Russia plans to have H1N1 vaccine in October
The first batches of Russia's new vaccine against (A)H1N1 swine flu may be ready by October, and full-scale production may start in November.
The domestic company Microgene has capacity to produce up to 40 million doses of the new vaccine, according to local sources.
Early last month, Roszdravnadzor, Russia's federal service for the surveillance in healthcare and social development, proposed a fast-track procedure for authorising clinical trials, evaluating and registering the new vaccine, which has been approved by leading specialists in the field.
Professor Oleg Kiselev, the director of the St Petersburg-based institute of influenza of the Russian Academy of Medical Sciences, told the local newspaper Vzglyad (glance) that Phase I clinical trials of the vaccine should begin in mid-August. The product is to be used in lower doses than a similar vaccine being developed in the US, and is likely to be cheaper, at an estimated price of Rb120-150 ($3.85-4.80) per dose, he added.
The institute of influenza is one of five leading research institutes specialising in virology, biotechnology and related sciences with which the health ministry signed agreements to develop an anti-H1N1 virus vaccine, and its work is at the most advanced stage.
A World Health Organization delegation led by Marc Danzon, director of its European office, recently visited the institute of influenza to look into its vaccine development. The institute is one of the WHO's collaborating centres for reference and research on influenza. Mr Danzon said that the results received so far would be sent to the WHO's experts for further evaluation.
Russia received strains for the development of an inactivated vaccine from the US and the UK. Separately, the institute of experimental medicine at the Russian Academy of Medical Science has obtained another strain that is suitable for producing a live vaccine against swine flu, and which can be administered as nose drops. A pilot series of this product is also expected to be made at Microgene's facility.
Earlier this year, Russian healthcare authorities decided to conduct double vaccination against two types of flu. Vaccination against seasonal flu was planned to start from August 1st. Children and elderly people are to be the first vaccinated, and the vaccination of doctors is planned to begin next month. A second vaccination, against swine flu, is to be carried out when the new vaccine is available later in the year.
The Russian government has allocated an additional Rb3 billion to purchase the new vaccine; it announced earlier that it would spend the same amount on buying vaccines against ordinary seasonal flu.
Professor Kiselev said that a list of antivirals to treat swine flu, including both locally made and imported products, has been approved. One is the locally produced Triazaverin, an antiviral developed by the Ekaterinburg-based institute of organic synthesis (IOS) of the Russian Academy of Sciences and initially intended for bird flu. A local enterprise currently makes a finished form for clinical trials (now in their final stage, according to local sources) from the active pharmaceutical ingredient made at the IOS's production facility. Full-scale production might start at the beginning of next year.
Additionally, the Russian vaccines manufacturer Petrovax has announced that it will produce 12 million doses of the Grippol Neo-mono vaccine against swine flu by the year-end and that its preclinical and clinical trials should be completed in September. It has begun production of nine million doses of Grippol Plus vaccine against seasonal influenza, of which around seven million doses are intended for the state vaccination programme. Overall, the company plans to make 22 million doses of anti-flu adjuvant vaccines in disposable syringes this year.