of the day, things did not go nearly as well as originally planned and the global production of vaccine fell far short of these estimates.

 

In fairness, the yield from the seed virus proved less than anticipated and the use of adjuvants – to reduce the amount of antigen needed per shot – was met with public resistance.

 

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On the plus side (and this isn’t well appreciated), the vaccine produced came off the assembly line sooner than expected (albeit in small quantities), and has proven to be both safe and effective.

 

Which has to be seen as a considerable victory, even if the ultimate number of doses produced was disappointing.

 

In a world of 7 billion, the reality is that our ability to manufacture and (just as importantly) distribute a pandemic vaccine in  a short amount of time remains severely limited.

 

It is really a matter of unforgiving numbers.

 

Numbers that start with billions of people at risk from any novel pandemic virus, and end with the number of doses of vaccine that can be delivered in six to twelve months.

 

While improvements have been made in global vaccine manufacturing capacity since 2009, rolling out a pandemic vaccine is a huge undertaking.

 

It is likely that relatively few people could expect to see any novel pandemic vaccine in less than six months from the time production started.

 

And most of the world would probably still be waiting after a year.

 

Five  and a half years after she first wrote it, there is probably no better overview of the problems in the creation, production, and distribution of a pandemic vaccine than Maryn McKenna’s  award winning 7-part series the Pandemic Vaccine Puzzle which she penned in 2007 for CIDRAP.

 

Part 1: Flu research: a legacy of neglect
Part 2: Vaccine production capacity falls far short
Part 3: H5N1 poses major immunologic challenges
Part 4: The promise and problems of adjuvants
Part 5: What role for prepandemic vaccination?
Part 6: Looking to novel vaccine technologies
Part 7: Time for a vaccine 'Manhattan Project'?
Bibliography

Well worth revisiting.