Why Sputnik V vaccine rollout may not hit full capacity until August-September

Representative image of the Russian Sputnik V COVID-19 vaccine

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The Sputnik V COVID-19 vaccine rollout in India may not reach full capacity until August-September because manufacturers in Russia are struggling to keep pace with export orders, sources told Moneycontrol.

Additionally, Russia and other countries are seeing a surge of COVID-19 infections linked to the Delta variant and the authorities may divert some of the supplies to their local inoculation drives.

The vaccine developed by Gamaleya National Center of Epidemiology and Microbiology in Moscow with backing from Russia’s sovereign wealth fund is produced by Binnopharm, R-Pharm, Generium and other pharmaceutical companies. Binnopharm can produce 1.5 million doses of the vaccine per year.

The Indian government currently estimates it will get at least 100 million doses of Sputnik V by December, compared with a projection in May of about 156 million doses. The procurement is part of a plan to vaccinate all of India’s adult population against COVID-19 by December 31.

Dr Reddy’s Laboratories, which holds the sole distribution rights for the first 250 million doses of the Sputnik V vaccine in India, as per its agreement with the Russian Direct Investment Fund, had indicated earlier that it would import about 36 million doses of Sputnik V from Russia and was expecting the commercial rollout by July.

The Hyderabad-based pharma company has so far received over 200,000 vaccines from RDIF for the pilot launch of Sputnik V in tie-ups with large private hospitals across the country. The company is testing cold-chain logistics, distribution and inoculation bookings for Sputnik V on the CoWIN website.

Emails sent to Dr Reddy's and RDIF are yet to elicit response at the time of publishing the story.

Hospitals are complaining that the promised supplies are not reaching them.

“They (Dr Reddy’s) promised in a day or two. There is no clarity on whether they will come or not,” said Alok Roy, chairman of Medica Superspecialty Hospital in Kolkata.

Early this week, Dr Reddy’s said there was a “slight postponement” in the commercial launch of the Sputnik V vaccine because of the dependency on imported consignments and the time taken for quality testing in India, implying delays for India’s vaccination drive.

The company didn’t specify a commercial launch date for the Russian vaccine, which is one of three approved for emergency use in India.

“They (Dr Reddy’s) were looking at imports of 40-50 lakh doses in the initial months, but the expectations are more subdued now,” said Amey Chalke, vice president at Haitong Securities India.

Please read here about the delay in commercial rollout.

To be sure, the delays aren’t specific to India. There are reports about Argentina, Mexico, the Philippines and Guatemala, among others, reporting delays in receiving Sputnik V supplies.

Complex manufacturing

RDIF has signed fixed-price contracts for the manufacture of the Sputnik V vaccine in India with Hetero Biopharma, Gland Pharma, Stelis Biopharma, Virchow Biotech, Shilpa Medicare and Panacea Biotec. The six manufacturers together may produce about 1 billion doses of the vaccine.

An executive of a pharma company that’s manufacturing Sputnik V told Moneycontrol on condition of anonymity that the production of validation batches has started and their commercial rollout is expected from October.

“In the case of Sputnik V, it is two different vaccines. We need two different facilities. There is complexity in manufacturing. We are learning. The process takes about four to five months,” the executive said.

Sputnik V uses two different vectors for the two shots needed to complete a course of vaccination.

“We can expect supplies ramping up towards the fag end of the second quarter of FY21, with domestic manufacturers coming on stream. For most of these contract manufacturers, vaccine making is new – that also adds to the challenge,” Chalke said.