Proper Observation, Research, Documentation Is Required To Study The Impact & Effects Of The Vaccine On Pregnant Women And Lactating Mothers: DCPCR Tells Supreme Court

On a writ petition filed by the Delhi Commission for Protection of Child Rights raising the issue of COVID vaccination for pregnant and lactating women, the Supreme Court had on December 3 granted liberty to the petitioners to formulate concrete suggestions to strengthen the existing framework for protecting this group in ensuring that they have proper access to vaccination against COVID-19.

In its note submitted to the Court, the Commission has urged that the monitoring and tracking mechanism of Adverse Events Following Immunization ('AEFI') currently formulated as mentioned in the Preliminary Affidavit of the Union of India suffers from the following shortcomings:

a. The Government of India's affidavit mentions that all pregnant women who are getting vaccinated will be line-listed on the CoWIN portal with basic demography details and photo identity number. Any adverse effects report is also entered where the category can be identified as "Pregnant Women & Lactating Mothers", thereby maintaining a tracking mechanism for PW&LM. However, there is absolutely no mechanism to identify one-self as pregnant woman or lactating mother on Co-WIN portal and no such questions are being asked in practice to any women reaching vaccination centers, there is absolutely no mechanism for line-listing as claimed by the Government of India.

b. As per the current system AEFI is reported by either the vaccinator or the District Immunization Officer in the CoWIN portal. Thereby, only providing a mechanism for recording immediate adverse effects of the vaccine and not long term AEFI. Currently, the Government of India is not tracking any adverse events post 30 minutes of the vaccination. This tracking must be done for at least 30 days.

c. The second significant shortcoming in the approach adopted by the Government of India is that the entire onus is placed on the citizen, and almost none on the Government. It remains unclear how a pregnant/lactating woman will know how and whom to report once she leaves the center. Is she required to physically come back to the center for informing if there is an adverse event? How will those women inform who got vaccinated at temporary or mobile camps being organized? This in practice deprives any meaningful tracking mechanism for reporting adverse effects.

d. There is no proposed mechanism for private hospitals to report vaccine related complications in real time to the relevant government officers to enable immediate access of the affected party to assistance.

Government Tracking is Required

The petitioners have submitted that the current approach of the government is passive and the stakes of passive governance in this instance is incredibly high for the lives involved. Tracking by the nodal agencies of the government delivering maternity benefits with regards to any post-vaccination adverse effects. The tracking of the effects on each pregnant and lactating woman who has received the vaccination can be done by the government at time-intervals suggested by experts. The government of India must set up a call-center wherein pregnant women or lactating mothers can be called at regular intervals (say 3rd, 10th, 30th day or as suggested by medical experts) to check and remedy any adverse effects promptly and proactively. This will serve two purposes: robust documentation of adverse effects of vaccination on pregnant women and lactating mothers, and enabling the Government to remedy the cases where the adverse effect has been observed. However, this regular tracking and follow-up would require the Government to know which of the vaccinated people are pregnant women and lactating mothers. Hence, the self-identification option on the Co-WIN portal is crucial all the more.

"On the CoWIN portal, there is no option for pregnant and lactating women to "Raise an Issue". An option of reporting adverse effects for Pregnant and Lactating Women (and others) on the Co-WIN portal is required. The Government of India may add this simple feature and build processes for prompt and immediate response systems at the local level", it is advanced.

Access to necessary healthcare services

It is pointed out that:

a) There is no mechanism for pregnant women and lactating mothers to report adverse effects remotely (after leaving vaccination center) and in real time get access to necessary information such as specialized healthcare providers, government assistance schemes, etc., to deal with the adverse effects.

b) No information has been provided of any government schemes to provide swift emergency and long term free medical care and attention to pregnant women and lactating mothers who suffer from AEFI after leaving the vaccination center.

c) Setting up of a mechanism in place that can connect pregnant women and lactating mothers to the gynecologists in their nearby government dispensaries through Anganwadi or ASHA workers.

Publication of Data on effects of Vaccination on Women

Urging that public confidence and encouragement would be built if the Government publishes regular data with respect to vaccination of pregnant women and lactating mothers, it is suggested that government of India must undertake to publish the following information in its vaccination bulletin on weekly basis:

a. Number of pregnant women vaccinated (week and cumulative)

b. Number of lactating mothers vaccinated (week and cumulative)

c. Number of minor adverse events reported (week and cumulative) in pregnant women

d. Number of major adverse events reported (week and cumulative) in pregnant women

e. Number of minor adverse events reported (week and cumulative) in lactating mothers

f. Number of major adverse events reported (week and cumulative) in lactating mothers

It is indicated that the "multi-centric project" to be conducted as a study that has been proposed has only envisaged the monitoring of adverse effects in PW in the relevant "study sites and does not propose a pan-India collection of data and information. Since the interaction between the vaccine and other factors (hereditary, environmental, etc.) are not yet known, any study to map long term AEFI should not be restricted to a few chosen sites and must take into account a comprehensive data set for a meaningful study. Further, the Government of India must undertake to publish the results of the study to build public confidence.

"A specific filter category can be added to the CoWIN portal for pregnant women and lactating mothers while booking slots for vaccination to maximize convenience and safety through dedicated time and special days, as suggested by UOI. She can also be given preference at the Center for receiving the vaccination", it is averred.

Finally, it is advanced that adequate public awareness has not been created regarding the provision of reporting adverse effects to the concerned medical officer/ District Immunization Officer. Efforts must be undertaken to inform people that AEFI must be necessarily informed to the concerned Officer, in order to ensure that complete information about AEFI is available with the relevant authorities.