Post-immunization adverse events are a critical issue: Department of States, UTs
The Union Ministry of Health on Tuesday did not rule out the possibility of a post-vaccination adverse event each time the Covid-19 vaccination program starts, and asked the Union states and territories to strengthen the mechanism at the district level to deal with them.
“Post-Immunization Adverse Events (AEFI) are a critical issue. Even during the universal vaccination programs that have been going on for decades, children and pregnant women experience some adverse effects after vaccination.
“So we cannot deny the possibility of an adverse event at the beginning of the Covid-19 vaccination. In the countries where vaccination has already started, particularly the UK, adverse events occurred on the first day. It is therefore important that states and territories of the Union also prepare for this, ”said Union Health Minister Rajesh Bhushan at a press conference here.
AEFI’s fear is realistic given that it is an adult vaccine. “Our AEFI system was targeted at children and women, and these vaccinations take place in specific ways, from hospitals to communities.
“But when we look at adults there are certain practical issues that need to be addressed. Second, these vaccinations are on several new platforms that add complexity. When an EUA (Emergency Use Authorization) is issued, it requires more responsibility, ”added Dr. VK Paul, member of Niti Aayog (Health), added.
He said detailed instructions on how to prevent and control infections during vaccination and treatment of light, severe and severe patients (AEFI) were provided.
Around 29,000 cold chain points, 240 walk-in refrigerators, 70 walk-in freezers, 45,000 ice-lined refrigerators, 41,000 freezers and 300 solar refrigerators are used to store Covid-19 vaccines.
“All the necessary vaccines have been shipped to the states,” said Bhushan.
“States were asked to identify at least one AEFI administrative center in each block. PHCs, CHCs, county hospitals, private health facilities or other fixed health facilities with doctors and paramedical staff can be identified as AEFI management centers, ”he said.
Regarding AEFI, Dr. Paul advised that vaccine manufacturers, in addition to the importance attached at government level to controlling, saving, reporting and taking action in such cases, are conducting a Phase IV clinical study or post-market surveillance in which they oversee and monitor the surveillance systematically track the effects of the vaccine after its adoption.
When asked about AEFI for the Covid-19 vaccine, Dr. Paul: “This is an adult vaccine. Our AEFI system was targeted at children and women, and these vaccinations take place in specific ways, from hospitals to communities.
“But when we look at adults there are certain practical issues that need to be addressed. Second, these vaccinations are on several new platforms that add complexity. When an EEA is given, it also demands more responsibility. After all, there are always new aspects, side effects and situations that need to be considered. “Above all, a large number of beneficiaries and target groups should be approached in mission mode in a short time. Therefore, it needs to be built on the AEFI standard principles and specifically tailored to the broader dimension of the requirements of this particular vaccine kit, ”he added.
In a recent communication to states / territories of the Union, the department has called for the involvement of over 300 medical colleges and other tertiary care hospitals across the country to manage adverse events or cases of side effects in people after vaccination. In addition, states were ordered to have neurologists, cardiologists, respiratory medicine, obstetricians, gynecologists, and pediatricians on hand to manage post-vaccination side effects.
According to the letter, the Union’s Ministry of Health has recommended changing membership of AEFI state committees to include neurologists and cardiologists. Respiratory medicine specialists who can identify such events and distinguish them from events related to vaccines or vaccinations.
Also, states were told to augment pre-existing adverse events after vaccination boards or AEFI boards. States have been told to include drug inspectors on these AEFI committees to investigate the causes of side effects from vaccination.