WHO EUL for Sputnik V stuck, but exports from India likely to remain unaffected

Sputnik V, the lowest consumed COVID-19 vaccine under India's national coronavirus inoculation program, is striving to receive the Emergency Use Listing (EUL) from the World Health Organization (WHO) amidst the ongoing Russia-Ukraine war.

According to WHO's latest guidance document released this month on landscape of COVID-19 vaccines, additional information has been submitted regarding Sputnik V which has been developed by Gamaleya Research Institute and backed by Russian Direct Investment Fund (RDIF), Russia's sovereign wealth fund.

The WHO document stated that several meetings have been and continue to be held. It further said that it is awaiting completion of rolling submission and Corrective and Preventive Actions (CAPA) to last inspection. Anticipated date will be set once all data is submitted and follow-up of inspection and observations completed, the WHO said.

WHO's EUL procedure assesses the quality, safety and efficacy of COVID-19 vaccines and is a prerequisite for COVAX vaccine supply. It also allows countries to expedite their own regulatory approval to import and administer COVID-19 vaccines.

There have been doubts about Sputnik V's future in India. Although several pharma companies are planning to make the vaccine locally, yet the demand for the vaccine in India has been low.

Russia was to export 250 million doses of Sputnik V to India, which was among the major planned producers of the vaccine. In total, Indian companies planned to produce at least 1,152 million doses of Sputnik V per year. Furthermore, Mexico ordered a total of 24 million doses of the vaccine. Sputnik V was authorised in more than 70 countries worldwide as of January 2022.

India remains the largest production hub for Russia's Sputnik V and its single-dose version, Sputnik Light. To facilitate the necessary production capacities, RDIF has reached agreements with leading Indian pharmaceutical companies, including Serum Institute of India (the world's largest vaccine producer), Gland Pharma, Hetero Biopharma, Panacea Biotec, Stelis Biopharma, Virchow Biotech and Morepen. The RDIF also has a tie-up with Dr Reddy's for the production of Sputnik V and the pharma major has the distribution rights of the vaccine in India.  Sputnik V received the emergency use authorisation in India last year, while Sputnik Light got the approval from the country's Drugs Controller General of India (DCGI) last month.

Pharma companies have indicated that as India's pharmaceutical companies have already struck pre-purchase deals with the RDIF and the raw material has already been procured much before the Russia-Ukraine war, production of the vaccine in India is expected to be minimally impacted.

 "On Sputnik supplies, we have manufacturing capabilities in India. Drug substance is not imported and hence there is no impact," Dr Reddy's spokesperson told BT.

Pharmaceutical industry experts believe that the impact on Sputnik being locally manufactured will be minimal.

"Despite Sputnik being launched in India and Gamaleya lining up multiple manufacturers, the demand for the product is minimal. It hasn't received EUA after so many months and is unlikely to now. Hence even thought RDIF is sanctioned by the US, it will have minimal impact as most of the requirements to manufacture Sputnik must already be available in India and import of those materials may not be necessary," said pharmaceutical analyst Salil Kallianpur.

"Local manufacturers in India wont face problems because they have pre-purchase deals with RDIF and consumption isn't thier headache. The pharmaceutical companies will still manufacture the vaccine as material purchase may have happened already and is in storage and the demand is low," he said.

Demand of Sputnik V in India as been extremely low with barely 12,20,136 doses administered as on Thursday among the total over 181 crores doses inoculated so far in the country.

"Despite the fact that India exports about 4 million Sputnik doses, that may continue unabated for two reasons: one is that the demand of Sputnik V is low and the vaccine has not received the EUL from WHO yet. India already has several other alternative vaccines to choose from. Dr Reddy's, the main manufacturer, sees no risk with import from Russia as they already have capability to make all materials needed for Sputnik and have reduced dependence on Russia /RDIF," said Kallianpur.
 
An opportunity for Sputnik V may be in the prevailing vaccine inequality across the world. Pharma analysts further state that as the COVID-19 pandemic is ebbing away, the future of Sputnik V will still be uncertain.

WHO set a target for all countries to vaccinate 10 per cent of their populations by the end of September 2021. 56 countries, effectively excluded from the global vaccine marketplace, were not able to reach this target – and most of them in Africa.

Besides, several countries missed the WHO targets of vaccinating 40 per cent of the population last year, and may miss the target of vaccinating 70 per cent by the middle of this year.

"As the global north continues to hoard doses of other vaccines, Sputnik may become an alternative. However as the severity of the pandemic reduces, those vaccine reserves are likely to be released to poorer countries as "humanitarian acts". This may further impact Sputnik uptake if the war further reduces chances of an WHO audit and EUL approval," said Kallianpur.

The RDIF recently said in a statement that from day one it has been focused on people and improving their quality of life. RDIF helped protect millions of people in over 70 countries through its humanitarian mission to fight coronavirus infection, it said.

"RDIF supports restoration of peace and hopes negotiations between representatives of Russia and Ukraine are successful. RDIF and its international partners believe that only diplomacy can end this conflict and save human lives," it said.