DRL plans to start paediatric trials of Sputnik Light vaccine soon

DRL plans to start paediatric trials of Sputnik Light vaccine soon

Soon India may have another option in paediatric Covid-19 vaccines in Sputnik Light as Dr Reddy’s Laboratories (DRL) is firming up clinical trial protocols to begin testing in children. What’s more, is in discussions with the Indian regulator on using Sputnik as a booster shot to be taken six months after any vaccine regimen. The Hyderabad-based company, which is the Indian partner of Russian Direct Investment Fund (RDIF), is working actively on ‘life-cycle management’ of the Sputnik V vaccine. Deepak Sapra, CEO (API and pharmaceutical services), said that the firm was working on several options for the Russian vaccines. “The clinical trials for Sputnik Light in India are on and we expect to submit data to the Drugs Controller General of India (DCGI) in November. Moreover, we have finalized the clinical trial protocol for the booster dose trials too. We are currently discussing the same with the DCGI. This apart, a separate trial on children would also be done with Sputnik Light vaccine in India. And lastly, we are also discussing with our partners for exporting the India-made Sputnik to several countries,” Sapra elaborated the strategy. As for Sputnik Light (the first dose component of Sputnik V which uses two different vectors Ad26 and Ad5 in the two doses) trials in children, plans to do it in two age groups – 2-12 years and 12-18 years. “We are now finalising the trial protocol for the same. As for dosage and strength for children, these would be decided soon. Indian sites can make and supply the Sputnik Light for children,” Sapra said. As for the booster shot, the company said that they would test it as a booster after someone has completed vaccination with any Covid19 vaccine. “Once someone has completed the vaccine regimen of any Covid19 vaccine, he can take a Sputnik shot as a booster after six months. Right now we are doing a trial for a booster after six months,” Sapra said. Around 1.1 million doses of Sputnik V vaccine have been given in India so far. However, the demand for the vaccine in the private market is ‘soft’, DRL admitted.

As such demand for paid vaccines at private centers has significantly come down in the recent months. DRL sells the Sputnik only through the private channel.

It is discussing with the Indian government now to sell the Sputnik Light – single dose vaccine – to the government. When asked if there could be a reduction in prices as Indian sites have begun manufacturing, Sapra said that discussions on pricing were on, but would depend on the Indian government, and DRL’s partners in Russia and India. Sputnik V was launched in the private market for Rs 995 a dose. The company is thus looking for more avenues to ensure sustained demand for Sputnik vaccines. Export is one such option. “We are discussing with our partners for exporting to countries in the Asia-Pacific region, African countries apart from Latin American and Central American countries,” Sapra said. Supplies from the Indian sites, however, will hold the key to exports and selling large volumes within India. DRL has struggled with supplies from Russia since the beginning. In September, DRL, the sole distributor of Sputnik V in India under an agreement with RDIF, was sitting on a stock of 2.6 million first dose component of Sputnik V. Such a situation had evolved as the company had received around 3.1 million doses of first dose component and only 450,000 doses of the second dose component from Russia. This had held back a large-scale roll out of the vaccine here. Sputnik V is a heterogeneous vaccine where the first and second doses are different and use two different vectors Ad26 and Ad5. Thus to roll out the vaccine, DRL needed both the components in hand. In the first week of September, Panacea Biotec, a manufacturing partner of RDIF, supplied the first shipment of one millon doses of the second dose component of Sputnik V for sale in India. On Friday Sapra claimed that DRL did not have any significant stock of the dose-1 of Sputnik V. “Already three Indian sites are making the component 1 and around two sites are making dose 2 of Sputnik V here,” he said without divulging the names of the manufacturing partners. India is the leading production hub for production of Sputnik vaccine. RDIF had earlier reached agreements with a number of pharmaceutical companies in India (Gland Pharma, Hetero Biopharma, Panacea Biotec, Stelis Biopharma, Virchow Biotech and Morepen) for production of the Russian vaccine–more than 850 million doses per year. Serum Institute of India was roped in later for another 300 million annual doses. Around 250 million doses are planned for India at the moment.

DRL working on enhancing Covid portfolio

  • DRL is working on several product extensions as well as market expansions for its Covid products portfolio. For example, it is working on bringing in a 1 ml liquid intravenous injectable version of Gilead’s remdesivir, a drug widely used for moderate to severe Covid patients.
  • Similarly, for its oral antiviral drug favipiravir which it sells under an agreement with Japanese innovator FujiFilm, it is looking to expand markets beyond India, the company said. As for MSD’s drug Molnupiravir, which is currently undergoing clinical trial in India, the company said it has already shared interim data with the drug regulator. DRL is also trying to have label expansion for mild patients for the 2-DG or 2-Deoxy-d-Glucose that it developed with the Institute of Nuclear Medicine & Allied Sciences, a Defence Research and Development Organisation arm.

  • DRL preparing clinical trial protocol for Sputnik Light testing on children

  • Paediatric trial will be on two cohorts – 2-12 and 12-18 yrs

  • DRL in talks with DCGI for booster dose trial of Sputnik

  • Booster shot of Sputnik after 6 months of completion of any Covid vaccine regimen

  • DRL looking to export Sputnik to African, Latin American, Asia-Pac countries

  • Three sites in India now making dose-1 of Sputnik, 2 sites making dose-2 of Sputnik

  • DRL is discussions with Indian govt to sell Sputnik Light

  • Pricing discussions on with GoI

  • Prices may come down depending on discussions with GoI, DRL’s partners in Russia and India

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First Published: Fri, October 29 2021. 18:02 IST

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