Global Insight Perspective | |
Significance | The makers of Russian 'flu vaccine Grippol have said that Western drug manufacturers are using negative PR tactics against the company to promote their own vaccines. |
Implications | Around 70 cases of adverse effects have been noted among patients who were administered Grippol this year, causing nine regions across Russia to suspend their 'flu inoculation programmes. Mikrogen states that it is under pressure from Western companies that want to overtake it as Russia's sole provider of reimbursable 'flu jabs. |
Outlook | The small number of people affected (70 out of 19 million) will mean that the vaccine is unlikely to be withdrawn permanently. However, authorities may insist that Grippol comes with a stronger warning label from next year. Given the difference in cost between Grippol and its imported competitors, the only way the National Health Project can afford to take on new vaccines is by lowering their price. |
Western Drug-Makers Face Accusation
Accusations are flying in Tatarstan, the Russian republic in which state-owned vaccines consortium Mikrogen is based. Makhamat Alsynbayev, director-general of Mikrogen's Immunopreparat unit, has told Kommersant that Western pharmaceutical companies have helped to propagate a negative PR campaign against his company, which manufactures the Grippol influenza ('flu) vaccine. Grippol is currently the only vaccine to be provided through the National Health Project (NHP), with 22 million doses produced and distributed across the country during 2006, subsidised entirely by the government (a further 4.5 million doses were also produced for non-reimbursable retail purchase). However, the product came under fire earlier this month, when over 70 people across the country developed allergic reactions to it (see Russia: 24 November 2006: Adverse Reactions Force Russian Regions to Call Time on 'Flu-Vaccine Programme). Nine regions across Russia have now halted their 'flu jab programmes, despite the fact that around 19 million inoculations have already taken place.
Alsynbayev maintains that Western pharma multinationals, including Sanofi Pasteur (France) and Solvay (Belgium), are attempting to discredit Grippol's safety record in order to show their own rival products in a more favourable light. Sanofi Pasteur's Vaxigrip and Solvay's Influvac both compete with Grippol on the Russian market, but Grippol has thus far remained the preferred choice of the NHP for reimbursement, because of its considerably lower cost. Unlike countries such as the United States, Russia has secured a contract with only one vaccine producer to supply the entire country. According to Kommersant, Alsynbayev revealed that the wholesale price of one ampoule of Grippol is 40 roubles (US$1.52), whereas similar vaccines imported from abroad are currently priced at US$8-12 per ampoule.
Outlook and Implications
Neither Solvay nor Sanofi Pasteur have responded to Alsynbayev's accusations, but with a single vaccine dominating the entire country's reimbursable 'flu-jab programme, all of the parties involved certainly have a lot to play for. Indeed, the NHP is thought to be looking at an increase in its vaccine provision to 30 million doses for the 2007/08 'flu season, for which it has budgeted some 6.1 billion roubles.
However, even if the Western companies are taking advantage of Immunopreparat's troubles to showcase their own products, it does not detract from the questions surrounding the sudden spate of adverse reactions to Grippol. The product has been on sale in Russia and other CIS countries for well over 10 years, and Mikrogen is reportedly preparing to ship 600,000 doses to Ukraine and a further one million doses to Kazakhstan over the next few weeks. Alsynbayev has rejected outright the possibility that counterfeit versions of the vaccine have entered the supply chain, saying that these are impossible to replicate, given the changing nature of the 'flu virus. Instead, Immunopreparat's deputy director Marseille Touygunov has blamed incorrect administration of the vaccine by doctors. Like most influenza vaccines, Grippol is produced from chicken eggs, and doctors are reportedly meant to ask patients about egg allergies prior to administering the inoculation.
Global Insight maintains that the relatively small number of people affected (70 out of 19 million) will mean that the vaccine is unlikely to be permanently withdrawn or substituted by the NHP, although the authorities may insist that Grippol comes with a stronger warning label from next year. The health authorities will come under pressure from the pharma industry—and, potentially, from concerned members of the public—to add other vaccines to the supply chain, but given the vast difference in price between imported and domestic 'flu jabs, this is unlikely to happen on a very large scale. One potential way around this, however, could be to add 'flu vaccines to a list of imported drugs forced to lower their prices, which the government implemented earlier this year in order to level the playing field between domestic and foreign pharma players (see Russia: 19 May 2006: Lower Prices on Imported Pharmaceuticals in Russia from 1 June).