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Influenza ( 2009 H1N1 ) Vaccine Market

Influenza, 2009 H1N1 Global Market Trends

This knol presents an analysis of the global market for vaccines to treat Influenza ( 2009 H1N1 ) for the current year. It is estimated that the combined global market for seasonal influenza vaccine will increase by 15% in 2009 to $3500 million. The pandemic influenza vaccines market is estimated at $12 billion for the 1 billion doses a year current global output, half for the year 2009 and the other for next year. Operating at peak production the pharmaceutical industry can produce 90 million doses per week. WHO has given a price range of $20 to $2.5 for pandemic vaccine per dose. Addition of adjuvant and shift to cell cultures can stretch the present global production capacity to increase protection for world population. Results of clinical trial with tested 2009 H1N1 vaccines indicate that a single dose may offer protection to over 90% of the vaccinated subjects. The total global market for Influenza including 2009 H1N1 is projected to be $10.4 billion during the current winter (2009-2010) . If these projections are correct, the global vaccine market may grow from $24 billion in 2008 to $29 billion in the current year. These figures confirm the remarkable turnaround for the vaccine industry from the bleak horizon of late 1990s and upto 2003.

Table des matières


Krishan Maggon
Consultant Pharmaceutical Biotechnology R&D & Advisor
Geneva, Switzerland & New York, USA
Salim Djelouat
Professor Medical Analyses and Medical bacteriology / Scientific Author / knolAuteur

Garry Jenkins
Author, Journalist & Editorial Consultant, London, United Kingdom
Patrick Lahaye
Patrick Lahaye
Infographiste 2D & 3D, Webmaster, Belgique
Knol Publishing Guild (KPG)
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This knol analyses the vaccine market for seasonal and 2009 H1N1 influenza for the current year.
An attempt has been made to generate market research and intelligence data in realtime for the 2009 H1N1 pandemic outbreak.

The Avian Influenza Pandemic in Asia served as a test case to plan for future pandemic outbreaks. 
The lessons learned and recommendations made during the Avian Influenza H5N1 outbreak have been adopted by the industry to meet the unexpectedly high demand and to scale up production of vaccines.[1][2][3][4][5][6][7][8]
The current market for seasonal Influenza is dominated by two therapeutic categories: vaccines to protect vulnerable populations for seasonal (elderly, immunocompromised patients), Pandemic (children, pregnant women, obesity, chronic disease and immunocompromised patients) and neuraminidase inhibitor antivirals Tamiflu® (Roche) and Relenza® (Glaxo Smith Kline).[9]  For the 2009 H1N1 Pandemic influenza vaccine sale projections, traditional methods and models are not suitable or reliable. In the past, these methods have failed to predict strong demand by arthritis patients for tumor necrosis factor alpha blockers and revival of the vaccine industry. [10][11][12] The vaccine industry requires forecast or projections due to long term planning, confirmed sales order and production scheduling to meet surging demand during Pandemic outbreak.[13][14][15][16][17][18]

Regulatory Requirements

All vaccines must pass safety and efficacy criteria for FDA/EMEA approval and marketing. Influenza vaccines are manufactured according to Good Manufacturing Practise to ensure quality.  The current regulations for yearly approval of influenza vaccines (FDA, EMEA, WHO) are listed in Appendix A. These include testing for antibody titres, any transient adverse events like pain or swelling at injection site or any other adverse reactions. To qualify for registration, vaccines must generate sufficient antibody response in 70% of treated subjects within 2-3 weeks and not cause any serious adverse reaction.[19][20][21][22][23] It is very difficult to show superior safety or efficacy of one brand over any other brand or detect rare side effects in trials. Such a trial will involve over 5-10 million subjects, follow up over 1 year and will be very costly to manage, monitor and analyse with unpredictable outcome. These objectives can be achieved with current postmarketing surveillance or Vaccine Watch. The efficacy of current seasonal and pandemic influenza vaccines has ranged from 60-90%. Testing of drugs and vaccines in babies and pregnant women raises variety of ethical concerns about the need for testing, which must be addressed. NIAID has announced that it is testing the efficacy of 2009 H1N1 vaccines in high risk groups [24][25][26].  The strains for yearly influenza vaccines are selected and recommended. The current seasonal vaccine strains as recommended by experts of WHO/CDC are provided in Appendix B.  The types of vaccines are described in Table 1. The regulatory burden adds to 70% of the current cost of vaccines. A new vaccine requires testing in over 10000 subjects and may cost over $ 1 billion for R&D and additional 400 million on the GMP manufacturing facility [10][12][27][28][29][30][31].

Data Collection and Analysis

A database of top selling  human vaccines and biologic brands  has been maintained since 2002. The information collected from company annual and quarterly reports, FDA/EMEA approval, medical meetings and financial press and media is included and regularly updated. In case of foreign currency, the exchange rate used by the company in its report is utilized for dollar conversion . The database has tracked most of the recently launched brands approved by the FDA and EMEA. Company reporting under strict SEC regulations is more reliable for sales of its own brands than commercial market research firm confidential and patented data collection methods. In case of co marketing by different companies for the same brand or active ingredient under different brand, the figures are added up to arrive at total sales. Brand names of the medicines are used as sales are reported for the brands, companies rarely provide breakdown of sales by active ingredient or generic name. The sales estimate for seasonal influenza vaccines is based on actual 6 months sales in 2009, company own sales projections and guidance for analysts and the normal sales increase during the winter influenza period from previous years [12][29][32][33]. The actual sales data from the major companies validate the above projections.
Vaccine sales are reported under a variety of categories. For influenza vaccines, sales are reported for all brands collectively or in case of low sales, combined with other types of vaccines. For the 2009 H1N1 vaccine estimate a variety of news sources, press releases by WHO, CDC, FDA, EMEA, medical journals and industry were used to collect information used in Tables 2-3. These sources and headlines are described and listed in Appendix C and D.[12][29][34]

I Never Get The Flu

Source: National Center for Immunization and Respiratory Diseases 
Running Time: (1:01)Release Date: 12/15/2009

CDC Video Player.  Flash Player 9 is required.
CDC Video Player.
Flash Player 9 is required.
The pharmaceutical industry is facing a range of pressures, both logistically, ethically and politically. It is under pressure to meet high demand and is working round the clock to achieve this. In addition it has donated vaccine to the World Health Organisation, reduced prices for poor countries and charities. There are also Governmental requirements. The purchase prices of influenza vaccines and antivirals are dictated by Governments as bulk purchase. Under US law, for instance, industry has to give maximum discount to government purchasers. These discounts are in the range 20-30% of the market price. The market value of the vaccines produced is used with a standard 30% discount ( free samples, donation, volume discount etc. (See direct links to Industry Sites provided at the end of the article). Cell cultured vaccines are priced higher due to higher cost of production and suitability for persons allergic to egg proteins. Similarly Flu Mist is priced higher than traditional egg based vaccines. WHO and  French media reports indicate that over 1 billion doses of Pandemic 2009 H1N1 vaccines were ordered by governments. Swiss media has indicated that its Government paid 93 million Swiss francs ( $90 million) for 13 million doses of pandemic vaccine
Most of the 2009 H1N1 vaccines produced passed current safety and efficacy criteria and were approved by regulatory authorities in major markets. These include vaccines with adjuvants, produced by cell culture and inactivated virus used in Pandemic FluMist. The FDA has not approved any influenza vaccine containing adjuvents in over 70 years. These vaccines have been available in Europe for the past five years. WHO has recommended the use of 2009 H1N1 Flu Mist for all including pregnant women. EMEA has not approved Flu Mist which has been marketed in US for over 7 years [35][36][37][38][39][40][41].

Pathogen free fertilized eggs are used. Each of the three strain of the virus is grown separately by injection and stimulating the production of antivirus antibodies. After incubation for few days, the virus is separated from egg, purified and inactivated and combined with two other starins to produce 1 dose of the trivalent seasonal influenza vaccine. The egg derived vaccine is not recommended for persons allergic to egg proteins. Flu Mist uses a live inactivated virus and is contraindicated during pregnancy and in patients with asthma and other respiratory problems in the US.
One egg is required to produce 1 dose (15 mcg) of trivalent seasonal influenza vaccine. In case of a monovalent 2009 H1N1 Pandemic vaccine and with adjuvant, one egg may produce 2 doses or more.  In case of low yields, 2 eggs may be required to produce 1 dose of vaccine. During bird flu epidemic, CDC provided $2 billion of R&D funding to the leading vaccine companies to develop cell cultured manufacture of vaccines in 2005. Cell cultured vaccines and vaccines with adjuvants are approved in Europe but not in US.  
Novartis has produced pandemic H1N1 virus by cell culture using dog kidney cell line. Its cell cultured H5N1 Pandemic bird flu vaccine was approved by the EMEA but not by the FDA. Novartis has reported only 30% yield with the H1N1 pandemic vaccine as the virus grows poorly in eggs (Appendix D).
Over 90% of the current Influenza vaccines are produced in eggs and only 10% in cell cultures. Under Pandemic outbreaks, it is easier to scale up cell culture vaccine production to meet high demand.
Acambis has developed a universal influenza vaccine and has tested in Phase I trials. A monoclonal antibody for prophylalaxis is in development besides newer cell cultured and adjuvent enhanced vaccines.



The list of currently approved vaccines is described in Appendix E. Appendix F lists the variety of influenza vaccines produced by Novartis in traditional egg culture, cell culture in protein free medium and with and without adjuvant MF059 and preservative thimoseral.
The sales of seasonal Influenza vaccines for the past few years is shown in Fig 1 [12][29]. There has been constant increase in the demand and use of influenza vaccine mainly in the Western World. However the coverage is still low and it does not reach all the elderly persons and children requiring protection.

Global Seasonal Influenza Vaccine Market

Table 2 lists orders for the 2009 H1N1 vaccines placed by selected OECD Governments. Although it is the same threat, the announcements have either given the dollar amounts or doses ordered and rarely the doses and cost are listed together (USA $2 billion, France 80 million doses and over $ 1 billion, UK 60 million doses, Germany, Italy, Japan, Spain) . Sanofi Aventis and Glaxo Smith Kline have donated 100 and 50 million doses of vaccines to the WHO for distribution in poor countries. These donations amounted to  10% of production capacity of the two companies. Sanofi Aventis capacity is thus 1 billion doses and Glaxo Smith Kline 500 million doses, together the two companies account for 50% of the global production. Eight of the OECD rich countries have donated a total of 50 million doses ( Appendix C ) [33][34][36]. Sanofi Aventis is committed to supply 75 million doses of its pandemic vaccine to the US government and has increased production capacity to 125 million doses in its US plant and will supply 45% of US orders.
The 2009 H1N1 Vaccine can be sold at around $10-20 in OECD countries, in the range of $5-10 in mid level  developing economies and in the range of $2.5-5 in the poor countries (paid by charities, foundations and global agencies, World Bank). This model by charging patients and countries by their ability to pay is better than providing free treatments.
Rich nations have locked in and ordered most of the current capacity for antivirals and pandemic flu vaccines. France and UK have ordered supplies to cover entire population while Germany for 30% and USA for over 40% of its population in the first phase and 80% in the second phase if required.

The CDC Revised estimates provides a good overview of the spread of the 2009 H1N1 in the US.

CDC Estimates of 2009 H1N1 Cases and Related Hospitalizations and Deaths from April-November 14, 2009, By Age Group

2009 H1N1
Mid-Level Range*
Estimated Range *

0-17 years ~16 million ~12 million to ~23 million
18-64 years ~27 million ~19 million to ~38 million
65 years and older ~4 million ~3 million to ~6 million
Cases Total ~47 million ~34 million to ~67 million
0-17 years ~71,000 ~51,000 to ~101,000
18-64 years ~121,000 ~87,000 to ~172,000
65 years and older ~21,000 ~15,000 to ~29,000
Hospitalizations Total ~213,000 ~154,000 to ~303,000
0-17 years ~1,090 ~790 to ~1,550
18-64 years ~7,450 ~5,360 to ~10,570
65 years and older ~1,280 ~920 to ~1,810
Deaths Total ~9,820 ~7,070 to ~13,930
* Deaths have been rounded to the nearest ten. Hospitalizations have been rounded to the nearest thousand and cases have been rounded to the nearest million. Exact numbers also are available.

Table 1    Types of  Influenza Vaccines

  • Seasonal Influenza Vaccines: egg based
       With and without thimerosal (Multidoses contain the preservative,
        single dose vials are free from it)
        With and without adjuvants
  • FluMist Live  Inactivated Virus
  • Cell Cultured Seasonal Influenza Vaccines: free from egg proteins
        With and without adjuvants
  • 2009 H1N1 Influenza Vaccines  Egg  based
  • 2009 H1N1 Flu Mist , Live attenuated
  • Cell Cultured 2009 H1N1 Vaccines
      With and without thimerosal 
    With and without adjuvants  

Table 2. Pandemic Influenza (2009 H1N1) Vaccine Orders

Country Doses  Ordered  million  Market Value $ million
USA 251
UK 132 1980
France 94 1500
China* 65
Japan 53 840
                             Germany       50                                 900
Canada 50 800 
Italy 48 765
Spain 37 590 
Netherlands 34 540 
Portugal 28 440 
Greece 24 380 
Australia 21  340 
Hungary 20 320 
Sweden  18  290 
Switzerland, South Korea
13 , 13
210, 210
Belgium  12  190 

About 1 billion doses of vaccines were ordered by governments of major economies and Western countries.

Pandemic Influenza (2009 H1N1) Vaccine Orders : Doses Ordered million


Pandemic Influenza (2009 H1N1) Vaccine Orders : Market Value $ million

 OECD countries account for 99% orders for the current world influenza vaccine production capacity.
US, UK, France, Italy, Switzerland, Australia, Brazil, Norway have annonced donation of 10% of H1N1 Vaccine to WHO for poor countries.
* Local Chinese vaccine is cheaper and costs $5-10 per dose. 
How to estimate the market for Pandemic Inflenza H1N1 Vaccine, which is sold out even before production and there is limited supply insufficient to meet demand. Indirect methods have been used and data compiled from News Sources ( Appendix C, D. Table 3 )

Cancelled Orders

European Governments which ordered 2 doses per person to cover the entire population have started negotiating with the vaccine industry to cancel orders of undelivered vaccines for the 1Q 2010. France has cancelled 50 million doses of the vaccine from Sanofi Aventis, Glaxo Smith Kline and Novartis. Germany has cancelled 30% of its 50 million dose order. Greece has cancelled 75% of its order while Belgium and Norway have cancelled 30% of the order. Spain, UK, Switzerland have cancelled orders. US has cancelled orders. These cancelled orders will affect the sales in 2010 and have only minimal impact on the 4Q2009 sales of vaccines. Glaxo Smith Kline have provided an estimate of its pandemic vaccine sales in the 4Q09 as 1.36 billion dollars (130 million doses sold, 60 million donated to the WHO) 
Table 3.  Pandemic Influenza ( 2009 H1N1 ) Vaccine Market Forecast
WHO  Production Capacity  Estimate    2-4 billion doses ( 90 million doses per week maximum)
WHO Price range  per dose    $ 20 -   $ 2.5
Donation to WHO          Sanofi Aventis         100 million doses
                                     Glaxo Smith Kline    50 million
                                      8 Rich countries       50 million  
Reduced pricing for poor countries               150 million
Produced in low cost countries                      150 million

Market Price of 1 billion doses                       $ 15 billion

Price paid by Governments                            $5-8 billion 
Global Market  conservative estimate and WHO pricing:  $ 10 billion

Market Projections for the year 2009 Influenza season :   $ 5 billion

Market Projections for the year 2010 Influenza season :   $ 5 billion

WHO has requested 1.5 billion dollars from donor countries to buy vaccines, Tamiflu ( $520 million) and Relenza for poor countries.

WHO has regularly increased its global vaccine production capacity estimate from  900 million, 2 billion and now 4.9 billion doses by 36 vaccine companies. Over 90% of influenza vaccine is produced in OECD countries and poor countries with population of 2.6 billion have no local vaccine production. Global syringe production is only 40 million pieces per year.
The above estimate is backed up by last year sales of seasonal influenza vaccines where 
450 million doses were sold for $3.1 billion ($10 per dose). Pandemic influenza vaccine average market price is $10 per dose. News sources show large deviations, Australian government paid only $89 million for 21 million doses to CSL. Sanofi Aventis indicated a price near 7 Euro per dose (real price) for French Government, while the Government claims that it ordered 94 million doses worth 871 million euro or $1236 million (market price).[30][31][33][34]. The French government ordered 50 million doses from Glaxo Smith Kline, 28 million doses from Sanofi Pasteur, 16 million doses from Novartis at average price of 6.25 euro per dose. Baxter cell cultured Pandemic flu vaccine which can be used in persons allergic to egg proteins was purchased at a price of 10 euro per dose and the government ordered 50000 doses. German government has been criticized for paying $900 million for 50 million doses from GSK. GSK states that 22 Governments have ordered 440 million doses of its Pandemic 2009 H1N1 vaccine.
Table 4 lists the sales projections for influenza vaccines for the leading vaccine companies and Table 5 provides an estimation of the overall global influenza market.

Table 4. Pandemic Influenza ( 2009 H1N1 ) Vaccine Sales 

Company  2009 sales $ millions
Sanofi Aventis 1000
Glaxo Smith Kline 1000
Novartis 1000
Baxter 500
MedImmune 500
Sino Vac 200
CSL 200
Solvay 100
Other Companies 1200

Company sales data available, pricing and government orders are considered business secrets. Many leading companies have provided 4Q 2009 sales data. Similar levels of sales are expected in the 1Q 2010 as well by Novartis, Glaxo and Sanofi Aventis.

  • All the Pandemic vaccines produced by cell cultures (10%), egg based (90%), with adjuvants and pandemic Flu Mist are safe, effective and approved in the USA, Europe and Japan.
  • The average price of 1 dose is $15 or Euro 10, price paid by governments are in $7-10 per dose.
  • These vaccines are added to the Western Government stockpile as well.
  • 10% of the production is donated to WHO or offered at reduced prices to the poor countries.
  • Delay in regulatory approval, peak production level, external factors  may shift >30% of the revenue to next year.
  • Vaccine companies have accepted orders based on the production capacity and schedule and delivered on the first come first served basis.

Table 5  Global Influenza Market 2009

 Product Estimated Sales 2009 $ million
 Relenza®  1100
 Tamiflu®  3100
 Seasonal Vaccine  3500
 Pandemic 2009 H1N1 Vaccine  5700
Total 13400

If the costs of Face Mask, Hand wash soaps and antiseptic hand lotions, hospitalizations, syrups, pharmacy and doctors fees are included, the total 2009 H1N1 market was over $ 100 billion in 2009. 


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The leading influenza vaccine companies are Sanofi Aventis, Glaxo Smith Kline, Baxter, Novartis and Astra Zeneca (MedImmune). Two other vaccine majors Wyeth and Merck are not directly involved with the manufacture of influenza vaccines. Merck joint venture with Sanofi Aventis under Sanofi Aventis Pasteur  MSD  provides some sales of influenza vaccines [12][29][32].  The importance of vaccine is underlined by recent takeovers of Wyeth by Pfizer, MedImmune by Astra Zeneca and equity stake in Crucell by Johnson  & Johnson.

Several other companies manufacture influenza vaccines by the traditional egg culture method. These are  Solvay, Crucell, Serum Institute, SinoVac. Baxter pandemic (avian and 2009 H1N1) and Novartis seasonal influenza vaccines produced by cell cultures were approved by the EMEA in Europe. The adjuvents containing seasonal and pandemic vaccines from Glaxo Smith Kline and Novartis were approved in Europe and no safety issues emerged after several years of marketing.

The total global sale of seasonal influenza vaccines in 2008 were $3.0 billion. The total global market for vaccines in 2008 was $ 25 billion[12][29]. The leading influenza company was Sanofi Aventis (FluZone®) with sales of $1.08 billion followed by Glaxo Smith Kline flu vaccines (Fluarix®, Flu Laval®, Flu pandemic brands) at $520 million in 2008. The price of the leading brand FluZone was $10-13 per unit dose in the USA and Europe. However if discounts are considered, vaccine makers may only get $8-10 per dose at wholesale price. These prices are better than the 2-3 dollar per unit prices which were charged in the 1990s. Sanofi Aventis sales included supplies of pandemic avian influenza vaccine worth $300 million  for stockpile in the USA. Based on 45% share of the world influenza vaccine market for Sanofi Aventis gives a figure of only $2.3 billion for the global market, which is based on IMS data. IMS has historically undervalued the vaccine and biologics market. It may not include sales by Indian, Chinese, Russian, Brazilian and South African companies. Authors estimate is backed by a recent paper from Datamonitor staff in Nature which estimated the 2008 influenza market at $ 2.8 billion.[42]. In their latest 3 Q 2009 report, Glaxo Smith Kline ($1.5 billion), Sanofi Aventis ($1 billion) and Novartis ( $750 million) have indicated expected 4Q 2009 and yearly sales increase due to Pandemic influenza vaccine.These companies have projections of similar high level of sales in the first Q of 2010 as well [43][44][45][46] . Sanofi Aventis estimates the global vaccine market to increase to $35 billion by 2013 ($ 23 in developed countries + 12 billion in developing countries) and has invested over $2.5 billion in production facilities. Sanofi Aventis  total vaccine sales in 2009 are estimated at $ 5 billion.

Adverse reactions to seasonal flu vaccine include aches, fever and sore arms. Allergy to egg proteins used for vaccine cultures in some patients leads to rare cases of hives, dizziness and breathing problems. For, as yet unknown reasons, the most serious side effect, Guillain-Barrè Syndrome, is reported in 1 out of 100,000 patients receiving vaccine or 1 out of 1 million (WHO). This condition leads to serious nerve damage and muscle weakness [58][86][90][91][92][93][97][98][99][100][102][104]
Leading vaccine companies have done clinical testing of the Influenza 2009 H1N1 Vaccines in healthy volunteers. Clinical trials were started and completed in Australia, USA, China, India and Europe. The USA government tested Sanofi Aventis and CSL vaccines in 2400 healthy subjects at 8 medical and university hospitals. Most of the hospitals and virologists and investigators are involved in testing of seasonal flu vaccine. Other companies Novartis, Glaxo, Merck, Baxter had their own clinical testing programmes to obtain FDA and EMEA approval. Novartis started and completed clinical testing of its pandemic flu vaccine in 6000 volunteers in Germany, UK and USA. Sanofi Aventis clinical testing of its vaccine was completed in Europe  Presence of high level of antibody titre to Swine Flu and absence of severe adverse reaction is required for for regulatory approval. Presence of sufficient levels of antibody titres determined the single dose dose schedule  for most and a 2 dose schedule for children under 10 years of age. The vaccination of pregnant women hasbeen discussed and the antibody response is similat to normal adult populations. Mothers pass on antibodies to the fetus thus protecting their babies during the first 6 months of life. The Swine Flu vaccine  has been
approved in US and Europe and is available in limited numbers and production may peak by December 2009. The FDA and EMEA have approved several 2009 H1N1 vaccines  with ongoing review of the data and fast tracked approval of Pandemic vaccine. There is going to be sufficient vaccine for persons who want it, there is going to be shortage if everyone wants the vaccine [70][74][80][81][82][83][84][85][87][88][89][96][97][98][102][103].

The vaccine industry has done a great job by increasing production from 450 million doses in 2008 to 3 billion doses in 2009. Governments have dictated their price to the industry which provides for some profits but excludes windfall profits. A similar capacity increase during the avian influenza outbreak failed to provide any revenue or confirmed orders for the industry. Despite excellent safety record of adjuvents in Europe, none of the adjuvent containing 2009 H1N1 vaccine has been approved in the USA. Use of adjuvents can reduce the required dose by half to one third and thus make the current supply reach more subjects. Similarly cell cultured vaccine has not been approved by the FDA. Despite the safety record of the nasal spray Flu Mist, it has not been approved in the European union countries.

The vaccine industry exodus from the USA began in late 1980 under the onslaught of vaccine foes, religious rights and back to nature groups. The vaccine industry in the 1990s was characterized by low priced vaccines with low margins and threat of class action lawsuits. The vaccines sales were seasonal and unpredictable and variable with sales of few millions. The link of  children vaccine containing mercury preservative thimerosal to increasing cases of autism led to over 6000 class action and product injury lawsuits in the USA. The industry was running scared  from  product injury and class action lawsuits and was staring at bankruptcy. By the end of  last century, the vaccine nanufacturing companies in the US went down from 25 in early 1980s to only 5 by  2004. These were Wyeth, Chiron (Novartis), Merck, Sanofi Aventis Pasteur and MedImmune (Astra Zeneca).  In addition after billions of dollars investment over several decades, most of the vaccines developed for Malaria, AIDS, RSV  and Contraception failed in clinical trials. Thus by the end of last century industry was facing bankruptcy from class action lawsuits. On top FDA regulatory burden was increasing and a new vaccine required testing in over 10000 subjects.  Industry bail out of vaccine R&D and call for protection from class action and product injury lawsuits.These developments led to the current domination of European companies Sanofi Aventis and Glaxo Smith Kline in the global vaccine market. Glaxo Smith Kline and Baxter are back and CSL is the new company in the US market [47][48][49][50][51][52][53][54][55][56][57].

During the 1998-2005 period there were vaccine shortages in the USA at regular intervals due to FDA inspection of European plants, upgrading facilities to GMP, increased production or routine maintainence.on The US vaccine shortages due to closure of Chiron facility in the UK led the the US government recognize the starategic importance of the vaccine manufacturing in the USA.

The Vaccine Injury Act was passed in 1988 to provide compansation to victims harmed by vaccines and is funded by a tax on each dose of vaccine (0.75 $) sold in the US. Currently 16 vaccines are covered under this program including seasonal influenza vaccine, Pandemic avian influenza vaccine and 2009 H1N1 vaccines and antivirals. Under this act a government court pays compensation to persons harmed by vaccines, the awards are capped and the vaccine industry is protected. After several years of litigation and review of over 940 scientific articles, and testimony from 68 experts, the special court has sided with experts of Institute of Medicine and CDC who have discounted the link between thimerosal containing MMP vaccines and autism in children. The medical and scientific communities have carefully and thoroughly reviewed the evidence concerning the vaccine-autism theory and have found no association between vaccines, thimerosal and autism.

The market for seasonal influenza vaccine is influenced by weather, duration and severity of the influenza season, media coverage, public awareness, availability and supply of the vaccine. The demand and market for vaccine remains variable and unpredictable. The revival of the vaccine industry has been helped by the launch of newer blockbuster vaccines like Prevnar and Gardasil, R&D funding worth $.3-5 billion from NIH/CDC for development of vaccines against bioterror microbes like Anthrax and production of cell cultured vaccines. The pandemic 2009 H1N1 outbreak has helped the industry and consolidates vaccine revival. It has made influenza pandemic vaccine a year round manufacturing and marketing product. Addition of pandemic vaccine in government stockpile can help the vaccine industry during its lean times and provide steady revenue stream before the next pandemics. This market is exclusively dependent on government orders for stockpile and supply and is short term and valid only for the current epidemic.However increasing opposition to mass vaccination on religious, moral, ethical safety and fear reasons may derail the safety and efficacy backed by strong scientific and medical evidence and marketing of 300-100 million doses per year [47][48][49].

The French government decision to cancel previously confirmed order of 50 million doses of vaccine from Glaxo Smith Kline (32 million), Sanofi Aventis (11 million) and Novartis ( 7 million) may negatively impact the market for 2009 H1N1 vaccine in 2010. The government may have to pay penalty as the companies have to cover the cost of production. Governments of Germany, Spain and Switzerland have similarly to try and cancel orders for undelivered vaccines. These cutbacks show a declining demand for pandemic vaccine with low mortality and low uptake of the vaccine. This leaves once again vaccine companies to pick up the cost of increased production capacity? Sanofi Aventis and Novartis were expected to have sales of 1 billion and 600 million dollars for the year 2010. There is strong demand from other countries like Ukraine, UAE and European governments have sold part of their stocks.

Pandemic H1N1 pharmacovigilance 

Vaccine Recalls in the US: These recalls were due to the decline in the potency of some batches of the 2009 H1N1 vaccine during testing. The antigen may be sticking to the walls of the syringe or container. No safety issues are involved and the slight drop in antigen does not alter clinical immune response in vaccinated persons.

Sanofi Aventis Pasteur has recalled 4 batches of pediatric prefilled syringes (about 800,000 doses) as the the level of antigen was below specifications during routine antigen analysis.

Astra Zeneca (MedImmune) has recalled 4.7 million doses (13 lots) of its Nasal spray Vaccine as the potency of the vaccine was lower than the predetermined specifications during its routine testing

Status at 24 March 2010

This update by the European Medicines Agency (EMA)

WHO has reported 16800 deaths from H1N1 pandemic and the disease had spread to 213 countries and territories.
The disease killed 2840 victims in Europe.

A total of 14015 ADRs were reported, a vast majority were non serious

There were 2078 serious cases due to 2009 H1N1 infections in Europe.

The benefit/risk ratio of pandemic vaccines and antivirals remains positive and no serious adverse event has been reported so far.
About 50 million persons (544000 pregnant women) have been vaccinated in the European Union. Over 165 million doses of the vaccines were distributed

The reported adverse reactions with the 3 approved vaccines (Celvapan, Focetria and Pandemrix) have been as expected, mild and reversible 
symptoms such as fever, nausea, headache, allergic reaction, injection site pain and swelling. 
There were 130 cases related to abortion (57), stillbirth (11), Premature labor and baby (11) and 13 other pregnancy related outcomes. The normal rate of fofoetal mortality in EU is 2.6 to 9.1 per 1000 births and abortions/miscarriage is 12-15%. Thus the total number of cases reported with vaccines are within normal background range of the population.

There were 49 cases of Guillain Barre Syndrome and 1 case of Miller Fischer Syndrome (variant of GBS) were reported in relation to pandemic vaccines were reported to the EMEA. Considering that 42 million persons were vaccinated and these are considered normal background rates of GBS (1.1-1.8 per 100,000 persons). Multiple sclerosis 13 cases were reported, 2 on Focetria and 9 with Pandemrix. Out of 13 cases, 9 were with preexisting MS which flared up and 2 were within a short span after vaccination.

Vaccine/AntiviralDoses Distributed  millionPersons injected/treated  millionAdverse Drug reactions
Reports                  No ADRs
Serious ADRs
Celvapan9.1659000518                         -21 eye disorders
Focetria366.52947                       52286 facial palsy, 6 intra uterine deaths, 4 deaths
Pandemrix1122910547                       5 thrombocytopenia, 5 hearing loss, 3 seizures, 1 delayed hypersensitivity, 1 death,
26 deaths underlying causes
21.11058                       2 deaths


Background cases in General population

Fetal deaths  4-5 per 1000 deliveries
Facial palsy  29-36 per 100000
GBS Syndrome 2 per 100000
Thrombocytopenia 5-10 per 100000


Most of the deaths reported after vaccinations were due to underlying risk factors
or chronic diseases.

High risk of hospitalizations and fatalities in children and pregnant women.

Close Monitoring Required

Eye disorders
Seizures linked to poorly controlled epilepsy 
Delayed hypersensitivity reaction
Updated  CDC Estimates from April 2009 – February 13, 2010 for 2009 H1N1 infections USA

Using the same methodology CDC has again updated the estimates to include the time period.
  • CDC estimates that between 42 million and 86 million cases of 2009 H1N1 occurred. The mid-level in this range is about 59 million people infected with 2009 H1N1.
  • CDC estimates that between about 188,000 and 389,000 H1N1-related hospitalizations occurred. The mid-level in this range is about 265,000 2009 H1N1-related hospitalizations.
  • CDC estimates that between about 8,520 and 17,620 2009 H1N1-related deaths occurred. The mid-level in this range is about 12,000 2009 H1N1-related deaths.

FDA/CDC Vaccine Adverse Event Reporting System (VAERS) and the Vaccine Safety Datalink (VSD).

March 24, 2010

FDA and CDC are assessing H1N1 vaccine safety on a continuing basis and have published a detailed report describing the safety profile of H1N1 vaccines in the United States ( 

About 127 million doses of the H1N1 vaccine were shipped and 86 million persons vaccinated with 91 million doses. This report analyzes the safety data after 11.3 million doses of live, attenuated monovalent vaccine (LAMV) for intranasal administration and 34.9 million doses of monovalent, inactivated, split-virus or subunit vaccines for injection (MIV) were distributed. As noted in the report, FDA and CDC evaluated 10172 reports of adverse events submitted to VAERS.
The analysis of VSD data was based on 438,376 people vaccinated with H1N1 vaccines (323,345 MIV and 115,031 LAMV) in 
managed-care organizations in the VSD as of November 24. No substantial differences between H1N1 and seasonal influenza vaccines were noted in the proportion or types of serious adverse events reported. No increase in any of the pre-selected adverse events under surveillance, such as Guillain-Barré syndrome, has been seen in VSD data. There were 6% or 553 reports of serious adverse events including 40 deaths. preliminary investigations fail to account for a common cause of deaths or linkage to vaccination. There were 56 reports of Guillian Barre Syndrome, each week, 80-160 cases of GBD are reported in US.

According to the January 22, 2010 update of FDA and CDC vaccine safety monitoring activities, as of January 15, 2010, the total number of doses of H1N1 vaccines distributed was 127 million and the vast majority (93%) of adverse events reported to VAERS were classified as "non-serious" (e.g., soreness at the vaccine injection site). Weekly updates on FDA and CDC vaccine safety monitoring activities are available through the VAERS web site ( 

The National Vaccine Advisory Committee (NVAC) created the H1N1 Vaccine Safety Risk Assessment Working Group to review 2009 H1N1 vaccine safety data. This working group of outside experts conducts regular, rapid reviews of available data from the federal safety monitoring systems and presents them to NVAC and federal leadership for appropriate policy action and follow-up available at (

To date, our experience with the H1N1 influenza vaccination program has met high safety expectations, based on the track record of the licensed seasonal vaccines, including live attenuated and inactivated vaccines. We are also collaborating with other agencies around the world to share our vaccine safety information and experiences. Should any safety concerns arise, we will evaluate them thoroughly and bring them to the public’s attention quickly. 

VAERS Summary:

 As of December 30, 2009, 99.3 million doses of 2009 H1N1 vaccine had been shipped to vaccination providers in the United States.
 As of December 30, 2009, VAERS had received 7326 adverse event reports following 2009 monovalent H1N1 vaccination.
 The vast majority (94%) of adverse events reported to VAERS after receiving the 2009 monovalent H1N1 vaccine are classified as “non-serious” (e.g., soreness at the vaccine injection site).
 Of the 10172 reports, 636 (6%) were reports that were classified as “serious” health events (defined as life threatening or resulting in death, major disability, abnormal conditions at birth, hospitalization, or extension of an existing hospitalization)*.
 The percentage of reports involving what would be considered serious health events is not different between 2009 H1N1 and seasonal influenza vaccines. Additionally, no new or unusual events or pattern of adverse events have emerged.
 Among the 440 reports of serious health events, there were 51 reports of death. Preliminary findings do not indicate a common cause or pattern (such as similarities in age, gender, geographic location, illness surrounding death, or underlying medical conditions) to suggest that these deaths were associated with the vaccine. 
 VAERS has received 103 reports of Guillian-Barré syndrome (GBS), for which follow-up assessments are underway. In the United States, about 80-160 cases of GBS are expected to occur each week, regardless of vaccination.

VAERS Limitations

 When reviewing data from VAERS, please keep in mind what the system is designed to do and what it is unable to do:
o VAERS is a national reporting system, in which reports are submitted voluntarily by people who think an adverse event occurred after vaccination. VAERS does not solicit reports in any systematic way from all people who have been vaccinated. Reports can be submitted by anyone, including healthcare providers, patients, or family members. Because of this feature, VAERS reports may and often do include incorrect and incomplete information. VAERS reports often lead to more complete follow-up and review of medical records.
o VAERS staff follow-up on all serious and other selected adverse event reports and obtain additional medical, laboratory, and/or autopsy records when available. As a result of the follow-up/review process, coding terms (e.g., serious or non-serious) for individual VAERS reports may change based on the information received. These changes are reflected in the weekly updates of VAERS data in the WONDER database. VAERS data in WONDER should be used with caution because numbers and conditions are often updated. Events reported in VAERS should not be viewed as evidence that the vaccine directly caused the event. Data does not infer causality. Further investigation is warranted.
o Underreporting, or failure to report events, is also one of the main limitations of VAERS. Serious medical events are more likely to be reported than minor events.
o Most importantly, VAERS cannot determine cause-and-effect. VAERS accepts all reports without regard to whether or not the event was caused by the vaccine. The report of an adverse event to VAERS does not mean that a vaccine caused the event. It only indicates that the event occurred sometime after administration of the vaccine. Proof that the event was caused by the vaccine is NOT required in order for VAERS to accept the report.
o No reports are deleted from VAERS. Therefore, it is possible to have more than one VAERS report on an individual case (e.g., a physician and a patient may have filed separate reports for the same case).


WHO expert panel recommends a single dose of 2009 H1N1 vaccine for all subjects including children. WHO endorses use of already approved adjuvents in pandemic vaccines and has recommended the use of nasal spray live attenuated vaccine FluMist 2009 H1N1 for pregnant women.


Although adjuvents are considered safe, the adjuvent containing pandemic vaccines were not approved in the US. Recommends 2 dose schedule for children 6 months to 9 years old. The live virus containg nasal spray FluMist is not recommended for pregnant women and children less than 2 years of age.


Has not approved the use of live attenuated virus containing nasal spray FluMist in Europe. Adjuvents containing vaccines (As04 and MF059) are approved. Recommends 2 dose schedule of the pandemic flu vaccine for all inspite of clinical studies showing immuno protection with one dose of vaccine. This may be a way to cover European experts and politicians who ordered 2 dose of vaccine per person?


Thanks are due to Mr. Jean-Antoine de Mandato (PDP, Geneva) for providing office facilities and administrative support.

Conflict of Interest

Author KM works in the pharmaceutical and biotechnology industry which may imply conflict of interest to readers.

Authors do not endorse any brands and companies mentioned in this article.

Enquiries about funding or sponsorships of this article are welcome.

Krishan Maggon                                                                            

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2009 H1N1 Flu

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Situation Update

The weekly activity update is being provided one day early due to the Federal Holiday on Friday.
Map of flu activity in the U.S.Flu activity continued to decline in the United States during the week of December 13-19, 2009, as reported in FluView. The number of states reporting widespread flu activity decreased from 11 to 7. Visits to doctors for influenza-like illness, flu-associated hospitalizations, and flu-associated deaths all declined from the previous week.   Flu is unpredictable and activity can rise and fall throughout the season, but flu is is likely to continue for months caused by either 2009 H1N1 viruses or regular seasonal flu viruses. In addition to seasonal flu vaccine, a vaccine against the 2009 H1N1 virus has been produced and is the best way to protect against the pandemic virus. Supplies of this vaccine are increasing and many places have opened up vaccination to anyone who wants it. Find a vaccine.

Other 2009 H1N1 Flu Topics

How the illness is diagnosed, recommendations for lab testing…
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What You Can Do to Stay Healthy

  • Get vaccinated. Vaccination is the best protection we have against flu.Seasonal flu vaccine is available now and initial doses of 2009 H1N1 flu vaccine also are available, with additional doses available later this year.
  • Influenza is thought to spread mainly person-to-person through coughing or sneezing of infected people.
  • Take everyday actions to stay healthy.
    • Cover your nose and mouth with a tissue when you cough or sneeze. Throw the tissue in the trash after you use it.
    • Wash your hands often with soap and water. If soap and water are not available, use an alcohol-based hand rub.
    • Avoid touching your eyes, nose and mouth. Germs spread that way.
    • Stay home if you get sick. CDC recommends that you stay home from work or school and limit contact with others to keep from infecting them.
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Dec 1 ALERT: Fraudulent emails referencing CDC-sponsored State Vaccination Program »

Situation Update

Map of flu activity in the U.S.During the week of November 29-December 5, 2009, flu activity continued to decline in the United States as reported in FluView. The number of states reporting widespread flu activity decreased from 25 to 14. Visits to doctors for influenza-like illness and flu-associated hospitalizations declined from the previous week, however flu-associated deaths increased.
See More On Key Flu Indicators »

Other 2009 H1N1 Flu Topics

How the illness is diagnosed, recommendations for lab testing…
Infection Control
Healthcare guidance, occupational safety, facemasks & respirators…
Use of Tamiflu and Relenza for treatment or prevention of H1N1 flu…
Emergency Use Authorization
Info about CDC-requested & FDA-issued EUA drugs & devices…

What You Can Do to Stay Healthy

  • Get vaccinated. Vaccination is the best protection we have against flu. Seasonal flu vaccine is available now and initial doses of 2009 H1N1 flu vaccine also are available, with additional doses available later this year.
  • Influenza is thought to spread mainly person-to-person through coughing or sneezing of infected people.
  • Take everyday actions to stay healthy.
    • Cover your nose and mouth with a tissue when you cough or sneeze. Throw the tissue in the trash after you use it.
    • Wash your hands often with soap and water. If soap and water are not available, use an alcohol-based hand rub.
    • Avoid touching your eyes, nose and mouth. Germs spread that way.
    • Stay home if you get sick. CDC recommends that you stay home from work or school and limit contact with others to keep from infecting them.
  • Follow public health advice regarding school closures, avoiding crowds and other social distancing measures.
  • Stay informed. This website will be updated regularly as information becomes available.
  • Call 1-800-CDC-INFO for more information.
Contact Us:
  • Centers for Disease Control and Prevention
    1600 Clifton Rd
    Atlanta, GA 30333
  • 800-CDC-INFO
    TTY: (888) 232-6348
    24 Hours/Every Day
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FDA 2009 H1N1 (Swine) Flu Page

The FDA plays a vital role on the team led by the U.S. Department of Health and Human Services in the fight against the 2009 H1N1 virus. The agency works closely with the Centers for Disease Control and Prevention, National Institutes of Health, other federal government agencies, and global partners such as the World Health Organization and foreign governments to protect public health during the 2009 H1N1 pandemic.
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FDA ensures the safety, effectiveness and supply of flu antiviral drugs.
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FDA approves diagnostic tests for laboratories, clinics and doctor’s offices.
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2009 Flu Info
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 ECDC logoEuropean Center for Disease Prevention and Control
Pandemic (H1N1) 2009 

ECDC has been continuously monitoring the pandemic and regularly updates its risk assessment. This has shown that after transmitting at variable rates over the summer the pandemic is now accelerating in most European countries and all the indications are that this pandemic will be a highly significant event for Europe.
We know that risk groups; people with significant underlying health conditions, pregnant women and young children are especially affected by the virus, but the risk extends to other entirely healthy people. While many people may experience only a mild illness there are many, including young healthy individuals, who will develop severe disease and may die.
EU citizens should continue to take appropriate preventative measures e.g. personal hygiene measures. Vaccines are becoming available across the EU and national vaccination programmes are starting. Given the significant risks to health from the pandemic ECDC would strongly advise all those Europeans who are offered the vaccine to be vaccinated. By being vaccinated you protect not just your own health, but that of the people around you. 
Vaccination is always an emotive issue and EU citizens rightly require assurance that vaccines are both safe and effective. Influenza vaccines have been used for more than 60 years and have one of the best record of safety in all age groups. ECDC expects the influenza (H1N1) 2009 vaccine to have a similar safety profile as seasonal flu and we will continuously monitor their application across the EU to ensure the most up to date information is available to all.

 Zsuzsanna Jakab, ECDC Director


Intensity of influenza A(H1N1)v activity in EU and EFTA countries

Click on the map to enlarge the picture
 Reported cumulative number of confirmed fatal cases of influenza A(H1N1)v in EU and EFTA countries
Number of confirmed deaths among pandemic (H1N1) 2009 influenza cases by week of notification in EU and EFTA countries.
Number of confirmed deaths among pandemic (H1N1) 2009 influenza cases - week 46


Daily update - Pandemic H1N1 2009 (14/12/2009)
Global Health Security Initiative: statement concerning pandemic and vaccination; EpiSouth update: several countries in the region still showing high or medium level influenza activity; Weekly influenza surveillance overview: In the majority of countries influenza activity is widespread but thirteen countries have reported decreasing rates of influenza-like illness for at least the last two weeks; A total of 1 333 fatal cases in Europe and EFTA countries and 9 530 in the rest of the world have been reported up to date.
Daily update - Pandemic H1N1 2009 (11/12/2009)
Weekly Influenza Surveillance Overview to be published today; Eurosurveillance updates published; A total of 1 227 fatal cases in Europe and EFTA countries and 9 340 in the rest of the world have been reported up to date.
Daily update - Pandemic H1N1 2009 (10/12/2009)
Draft WHO influenza global public health research agenda 2009-10 published. A total of 1 147 fatal cases in Europe and EFTA countries and 9 255 in the rest of the world have been reported up to date.
Daily update - Pandemic H1N1 2009 (09/12/2009)
Germany considering sales or donations of surplus pandemic vaccine stock. ECDC describes new clinical management guidance of human pandemic infections produced by WHO and discusses the public health measures that could minimise the impact of pandemic. A total of 1 084 fatal cases in Europe and EFTA countries and 8 990 in the rest of the world have been reported up to date.
Daily update - Pandemic H1N1 2009 (08/12/2009)
Updates from U.S.A. and Canada included Updates from Moldova, Ukraine, Belarus and Russia included; CIDRAP launches promising practices database; A total of 1 079 fatal cases in Europe and EFTA countries and 8 892 in the rest of the world have been reported up to date
View all items



Due to the rapidly evolving situation, documents issued by ECDC and postings on the website before 10 June 2009 contained variations when referring to the newly emerged influenza A( H1N1) virus. As of 10 June 2009 the name for the virus used in ECDC's communications is influenza A(H1N1)v, ‘v’ standing for variant.


Vaccination highlights


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Pandemic (H1N1) 2009

A man walking with a suitcase and a shoulder bag.
WHO/Christopher Black
In focus: Travel
In this period of more frequent travel, there is no scientific reason to delay international travel to reduce spread of pandemic influenza infection. However, if you are ill it is prudent to delay travel.
:: Frequently asked questions about travel


Vaccines for pandemic influenza A (H1N1)

Antiviral drugs and pandemic (H1N1) 2009


For national authorities

Complete list by category


Weekly Epidemiological Record
Articles on pandemic influenza
Gathering vital evidence on pandemic influenza
Laboratory work in the WHO European Region

WHO use of advisory bodies in responding to the influenza pandemic
3 December 2009
Oseltamivir resistance in immunocompromised hospital patients
2 December 2009
Archives of briefing notesSITUATION UPDATES

Pandemic (H1N1) 2009 - update 78
11 December 2009
Full list of updates


For more information, call the special media telephone line:
+41 22 791 5000
Virtual press briefings

Centre for Strategic Health Operations (SHOC)

Pandemic (H1N1) 2009 news via RSS feed

RSS help page

WHO African Region

WHO Region of the Americas

WHO Eastern Mediterranean Region

WHO European Region

WHO South-East Asia Region

WHO Western Pacific Region


Meeting reports


Related links


Appendix A    Current regulations for testing and regulatory approval of Vaccines



Risk Management Plans for pandemic influenza vaccines





Plennevaux E, Sheldon E, Blatter M, et al. Immune response after a single vaccination against 2009 influenza A H1N1 in USA: a preliminary report of two randomized controlled phase 2 trials. Lancet 2010 Jan 2;375(9708):41-8 [Full text]
Vajo Z, Tamas F, Sinka L, et al. Safety and immunogenicity of a 2009 pandemic influenza A H1N1 vaccine when administered alone or simultaneously with seasonal influenza vaccine for the 2009-10 influenza season: a multicentre, randomized controlled trial. Lancet 2010 Jan 2;375(9708):49-55 [Full text]
Liang X-F, Wang H-Q, Wang J-Z, et al. Safety and immunogenicity of 2009 pandemic influenza A H1N1 vaccines in China: a multicentre, double-blind, randomized, placebo-controlled trial. Lancet 2010 Jan 2;375(9708):56-66 [Full text]
Kelly H, Barr I. Large trials confirm immunogenicity of H1N1 vaccines. (Editorial) Lancet 2010 Jan 2;375(9708):6-8 [Full text]
Pfeifer D, Alfonso C, Wood D. Defining the safety profile of pandemic influenza vaccines. (Editorial) Lancet 2010 Jan 2;375(9708):9-11 [Full text]


Appendix  B  Seasonal Influenza Vaccine 2009

The panel recommended that vaccines to be used in the 2009-2010 influenza season contain the following:
  • an A/Brisbane/59/2007 (H1N1)-like virus; *
  • an A/Brisbane/10/2007 (H3N2)-like virus; **
  • a B/Brisbane/60/2008-like virus.
*A/Brisbane/59/2007 is a current vaccine virus; A/South Dakota/6/2007 (an A/Brisbane/59/2007-like virus) is a current vaccine virus used in live attenuated vaccines.
**A/Brisbane/10/2007 and A/Uruguay/716/2007 (an A/Brisbane/10/2007-like virus) are current vaccine viruses.
The influenza vaccine composition to be used in the 2009-2010 influenza season in the U.S. is identical to that recommended by the World Health Organization on February 12, 2009.

Appendix C.

Government Orders and Pricing   Based on news media and press release.

These are some of the news headlines used for data extraction

Le virus H1N1 voyage à une vitesse incroyable

Global Vaccine Provision - Country-by-Country

Australia: The Australian company CSL projects to sell $300 million of influenza vaccine in 2009. The Australian government paid $90 million for 21 million doses.
France:  94 million doses of Pandemic vaccine ordered at a price of Euro 1000 million or $1500 million
USA : 195 million doses, stockpile of Tamiflu and Relenza, maybe Peramivir?   Total budget $4.5 billion for 2009. 
UK   90 million doses ordered, £ 2.2 billion funding provided for R&D to tackle H1N1 Pandemic
Germany  : Ordered stockpile of Relenza to cover 30% of its population
Japan : 53 million doses of vaccine, 13-17 million domestic, rest imported, antivirals stockpile   > 1 billion.
China :  5% of its population covered = 65 million doses = 650 million 
10 local companies making the vaccine like SinoVac. Sino vac to supply 10 million doses at the rate of 2 million doses per month, Huanlang to supply 13 million and Shanghai Biologicals 10 million doses?
Local vaccine to cost 30% less, ie priced at $10 instead of $ 15 international price.
India   4 million doses ordered from Sanofi Aventis at a price of $15 per dose to cover healthcare providers and essential staff. Three local companies Serum Institute of India, Pune; Bharat Biotech, Hyderabad and Pancea Biotech have recieved WHO seed stock to manufacture Pandemic H1N1 flu vaccine by traditional method. India has no tradition of seasonal flu vaccination and clinical testing in local population is required to prove safety and efficacy. Cipla and other companies have made copies of Tamiflu and Relenza for export and to supply to Indian Government.
Brazil  18 million doses of vaccine ordered from Sanofi Aventis at a cost of $270 million.
Based on the direct orders from OECD countries to cover 70% of the population, the market is in the range of $9.2 billion. However, some of these orders may be filled in 2010 winter.  

Appendix D    Industry Response to Influenza A (H1N1) Pandemic

This Pandemic Influenza Web site provides information for the public, health-care professionals, and the media on pandemic influenza, vaccines, and links to more information.
Timeline of events surrounding sanofi pasteur's public health efforts regarding A(H1N1)

H1N1 Glaxo Smith Kline

Related materials:

[Ways to produce a flu vaccine chart]

Animations of the cell culture-based vaccine manufacturing process Viral Flu (Influenza) Inspection of a syringe containing H1N1 vaccine during filling process. MF59 filling under strict clean room conditions
Flu vaccine production
Flu vaccine filling & packaging
Vaccine R&D

Fact sheets:
Novartis Vaccines and Diagnostics (57 KB)
Flu Cell Culture Manufacturing and the Novartis Proprietary Cell Line (160 KB)
MF59® Adjuvant (63 KB)
Pandemic Influenza (51 KB)
Seasonal Influenza (65 KB)


Appendix E   List of approved Influenza Vaccines USA/Europe


Pandemic influenza vaccines centrally authorised in the EU


Click on the name of each medicine in the table below to review its European public assessment report (EPAR).
Vaccines developed for pandemic influenza
Mock-up vaccines
Pre-pandemic vaccines

FDA Approved Influenza Vaccines

Injectable Vaccines  2009 H1N1

Intranasal Vaccine

Appendix F     Marketed Brands of Influenza Vaccines by Novartis

Highly purified influenza vaccine for adults and children above six months; one of the best tolerated influenza vaccines
Learn more Novartis flu vaccines

A preservative-free influenza vaccine for adults and children above six months that is proven by years of experience
Learn more Novartis flu vaccines

Cell culture-based influenza vaccine for adults above 18 years of age
Learn more Novartis flu vaccines

Active influenza immunization for the elderly, especially for patients with chronic conditions like diabetes or cardiovascular or respiratory diseases
Learn more Novartis flu vaccines

Subunit influenza vaccine that is a leading product in the US and is approved for sale in more than 20 countries
Learn more Novartis flu vaccines
Other companies ( Sanofi Aventis, Glaxo Smith Kline ) have not provided a comprehensive list of marketed Influenza Vaccine Brands at their web sites.


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