Thursday, 28 October 2021

Sputnik V to go on Full stream production in India from September

Sputnik V to go on Full stream production in India from September

Russia's Sputnik V has reported hitting a roadblock in developing the second dose of the Covid-19 vaccine in India.

Sources in government have said that the Russian vaccine maker is facing manufacturing issues producing the second component of the adenovirus vector-based vaccines.

Sources of Government said a team of Russian scientists visited India for over a month to trail and iron out domestic manufacturers' technical issues in producing AD5. Authorities said the second component of the vaccine is harder to manufacture because of its design as an adenovirus vector-based vaccine.

Unlike other vaccines, which use the same doses for the first and second shots, Sputnik V uses two different ingredients in Covid 19 vaccine - two types of adenovirus vectors (rAd26) shot and (rAd5) for the second vaccination. While Ad26 is the primary vaccine, Ad5 is a booster shot given 21 days or three weeks apart.

Producing AD5 is time-consuming because the production or quality of the virus grown in the cell culture of the second dose is low. If the product is low, the quantity of amounts produced is low.

However, the Russian Direct Investment Fund (RDIF) told India Today that reports about delays in producing the second component of Sputnik V in India.

"A number of RDIF partners in India have already produced the second component batches, which are undergoing verification at the Gamaleya Center in Russia. Transfer of technology to partners in India is also in process and there is an active exchange between Russian and Indian vaccine production specialists. RDIF plans to accelerate deliveries of Sputnik V and Sputnik Light to India already in August."

"Production in India is expecting to come fully production in September, and RDIF expects India to become a central production hub for the Sputnik V vaccine with such companies as Serum Institute of India,

The world's biggest vaccine producer, Gland Pharma, Hetero Biopharma, Panacea Biotec, Stelis Biopharma, Virchow Biotech, and Morepen Laboratories are working to produce the vaccine," the RDIF told India Today.

Problem faces in production have cause affect the availability of doses for the vaccination objective set by the government to vaccinate all above 18 years by year-end. In an affidavit submitted in the Supreme Court on vaccine doses filed by the central government, Sputnik V projected estimating quantity were limiting to ten crores between August and December 2021.

The government lowered this projection from an earlier estimation of 15.6 crore doses of the Sputnik V vaccine for August-December 2021. The projected measure was for 216 crore doses till December.

Still, In a press conference on July 2, VK Paul, a Niti Aayog member, said, "The government's plan of 216 crore dosage is an positive one, which was made by banking on "reputation" of vaccine manufacturers, and should be seen in a dynamic context."

To date, 4,44,638 doses of the Sputnik V vaccine have been issuing in India, according to data on the Co-Win platform. The second jab of the Sputnik V vaccines is slating to be giving in vaccination centers and selected hospitals in India this week.

At present, Sputnik V vaccines being administering in India have been importing.

Sputnik V togo on Full stream production in India from September 1getty image

Read More: 200 million extra Covid-19 Pfizer vaccine received by US from Pfizer

Ministry of External Affairs, V Muraleedharan told Rajya Sabha.

"India has imported around 31.5 lakh quantity of Sputnik 1 and 4.5 lakh quantity of Sputnik 2 vaccine till date,"

A company spokesperson said:

"We have received 31.5 lac doses of component 1 and 4.5 lakh doses of component 2 of Sputnik V vaccines in India. We are very working closely with the RDIF to ramp up supplies. We are working very closely with our six partners in India for manufacturing readiness. Meanwhile, the pilot program that we launched in May 2021 has since then seen gradual and steady commercial scale-up all over India. We have partnered with major hospitals around the country and set up our cold chain infrastructure across 300+ locations since the vaccine requires an -18 degree C temperature. The Sputnik V vaccine has been rolling out across 80 cities in India, with over 2.5 lakh people vaccinated so far.

In India, Dr. Reddy's submitted a proposal to the drug regulator on June 30 for an emergency use authorization (market authorization) and a Phase 3 clinical trial protocol for Sputnik Light—a single dose of the vaccine.

But even the single-dose proposal has hit a regulatory wall. India's SEC panel under the drug regulator denied permission to Dr. Reddy's for a EUA.

The Russian vaccine was supposed to begin manufacturing a significant quantity of doses in July. The timeline has now been pushing to August. In India, the RDIF has production agreements with the Serum Institute of India, Gland Pharma, Hetero Group of Companies, Panacea Biotec, Stelis Biopharma, Virchow Biotech, and Morepen. Dr. Reddy will import 25 crore doses for India from Russia under the contract, and it has been reporting.

Recently, a technology transfer for Sputnik V in India through a tie-up with the Serum Institute of India, RDIF said that the first batch of vaccines is expecting to roll out from the manufacturing units in September.

The statement read by RDIF.

"As part of transfer of technical process, SII ( Serum institute of india) has already vector samples and received cell from Gamaleya Center. With their import approved by Drug Controller General of India, the cultivation process has begun,"

According to The Lancet results, Sputnik V's effectiveness was to be 91.6 percent after Phase 3 trials. At the same time, the Sputnik Light vaccine has an efficacy level of almost 80% is higher than that of many two-dose vaccines, claims RDIF.

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