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Report of considerably increased global capacity for production of seasonal and pandemic vaccine ? reports of a WHO Survey May 2009 (ECDC, with commentary)
ECDC Health Content - Report of considerably increased global capacity for production of seasonal and pandemic vaccine ? reports of a WHO Survey May 2009
Scientific Advances - Pandemic (H1N1) 2009
Report of considerably increased global capacity for production of seasonal and pandemic vaccine ? reports of a WHO Survey May 2009
Collin N; de Radigu?s X; the World Health Organization H1N1 Vaccine Task Force
Vaccine production capacity for seasonal and pandemic (H1N1) 2009 influenza. Vaccine 2009 Jun 27. [Epub ahead of print].
Description:
This paper describes the results of a survey conducted in May 2009 by the World Health Organisation (WHO) after the emergence of the pandemic strain A(H1N1) 2009 among all influenza vaccine manufacturers. This was to review the current status of Northern Hemisphere seasonal vaccine production and to project the potential supply of a specific pandemic influenza A(H1N1) 2009 vaccine over a one-year period. The survey was based on a questionnaire sent electronically to 36 known or potential influenza vaccine manufacturers. It investigated each manufacturer?s trivalent seasonal influenza vaccine production status at three different points in time ? the end of May, end of June and end of July 2009 ? as well as their plans to produce specific influenza A(H1N1) 2009 virus vaccine.
In total, 25 manufacturers indicated their intentions to produce pandemic vaccine; 21 of them are also currently producing seasonal influenza vaccine. The results of the analysis were stratified according to their manufacturing capacity into two groups: the first group (group A) were all manufacturers (n = 7) that reported being able to produce at least 2 million doses of influenza A(H1N1) 2009 pandemic vaccine per week and the second group (group B) comprised the remaining 18 manufacturers with smaller capacities.As of June 2009, the total global (Northern and Southern hemispheres) annual capacity for trivalent seasonal influenza vaccine production stands at 876.4 million doses with group A companies responsible for 64% of this figure.
The target for 2009-10 Northern hemisphere production was reported at 492.8 million doses, an approximate 5% increase over the 470 million doses used during the season 2008-09. The actual status of the Northern hemisphere seasonal vaccine production was, as of 31st May 2009, 65.8% of the total planned for bulk H1N1 antigen, 73.4% of the total planned for bulk H3N2 antigen and 39.5% of the total planned for bulk B antigen.
Of the total target of 492.8 million doses of trivalent seasonal influenza vaccine expected to be produced for the season 2009-10, 38.0% was expected to be ready by the end of May, 72.2% by the end of June and 91.2% by the end of July.
Considering the capacity to produce a specific pandemic A(H1N1) 2009 vaccine, manufacturers were then asked to estimate their maximum production capacity based on three major assumptions:
The resulting estimates found that in the best case scenario, a maximum 94.5 million doses of influenza A(H1N1) 2009 vaccine could be produced per week which corresponds to 4.9 Billion doses in one year. More than 85% of the potential production output would be coming from group A companies. Eleven out of 25 manufacturers were willing to reserve 10% of doses for developing countries.
The authors commented that additional information would be needed on the number of doses that confer full protection and on what priority and risk groups should be targeted for vaccination to better interpret these figures. According to the author conclusions by the time most manufacturers are technically ready to initiate large-scale production of the new influenza vaccine (around June-July 2009), between 350 and 450 million of the total 492.8 million planned doses of seasonal influenza vaccine will already have been produced.
ECDC Comment (21st July 2009):
The results of this WHO survey are relevant and encouraging as they indicate that vaccine manufacturers, large & established and smaller & new are willing to invest in the risky area of influenza vaccine production. They are in broad accordance with the more speculative results of the earlier private surveys by the Oliver Wyman company with the PATH organisation but are more firm as the companies are making more real commitments.[1,2] It seems likely that these increases represents the willingness of companies to take on financial risks as well as technological advances such as dose-sparing through use of adjuvants. The seasonal vaccine capacity has further increased since 2008/2009 and the 2009/2010 production will be almost complete by the end of July 2009, ahead of when it is usually completed in the annual cycle. This means that the emergence of the pandemic virus has not affected the production of the seasonal vaccine and if countries wish they can begin their seasonal influenza campaigns early, thus avoiding the situation of running simultaneous campaigns with seasonal and pandemic vaccines. The estimated 4.9 billion doses of pandemic vaccine produced in one year in the Northern Hemisphere is a best case scenario, and it is likely to be an overestimate. Several obstacles may occur that would lessen significantly such an estimate.
In addition to those mentioned by the authors (vaccine yield, antigen-sparing strategy, full capacity production for 12 months) other factors should also be considered.
Firstly not all vaccine manufacturers will receive marketing authorisations at the same time depending on the availability of mock-up dossiers for pre-pandemic vaccines and on the early results on quality, safety and immunogenicity.
Secondly being a biologic process there are always uncertainties and risks in influenza vaccine production. For example there are reports that the growth of the virus seed used to produce the pandemic vaccines may be lower than that of seasonal viruses. In is encouraging that most, though not all manufacturers stated that they would be willing to reserve some of their production for developing countries. However it remains unclear how this all will be done and what mechanisms will be in place to ensure vaccine delivery and administration in either industrialised countries or the setting of developing countries.[3] Probably the biggest barrier are the sheer cost of the programmes and the major but necessary regulatory and licensing hurdles that are in place to ensure that safety is monitored and any problems detected in a timely manner.
Finally though it has to be noted that this is all encouraging for the long-term WHO GAP programme to increase seasonal vaccine production globally.[4]
References:
[1] Oliver Wyman and PATH Influenza Vaccine Strategies for Broad Global Access
[2] Oliver Wyman, IFPMA, WHO Influenza vaccine, supply and demand. Summary of findings March 2009
[3] ECDC Some Suggested ?Acid Tests? for helping assess, strengthen local preparedness for moderate or severe pandemics. February 2007
[4] WHO Global pandemic influenza action plan to increase vaccine supply. WHO Geneva Immunization, Vaccine and Biologicals. Epidemic and Pandemic Alert and Response. September 2006
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<cite cite="http://www.ecdc.europa.eu/en/health_content/sciadv/090728_sciadv.aspx">ECDC Health Content</cite>
Report of considerably increased global capacity for production of seasonal and pandemic vaccine ? reports of a WHO Survey May 2009
Collin N; de Radigu?s X; the World Health Organization H1N1 Vaccine Task Force
Vaccine production capacity for seasonal and pandemic (H1N1) 2009 influenza. Vaccine 2009 Jun 27. [Epub ahead of print].
Description:
This paper describes the results of a survey conducted in May 2009 by the World Health Organisation (WHO) after the emergence of the pandemic strain A(H1N1) 2009 among all influenza vaccine manufacturers. This was to review the current status of Northern Hemisphere seasonal vaccine production and to project the potential supply of a specific pandemic influenza A(H1N1) 2009 vaccine over a one-year period. The survey was based on a questionnaire sent electronically to 36 known or potential influenza vaccine manufacturers. It investigated each manufacturer?s trivalent seasonal influenza vaccine production status at three different points in time ? the end of May, end of June and end of July 2009 ? as well as their plans to produce specific influenza A(H1N1) 2009 virus vaccine.
In total, 25 manufacturers indicated their intentions to produce pandemic vaccine; 21 of them are also currently producing seasonal influenza vaccine. The results of the analysis were stratified according to their manufacturing capacity into two groups: the first group (group A) were all manufacturers (n = 7) that reported being able to produce at least 2 million doses of influenza A(H1N1) 2009 pandemic vaccine per week and the second group (group B) comprised the remaining 18 manufacturers with smaller capacities.As of June 2009, the total global (Northern and Southern hemispheres) annual capacity for trivalent seasonal influenza vaccine production stands at 876.4 million doses with group A companies responsible for 64% of this figure.
The target for 2009-10 Northern hemisphere production was reported at 492.8 million doses, an approximate 5% increase over the 470 million doses used during the season 2008-09. The actual status of the Northern hemisphere seasonal vaccine production was, as of 31st May 2009, 65.8% of the total planned for bulk H1N1 antigen, 73.4% of the total planned for bulk H3N2 antigen and 39.5% of the total planned for bulk B antigen.
Of the total target of 492.8 million doses of trivalent seasonal influenza vaccine expected to be produced for the season 2009-10, 38.0% was expected to be ready by the end of May, 72.2% by the end of June and 91.2% by the end of July.
Considering the capacity to produce a specific pandemic A(H1N1) 2009 vaccine, manufacturers were then asked to estimate their maximum production capacity based on three major assumptions:
- that the production yield is similar to that for seasonal vaccines;
- that each company uses the most antigen-sparing dose and
- that the production is maintained at full capacity for the whole 12 month period.
The resulting estimates found that in the best case scenario, a maximum 94.5 million doses of influenza A(H1N1) 2009 vaccine could be produced per week which corresponds to 4.9 Billion doses in one year. More than 85% of the potential production output would be coming from group A companies. Eleven out of 25 manufacturers were willing to reserve 10% of doses for developing countries.
The authors commented that additional information would be needed on the number of doses that confer full protection and on what priority and risk groups should be targeted for vaccination to better interpret these figures. According to the author conclusions by the time most manufacturers are technically ready to initiate large-scale production of the new influenza vaccine (around June-July 2009), between 350 and 450 million of the total 492.8 million planned doses of seasonal influenza vaccine will already have been produced.
ECDC Comment (21st July 2009):
The results of this WHO survey are relevant and encouraging as they indicate that vaccine manufacturers, large & established and smaller & new are willing to invest in the risky area of influenza vaccine production. They are in broad accordance with the more speculative results of the earlier private surveys by the Oliver Wyman company with the PATH organisation but are more firm as the companies are making more real commitments.[1,2] It seems likely that these increases represents the willingness of companies to take on financial risks as well as technological advances such as dose-sparing through use of adjuvants. The seasonal vaccine capacity has further increased since 2008/2009 and the 2009/2010 production will be almost complete by the end of July 2009, ahead of when it is usually completed in the annual cycle. This means that the emergence of the pandemic virus has not affected the production of the seasonal vaccine and if countries wish they can begin their seasonal influenza campaigns early, thus avoiding the situation of running simultaneous campaigns with seasonal and pandemic vaccines. The estimated 4.9 billion doses of pandemic vaccine produced in one year in the Northern Hemisphere is a best case scenario, and it is likely to be an overestimate. Several obstacles may occur that would lessen significantly such an estimate.
In addition to those mentioned by the authors (vaccine yield, antigen-sparing strategy, full capacity production for 12 months) other factors should also be considered.
Firstly not all vaccine manufacturers will receive marketing authorisations at the same time depending on the availability of mock-up dossiers for pre-pandemic vaccines and on the early results on quality, safety and immunogenicity.
Secondly being a biologic process there are always uncertainties and risks in influenza vaccine production. For example there are reports that the growth of the virus seed used to produce the pandemic vaccines may be lower than that of seasonal viruses. In is encouraging that most, though not all manufacturers stated that they would be willing to reserve some of their production for developing countries. However it remains unclear how this all will be done and what mechanisms will be in place to ensure vaccine delivery and administration in either industrialised countries or the setting of developing countries.[3] Probably the biggest barrier are the sheer cost of the programmes and the major but necessary regulatory and licensing hurdles that are in place to ensure that safety is monitored and any problems detected in a timely manner.
Finally though it has to be noted that this is all encouraging for the long-term WHO GAP programme to increase seasonal vaccine production globally.[4]
References:
[1] Oliver Wyman and PATH Influenza Vaccine Strategies for Broad Global Access
[2] Oliver Wyman, IFPMA, WHO Influenza vaccine, supply and demand. Summary of findings March 2009
[3] ECDC Some Suggested ?Acid Tests? for helping assess, strengthen local preparedness for moderate or severe pandemics. February 2007
[4] WHO Global pandemic influenza action plan to increase vaccine supply. WHO Geneva Immunization, Vaccine and Biologicals. Epidemic and Pandemic Alert and Response. September 2006
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