Dr Reddy's has said there is a "slight postponement" in the timeline of the commercial launch of Sputnik V coronavirus vaccine due to dependency on imported consignments, and quality testing in India, a statement that has implications for India's vaccination drive.
The Hyderabad-based drug maker didn't specify the commercial launch date of the Russian vaccine, one of the three cleared for emergency use in India.
"Our cold storage and other logistical arrangements are being executed in line with our commercialisation plan and are on track with no issues," the company spokesperson said on June 29.
The delay comes at a time when India is looking to step up the vaccine drive to innoculate all eligible people by the end of 2021. The Russia-made Sputnik vaccine, to be manufactured in India by Dr Reddy's and a few other Indian pharma firms, is integral to meeting the ambitious target.
There are reports that the Union Ministry of Health and Family Welfare is looking into delays in supply of Covaxin doses and has discussed the issue with the manufacturer Bharat Biotech.
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.
Covishield, the local name for AstraZeneca-Oxford university vaccine being manufactured by Serum Institute of India, accounts for the bulk of vaccines in India.
Around three million doses of Sputnik have arrived in India and the consignment of the second dose is likely to land by the end of June. The company said it is updating government authorities, media and members of the public on a regular basis.
Dr Reddy's is the brand custodian of the Sputnik V vaccine in India and has the sole distribution rights for the first 250 million doses of the vaccine in India as per its agreement with Russian sovereign fund RDIF.
Sputnik V is priced at Rs 995 per dose including GST.
The first 50 million jabs will be imported from Russia to ensure a speedier rollout before Indian pharma companies start producing Sputnik V.
"We have partnered with major hospitals all over the country. As part of the pilot phase, several partners have successfully administered Sputnik V, including some limited stock pilot roll-outs to the public in various cities," the company said.
The limited pilot soft launch of the Sputnik V vaccine in India that was initiated by Dr. Reddy’s in Hyderabad on May 14 has been successfully scaled up to Vizag, Bengaluru, Mumbai, Kolkata, Delhi, Chennai, Miryalaguda, Vijayawada, Baddi, Kolhapur, Kochi, Raipur, Chandigarh, Pune, Nagpur, Nashik, Coimbatore, Ranchi, Jaipur, Lucknow and Patna.
The company said by the end of this final leg of the pilot phase, it aims to reach 28 cities.
"This pilot phase has allowed us to test our cold storage arrangements of -18 degree C temperature in these cities, CoWIN integration, track-and-trace and other logistical arrangements ahead of our commercial launch," it said.Adequate numbers of cold chain units were being deployed, and the last-mile cold chain arrangement was being validated at every partner hospital to ensure seamless storage and handling of the vaccine, the statement added.