New Delhi: As India prepares to launch its largest vaccination program, probably with a Covid-19 vaccine that has received only rapid approval due to the current pandemic situation, the Indian Government has begun to create an elaborate mechanism to control adverse events after immunization (AEFI).
The Covid vaccine program will be unique as well because it will target only adults, and states have been asked to quickly detect and promptly respond to any AEFIs to ensure that public confidence in the new vaccine does not diminish.
Potential vaccinators are trained with detailed instructions on infection prevention and control practices and management of mild, severe, or severe AEFIs.
The vaccination guidelines shared with the states also address this for a very long time. States were asked to identify at least one AEFI management center in each block, which can be a primary health center or community health center, a district hospital or even a private health facility that has medical staff and paramedics.
Each vaccine site will be linked to a designated AEFI management center. All such adverse events will be reported through the Co-Win program created to control and administer the Covid-19 vaccine program.
Also read: How to ensure a smooth Covid vaccine – the Indian polio program has some lessons
Why so many new plans?
The question is why a vaccine that will examine India’s General Drug Registry on safety, immunogenicity and efficacy needs such well-arranged plans for AEFI management when India already has a system under its Universal Immunization Program. .
India’s Universal Immunization Program treats about 2.64 crore mothers and babies annually, but the vaccine drive with Covid-19 with the first four priority groups consisting of 30 crore people – all adults, some with comorbidities – is the first such exercise ever done in the country. .
Asked why the new AEFI plans were required, the government think tank NITI Aayog Member (Health) Dr VK Paul gave three reasons. “First it’s an adult vaccine; our AEFI system was aimed at children and women. These vaccinations take place in a certain way starting from hospitals and later into the community. When dealing with adults, one has to deal with the practical aspects of a physical place, ”Paul said.
“Secondly, these vaccinations are new platforms; in fact, many new platforms. That brings a different complexity. Also, if an emergency authorization use (EUA) is received, please remember that it is an emergency authorization that brings (a requirement for) more responsible behavior, ”he explained.
For a new vaccine, added NITI member Aayog, there are also newer types of adverse events that one may be looking at.
“AEFI for a new vaccine means there are always new aspects, new situations, new side effects that need to be remembered. Some vaccines will cause an allergic reaction; others may have a very high fever; some others may have second-day complications. vaccination must also be taken into account, ”Paul said.
“Adult vaccination, EUA, and especially this time there is a very large number of beneficiaries to be dealt with in a short period in mission mode. There is a need to build on AEFI standard principles and make it specific to full dimension requirements of this particular set of vaccines” , he added.
The reporting and monitoring of AEFIs during vaccination will also be used to generate post-marketing surveillance data of the vaccine.
Also read: 5-member teams, mobile sites, avoid “mixing” – guidelines from the Center’s Covid vaccine to states
All beneficiaries to be advised
While vaccinators have already been trained to identify signs of AEFI and treat common cases such as anaphylactic shock, the guidelines for vaccination against Covid-19 also stipulate that each beneficiary should be advised of the possible side effects.
“All beneficiaries should be advised of adverse events that may occur after a Covid-19 vaccine. These are expected to be mild events such as local pain and swelling, and mild to moderate fever, etc. However the list of expected events could be different in terms of the safety profile of the Covid-19 vaccine (s), which is finally getting approved for use, “said the document released last week.
All serious or severe AEFIs will be investigated by the district immunization officer or by the district AEFI committee.
Responding to a question about reports of a deadly fungal infection in patients with Covid-19, Dr. Paul said, “We are aware of this, we have this information. This is a fungal disease, especially in diabetics, even in the absence of Covid. “This is a destructive disease; the cure is quite difficult because there is multifaceted depression (of physiological processes) in Covid, and because it is a ubiquitous disease, it affects many organs – some more some less.”
He warned: “As we get more information about Covid, we understand new things. They (Sir Ganga Ram Hospital) have done things according to protocol. We have to be careful. This disease can be mild or asymptomatic, but also serious, and we see complications that have not been described so far. “
‘Have faith in institutions’
Reporting on the status of vaccine approvals – Bharat Biotech, Serum Institute of India (for the Oxford-AstraZeneca vaccine) and Pfizer – have already requested urgent authorization – Dr Paul has reiterated his call on people to trust the country’s institutions.
“The subject matter expert committee in the drug lord’s office has specialist experts, as well as experts from various fields … The nominations are being considered. But this will not affect the timing of vaccination, as this has been taken into account, ”said NITI member Aayog.
“EUA will receive only after reasonable satisfaction with safety, immunogenicity and efficacy,” he insisted.
Bharat Biotech and Serum Institute were asked to give more data on their respective vaccines.
Also read: No pressure on drug regulator to approve Covid vaccines, says VK Paul, member of NITI Aayog
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