(a) whether any mechanism is in place to monitor and capture data on the adverse impact and related events arising out of administration of COVID-19 vaccines on lactating mothers and their infants in the absence of clinical trials in this regard;
(b) if so, the details thereof; and
(c) the State-wise details of such adverse effects/ events recorded along with the nature/type of such impact so far during each interval of COVID vaccination?
THE MINISTER OF HEALTH AND FAMILY WELFARE
(DR MANSUKH MANDAVIYA)
(a) to (c) A Statement is laid on the Table of the House.
STATEMENT REFERRED TO IN REPLY TO LOK SABHA
STARRED QUESTION NO. 150* FOR 11TH FEBRUARY, 2022
(a) to (c) All Adverse Event Following Immunization (AEFI) including those of lactating mothers are monitored through a well-structured & robust AEFI surveillance system. Causality Assessment of all serious and severe AEFIs are carried out by the designated AEFI committee to determine if AEFI is related to vaccine or vaccination process or otherwise.
The National Adverse Event Following Immunization (AEFI) Committee monitors vaccine safety and recommends action to improve AEFI surveillance. Periodic letters and monthly state specific presentations on performance of AEFI surveillance with action points is also shared with the States/UTs. States/UTs are advised to regularly sensitize health care service providers including private health care providers to report AEFI following vaccination.
As on 3rd Feb’22, a total of 13 AEFIs were reported among lactating women, all were minor AEFIs. State wise details is as under:
S. No. State AEFIs reported in lactating mothers
1 Assam 1
2 Chhattisgarh 1
3 Kerala 2
4 Madhya Pradesh 2
5 Odisha 1
6 Rajasthan 1
7 Tamil Nadu 1
8 Telangana 1
9 Uttar Pradesh 1
10 West Bengal 2
Grand Total 13
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