India is steadily moving forward in its efforts to provide immunisation to its frontline workers with DCGI approved Covishield and Covaxin. On one side India is supplying the COVID-19 vaccines to neighbouring countries including Bhutan, Maldives, Nepal, Myanmar, and Bangladesh, on the other side, the country’s vaccine production and delivery capacity is being used by foreign vaccine manufacturing companies for greater good. It would be important that India takes a collective approach in this fight against COVID 19. In fact, to cater to the vaccination process of the world’s largest democracy, it would be pertinent to bring in more safe and effective vaccines from other countries.
However, on February 24, 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 vaccines 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% 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 partnership between Dr Reddy’s Laboratories and Russian agencies. Sputnik V is being commercialized globally by Russian Direct Investment Fund (RDIF). RDIF had in September signed a pact with Dr Reddy’s, wherein the Indian drug maker 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. The recently approved COVID 19 vaccine in India, AstraZeneca has reported 62.1% 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% 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, Drugs Controller General of India (DCGI) mentions that AstraZeneca shows average 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. A mindful verdict can go a long way in boosting the confidence among people in India and worldwide, who are eagerly awaiting the vaccines,” says Dr. Gajendra Singh, Public Health Expert.
Adding to the same, Dr. Gajendra Singh, Public Health Expert added, “To bring in the appropriate vaccine for India, one must evaluate more than one factor. The efficacy depends on the foundation on which a vaccine is built. While Sputnik V uses human adenovirus platform, some of the other vaccines like Pfizer and Moderna vaccines are made using messenger RNA, or mRNA, a technology that delivers a bit of genetic code to cells — in effect, a recipe to make the surface protein (known as spike) on the SARS-2 virus. 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 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 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. MB Bureau