Dr Reddy’s applies for Sputnik authorisation
NEW DELHI: Dr Reddy’s on Friday applied for the emergency use approval of the Sputnik V coronavirus vaccine developed by Russia’s Gamaleya Institute, setting the ball rolling in what could lead to India getting access to a third shot to fight the pandemic.
Sputnik V has shown an efficacy rate of 91.6% in preventing Covid-19 in Phase 3 trials. The vaccine uses a similar adenovirus vector as the Oxford-astrazeneca vaccine, whose Indian variant is Covishield. Apart from
Covishield, India uses the domestically developed Covaxin.
“The efficacy of Sputnik V was reported to be 91.6% by The Lancet, which is an impressive development in the fight against Covid-19. The initiation of the EUA process will be a critical step forward for us in ensuring speedy access to the Sputnik V vaccine in India,” Dr Reddy’s laboratories co-chairman and managing director GV Prasad said.
As part of the review process for emergency authorisation, the company will submit safety data from the Indian Phase 2 trial and interim data from Phase 3.
SPUTNIK V HAS SHOWN AN EFFICACY OF 91.6% IN PREVENTING COVID-19 IN
PHASE 3 TRIALS
NEW DELHI: Dr Reddy’s on Friday applied for the emergency use approval of the Sputnik V coronavirus vaccine developed by Russia’s Gamaleya Institute, setting the ball rolling in what could lead to India getting access to a third shot to fight the pandemic.
Sputnik V has shown an efficacy rate of 91.6% in preventing Covid-19 in Phase 3 trials. The vaccine uses a similar adenovirus vector as the Oxford-astrazeneca vaccine, whose Indian variant is Covishield. Apart from Covishield, India uses the domestically developed Covaxin, and has inoculated over 10 million people since kicking off the drive on January 16.
“The efficacy of Sputnik V was reported to be 91.6% by The Lancet, which is an impressive development in the fight against Covid-19. The initiation of the EUA process will be a critical step forward for us in ensuring speedy access to the Sputnik V vaccine in India,” Dr Reddy’s laboratories co-chairman and managing director GV Prasad said.
As part of the review process for emergency authorisation, the company will submit safety data from the Indian Phase 2 trial and interim data from Phase 3 – a regulatory filing process similar to the one adopted by the Serum Institute of India (SII).
Vaccines developed outside of the country will need to also undergo a bridging trial. Dr Reddy’s is conducting a Phase 3 bridging trial to establish immunogenicity of the vaccine in about 1,500 participants. The Phase 2 trial in India on 100 participants showed “no safety concerns,” according to the company.
In the global trials, the vaccine also maintained a consistent efficacy at 91.8% among group of 2,144 volunteers over 60 years, the company said. The company said that it was one of the three vaccines that had shown such high efficacy; the other two being Moderna and Pfizer. The efficacy rate of the Oxford-astrazeneca vaccine (whose data was used for Covshield’s approval) was 62%.
In the case of Covaxin, efficacy data is awaited since Phase III trials have not progressed far enough. The vaccine had been approve by the Drug Controller General of India (DCGI) in a “clinical trial mode”, where all those who are vaccinated will be followed-up on.
The vaccine has been administered to more than two million people worldwide, the company said, listing Russia, Bolivia, Kazakhstan, Turkmenistan, Palestine, UAE, Paraguay, Hungary, Armenia, Algeria, Bosnian Serb Republic, Venezuela and Iran as countries where it is in use.
The application for any vaccination is sent to a subject expert committee, which if satisfied with the data, recommends a vaccine for approval to the Drug Controller General of India.
“The journey from the virus to vaccine has been very exciting. In just twelve months, we not just have a basket of vaccines, we also have different vaccine platforms... This gives us a lot of confidence that India will be a global hub for Covid-19 vaccines as well,” said Dr Renu Swarup, secretary, department of biotechnology at a webinar on Thursday.
Sputnik V was initially met with some controversy after being rolled out before the final trial data had been released. But scientists, while releasing the final Phase III data, said its benefit has now been demonstrated.
In a comment published alongside the Lancet paper, professors Ian Jones and Polly Roy said: “The development of the Sputnik V vaccine has been criticised for unseemly haste, corner cutting, and an absence of transparency.
“But the outcome reported here is clear and the scientific principle of vaccination is demonstrated, which means another vaccine can now join the fight to reduce the incidence of Covid-19”.
AMRITSAR: Akal Takht acting jathedar Giani Harpreet Singh on Friday said that the Centre had committed a historic wrong by not permitting the Sikh jatha (group) to visit Pakistan on February 21 to attend the centenary of the Nankana Sahib massacre at the birthplace of Sikhism founder Guru Nanak, and urged it to reconsider its decision.
In a video message released, Singh said: “The Nankana Sahib massacre is an important chapter in the history of Sikhs who sacrificed self to liberate the sacred historic gurdwaras from the clutches of mahants who were indulging in immoral acts under the patronage of British rulers... The Indian government is wrong in denying the Sikh jatha permission to attend the main event in Pakistan.” The Centre had denied permission citing security concerns and Covid-19.