Sputnik maker ties up with Indian firm to produce 100 mn doses

The makers of Russian Covid-19 vaccine, Sputnik V, have tied up with another Indian vaccine manufacturer, Panacea Biotec, to produce 100 million doses of their Covid-19 vaccine

The makers of Russian Covid-19 vaccine, Sputnik V, have tied up with another Indian vaccine manufacturer, Panacea Biotec, to produce 100 million doses of their Covid-19 vaccine. The vaccine has shown an efficacy of 91.6%.

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“Vaccine partnerships are the only way to overcome the pandemic. The world continues its fight against coronavirus and we see a growing interest in Sputnik V vaccine as it is one of the best vaccines available. Cooperation with Panacea Biotec is an important step to produce the vaccine in India and to supply our international partners around the world,” said Kirill Dmitriev, chief executive officer, RDIF.

Production of Sputnik V at Panacea Biotec sites will help facilitate global supply of Sputnik V to international partners of Russian Development Investment Fund (RDIF), Russia’s sovereign wealth fund, RDIF said in a statement.

Till date, Sputnik V has been registered in 59 countries. In India, RDIF has already tied up with fivelocal companies-- Dr Reddy’s, Hetero Biopharma, Gland Pharma, Stelis Biopharma and Virchow Biotech-- for Sputnik V.

“We are pleased to collaborate with RDIF to produce Sputnik V for global markets. Panacea Biotec brings decades of vaccine manufacturing and distribution know-how to scale-up Sputnik V supplies. Panacea Biotec will produce Sputnik V in its internationally accredited facilities complying to strict GMP standards and prequalified by WHO,” said Rajesh Jain, managing director, Panacea Biotec.

Sputnik V developed by the Gamaleya National Research Institute of Epidemiology and Microbiology was registered by the Ministry of Health of Russia and became the world’s first registered vaccine against Covid-19 based on the established human adenoviral vector platform.

In September 2020, Dr Reddy’s and RDIF entered a partnership to conduct the clinical trials of the Sputnik V vaccine and the rights for distribution in India. In February this year, Dr Reddy’s applied to India’s drugs regulator for emergency use authorization of Sputnik V in the country. The application is still pending with the drugs controller, as the subject expert committee has sought more data from the clinical trials.

Once approved, Sputnik V will be the third vaccine that will be used in India’s Covid-19 immunisation programme that was launched on January 16, this year.

Meanwhile, Zydus Cadila on Monday also announced that it has sought national drugs controller’s approval for use of its viral hepatitis drug in treating Covid-19 patients as its phase 3 clinical trials with the drug showed promising results.

According to the company, 91.15% of patients treated with Pegylated Interferon Alpha 2b, PegiHepTM were reverse transcription polymerase chain reaction (RT PCR) negative by day 7 as compared to 78.90% on the standard of care arm in its phase 3 trials. Also, the drug reduced the duration for supplemental oxygen to 56 hours from 84 hours in moderate Covid-19 patients.

“…the interim results indicate that PegIFN, when administered early on, could help patients recover faster avoiding much of the complications seen in the advanced stages of the disease. PegIFN in COVID19 has several add-on advantages compared to other anti-viral agents. The treatment regimen would be less cumbersome and more affordable for patients as Pegylated Interferon Alpha 2b, is a single dose regimen. It would also ensure better compliance,” said the company in a statement.

The drug— PegIFN— has well-established safety with multiple doses in chronic hepatitis B and C patients over the years.

Aging reduces the body’s ability to produce Interferon Alpha in response to viral infections and may be associated with higher mortality in elderly patients. If given early during infection, the drug can replace this deficiency and aid a faster recovery process.

Patients on Pegylated Interferon Alpha 2b during the trial also showed lesser need for supplemental oxygen, indicating that it was able to control respiratory distress and failure that has been one of the major challenges in treating Covid-19.

“The findings are in line with recently reported importance of early IFN treatment given in combination with steroids in the treatment of COVID-19 (Lu et al, Signal Transduction and Targeted Therapy (2021) 6:107, a Nature publication. With these positive results, the Company has applied for an approval for additional indication with the DCGI for the use of PegIFN in the treatment of COVID 19,” said the company.

The Phase 3 trials were conducted on 250 patients across 20-25 centres in India, and the company is in the process of publishing detailed results of the trials in a peer-reviewed scientific journal.

“We are encouraged by the results of Phase 3 study of Pegylated Interferon alpha 2b which has confirmed the potential to reduce virus titres when given earlier in the disease. With Indian Innovation at the forefront helping the country fight the pandemic with diagnostics, vaccines and therapeutics, this marks an important milestone. At Zydus, we stand committed to our endeavour of supporting patients and caregivers with access to treatment options that are affordable and can help in better disease management of COVID 19 at different stages,” said Sharvil Patel, managing director, Cadila Healthcare Ltd.