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Sanofi, Glaxo Must Get Ready for Swine Shot, WHO Says (Update2)
By Jason Gale and Dermot Doherty
May 19 (Bloomberg) -- The World Health Organization urged Sanofi-Aventis SA, GlaxoSmithKline Plc and other drugmakers to start preparations for a swine flu vaccine and be ready to mass- produce a shot as early as mid-July.
WHO Director-General Margaret Chan endorsed an expert panel?s recommendations that drugmakers should develop batches for testing and get documents ready for regulators to speed the approval process. They shouldn?t stop making seasonal flu shots, the agency said today.
?Those are recommendations coming from SAGE to me and I accepted their recommendations,? Chan said today at a press conference in Geneva, referring to the Strategic Advisory Group of Experts.
The WHO, armed with limited information about the new flu?s virulence, wants pharmaceutical companies to speed production of the vaccine that protects against seasonal influenza, which can kill up to 500,000 people a year, while scientists take a few more weeks to select the fastest-growing strain of the H1N1 virus to form the basis of a protective pandemic vaccine.
?We should be prepared,? Chan said in a May 15 interview. ?We don?t want to give the virus a chance to surprise us again and again.?
The WHO, which met with drugmakers last week to discuss vaccination plans, is inching closer to a recommendation that drugmakers focus on producing only a pandemic shot.
Seasonal Flu Shots
Because Chan adopted today?s panel recommendation, the same group will meet again in a few weeks to review the speed at which drugmakers are building their seasonal vaccine stockpiles as well as the spread and severity of swine flu. Based on that assessment, they may recommend that drugmakers switch from making seasonal flu vaccines to producing swine flu ones. Chan will then decide whether to endorse the panel?s advice.
WHO estimates seasonal vaccine production will be 73 percent complete by the end of next month and 90 percent complete by July 31.
The worldwide swine flu outbreak has caused 9,830 infections and 79 deaths since it was first identified in Mexico and the U.S. at the end of April. Health officials from more than 190 countries meeting for the World Health Assembly in Geneva this week are debating whether the infection is spreading widely enough to declare the first pandemic since 1968.
Chicken Eggs
Based on cases so far, the swine-derived strain is at least as contagious as seasonal flu and has the ability to sustain community spread, the Geneva-based WHO said today in a guidance document on its Web site.
?There is, therefore, no reason to expect that ongoing spread of the virus will stop,? the agency said.
WHO guidelines state that a pandemic involves disease spreading in communities in a country outside the initially affected region.
U.S. Health and Human Services Secretary Kathleen Sebelius said there is ?broad consensus? among delegates that the WHO should have greater flexibility in declaring a pandemic. Health ministers from the U.K. and Japan, which have each reported more than 100 cases, yesterday said the WHO should consider severity of disease and other factors in addition to geographic spread.
Sebelius said laboratories are testing several strains of the new flu to determine which one is the best to use in a vaccine.
Vaccine Virus
Glaxo of London, Paris-based Sanofi and Switzerland?s Novartis AG said today that they expect to get the best strain selected, known as the vaccine virus, at the end of the month. Distribution may be delayed by one or two weeks as laboratories modify the virus so it?s incapable of causing disease.
?Our companies stand ready to produce H1N1 vaccines when the recommendation comes from the WHO,? said Michael D. Boyd, acting director general of the International Federation of Pharmaceutical Manufacturers & Associations, in a statement released today after drugmakers met Chan and United Nations Secretary-General Ban Ki-Moon.
Chan said the WHO will look at different mechanisms to ensure that poor nations get access to vaccines and antivirals.
?Some companies have pledged donations and some companies have pledged to reserve a certain percentage of their production,? Chan said. In addition, vaccine makers ?agreed to a tiered pricing so that a reasonable and affordable price can be offered? to poorer countries.
Glaxo, Novartis
Glaxo, Novartis, Sanofi, Baxter International Inc. and Crucell NV were among the companies participating in the meeting, according to their Geneva-based trade group.
Finding the strain that?s best able to multiply is important because relying on a slow-growing virus could reduce global supplies of vaccine, the WHO said.
Drugmakers cultivate batches of the vaccine virus to identify the fastest-growing strains, which are injected into chicken eggs. In the egg, the virus multiplies and can be harvested, purified and incorporated in a vaccine. The product then requires testing to ensure it works and is safe to use.
Once the process is completed, drugmakers submit data on the vaccine for regulatory approval. The process of growing, testing and seeking approval means a vaccine won?t be available for several months after production begins, according to health officials.
4.9 Billion Doses
The WHO estimates it would take about a year after drugmakers begin production to make as many as 4.9 billion doses of pandemic vaccine. Two shots may be needed for protection, especially in younger people who may not have any natural immunity to H1N1 viruses. Older people may have some protection because they were previously infected by similar viruses.
Chan said that, unlike the seasonal flu shot that uses three virus strains, a swine flu vaccine would use one strain, enabling drugmakers to triple the current seasonal output of 900 million doses. Using an additive that boosts immune response would also boost production capacity, she said. Still, 4.9 billion doses is a ?very optimistic maximum? that depends on whether people would need one or two shots, she said.
Governments are already trying to secure supplies before a pandemic is declared. The U.K., France, Belgium and Finland agreed to buy about 158 million shots from Glaxo and Baxter of Deerfield, Illinois, according to statements last week from Glaxo and the U.K. government. The U.S. hasn?t ordered any, Sebelius said today in Geneva.
To contact the reporters on this story: Jason Gale in Singapore at j.gale@bloomberg.net; Dermot Doherty in Geneva at Ddoherty9@bloomberg.net
Last Updated: May 19, 2009 12:46 EDT
http://www.bloomberg.com/apps/news?pid=20601102&sid=aTZfnknCRnJg&refer=uk
By Jason Gale and Dermot Doherty
May 19 (Bloomberg) -- The World Health Organization urged Sanofi-Aventis SA, GlaxoSmithKline Plc and other drugmakers to start preparations for a swine flu vaccine and be ready to mass- produce a shot as early as mid-July.
WHO Director-General Margaret Chan endorsed an expert panel?s recommendations that drugmakers should develop batches for testing and get documents ready for regulators to speed the approval process. They shouldn?t stop making seasonal flu shots, the agency said today.
?Those are recommendations coming from SAGE to me and I accepted their recommendations,? Chan said today at a press conference in Geneva, referring to the Strategic Advisory Group of Experts.
The WHO, armed with limited information about the new flu?s virulence, wants pharmaceutical companies to speed production of the vaccine that protects against seasonal influenza, which can kill up to 500,000 people a year, while scientists take a few more weeks to select the fastest-growing strain of the H1N1 virus to form the basis of a protective pandemic vaccine.
?We should be prepared,? Chan said in a May 15 interview. ?We don?t want to give the virus a chance to surprise us again and again.?
The WHO, which met with drugmakers last week to discuss vaccination plans, is inching closer to a recommendation that drugmakers focus on producing only a pandemic shot.
Seasonal Flu Shots
Because Chan adopted today?s panel recommendation, the same group will meet again in a few weeks to review the speed at which drugmakers are building their seasonal vaccine stockpiles as well as the spread and severity of swine flu. Based on that assessment, they may recommend that drugmakers switch from making seasonal flu vaccines to producing swine flu ones. Chan will then decide whether to endorse the panel?s advice.
WHO estimates seasonal vaccine production will be 73 percent complete by the end of next month and 90 percent complete by July 31.
The worldwide swine flu outbreak has caused 9,830 infections and 79 deaths since it was first identified in Mexico and the U.S. at the end of April. Health officials from more than 190 countries meeting for the World Health Assembly in Geneva this week are debating whether the infection is spreading widely enough to declare the first pandemic since 1968.
Chicken Eggs
Based on cases so far, the swine-derived strain is at least as contagious as seasonal flu and has the ability to sustain community spread, the Geneva-based WHO said today in a guidance document on its Web site.
?There is, therefore, no reason to expect that ongoing spread of the virus will stop,? the agency said.
WHO guidelines state that a pandemic involves disease spreading in communities in a country outside the initially affected region.
U.S. Health and Human Services Secretary Kathleen Sebelius said there is ?broad consensus? among delegates that the WHO should have greater flexibility in declaring a pandemic. Health ministers from the U.K. and Japan, which have each reported more than 100 cases, yesterday said the WHO should consider severity of disease and other factors in addition to geographic spread.
Sebelius said laboratories are testing several strains of the new flu to determine which one is the best to use in a vaccine.
Vaccine Virus
Glaxo of London, Paris-based Sanofi and Switzerland?s Novartis AG said today that they expect to get the best strain selected, known as the vaccine virus, at the end of the month. Distribution may be delayed by one or two weeks as laboratories modify the virus so it?s incapable of causing disease.
?Our companies stand ready to produce H1N1 vaccines when the recommendation comes from the WHO,? said Michael D. Boyd, acting director general of the International Federation of Pharmaceutical Manufacturers & Associations, in a statement released today after drugmakers met Chan and United Nations Secretary-General Ban Ki-Moon.
Chan said the WHO will look at different mechanisms to ensure that poor nations get access to vaccines and antivirals.
?Some companies have pledged donations and some companies have pledged to reserve a certain percentage of their production,? Chan said. In addition, vaccine makers ?agreed to a tiered pricing so that a reasonable and affordable price can be offered? to poorer countries.
Glaxo, Novartis
Glaxo, Novartis, Sanofi, Baxter International Inc. and Crucell NV were among the companies participating in the meeting, according to their Geneva-based trade group.
Finding the strain that?s best able to multiply is important because relying on a slow-growing virus could reduce global supplies of vaccine, the WHO said.
Drugmakers cultivate batches of the vaccine virus to identify the fastest-growing strains, which are injected into chicken eggs. In the egg, the virus multiplies and can be harvested, purified and incorporated in a vaccine. The product then requires testing to ensure it works and is safe to use.
Once the process is completed, drugmakers submit data on the vaccine for regulatory approval. The process of growing, testing and seeking approval means a vaccine won?t be available for several months after production begins, according to health officials.
4.9 Billion Doses
The WHO estimates it would take about a year after drugmakers begin production to make as many as 4.9 billion doses of pandemic vaccine. Two shots may be needed for protection, especially in younger people who may not have any natural immunity to H1N1 viruses. Older people may have some protection because they were previously infected by similar viruses.
Chan said that, unlike the seasonal flu shot that uses three virus strains, a swine flu vaccine would use one strain, enabling drugmakers to triple the current seasonal output of 900 million doses. Using an additive that boosts immune response would also boost production capacity, she said. Still, 4.9 billion doses is a ?very optimistic maximum? that depends on whether people would need one or two shots, she said.
Governments are already trying to secure supplies before a pandemic is declared. The U.K., France, Belgium and Finland agreed to buy about 158 million shots from Glaxo and Baxter of Deerfield, Illinois, according to statements last week from Glaxo and the U.K. government. The U.S. hasn?t ordered any, Sebelius said today in Geneva.
To contact the reporters on this story: Jason Gale in Singapore at j.gale@bloomberg.net; Dermot Doherty in Geneva at Ddoherty9@bloomberg.net
Last Updated: May 19, 2009 12:46 EDT
http://www.bloomberg.com/apps/news?pid=20601102&sid=aTZfnknCRnJg&refer=uk