Adverse events following immunisation a critical aspect: Ministry to States, UTs
The Union Ministry of Health on Tuesday did not rule out possibility of an adverse event following immunisation whenever Covid-19 vaccination programme is launched and has asked the States and Union Territories to strengthen the mechanism at district level to deal with these.
“Adverse events following immunisation (AEFI) is a critical aspect. Even during universal immunisation programmes, which have been going on for decades, some adverse effects are seen in children and pregnant women after vaccination.
“So, we can’t deny the possibility of an adverse event when the Covid-19 vaccination begins. The countries where inoculation has already started, especially in the UK, adverse events took place on the very first day. So, it is essential that States and Union Territories prepare for this too,” Union Health Secretary Rajesh Bhushan said at a presser here.
The apprehension of AEFI is realistic given that this is an adult vaccine. “Our AEFI system was targeted to children and women and those vaccinations take place in a certain way, starting with hospitals and then into the communities.
“But when we deal with adults, certain practical aspects have to be tackled. Secondly, these vaccinations are in multiple new platforms that bring in complexity. If a EUA (emergency use authorisation) is given, it calls for more responsibility,” added Dr VK Paul, Niti Aayog member (Health).
Detailed instructions on infection prevention and control practices during vaccination and management of minor, severe, serious (AEFI) have been issued, he said.
Around 29,000 cold chain points, 240 walk-in coolers, 70 walk-in freezers, 45,000 ice-lined refrigerators, 41,000 deep freezers and 300 solar refrigerators will be used to store Covid-19 vaccines .
“All necessary resources of vaccination have been delivered to the States,” said Bhushan.
“States have been asked to identify at least one AEFI management centre in each block. PHCs, CHCs, district hospitals, private health facilities or any other fixed health facility with medical officers and para-medical staff can be identified as AEFI management centres,” he said.
Speaking about AEFI, Dr Paul said, apart from the importance being given at Government level on tackling, saving, reporting and taking action in such cases, the vaccine manufacturers conduct a Phase IV Clinical Trial or Post-Marketing Surveillance where they monitor and track the effects of the vaccine systematically after it has been passed.
Replying to a query about AEFI for Covid-19 vaccine, Dr Paul said, “This is an adult vaccine. Our AEFI system was targeted to children and women and those vaccinations take place in a certain way, starting with hospitals and then into the communities.
“But when we deal with adults, certain practical aspects have to be tackled. Secondly, these vaccinations are in multiple new platforms that bring in complexity. Further, if a EUA is given, it calls for more responsibility. Lastly, there are always new aspects, side-effects, situations that have to be kept in mind. “Above all, a large number of beneficiaries and target-groups are to be tackled over a short period of time in a mission-mode. Therefore, there is a need to build on the standard principles of AEFI and make it specific to the fuller dimension of the requirements of this particular set of vaccines,” he added.
In a recent communication to States/Union Territories, the Ministry has called for involvement of over 300 medical colleges and other tertiary care hospitals across the country to handle adverse events or cases of side effects on people post-vaccination. In addition, States have been told to keep ready neurologists, cardiologists, respiratory medicine experts, obstetrics, gynecologists and pediatricians to deal with post-vaccination side effects.
The Union Health Ministry, according to the letter has recommended that the membership of State AEFI committees should be revised to include neurologists, cardiologists. respiratory medicine specialists who can recognise such events and differentiate them from events related to vaccines or vaccinations.
Also, States have been told to ramp up the already existing adverse events following immunisation committees or AEFI Committees. States have been told to include drug inspectors in these AEFI committees to help investigate the reason of side-effects due to vaccination, sources said quoting the letter.
Wednesday, 16 December 2020 | PNS | New Delhi
