From the ECDC this morning, a review of our recent track record in producing a pandemic vaccine compared to the the goals and expectations of a little more than a year ago.
Since 2006 the World Health Organization has been actively working with the private sector to increase global pandemic vaccine capacity, initially in response to the perceived threat from the H5N1 virus.
In September of 2006 they released their Global Action Plan (GAP) for vaccine production titled:
In October of 2007, the WHO released this decidedly optimistic assessment of vaccine manufacturing prospects by the year 2010:
Projected supply of pandemic influenza vaccine sharply increases
23 OCTOBER 2007 | GENEVA -- Recent scientific advances and increased vaccine manufacturing capacity have prompted experts to increase their projections of how many pandemic influenza vaccine courses can be made available in the coming years.
Last spring, the World Health Organization (WHO) and vaccine manufacturers said that about 100 million courses of pandemic influenza vaccine based on the H5N1 avian influenza strain could be produced immediately with standard technology. Experts now anticipate that global production capacity will rise to 4.5 billion pandemic immunization courses per year in 2010.
In May of 2009, several weeks after the emergence of the novel H1N1 virus, Dr. Marie-Paule Kieny, director of the WHO's Initiative for Vaccine Research, estimated (via CIDRAP Experts to discuss swine flu vaccine decision May 14) global vaccine production 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.
An even more aggressive manufacturing projection came from a May document called Recommendations of the Strategic Advisory Group of Experts (SAGE) on Influenza A (H1N1) vaccines.
A review of 2009 production status for northern hemisphere seasonal vaccine indicates that industry plans to produce approximately 480 million doses of trivalent seasonal vaccine in 2009. Of this, 350 and 430 million doses will be available by 30 June and 31 July 2009, respectively.
For influenza A (H1N1), it is estimated that up to 4.9 billion doses could be produced over a 12‐month period after the initiation of full scale production if:
- There is a vaccine yield equivalent to that routinely obtained for seasonal vaccine and the use of the most dose‐sparing formulations.
- In this situation, there is a potential access for the UN of supplies of up to 400 million doses.
But things did not go nearly so well as hoped 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.
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.
The irony is, had the WHO’s projections been met over the past year, they would likely be subject to even more bashing from their critics over the costs and `waste’ given the ultimate mildness of the pandemic and the general public apathy towards getting vaccinated.
Proving, I suppose, that public health is often a thankless job.
Of course, the next time a virus emerges, we may not be quite so lucky. It could be highly virulent, and the demand for a vaccine extremely pressing.
So the need to bolster global vaccine manufacturing capacity remains.
Earlier this year CIDRAP covered many of these issues with:
Here’s the link to the ECDC report, including their commentary.
06 Jul 2010
Partridge J, Kieny M-P, the World Health Organization H1N1 Influenza Vaccine Task Force; Vaccine 2010 May 18. Initiative for Vaccine Research, World Health Organization, Geneva; Vaccine 2010 May 17. [Epub ahead of print]
In September 2006 the WHO published the Global pandemic influenza action plan to increase vaccine supply (GAP) in an attempt to increase the production capacity for seasonal influenza vaccines thus contributing to meet the vaccine demand during an influenza pandemic . The short term goal of the GAP was to enable the production of a pandemic vaccine sufficient to immunise 2 billion people within 6 months from the availability of a pandemic virus vaccine.
And here is a link to the Global Vaccine deployment figures as of July 2nd, 2010.