Covaxin approvals delay: Be transparent

WHO, DCGI and Bharat Biotech must be transparent about two key questions: Why have the processes taken so long? And if there were issues, how were they addressed?

The World Health Organization (WHO) this week, once again held off on deciding whether to grant Bharat Biotech’s Covaxin an emergency use license. The United Nations (UN) body has sought more clarifications and said its experts will meet again on November 3. This comes at a time when India’s independent drug regulator too has taken unusually long over a separate approval concerning the same vaccine. The Drugs Controller General of India (DCGI) is yet to accept the Subject Expert Committee’s (SEC) recommendations that the vaccine be given to children aged 2 and above. Both decisions are significant for India: The WHO approval could determine if people who have taken the shot are covered under vaccine mandates in other countries; and the DCGI decision will determine if the country could begin vaccinating children soon.

The UN body’s latest vaccine status report on October 20 too said an announcement is likely this month. But now the UN body has sought more clarifications and said its experts will meet again on November 3. (HT PHOTO)

The WHO approval process began with a rolling review more than three months ago. The company said in late September that it expects a decision soon, as did several experts from the Government of India and WHO. The UN body’s latest vaccine status report on October 20 too said an announcement is likely this month. Similarly, in the case of the approval for children, the SEC recommendation was announced on October 12. Typically, DCGI has accepted SEC suggestions regarding Covid-19 vaccines in a matter of days. This may be par for the course since regulatory agencies approve pharmaceutical products after pouring over scientific data. In the case of coronavirus vaccines, the focus on due diligence is as important as the urgency to quicken the approvals because haste can impact public confidence.

But so can an inordinate delay. The delays over the approvals to Covaxin are bound to lead to questions. This is particularly a risk because Covaxin’s approval in adults too began controversially. Although the vaccine was eventually established to be safe and effective, there was palpably higher hesitancy among health workers to take the dose in the early days of the roll-out. India now needs to avoid a repeat of this when it comes to Covaxin’s acceptance among children. To do that, WHO, DCGI and Bharat Biotech must be transparent about two key questions: Why have the processes taken so long? And if there were issues, how were they addressed? This will be crucial since Covid-19 vaccine hesitancy has underscored the need for the messaging to be measured: Risks cannot be overblown, and benefits cannot be understated. Lack of transparency threatens to do both.