COVID – 19: India Approves Sputnik V for Emergency Use, Other Foreign Vaccines to be Fast-Tracked for Approval: Centre

Manas Dasgupta

NEW DELHI, Apr 13: India will have the third option in its basket of Coronavirus vaccines with the Indian regulator the Drug Controller General of India (DCGI) approving the restricted emergency use of the Russia-made Sputnik V vaccine late on Monday night. With this, India will now have three vaccines against COVID-19, including Covishield — the Oxford-Astrazeneca vaccine manufactured by the Serum Institute of India — and Bharat Biotech’s Covaxin.

According to an official spokesman of the central government on Tuesday, the DCGI has also decided to fast track approvals for all other pending foreign-produced Covid-19 vaccines that have been granted emergency use authorisation in other countries. This has been done to expedite the pace and coverage of the ongoing vaccination drive in the country.

Calling vaccination as one of the critical pillars of Covid-19 control and management, the government said fast-tracking of approvals would facilitate easier access to foreign Covid-19 vaccines approved by credible foreign regulators.

The decision will pave the way for imports, fill and finish as well as production in India of those vaccines which have already been received such authorisation in other countries, the Centre said.

About Sputnik V, the government said Dr. Reddy’s Laboratories Ltd. (M/s DRL) had applied for the grant of permission to import and market Gam-COVID-Vac combined vector vaccine, popularly called Sputnik-V, developed by M/s Gamaleya Institute, Russia for Emergency Use Authorization. The Gam-COVID-Vac combined vector vaccine (Component I & Component II) has been developed by National Research Center for Epidemiology and Microbiology of the Ministry of Health of the Russian Federation, Moscow, Russia and is approved in 30 countries across the world.

M/s DRL has collaborated  with  National Research Center for Epidemiology and Microbiology of the Ministry of Health of the Russian Federation for obtaining regulatory approval for import for marketing in India. The interim results of Safety immunogenicity and efficacy from Russian Phase III clinical trial have been published in Lancet journal.

M/s DRL was permitted to conduct a Phase-II/III clinical trial in the country. The firm has submitted interim data from the ongoing Phase-II/III clinical trial in the country. The data from the clinical trial is being continuously assessed by the drug regulator in consultation with the Subject Expert Committee consisting of domain knowledge experts from the fields of pulmonology, immunology, microbiology, pharmacology, paediatrics, internal medicine, etc, as a rapid regulatory response.

The government spokesman said the SEC after deliberating on various critical areas for consideration including safety, immunogenicity, efficacy data from overseas clinical studies, indication, age group, dosing schedule, precautions, storage, warnings, adverse effects of special interest, risk benefit evaluation, proposed factsheet, recommended the vaccine for restricted emergency use in the country. The approval of the vaccine in Russia along with its conditions/restrictions was also reviewed by the SEC. The SEC noted that the safety & immunogenicity data presented by the firm from the Indian study is comparable with that of the Phase III clinical trial interim data from Russia.

The vaccine is indicated for active immunization to prevent COVID-19 disease in individuals above the age of 18 and will have to be administered in two doses of 0.5 ml each with interval of 21 days. (Day 0: Component I & Day 21: Component II). The vaccine has to be stored at -18°C. Dr Reddy’s Laboratories will import the vaccine for use in the country, the spokesman said.

The spokesman said along with Sputnik V, the government has planned to further increase its basket of vaccines with other vaccines developed in other countries in keeping with the recommendations of the National Experts Group on Vaccine Administration for COVID-19 (NEGVAC) which met on Sunday.

“The NEGVAC, after comprehensive deliberation, recommended that vaccines for COVID-19, which have been developed & are being manufactured in foreign countries and which have been granted emergency approval for restricted use by the drug regulators in other countries or which are listed in WHO (Emergency Use Listing) may be granted emergency use approval in India,” the spokesman said.

However, as a precaution, the government decided that in case of all such foreign vaccines, the first 100 beneficiaries of such foreign vaccines will be assessed for seven days for safety outcomes before it is rolled out for further immunisation programme within the country.

About Sputnik V, the spokesman said Dr Reddy’s has the rights for distribution of the first 100 million doses in India, which will be a combination of Indian and Russian made vaccines

The Russian developers of the Sputnik V Covid-19 vaccine have tied up with several Indian pharmaceutical firms to manufacture more than 850 million doses a year. The developers – Gamaleya National Research Center for Epidemiology and Microbiology named and Russian Direct Investment Fund (RDIF) – initially tied up with Dr Reddy’s Laboratories for trials, regulatory approvals and distribution of the vaccine. Since March, the developers have stitched up more agreements to ramp up the production of the vaccine in India. This includes agreements with Gland Pharma, Hetero Biopharma, Panacea Biotec, Stelis Biopharma and Virchow Biotech aimed at the production of more than 850 million doses a year.

India became the 60th country to approve Sputnik V. Other countries that have approved the Russian vaccine so far included Venezuela, Paraguay, the United Arab Emirates, Iran, Mexico, Pakistan, Bahrain, Egypt, Sri Lanka, Iraq, the Philippines, Cameroon and Mauritius. India is also the most populous country to register the Russian vaccine. “Total population of 60 countries where Sputnik V is approved for use is 3 billion people or about 40% of the global population,” RDIF CEO Kirill Dmitriev said.

“We appreciate the decision of India’s regulatory bodies to grant authorisation for Sputnik V. Approval of the vaccine is a major milestone as Russia and India have been developing an extensive cooperation on clinical trials of Sputnik V in India and its local production.”

He added, “India is a vaccine-manufacturing hub and our strategic partner for production of Sputnik V. RDIF has created partnerships with a number of India’s leading pharmaceutical companies for production of Sputnik V which will provide for both vaccination of the population in India and global distribution of the Russian vaccine.”

Collaboration on Covid-19 vaccines had also figured in a recent meeting between external affairs minister S Jaishankar and his Russian counterpart Sergey Lavrov, who noted RDIF had signed contracts with Indian firms to manufacture the Sputnik V vaccine. He didn’t rule out further cooperation to cover manufacturing of Indian vaccines in Russia.

Meanwhile, the cumulative number of Covid-19 vaccine doses administered in the country has crossed 10.85 crore, the Union health ministry said on Tuesday. A total of 10,85,33,085 vaccine doses have been administered through 16,08,448 sessions, as per the provisional report till 7 am today.

Even as the total number of new cases marginally declined to 1.61 lakhs on Tuesday, ten states, Maharashtra, Uttar Pradesh, Chhattisgarh, Delhi, Karnataka, Tamil Nadu, Madhya Pradesh, Gujarat, Rajasthan and Kerala have shown a rise in the COVID-19 daily cases accounting for 80.80% of the new infections reported in a day, the Union Health Ministry said. Maharashtra has reported the highest daily new cases at 51,751. It is followed by Uttar Pradesh with 13,604 while Chhattisgarh reported 13,576 new cases.