With Russia becoming the first country to approve a Covid-19 vaccine for large-scale public use, discussions about the availability and production of the Russian vaccine for people of other countries have begun. However, concerns related to the efficacy of the vaccine remain unaddressed as the Russian government has cleared the path for public use of the vaccine without conducting phase 3 clinical trials, according to an Indian Express report. The vaccine which has been developed by Moscow based Gamaleya Institute began its human trials only two months back. The other vaccine candidates who were so far on the top of the race to produce a vaccine including Oxford-AstraZeneca and USA’s Moderna had begun their human trials before the Russian vaccine but their vaccines are not expected to be approved for public use before early next year.
Production and Availability of Russian Vaccine
In addition to the Gamaleya Institute’s facility where the vaccine is being produced, Sistema which is Russia’s one of the biggest business groups has also decided to produce the vaccine. The business group has said that it intends to produce about 15 lakhs doses of the vaccine a year. However, considering the huge demand of the vaccine and limited capacity of the Russian pharma companies to match up with the demand, availability of the vaccine for people of other countries might take a long time. Though hardly any country has publicly expressed the desire to buy the Russian vaccine, a news report by Reuters quoted the head of the Russian Sovereign wealth fund as saying that more than 100 crore doses of the vaccine have been requested by other countries.
Availability of Russian vaccine in India
In accordance with the procedure the Indian government has adopted for other vaccine candidates, the Central Drugs Standard Control Organisation (CDSCO) is expected to ask Russia to conduct the phase 2 and phase 3 human trials on the Indian population before giving its approval for public use. The government has adopted a similar attitude with regard to the Oxford-AstraZeneca’s vaccine candidate whose phase 3 trials are expected to begin this week. The later stage clinical trials assume importance as the vaccine will be administered to a huge section of the population and it is also vital to check its efficacy on different population groups before approving it for public use.
Taking into consideration the extraordinary situation the country faces, CDSCO is well within its rights to give the emergency approval for the use of the vaccine like it did for the Remdesivir drug on the patients of Coronavirus without conducting its clinical trials. However, giving approval for a drug to be administered on a limited number of people who have already been infected with the disease is different from giving approval for the use of a vaccine which will be administered to a huge section of the population.
Production agreements for Russian vaccine
No India pharma company has so far signed a vaccine production and development agreement with Gamaleya Institute which has produced the Russian vaccine. Serum Institute of India which has signed the production agreements with Oxford-AstraZeneca and other vaccine candidates has also not signed any agreement with the makers of the Russian vaccine.