Exclusive: Sputnik V hits production roadblock for second dose of Covid vaccine

Russia’s Sputnik V has reportedly hit a roadblock within the improvement of the second dose of its Covid-19 vaccine in India. Sources within the authorities have mentioned that the Russian vaccine maker is going through manufacturing points with producing the second element (AD5) of the adenovirus vector-based vaccine.

Government sources mentioned a crew of Russian scientists visited India for over a month to attempt to iron out the technical issues being confronted by home producers in producing AD5. Sources mentioned the second element of the vaccine is more durable to fabricate as a result of of its design as an adenovirus vector-based vaccine.

Unlike different vaccines which use the identical composition of doses for the primary and the second shot, Sputnik V makes use of two completely different parts in its Covid vaccine – two varieties of adenovirus vectors (rAd26) for the primary shot and (rAd5) for the second vaccination. While Ad26 is the primary vaccine, Ad5 is a booster shot which is given 21 days or three weeks aside.

Also See: Moderna, Pfizer vaccines reach India’s neighbourhood. Apna number kab aayega?

Producing AD5 is time consuming as nicely, as a result of the yield — or high quality of virus that may be grown in a cell tradition — of the second dose (AD5) is low. If the yield is low, the amount of doses produced is low.

India Today reached out to the Russian Direct Investment Fund (RDIF) for a response, which is being awaited.

WILL DELAY INDIA’S VACCINATION TARGET

The points in production have impacted the supply of doses for the vaccination goal set by the Indian authorities to vaccinate all above 18 years by December 2021. In a Supreme Court affidavit on vaccine doses filed by the central authorities, the projected estimated doses anticipated from Sputnik V was pegged at 10 crore between August and December 2021.

This projection was lowered by the federal government from an earlier estimation of 15.6 crore doses of Sputnik V vaccine for August-December 2021. The projected estimation was for 216 crore doses until December, however In a July 2 press convention, VK Paul, Niti Aayog member (well being), mentioned “The government’s roadmap of 216 crore doses is an optimistic one, which was made by banking on the “reputation” of the vaccine producers, and ought to be seen in a dynamic context.”

Also See: Kerala in talks with Russia to set up Sputnik V vaccine manufacturing unit, says minister

Till date, 4,44,638 doses of Sputnik V vaccine have been administered in India, in keeping with knowledge on the Co-Win platform. The second dose of Sputnik V vaccine is slated to be administered in vaccination centres and chosen hospitals in India this week.

Also See: Covid vaccines for children: Here are the options in India

HEAVY DEPENDENCE ON IMPORTS

At current, Sputnik V vaccines being administered in India have been imported from Russia. “India has imported 31.5 lakh units of Sputnik component 1 and 4.5 lakh units of Sputnik component 2 vaccine till date,” MoS, Ministry of External Affairs, V Muraleedharan informed Rajya Sabha.

The doses of the Russian vaccine are being imported by Dr Reddy’s Laboratories. India Today additionally reached out to Dr Reddy’s for response to whether or not they have been going through points with importing the second element (element 2) of the Sputnik V vaccine to India.

An organization spokesperson mentioned: “We have received 31.5 lakh doses of component 1 and 4.5 lakh doses of component 2 of the Sputnik V vaccine in India. We are working closely with the RDIF to ramp up supplies. We are also working closely with our six partners in India for manufacturing readiness. Meanwhile, the pilot programme 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 -18 degree C temperature. The Sputnik V vaccine has been rolled out across 80 cities in India with over 2.5 lakh people vaccinated so far.

IDEA BEHIND SPUTNIK LIGHT

In India, Dr Reddy’s submitted a proposal to the drug regulator on June 30 for an emergency use authorisation (market authorisation) 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 an EUA. The minutes of the meeting, which India Today has seen, stated – “After detailed deliberation the committee recommended that the firm should present the safety, immunogenicity, efficacy data from the phase 3 clinical trials of the Sputnik Light vaccine that is being carried out in Russia for considering the proposal.

Further, as the safety and immunogenicity data of component one has already been generated in the country in another trial, there seems to be inadequate data and justification in conducting a separate similar trial.”

SPUTNIK V TIMELINE IN INDIA

The Russian vaccine was supposed to start manufacturing a major amount of doses in July. The timeline has now been pushed 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’s will import 25 crore doses for India from Russia beneath the contract, it has been reported.

Recently, a know-how switch for the production of Sputnik V in India by way of a tie up with the Serum Institute of India, RDIF mentioned that the primary batch of vaccines is predicted to roll out from the manufacturing models in September. “As part of the technical transfer process, SII has already received cell and vector samples from the Gamaleya Center. With their import approved by the Drug Controller General of India), the cultivation process has begun,” learn an announcement from RDIF.

According to outcomes revealed in The Lancet, the efficacy of Sputnik V was discovered to be 91.6 % after Phase 3 trials, whereas the Sputnik Light vaccine has an efficacy degree of nearly 80% is greater than that of many two-dose vaccines, claims RDIF.

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