3 min read.Updated: 13 Apr 2021, 05:44 AM ISTLeroy Leo
Nod gives authorities more ammunition to stem pandemic’s 2nd wave
The SEC’s recommendation is based on phase 2 and 3 bridging study of 1,600 participants by Dr Reddy’s in India
India on Monday authorized the emergency use of Russia’s Sputnik V vaccine, adding a third shot to its arsenal amid an acute shortage of vaccines in some parts of the country and a record surge in covid cases.
The subject expert committee’s (SEC’s) go-ahead to the Sputnik shot—a formal approval will follow from Drugs Controller General of India (DCGI) V.G. Somani—comes at a critical moment and gives authorities more ammunition to stem the second wave of the pandemic, the ferocity of which has taken experts by surprise.
To make matters worse, a shortage of vaccines may soon slow down the pace of vaccination.
“The SEC recommended EUA (emergency use authorization) for Sputnik V. Now the DCGI will take a look at Dr Reddy’s application, and once he gives the EUA, it will be final," a person aware of the development said, requesting anonymity.
The Russian Direct Investment Fund (RDIF), the global commercialization partner for the vaccine, confirmed in a statement that it was awaiting formal communication for the recommendation.
The SEC’s recommendation of the Sputnik vaccine is based on phase 2 and 3 bridging study of 1,600 participants by Dr Reddy’s Laboratories in India.
The study was aimed at establishing the safety of the vaccine in the Indian population, as it did in a Russian trial.
While Somani’s authorization will mean that India could soon have its third covid-19 vaccine, supply is likely to be tight in the short term as Dr Reddy’s Laboratories, the only company licensed to sell the vaccine in India, is likely to initially import it from Russia despite manufacturing tie-ups with five Indian contract manufacturers.
While the five vaccine manufacturers that have signed pacts with RDIF—Hetero Biopharma, Gland Pharma, Virchow Biotech, Stelis Biopharma and Panacea Biotec—plan to produce around 850 million doses per year, production isn’t likely to start soon.
Hetero Biopharma, which signed a manufacturing pact with RDIF in November, is running behind schedule, a second person said, adding that the company has not started production.
In November, when the manufacturing agreement for 100 million doses was announced, the two parties said that they planned to start the production of Sputnik V in early 2021.
Emailed queries sent to spokespeople for Hetero and RDIF on the production schedule were unanswered at the time of publishing.
Gland Pharma, Virchow Biotech and Stelis Biopharma, which signed the pacts last month, have all given a timeline between April and September for starting production of the two-dose vaccine.
Panacea Biotec, the only experienced Indian vaccine maker that has a pact with RDIF, may start production as early as next month, the second person said.
The company’s managing director, Rajesh Jain, declined to comment on the matter.
“There are complications with manufacturing Sputnik V vaccine. The vaccine involves giving two doses with separate viral vectors at an interval of three weeks. This means that manufacturers require two separate lines to manufacture the doses," the second person said.
Despite the current manufacturing bottlenecks, the vaccine could be key in India’s fight against the covid-19 pandemic as it has the highest efficacy among those that are available.
A Lancet study published in February showed that the vaccine had a 91.6% efficacy.
The vaccine comes in two forms, a liquid that needs to be stored at -18 degrees Celsius and a Lyophilized, or freeze dried, version that can be stored at 2-8 degrees Celsius.
It is not yet clear which of the two variants will be available in India.
Discussions over the pricing of the vaccine are going on between the Indian government and Dr Reddy’s Laboratories.
RDIF has said it will price the vaccine at less than $10 ( ₹750) per dose for the Indian market.
Serum Institute of India’s Covishield and Bharat Biotech International’s Covaxin are currently being used in India’s inoculation drive.
Another company that could soon release its phase 3 efficacy data is Zydus Cadila for its ZyCoV-D, following which it will seek an emergency use licence.
Biological E and Gennova Biopharmaceuticals are currently conducting phase 1 and 2 trials of their vaccines, while Serum Institute of India has started its phase 2 and 3 bridging study for Covovax, a version of the protein subunit vaccine developed by US-based Novovax.
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