<p>That at least one, and potentially two, Covid-19 vaccines could be ready for a mass roll out in the next few months is indeed a good start to the new year. Yet, the fact that regulatory approvals have been granted, even if they are only emergency authorisations, to the Oxford University-AstraZeneca-Serum Institute’s Covishield and Bharat Biotech’s Covaxin even before their phase 3 trial data is available has caused concern over the seeming haste. Emergency authorisations have been given to vaccines in the US and UK, too, but not without data from the phase 3 trials in those countries. The Indian approval has been given to Covishield without data from the phase 3 trial on some 1,600 volunteers in India. Covaxin is still undergoing phase 3 trials, and no data on its efficacy has been submitted or made public. The approval for it to be a ‘back-up’ and to be used only in ‘trial mode’ has been given on the basis of only safety data and that it does cause some immune response. Even that data has not been made public. The experts who gave these approvals may have good scientific reasons, but any doubts regarding the safety or efficacy of the vaccines will adversely affect the proposed vaccination programme.</p>.<p>Such doubts have been expressed by not just opposition leaders “who are not proud of anything Indian”, as BJP chief JP Nadda has sought to paint them, they have also been expressed by several public health experts. They have pointed out that not all data on the vaccine trials, especially for Covaxin, are either available yet or has been made public. They have pointed out the lack of transparency and reasoning in the approvals process. The minutes of the meeting of the Subject Expert Committee, for instance, have not been made public. The question on many people’s mind is, why this hurry, why this opacity, when data from the phase 3 trials are perhaps no more than a few weeks away? </p>.<p>The government must make all data and reasoning for the approvals public to remove such doubts. At the same time, opposition leaders such as Akhilesh Yadav do great disservice by calling the Covaxin “a BJP vaccine” and the like. The opposition is right to seek transparency from the government. But they should not sow suspicion about the vaccines in the minds of people. In other countries, top political leaders, including US President-elect Joe Biden and Vice President-elect Kamala Harris, have taken vaccine shots in public to inspire confidence in them. Perhaps JP Nadda can inspire such confidence in all of us by publicly taking the first shot of Covaxin in its approved ‘trial mode’.</p>
<p>That at least one, and potentially two, Covid-19 vaccines could be ready for a mass roll out in the next few months is indeed a good start to the new year. Yet, the fact that regulatory approvals have been granted, even if they are only emergency authorisations, to the Oxford University-AstraZeneca-Serum Institute’s Covishield and Bharat Biotech’s Covaxin even before their phase 3 trial data is available has caused concern over the seeming haste. Emergency authorisations have been given to vaccines in the US and UK, too, but not without data from the phase 3 trials in those countries. The Indian approval has been given to Covishield without data from the phase 3 trial on some 1,600 volunteers in India. Covaxin is still undergoing phase 3 trials, and no data on its efficacy has been submitted or made public. The approval for it to be a ‘back-up’ and to be used only in ‘trial mode’ has been given on the basis of only safety data and that it does cause some immune response. Even that data has not been made public. The experts who gave these approvals may have good scientific reasons, but any doubts regarding the safety or efficacy of the vaccines will adversely affect the proposed vaccination programme.</p>.<p>Such doubts have been expressed by not just opposition leaders “who are not proud of anything Indian”, as BJP chief JP Nadda has sought to paint them, they have also been expressed by several public health experts. They have pointed out that not all data on the vaccine trials, especially for Covaxin, are either available yet or has been made public. They have pointed out the lack of transparency and reasoning in the approvals process. The minutes of the meeting of the Subject Expert Committee, for instance, have not been made public. The question on many people’s mind is, why this hurry, why this opacity, when data from the phase 3 trials are perhaps no more than a few weeks away? </p>.<p>The government must make all data and reasoning for the approvals public to remove such doubts. At the same time, opposition leaders such as Akhilesh Yadav do great disservice by calling the Covaxin “a BJP vaccine” and the like. The opposition is right to seek transparency from the government. But they should not sow suspicion about the vaccines in the minds of people. In other countries, top political leaders, including US President-elect Joe Biden and Vice President-elect Kamala Harris, have taken vaccine shots in public to inspire confidence in them. Perhaps JP Nadda can inspire such confidence in all of us by publicly taking the first shot of Covaxin in its approved ‘trial mode’.</p>