Dr Reddy’s on January 29 said it is planning to apply for emergency-use approval (EUA) of Sputnik V COVID-19 vaccine by March.
The company said it has completed dosing of the Russian vaccine on about 70 percent participants in the phase-3 bridge trial, and expects to complete the trial in February, following which it will compile the data, and approach the Drug Controller General of India (DCGI) for EUA.
Dr Reddy’s is currently conducting trial on 1,500 volunteers. Sputnik V has to be given in two doses, with 21 days apart from each dose.
“We believe we should be in a position to launch the vaccine through EUA by the end of March,” Deepak Sapra, Chief Executive Officer, API and Pharmaceutical Services, said.
If EUA is granted, Sputnik V will become the third vaccine available to the government. India has already rolled out Serum Institute of India’s Covishield and Bharat Biotech’s Covaxin. The government plans to vaccinate 3 crore healthcare and frontline workers in the initial phase of the COVID-19 vaccination.
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.
Dr Reddy’s said it hasn't yet initiated any discussion on vaccine pricing with the government.
“We are looking at working closely with the government of India. In addition to that, we are also looking at the open market, so that we can maximise the availability of vaccine,” he said.
“Over the 12-month period, we have a contract with our partner for 125 million patient doses (250 million doses) for India. This will enable 125 million people or 9 percent of India’s population to be vaccinated,” Sapra said.
“The product is going to come largely from our two partners which manufacture in India, and a little bit will be imported from Russia,” Sapra added.
Sapra said that Dr Reddy's is in talks with Russia's sovereign wealth fund RDIF to expand the scope of partnership to cover more countries, where Dr Reddy's has a presence.
The price of Sputnik V is less than $10 per shot, making it affordable around the world.
The Sputnik V vaccine has been approved in Russia, Belarus, Serbia, Argentina, Bolivia, Algeria, Palestine, Venezuela and Paraguay. The process to approve the vaccine in the EU has been initiated.
So far, over 1.5 million people have been vaccinated with Sputnik V. RDIF also has distribution agreements with other companies in India. RDIF says that Sputnik has showed over 90 percent efficacy in the interim analysis.
The vaccine is said to be stable at 2-8 degrees Celsius, which makes it compatible with cold-chain conditions in most of the developing world.Dr Reddy's and Hetero have signed up with RDIF to manufacture and distribute 200 million doses of the vaccine in India.