Phase 3 Trial Clear & Transparent, Claim Russian Scientists : Sputnik V Arrives In India | may 14 | 2021 | Friday |

Phase 3 Trial Clear & Transparent, Claim Russian Scientists : Sputnik V Arrives In India | may 14 | 2021 | Friday |

  • “Nearly 18 crore doses of COVID19 vaccine have been administered in India till date.”
  • “Around 216 crore doses of vaccines will be manufactured in India between August-December”

New Delhi/Bhubaneswar: NITI Aayog Member (Health), Dr VK Paul on Thursday announced that Russian COVID-19 vaccine- Sputnik V has arrived in India.

Sputnik V production will begin in July and it is estimated that 15.6 crore doses will be manufactured,” said Dr VK Paul, NITI Aayog Member (Health).

While briefing media Paul said, “I’m happy to say that we’re hopeful it’ll be available in the market next week and the sale of the limited supply that has come from Russia, will begin next week.”

“Supply will also follow. Its production will begin in July and it is estimated that 15.6 crore doses will be manufactured in that period,” he added.

Giving a stock of the COVID vaccination drive conducted across different states in the country, Paul said that nearly 18 crore doses of COVID19 vaccine have been administered in India till date. The number of vaccines administered in the US stands at around 26 crores and comparing the figures, India stands in third place.

“We are happy to report that 1/3rd of 45 and above are protected. 45 and above age group contributes to 88% of deaths,” Paul said.

Sputnik V vaccines from Russia arrive in Hyderabad vaccination drive latest  news | India News – India TV

Further clarifying about vaccine manufacturing in the country Paul said, “Around 216 crore doses of vaccines will be manufactured in India between August-December and with this flow, vaccines will be available for all as we move forward.”

The Department of Biotechnology along with other concerned departments, MEA have been in touch with Pfizer, Moderna, Johnson & Johnson from the starting phase. They were officially asked if they’d like to send doses to or manufacture in India.

However, the abroad vaccine manufacturing companies had said that they are working in their own way and they would talk of vaccine availability in Q3, in 2021, informed Paul.

We are connected to them. I’m hopeful that they’ll step forward to increase availability in India. Any vaccine that is approved by FDA, WHO can come to India. Import license will be granted within 1-2 days. No import license is pending,” clarified Paul.

Meanwhile, Russian scientists said that the phase 3 trial of Sputnik V Covid-19 vaccine is clear, transparent and fully complies with the regulatory standards that exist for the provision of clinical trial data.

Sputnik V vaccine: India receives first consignment from Russia | The News  Minute

The clarification comes after concerns were raised by various scientists over data discrepancies and substandard reporting of interim data of the Coronavirus jab.

A team of scientists from universities in the US, the Netherlands, Italy, France and Russia had earlier flagged concerns over Sputnik V Phase 3 trial, specifically on discrepancies in data sharing, trial protocols, inconsistencies in data reported and numerical results.

“We lack some crucial information, such as the clinical parameters determining suspected Covid-19, what diagnostic protocols were used, when the PCR testing was done, what specific method was used, or how many amplification cycles were used,” said the scientists in the ‘online first’ section of medical journal The Lancet.

They had also pointed out problematic data and lack of transparency in the published Phase 1/2 results.

Clear and transparent regulatory standards exist for provision of clinical trial data, including data reported in clinical study reports that are considered sufficient for regulatory review and approvals. The reporting of the interim analysis in the Phase 3 Sputnik V clinical trial fully complies with those standards,” said scientists from the Ministry of Health of the Russian Federation in Moscow.

Their reply was also published in the Lancet’s ‘online first’ section.

“It is on this basis that Sputnik V has received registration in 51 countries, which confirms our full transparency and compliance with the regulatory requirements,” they added.

The scientists noted that “the safety and immunogenicity of the Sputnik V vaccine has been confirmed in multiple studies”, including in Argentina, where vaccination with Sputnik V began.

“Authorised in 64 countries with a population of 3.2 billion people, #SputnikV consistently demonstrates safety and efficacy in real world data from Argentina, Mexico, Hungary and other countries,” SputnikV tweeted with a link to the Russian scientists’ reply.

Sputnik V: 1st batch of Russian Sputnik V vaccine arrives in India - The  Economic Times Video | ET Now

In April, Sputnik V, developed by Russia’s Gamaleya National Center, became the third vaccine to be cleared for use in India, after the Serum Institute of India’s Covishield and Bharat Biotech’s Covaxin were cleared in January.

With an efficacy of 91.6 per cent, Sputnik V was the first vaccine against Covid-19 in the world.

It will be available in markets across the country from early next week, the Union Ministry of Health and Family Welfare (MoHFW) announced on Thursday.

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Coronavirus vaccine | may1 News | 2021 | India To Receive Sputnik V Vaccine Consignments From May 1

New Delhi: Amid the raging second wave of the Covid-19 pandemic in India, the country will start receiving consignments of Russian Sputnik V vaccine doses from May 1 onwards.

India is expected to receive 5 million doses of the vaccine by June.

According to media reports, around 150,000 to 200,000 doses of the vaccine will be delivered by early May and another 3 million doses by May end.

After Covishield and Covaxin, Sputnik V, developed by Gamaleya National Research Institute of Epidemiology and Microbiology in Moscow, is the third Covid-19 vaccine to get emergency use approval in India.

According to the guidelines, the vaccine is indicated for active immunisation to prevent Covid-19 in individuals over 18 years of age and it needs to be stored at a temperature of minus 18-degree Celsius in liquid form.

However, it can be stored at 2-8-degree Celsius in its freeze-dried form in a conventional refrigerator, making it easier to transport and store.

In a recent study, published in the journal The Lancet, the efficacy of Sputnik V was determined to be 91.6 per cent.

“There is a need to generate evidence about its efficacy in the Indian population. Sputnik V will provide one more option to the country to boost its vaccination drive,” Harshal R Salve, associate professor at the Centre for Community Medicine, AIIMS Delhi, had earlier told IANS.

The vaccine should be administered in two doses of 0.5 ml each with an interval of 21 days.

While speaking to IANS recently, N.K. Arora from the Indian Council of Medical Research said that the composition of the first dose will be different from the second dose and there should be at least a three to four weeks gap between the first and the second shot .

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