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, 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”.
The asymmetrical shape of power that colours sexual abuse was on display on February 17 when former minister MJ Akbar entered courtroom 203 on Rouse Avenue. Escorted by a phalanx of police personnel and his team of lawyers, Akbar was there to hear the verdict of additional metropolitan magistrate, Ravindra Kumar Pandey.
The verdict acquitted journalist Priya Ramani against whom Akbar had brought charges of criminal defamation. The judge accepted Ramani’s assertion that “the complainant is not a man of sterling reputation” and ruled that even though her article was per se defamatory, a woman’s right to dignity superseded the right to reputation.
It’s an extraordinary judgment that has ramifications far beyond an individual case where a victim of sexual harassment has had to defend herself in a court of law.
For one, it marks the first major legal victory in India’s MeToo Movement where chief justices, film actors and celebrated artists have been let off.
Second, it offers a rare empathetic ear to the “systemic abuse” of women at work and acknowledges that the “time has come for our society to understand the sexual abuse and sexual harassment”.
This too is unprecedented in a legal system where, hearing another case of sexual harassment, the Supreme Court ruled that it was wrong for a senior judge to “flirt” with a junior official. The use of the word “flirt” trivialised what Judge Pandey rightly calls “systemic abuse”.
Despite new laws passed in the aftermath of the December 2012 gang rape, India’s women continue to fight a battle of endemic sexual violence. On the day newspapers reported on Ramani’s victory came the horrific news of two Dalit sisters, found dead in Unnao, in a state that has seen an over 66% increase in crimes against women in the past four years and where the trauma of Hathras is yet to die down. Those who say why mention caste forget the fact that it is caste-enabled power structures that facilitates this violence.
This lopsided power structure is also why Bhanwari Devi, to whom we owe our law on workplace sexual harassment, is still awaiting justice after a lower court judge ruled that dominant caste men could not have raped her since she is a subordinate caste woman. Her case is still pending in the Rajasthan High Court.
The MeToo Movement undoubtedly gave a few women a voice and a platform, but it left out the vast majority of India’s working women, women employed as domestic workers, in brick kilns, as farm labourers, in garment factories. Dalit, tribal, trans and marginalised voices were never heard.
The verdict in favour of Ramani who had the support of both her family and her lawyer Rebecca John is worth celebrating and savouring. But it is not enough. It can never be enough until we rearrange power hierarchies to give all women the dignity and right to work without fear.