Good news finally came in the new year when the Indian government stamped a formal approval on the coronavirus vaccines developed by Oxford-AstraZeneca (these vaccines were made by Serum Institute of India in India) and Bharat Biotech for emergency roll-out on Sunday.
The decision comes even as there has been panic a mutant new strain has forced the world to realign goals and all the precautionary measures. Now, both these two doses will play a huge role in India’s vaccination drive. However, there still remains a number if unanswered questions as far as the procedure followed by the Drugs Controller General of India is concerned.
Although, green light has been shown to Bharat Biotech’s Covaxin, there are several riders and the fact remains that the candidate has not yet demonstrated its efficiency or for that matter, how safe is the vaccine. As per the company and its releases, the vaccine has only been judged in limited numbers and over a very short duration of time.
Vaccine makers have to give thousands of volunteers in phase III trials the dose or even a placebo and then, sit back and wait and witness if they develop infections. So, if the infections are lower by 50% in the vaccinated group, the efficacy rate comes to 50% -- and this is the accepted benchmark for success for any vaccine all across the globe.
Oxford-AstraZeneca had to go through six months to come to a conclusion. On the other hand, Pfizer-BioNTech and Moderna had to wait for the results for almost four months. However, in comparison, Covaxin’s late-stage trials only started one-and-a-half month ago, there is no data available on the efficacy rate and by all means, the intervening period is too short to gauge all the side-effects.
Now, it should be mentioned here that authorities have also put out a disclaimer that says that Covaxin will be put to use only if there is a shortage and if the new mutation takes hold. However, trust will play a huge part if people are to be vaccinated and hence, Bharat Biotech and the regulators must now put in all efforts to come out with all the disclosures around the vaccine. People have the right to know how safe the vaccine is, there are no two ways about it!