WHO raises concerns at Sputnik V bottling plant; company states 'not related to efficacy'

As India rolls out Sputnik V vaccine across the nation, the World Health Organization (WHO) uncovered problems at a Sputnik V manufacturing lab in Moscow. WHO released a  summary report detailing six issues it found during its May 31 to June 4 visit to the Pharmstandard Ufa Vitamin Plant in Ufa, southern Russia. The company clarified that the issue was not related to the safety or efficacy of the vaccine as the plant handling only bottling the vaccine vials.

WHO uncovers issues at Sputnik V plant, company denies

As per reports, WHO site inspectors flagged concerns of data integrity and testing results from monitoring during manufacturing and quality control, along with data on monitoring and control of aseptic operation and filling. The WHO team also expressed concerns over filling lines, sterility assurance, sterile filtration validation, and the risks of cross-contamination. Sputnik V has already applied for WHO approval and is already being used in 40 countries.

Pharmstandard Ufa Vitamin Plant statement

In response to WHO's concerns, Pharmstandard-UfaVITA issued a statement assuring all four concerns have been addressed. The company stated that WHO did not raise any questions about the safety and efficacy of the vaccine which undergoes the 'strictest double quality output control'. "Moreover, WHO interim inspection did NOT identify any critical issues with the actual vaccine's production, quality, clinical studies, possible side effects, nor with the double quality output control by both the Gamaleya Institute and the Russian health regulator," said Pharmstandard-UfaVITA. The company added that it responded to all concerns within 48 hours and welcomed another WHO inspection. Pharmstandard-UfaVITA currently runs only four out of 20 filling lines for the Sputnik V vaccine.

About Sputnik V

The vaccine’s efficacy is reported at 91.4%  based on data analysis of the final control point of clinical trials, states its official website, which has been reviewed by Lancet journal. In September 2020, Dr. Reddy’s and Russian Direct Investment Fund (RDIF) entered into a partnership to conduct the clinical trials of the Sputnik V vaccine and the rights for distribution in India. Russia plans to manufacture 850 million doses in India and is priced at Rs 1145 at private hospitals.

As per its official website, Sputnik V is the world’s first registered vaccine based on a well-studied human adenoviral vector-based platform. While the vaccine's overall efficacy is confirmed at 91.4%, it boasts a 100% efficacy against severe cases of coronavirus. Sputnik V is a two-dose vaccine that can be stored at a temperature of +2 to +8 degrees Celsius. Apart from India, Brazil, China, South Korea are RDIF's international partners.