In its affidavit, the Centre has said that the guidelines issued for monitoring of adverse events following COVID-19 vaccine allows for reporting of any suspected adverse event irrespective of the time interval between the day of vaccination and the day of onset of symptoms.
Pregnant and lactating women are informed about the risks of COVID-19 during pregnancy as also the benefits and likely side effects of the vaccination as per the advisory and Standard Operating Procedures (SOP), the Centre has told the Supreme Court.
In its affidavit, the Centre has said that the guidelines issued for monitoring of adverse events following COVID-19 vaccine allows for reporting of any suspected adverse event irrespective of the time interval between the day of vaccination and the day of onset of symptoms.
“As per the advisory and SOP issued dated July 2, 2021, 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.
"Thus, all pregnant women/lactating mothers who avail COVID-19 vaccination are made aware of the likely side-effects of the vaccination,” the affidavit said.
The Union ministry of Health and Family Welfare (MoHFW) has filed the affidavit on a plea filed by the Delhi Commission for Protection of Child Rights (DCPCR) seeking direction to the Centre to declare pregnant as well as lactating women as high-risk category, to be given priority for COVID-19 vaccination.
It said that if pregnant women decide to get vaccinated the vaccinator marks them as pregnant woman/lactating mothers on the CoWIN platform and thus, a list of all those women receiving the COVID-19 vaccine is maintained in the database.
On the petitioner's suggestion regarding tracking of Adverse Event Following Immunisation (AEFI) in hospitals and creating mechanisms for self-reporting through CoWIN or other platforms, the Centre said that the current AEFI surveillance system is adequately empowered to handle suspected AEFI related to COVID-19 vaccination.
“The AEFI surveillance system collects data of all adverse events related to 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”, it said.
The Centre said that under the AEFI surveillance system, the District Immunization Officers (DIOs) have been instructed to set up a network with private hospitals to report adverse events following immunization through Case Reporting Formats as soon as they are informed of any AEFIs.
“The DIOs also investigate the case and submit reports. Training has been given to State Officers and Instructions for training of all medical officers, private practitioners and front line health workers on their role in AEFI surveillance related to COVID-19 vaccination of pregnant women/lactating mothers were issued," it said.
On the suggestion of medical treatment for pregnant and lactating women who suffer from AEFIs, the Centre said it is being provided free of cost to beneficiaries who suffer AEFIs in all government health institutions.
“States and UTs have been asked to identify at least one AEFI management Centre in each block. State and district authorities (DIO/CMO or the Block MO) have been asked to proactively reach out to all health care service providers such as medical, hospitals (public, autonomous and private) and individual practitioners and sensitize them to report any adverse event following COVID-19 vaccine as per guidelines,” the centre said.
It added that MoHFW has established a patient to doctor telemedicine platform and accordingly, a National Telemedicine Service by the name of eSanjeevaniOPD was rolled out nationally by the ministry in the early stage of the COVID-19 pandemic. On September 20, last year, the top court had agreed to hear a plea of DCPCR and sought a response from the Centre.
The government said that till now 63,56,743 consultations have been effected on eSanjeevaniOPD, which is citizen friendly safe medium to seek health services by citizens in the confines of their homes.
On December 3, last year, the top court had asked the DCPCR to forward its suggestions, if any, to the Centre and if required, it will incorporate it in the national COVID-19 vaccination programme.
Advocate Vrinda Grover for the DCPCR had earlier submitted before the court that there is a need to declare women in these conditions as high-risk categories and since people are dealing with a virus which they do not know much about, there is a need to conduct continuous research on the effects of vaccination on them.
There is also a need to create a platform for registry of pregnant and lactating mothers for proper monitoring, she said.