The expert committee nominated by the Central Drugs Standard Control Organisation (CDSCO) has recommended the use of the Oxford University/AstraZeneca
vaccine AZD1222 for emergency use in this country. Given AstraZeneca’s decision to license the vaccine to Pune-based Serum Institute of India
(SII), this shot will be a primary component of the programme in India. Other vaccines in SII’s stable include the one developed by the US-based company Novavax, of which the Duke University Global Health Innovation Centre reports it will produce one billion doses, alongside 500 million of AZD1222. Novavax began Phase III trials in the UK in November and has begun them in the US and Mexico in the past few days, and the Indian regulator has sought further information before permitting a bridging trial here that could speed up approval. Being behind on the timeline is problematic; as more and more trials are conducted alongside effective vaccines already being developed, the trials will slow as there are fewer volunteers available. Indeed, the other vaccine given permission for “restricted use in emergency situation in the public interest as an abundant precaution”, from Bharat Biotech, does not seem to have even completed its Phase III trials as yet. The logic of rushing ahead with this approval is, therefore, unclear, given no other regulator has seen the data, no trials elsewhere have been completed — and preparation to roll out the vaccine is itself running late.
Several observers, including the head of SII, have noted that current plans do not enable a speedy enough roll-out. The longer the disease is widespread in the population, the greater the danger of a serious mutation. Dry runs have been conducted to examine the mechanisms that will ensure follow-ups in the case of adverse reactions and the quality and availability of cold chains. The Union health ministry had earlier said that some deliveries of cold-chain infrastructure would begin by the second week of this month. The vaccine delivery, administration, and follow-up programme will require all three levels of government to be involved, but as always much of the management task will have to be accomplished in state capitals. These vary in capacity, and the Union government must be prepared to create a flying squad of trouble-shooters. The government is also expecting the Co-Win app to play a crucial role in booking vaccination appointments, scheduling follow-ups and monitoring progress. Given the importance of this app, it must be transparently managed. There must also be easy offline processes for those without access to connected smartphones. It is far from clear how the tracking will be done.
It is clear that much remains to be done, even as the government continues to say that the programme will roll out in January. The initial vaccinations may indeed be accomplished next month, but the crucial question is how long it takes to achieve scale. The government cannot delay scaling up the programme for long, given that there are vaccine stockpiles being set aside, which will have to be used in a timely fashion. Questions of cost can also not be postponed for too long. Claims that the vaccine will be free for all do not seem prudent. That would overwhelm government resources. Those who can pay should be expected to pay through a parallel private-sector network.