Pregnant, Lactating Women Who Take COVID Vaccination Made Aware Of Likely Side Effects : Centre Tells Supreme Court

The Central Government has told the Supreme Court that all pregnant and lactating women who avail COVID-19 vaccination are made aware of the possible side effects of vaccines.

The Centre has filed an affidavit in response to the suggestions given by the Delhi Commission for Protection of Child Rights to strengthen the mechanism to vaccinate pregnant and lactating women against COVID-19.

The affidavit has been filed by the Central Government in the writ petition seeking directions to the concerned authorities under the Government of India to categorise Pregnant Women and Lactating mothers as belonging to the high-risk category and be given priority in vaccination.

Response To The Suggestions Made By The Petitioner

A. Declaring & Identifying Pregnant & Lactating Women At The Time Of Vaccination: Verbal Declaration With Regards To Pregnancy/Lactation Is Voluntary; Can Be Verified At Time Of Vaccination

Centre in its affidavit has said that verbal declaration regarding the status of pregnancy/lactation is voluntary and it can only be verified at the time of vaccination. Referring to the advisory dated July 2, 2021 it has further been stated that once a woman declares herself as pregnant /lactating woman, the vaccinator provides them with information about the risks of COVID-19 infection in pregnancy, the benefits of vaccination, along with the likely side effects of vaccination. Furthermore, it has been stated that if the pregnant woman decides to get vaccinated the vaccinator marks them as pregnant women / lactating mothers in the Co-WIN platform and thus, a line list of all those women receiving the COVID 19 vaccine is maintained in the database.

B. Tracking Of Adverse Events Following Immunization (AEFI) For 30 Days: No Time Limitation For Reporting AEFI; Can Be Reported Irrespective Of Time Interval B/W Day Of Vaccination & Onset Of Symptoms

On this aspect, the affidavit states that although there is no time limitation for reporting AEFI but the guidelines that are issued for monitoring AEFI allows for reporting suspected adverse events irrespective of time interval between the day of vaccination and the day of onset of symptoms.

C. Tracking AEFI's In Hospitals & Creating Mechanisms For Self Reporting Through CoWIN Or Other Platforms: Currently AEFI Surveillance System Is Empowered Adequately

The affidavit says that current AEFI surveillance system is adequately empowered to handle suspected AEFI related to COVID-19 vaccination.

"AEFI surveillance system collects data of all adverse events related Covid-19 vaccine. Beneficiaries including pregnant women/lactating mothers. The system is time-tested and well equipped to handle adverse effects of vaccination on pregnant women/lactating mothers," affidavit states.

D. Publication Of Data: Data Pertaining To All AEFI Events Is Available In Public Domain After Conducting Casualty Assessment

On this aspect, Centre's affidavit states that after the casualty assessment is done, data pertaining to all AEFI events which includes pregnant and lactating women is regularly made available in public domain. To avoid vaccination hesitancy, the centre's affidavit further states that publication of data regarding AEFIs without casualty assessment is not appropriate.

With regards to multi centre study, the affidavit states that the same is adequately empowered with acceptance confidence level and that the scientific studies are based on samples of data.

E. Specific Filter Category On CoWIN For Pregnant & Lactating Women

Centre's affidavit says that there is no verification mechanism at the time for booking slots for vaccination and the same has been kept at vaccine administration level on case to cases basis to ensure that no Pregnant Woman/ Lactating mother is left uncounseled and guided before she chooses to get vaccinated.

F. Awareness Is Being Provided To Medical officer/DIO For Reporting Adverse Effects 

Lastly on the aspect of awareness, Centre's affidavit states that adequate public awareness is being created regarding the provision of reporting adverse effects to the concerned medical officer/DIO.

"Posters with information regarding vaccination of pregnant woman are made available to all CVC's and visible at appropriate places. FAQs in this regards are also available on MoHFW website. It may also be noted that once a vaccinated individual seeks medical attention at a public or private hospital, as explained earlier, the AEFI surveillance system provides for a mechanism where such instances will be reported to the concerned DIs. Further, Counselling materials are also provided to frontline workers and vaccinators for inform and advice pregnant women/lactating mother regarding adverse effects of COVID-19 vaccination. Adequate awareness is also created through social media platforms," affidavit also states.

Case Title: Delhi Commission for Protection Of Child Rights v Union of India and Anr| Writ Petition (Civil) 572 of 2021