New Delhi: The much-awaited emergency licence for a Covid-19 vaccine in India is only a matter of time, now that the subject expert committee of the Drug Controller General of India (DCGI) has recommended it for the Oxford-AstraZeneca candidate Covishield and for Bharat Biotech’s Covaxin.
The health ministry, in a statement said, the subject expert committee of the drugs regulator, Central Drugs Standard Control Organisation (CDSCO), has made the following recommendations for the consideration and final decision of the Drugs Controller General of India (DGCI) — grant of permission for restricted emergency use of vaccine, subject to multiple regulatory conditionalities, to Serum Institute of India; grant of permission for restricted use in emergency situation in public interest as an abundant precaution, in clinical trial mode, specially in the context of infection by mutant strains, to Bharat Biotech; and grant of permission to conduct Phase 3 clinical trials to Cadila Healthcare.
However, for the average Indian aged less than 50 years and without any comorbidities, the wait for a jab is likely to extend till 2022.
The initial vaccine supply, even with two suppliers, is likely to be very slow and there is currently no clarity on when a shot can be bought at a pharmacy by a person who is not on the priority list.
The Government, according to sources, is keen that all the vaccines that become available now should be used to inoculate the four priority groups of vulnerable people — health workers, other Covid warriors like police, those aged over 50 years, and people of all ages with comorbidities.
These groups constitute an estimated population of 30 crore.
Dr K.S. Reddy, president of the Public Health Foundation of India (PHFI), noted that the vaccines that have been developed aim to prevent the infection from progressing to the disease stage, and hence need to be prioritised for those who are likely to be severely affected.
“The injectable vaccines have been developed and assessed to prevent the disease developing in persons exposed to the virus and not for preventing infection per se,” he said.
“They are not sterilising mucosal vaccines. Even vaccinated persons may transmit the virus for a short time if infected, without developing the clinical manifestations of the disease. So, the vaccine should be prioritised for the people who are likely to be severely affected if infected,” he added.
Why the 4 groups are priority
Among the groups that have so far been identified for priority vaccination are healthcare providers and workers in settings both government & private, a population of 1 crore, according to government estimates.
The second group — frontline workers like personnel of police, armed and other security forces, and municipal workers (excluding those in healthcare), among others, constitute another around 2 crore.
Then come the people aged more than 50 years and those lower in age but with comorbidities such as diabetes, hypertension etc or a compromised immunity. These would number around 27 crore.
That so far is the list drawn up by an expert panel set up by the government. The matter of including other groups, including teachers — schools have now been closed for nine months — also came up for discussion but no final call was taken.
Reddy said those aged over 50 form a priority group because they are likelier to have comorbidities, adding that the younger lot with comorbidities are at risk of developing severe disease.
Explaining why it is imperative to vaccinate essential workers — he said teachers ought to be a part of this group — he added that they should “be immunised on priority because, even if they do not become severely ill, they will be isolated for several days if infected, disrupting essential services”.
“Only later can other sections of the population be covered… By then, viral transmission too may have markedly slowed down or the virus may change to a milder form,” he added.
“Throughout this period, precautions like masks, physical distancing, hand hygiene, good ventilation and avoidance of crowds must be maintained. We must continue to keep the virus on the backfoot as we deliver the vaccine punch.”
Slow rollout expected
Vaccine availability and the need to keep routine health and immunisation services up and running will mean that states may not conduct Covid vaccinations more than once or twice a week.
The last time a similar number of people was vaccinated was in 2017 when 32 crore children were immunised with the measles rubella vaccine in campaign mode. States took 1-2 months to complete that drive. But now vaccine availability may be the limiting factor.
The subject expert committee of the DCGI has given conditional clearance for Covishield, which is being manufactured in India by the Pune-based Serum Institute of India.
The company currently has a stockpile of about 4-5 crore doses and has the capacity to increase monthly production to 10 crore by February.
At two doses per person and 10 per cent for wastage, India needs 66 crore vaccines to complete vaccinations of the 30 crore targeted people. The Union government has also said that it is not necessarily looking at vaccinating all citizens.
This means there’s a chance that those not in the priority groups may have to buy the vaccine to get it as and when it becomes freely available in the market.
Dr Gagandeep Kang, professor in the Department of Gastrointestinal Sciences at the Christian Medical College Vellore and a renowned vaccine expert, had told ThePrint in November that it could be 2022 before the average young Indian gets the shot — an opinion other experts have also expressed.
“If we look at all the vaccine priority groups, healthcare and frontline workers, elderly people, those with comorbidities, constitute about 30 per cent of any country’s population. For India, that is about 400 million people. So, if we do more than 800 million doses next year… we will be looking at 2022, but it is difficult to say till we have a licensed product.”