Russia’s long-awaited vaccine Sputnik V has reportedly hit a roadblock in manufacturing the second dose of its vaccine in India. Several sources in government have confirmed that the Russian vaccine developer faces manufacturing hurdles with the production of the second component (AD5) of the adenoviral vector vaccine. Government sources also informed that a group of Russian scientists had been to India for more than a month to try to find out about the technical issues faced by domestic manufacturers in the production of AD5.

According to experts. The second component of the vaccine is difficult to manufacture due to its adenoviral vector vaccine profile. So what makes Sputnik V different from other vaccines? Well, the Russian vaccine unlike the others which use the same composition of doses for both injections, Sputnik V uses two separate components in its vaccine. It uses two types of adenoviral vectors: rAd26 for the first dose and rAd5 for the second.

The main vaccine is Announcement26 and after 3 weeks or 21 days a booster dose is given which is rAd5. According to experts, the production of the second component is extremely time-consuming because the quality of the virus that can be produced in cell culture is considerably low. Therefore, if the yield is low, the amount of doses produced will be less.

Sputnik V will impact India’s vaccination target

The roadblock encountered by the producers of Sputnik V had a negative impact on the availability of vaccines for India’s vaccination target set by the government to vaccinate all over 18s by the end of December 2021. The central government has filed an affidavit with the Supreme Court on vaccine doses. which presented an estimate of the expected doses of the Russian vaccine manufacturer was set at 10 crore between August and December 2021.

This estimate has already been lowered by the government from an earlier projection of 15.6 crore in doses of Sputnik V for August-December 2021. The government expected 216 crore in doses until the end of December. But at a press conference held on July 2, Member of Niti Aayog (health) VK Paul announced that the government’s target of 216 doses is extremely promising, which was done based on the vaccine manufacturer’s commitments.

According to the data provided on the Co-winner platform, Sputnik V have delivered 4,44,638 doses to date in India. The second dose of the Russian vaccine is expected to be introduced in some hospitals and vaccination centers in India in the coming days.

India’s dependence on imports

Sputnik V not yet approved, SEC asks Dr Reddy for more data on vax |  Trade Standards News

Currently, Russian shots distributed in India have been imported from its mainland. According to V Muraleedharan, Minister of State, Ministry of Foreign Affairs, India has already imported 31.5 lakh units of Sputnik’s first component and 4.5 lakh units of its second component doses will date.

Dr Reddy’s laboratories in India are responsible for importing doses of the Sputnik V vaccine. According to a spokesperson for Dr Reddy’s Laboratories, they have already received 31.5 lakh doses of Sputnik V of the first component and 4, 5 lakh doses of the second component. The spokesperson also confirmed that the company is working closely with its six partners in the country to prepare for manufacturing.

The official also confirmed that the pilot program their company introduced in May 2021 has since seen a slow but steady increase in business across the country. Dr Reddy has partnered with several major hospitals across the country and has also set up their cold chain infrastructure in over 300 locations as the Russian vaccine requires -18 degrees Celsius Temperature. The Russian vaccine has been administered in 80 cities in India with more than 2.5 lakh of people vaccinated to date.

What was the idea behind Sputnik Light?

Sputnik V

Dr Reddy’s laboratories presented the Indian drug regulator on June 20 with a proposal for emergency use authorization (EUA) or marketing authorization and a protocol for the start of phase 3 of the drug. ” clinical trial for Sputnik light. This is a single dose of the vaccine.

Unfortunately, even the single-dose injection proposal was hampered by a regulatory hurdle. India’s SEC panel, which reports to the Medicines Regulatory Authority, cannot authorize the Indian pharmaceutical company to obtain an EUA. Some of the excerpts from the meeting quoted the following:

After extensive discussion, the committee suggested that the company present safety, efficacy and immunogenicity data from Phase 3 clinical trials of the Sputnik Light vaccine that are already underway in Russia to review the proposal. Additionally, as the safety and immunogenicity data for Dose 1 has already been generated in the country in another trial, there was inadequate data and rationale in conducting a separate similar clinical trial..

Timeline of Sputnik V in India

The Russian vaccine was due to start producing a large number of doses in July. The schedule has now been postponed to August. In India, the Russian Direct Investment Fund (RDIF) has manufacturing agreements with the Serum Institute of India, Hetero Group of Companies, Gland Pharma, Panacea Biotech, Virchow Biotech, Stelis Biopharma and Morepen. Dr Reddy is expected to import 25 crore doses of Sputnik V to India from Russia as part of the deal.

Currently, a technology transfer for the manufacture of Sputnik V in the country with a partnership of Serum Institute of India (SII), RDIF informed that the first batch of vaccine should be shipped from production units in September. In a statement, RDIF said that as part of the technology transfer process, SII has already collected samples of cells and vectors from the Gamaleya Center. The statement also confirmed that the cultivation process had already started with the import approval by the Drug Controller General of India.

According to data published in The Lancet, Sputnik V showed 91.6 percent effectiveness after phase 3 trials. On the other hand, Sputnik Light showed an 80 percent effectiveness level which, according to the RDIF, is superior to that of many two-dose vaccines.

Kerala government in talks with Russia

The Kerala government has started talks with Russia to set up a Sputnik V vaccine production plant in the state, as state government officials have confirmed. According to Minister of Industries P Rajeev, the state has already allocated 10 acres of land for this project. The Russian vaccine developed by National Institute for Epidemiology and Microbiology of Gamaleya is one of four Covid-19 vaccines accepted by India.

P Rajeev at a press conference informed that talks between Kerala and Russia had started a long time ago when there was a massive shortage of vaccines. Initial discussions are underway at the moment and discussions focus on the terms and conditions of both parties. The Chief State Secretary and industry officials are in conversation with Russian officials, the attorney general and the direct investment board. Both parties are expected to sign the agreement in a few days.

P Rajeev also mentioned that such a decision of the government of Kerala will immensely benefit the people of the state. Earlier, Kerala Chief Minister Pinarayi Vijayan asked state officials to make suggestions to companies ready to produce Covid-19 vaccines in the state. The government had charged Kerala State Drugs and Pharmaceuticals Ltd (KSDP) and a committee of experts to speed up the process. The government had decided to allocate the land for the Thonakkal Life Science Park to install the Russian vaccine production unit there.

Edited by Aishwarya Ingle

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