05 March 2021 | News
On February 24, India’s drug authority had asked Dr Reddy’s 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
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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.
On February 24, India’s drug authority had asked Dr Reddy’s 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.
“India should provide equitable access to its people to avail the best COVID-19 vaccines as developed across the world,” said Dr AM Deshmukh, President, Microbiologist Society, India.
“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). 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,” said Dr. Gajendra Singh, Public Health Expert.
“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”, he added.
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.