Sputnik V COVID vaccine phase 3 trials to begin in India this month

The phase III clinical trials of Russia's Sputnik V COVID-19 vaccine is set to begin in several countries including India in September 2020. This was confirmed by Kirill Dmitriev, the head of the Russian Direct Investment Fund on September 7, 2020. 

Besides India, the third phase of clinical trials of the Sputnik V vaccine will also be conducted in the United Arab Emirates (UAE), the Philippines, Saudi Arabia and Brazil.

Dmitriev stated that the post-registration studies involving more than 40,000 people began in Russia on August 26, before AstraZeneca started its Phase 3 clinical trial in the United States involving 30,000 participants.

When will the results come?

According to Kirill Dmitriev, the preliminary results of the Phase 3 trial of Sputnik V will be published by October-November 2020.

Sputnik V Phase 3 Trial in India

• Russia has been in close dialogue with the concerned Indian ministries, the Indian government and the leading drug manufacturers in the nation regarding the localised production of the Sputnik V COVID-19 vaccine in India. The nation has also achieved certain agreements with leading companies, confirmed Kirill Dmitriev.

• Dmitriev stated that India has historically been a very important partner of Russia and it is one of the leading countries in production. He highlighted that around 60 percent of all the vaccines in the world are produced in India. 

• He further added saying that Russia recognises India and it's potential to become one of the support for the production of the vaccine not only in Indian markets but for other countries as well. He said that they appreciate the well- balanced approach expressed by Indian partners, as right from the start they started asking questions how on the vaccine works and that Russia appreciates that they did not try to attack their vaccine but try to understand it.

• Dmitriev added saying that India's desire to understand their vaccine got them to realize that their approach based on the human adenoviral vaccine platform is the most reasonable approach.

Sputnik V vaccine phase I-II trial results

The Lancet medical journal had published the results of phase I-II clinical trials of the Russian Sputnik V vaccine on September 4, 2020. The results demonstrated the safety and efficacy of the COVID-19 vaccine. Phase 1 & 2 trials of the vaccine showed no serious adverse effects of any criteria, while the incidence of serious adverse events for other candidate vaccines ranged from 1 percent to 25 percent.

The Sputnik V vaccine was noted to have generated a stable humoral and cellular immune response in 100 percent of the clinical trial participants. The level of virus-neutralizing antibodies of volunteers vaccinated with the Sputnik V vaccine was seen to be 1.4-1.5 times higher than the level of antibodies of patients who had recovered from COVID-19.