Be prepared to handle adverse events that may crop up post-vaccination: Health Secretary
DCGI’s requirement for more data to grant EUA will not negatively impact the timeline for vaccine roll-out, inform government officials
Rajesh Bhushan, Union Health Secretary, in course of a media briefing on the action taken by the Government, preparedness and updates on COVID-19, at National Media Centre in New Delhi, informed that all of the 36 states and UTs have concluded meetings of State Steering Committee as well as State Task Force. 633 districts have already concluded meetings of District Task Force. Further, 23 Union Ministries and Departments under the Centre and States have been identified and assigned roles with respect to planning, implementation, social mobilisation, awareness generation etc., for the vaccine-roll out.
The Health Secretary informed that detailed instructions on Infection Prevention and Control Practices during vaccination have been issued in order to remain prepared to handle Adverse Events Following Immunization (AEFI) that may crop up post-vaccination. For this, states have been told to identify at least one AEFI Management Centre in each block. It can be a Primary Health Centre, Community Health Centre, District Hospital, private health facilities or any other fixed health facility with medical officers and para-medical staff. AEFI reporting will be done through Co-WIN. Every session sites will be linked to designated AEFI Management Centres, stated the Health Secretary.
The Health Secretary further informed:
- Training modules for medical officers, vaccinator officers/alternative vaccinator officers, cold chain handlers, supervisors, data managers, ASHA coordinators etc have been finalised.
- Physical training as well as training on virtual/online platforms have started.
- National and State Training of Trainers (ToTs) workshops have been completed.
- Guidelines have been issued for estimation of electrical and non-electrical cold chain equipment and their strengthening.
- Guidelines have been issued for management of cold chain at last cold chain points and session sites.
- 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.
Speaking about AEFI, Dr VK 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. He further urged, “If a vaccine or two comes after obtaining Emergency Use Authorisation, you should have complete faith on the fact that the vaccine is scientifically proven, matches global standards, safe and effective”.
Replying to a media query about AEFI for COVID-19 vaccine, Dr Paul informed, “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”.
In reply to a media query on Drugs Controller General of India (DCGI) seeking more information from SII, Bharat Biotech and Pfizer for grant of Emergency Use Authorization (EUA) to them, Health Secretary replied that this procedure will not negatively impact the time-line for the roll-out of the vaccine. Dr Paul replied, “This situation was factored-in from before as it is EUA. There should be more than reasonable satisfaction about the safety, immunogenicity and effectiveness of the vaccine”.
In reply to a media query on reports of infections linked with COVID 19 that is leading to loss of eyesight,