Drug maker Dr Reddy's on Wednesday said it will be importing Sputnik V vaccine from Russia in this quarter, and supplies from Indian manufacturers will commence from next quarter.
Earlier the Russian sovereign fund RDIF said that more than 50 million doses of Sputnik V vaccine will be available every month in India from May.
Dr Reddy's as per its licensing agreement with can produce up to 250 million doses of the Sputnik V vaccine, the deal allows to expand the volumes by mutual consent.
The company also clarified that it isn't seeking any funding from government to ramp up capacities.
"We don't expect to seek any funding from the government, other players also have infrasturcture. We don't see the need for funding," GV Prasad, Co-Chairman & MD of Dr Reddy's said.
Frequently Asked Questions
A vaccine works by mimicking a natural infection. A vaccine not only induces immune response to protect people from any future COVID-19 infection, but also helps quickly build herd immunity to put an end to the pandemic. Herd immunity occurs when a sufficient percentage of a population becomes immune to a disease, making the spread of disease from person to person unlikely. The good news is that SARS-CoV-2 virus has been fairly stable, which increases the viability of a vaccine.
There are broadly four types of vaccine — one, a vaccine based on the whole virus (this could be either inactivated, or an attenuated [weakened] virus vaccine); two, a non-replicating viral vector vaccine that uses a benign virus as vector that carries the antigen of SARS-CoV; three, nucleic-acid vaccines that have genetic material like DNA and RNA of antigens like spike protein given to a person, helping human cells decode genetic material and produce the vaccine; and four, protein subunit vaccine wherein the recombinant proteins of SARS-COV-2 along with an adjuvant (booster) is given as a vaccine.
Vaccine development is a long, complex process. Unlike drugs that are given to people with a diseased, vaccines are given to healthy people and also vulnerable sections such as children, pregnant women and the elderly. So rigorous tests are compulsory. History says that the fastest time it took to develop a vaccine is five years, but it usually takes double or sometimes triple that time.
India is the leading production hub for Sputnik V. RDIF has reached agreements with leading pharmaceutical companies in the country such as Gland Pharma, Hetero Biopharma, Panacea Biotec, Stelis Biopharma, Virchow Biotech and Shilpa to produce more than 850 million doses per year, sufficient to vaccinate more than 425 million people around the world.
Dr Reddy's said going forward about 60-70 percent of Sputnik V global volumes will be met from India.
Sputnik V received emergency use authorisation from India drug regulator early this week, following a bridge trial in India involving 1600 participants.
Dr Reddy's said the safety and immunogencity data generated in the bridge trial is in line with Russian trials.
The company said it is initiating pricing discussions with the government and other stakeholders.
Dr Reddy's which holds the marketing authorisation for Sputnik V will distribute the vaccine in India. The company said it is also responsible for harmonization of quality of Sputnik V vaccine across manufacturing sites in India, in addition to providing stewardship to manufacturing sites to commence manufacturing soon.
Dr Reddy's will also be responsible for the regulatory, safety and pharmcovigilance aspects of the vaccine in India. Dr Reddy's is also the custodian of the brand Sputnik V in India.
Dr Reddy's said it has lined up the cold chain and made the logistics arrangements to ensure delivery of the Sputnik V up to the last mile throughout the country.
The company said it will be using its own infrastructure and experience in cold chain handling. The company said it had made dry runs to test the cold chain and logistics.
"We have lined up the cold chain, right from the point of manufacture to global distribution centre in Hyderabad. We also lined up solutions like compact boxes which will be used to store and transport the vaccine to all parts of the country," said Deepak Sapra, Chief Executive Officer, API and Pharmaceutical Services.
Sputnik requires storage condition of -18 degrees C to -22 degrees C.
Sapre said the company is also working on alternate storage of 2-8 degrees C, which will be available in a few months.
The company said it is in the process of generating additional stability data, after which the necessary amendment request will be made to the regulator.