Could Sputnik V Become India’s 3rd Approved COVID Vaccine?
Sputnik V has demonstrated an efficacy rate of 91.6 per cent in the interim analysis of the Phase 3 clinical trials.
To cater to the vaccination process of the world's largest democracy, it would be pertinent to bring in safer and more effective vaccines from other countries.
However, on 24 February, India’s drug authority had asked Dr Reddy’s, the Indian pharmaceutical company facilitating the trials in the country, to supply data on immunogenicity for going ahead with the approval process.
However, experts across the country have been questioning the approval procedure given the fact that the country gave approval to two homegrown vaccines in January this year for emergency use based on modified standards. For instance, Covaxin was granted restricted approval in "clinical trial mode" without any efficacy data.
"The fact is that Covid-19 poses a significant threat to both health and economy globally and it is only by avoiding nationalistic policies and embracing global co-operation that countries across the world can beat the pandemic. It should be a global effort for humanity.
For example, India is already acknowledged as a key global production hub for having the largest vaccine manufacturing capacities in the world. Similarly, India should provide equitable access to its people to avail the best Covid-19 vaccines as developed across the world," said Dr. A.M. Deshmukh, President, Microbiologist Society, India.
Last month, the Lancet, one of the most reputed journals in the world, published the outcomes of the phase III of the clinical trials of Sputnik V. The trial results show a consistent strong protective effect across all participant age groups.
Also known as Gam-COVID-Vac, the vaccine uses a heterologous recombinant adenovirus approach using adenovirus 26 (Ad26) and adenovirus 5 (Ad5) as vectors for the expression of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spike protein.
The use of two varying serotypes, which are given 21 days apart, is intended to overcome any pre-existing adenovirus immunity in the population. Among the major COVID vaccines in development to date, only Gam-COVID-Vac uses this approach.
Sputnik V has demonstrated an efficacy rate of 91.6 per cent in the interim analysis of the Phase 3 clinical trials, which included data on 19,866 volunteers in Russia, who received both the first and second dose of the vaccine.
"The Phase 3 ongoing trial of Sputnik V may turn into a landmark in untiring journey of COVID Vaccination. It could be possible after a partnership between Dr Reddy's Laboratories and Russian agencies.
Sputnik V is being commercialized globally by the Russian Direct Investment Fund (RDIF). RDIF had in September signed a pact with Dr Reddy's, wherein the Indian drugmaker would conduct the bridging study and distribute doses to 100 million people if it were granted a license.
This was later increased to 125 million," says Dr. Gajendra Singh, Public Health Expert.
"The recently approved COVID 19 vaccine in India, AstraZeneca has reported 62.1 percent efficacy as per phase III clinical trial results published by the company in the Lancet in December, while Pfizer and Sputnik V approved in world reportedly has more than 90 percent efficacy against the virus.
Sputnik V can be stored at between two and eight degrees Celsius (between 35.6- and 46.4-degrees Fahrenheit), instead of the temperatures far below freezing required for some other vaccines.
As of now, Sputnik V and Pfizer had proven their efficacy to be 90+% while Oxford-AstraZeneca is standing on 62.1% as per their own paper that was submitted to the Lancet magazine.
Interestingly, the Drugs Controller General of India (DCGI) mentions that AstraZeneca shows an average of 70% effectiveness in preventing the COVID-19. This is the average/mean efficacy between the regular group that were injected two full doses- 62 percent and half a dose and full dose- 90 percent.
Important to note that India would go for a full-dose regimen. So clearly, there is a lack of transparency here and there should be an informed decision keeping all the aspects in mind," added Dr. Gajendra Singh.
Moreover, vaccines such as Covishield and Sputnik V are fit for Indian terrain since they can be stored between +2 degrees and +8 degrees in contrast with the mRNA vaccines which require an extreme temperature regimen of -70º-20ºC for storage.
Interestingly, Sputnik V vaccine has already been approved by several countries across North and South America, the Middle East, Europe, Asia and Africa, the recent ones being Mexico and Egypt.
With this, it is now approved for use in more than 35 countries making it one of the world's top three coronavirus vaccines in terms of the number of approvals issued by the regulatory authorities.
In the fight against a virus that brought the world to a standstill, it would be important to collectively find a conducive solution to reach the end point. India not only needs to continue the fight against the pandemic but also win it along with other countries of the world by adopting a pragmatic approach and think beyond nationalism.
(This story was published from a syndicated feed. Only the headline and picture has been edited by FIT).
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