The Subject Expert Committee (SEC) of the Indian drug regulator will meet today to consider granting emergency approval to Russia’s Covid-19 vaccine Sputnik V, news agency ANI reports. Drugmaker Dr Reddy’s had last week submitted the safety and immunogenicity data the SEC had asked in the first meeting held on 24 February.
“Meeting of Subject Expert Committee to be held today to deliberate on emergency use authorisation application of Russian vaccine Sputnik V. The vaccine manufacturers in India, Dr Reddy’s, have already submitted the safety and immunogenicity data of the third phase trials,” ANI said in a tweet.
Dr Reddy’s had entered into a partnership with the Russian Direct Investment Fund (RDIF) to conduct clinical trials of Sputnik V
Dr Reddy’s had applied for emergency approval for Sputnik V. The company had conducted Phase 2 trials in India with around 1,500 participants. Phase 3 trials are still underway.
“We expect to get the approval in the next few weeks. It is a two-dose vaccine. You take the first dose on day zero and the second one on day 21. The peak immunity develops somewhere between day 28 to day 42. So, it is a two-dose vaccine and we expect it to be available in the next few weeks,” Deepak Sapra, the company’s CEO, APIs and Services, was quoted as saying by news agency PTI.
India already has two approved COVID-19 vaccines – Covishield and Covaxin- that are currently being administered to eligible Indians. So far, frontline and healthcare workers, as well as people above 60 years of age and people over 45 years of age with co-morbidities, were being administered the vaccines. Now, from 1 April, the vaccination drive will cover everyone over 45 years of age.
India Covid-19 tally
As many as 53,480 fresh infections pushed India’s COVID-19 tally to 1,21,49,335, while 354 new fatalities, the highest single-day spike so far this year, took the death toll to 1,62,468, according to Union health ministry data updated on Wednesday. The active caseload increased to 5,52,566, the ministry data updated at 8 am showed.
Sputnik V efficacy
The Sputnik V vaccine has proven equally effective for all age groups, Alexander Gintsburg, the head of the Gamaleya research institute that developed the vaccine, has said. “Sputnik V demonstrated the same level of efficacy in all age groups. At first, there were doubts that the efficacy in people aged 60 and over would be lower … but it was absolutely not,” Gintsburg told the SolovyovLive show on YouTube.
Sputnik V is being developed by Russia’s Gamaleya National Research Institute of Epidemiology and Microbiology to fight against coronavirus based on the human adenoviral vector platform.