Intervention Application / Impleadment in Writ Petition (C) 572 of 2021

An Intervention / Impleadment has been sought in the case of Delhi Commission for Protection of Child Rights vs Union of India on the subject of vaccination for Pregnant Women and Lactating Mothers.

As per MoHFW guidelines dated 2nd July 2021, Pregnant women will be eligible to get vaccinated for Covid-19. Please find link to advisory here: https://www.mohfw.gov.in/pdf/OperationalGuidanceforCOVID19vaccinationofPregnantWoman.pdf

It is important to note that the vaccines only have Emergency Use Authorisation (EUA) and peer reviewed data on the safety trials of these vaccines is yet not available. There is no signed informed consent being taken for any individual.

Information from the Covid 19 Vaccine Fact Sheet / Product Inserts

Covaxin:
“WHAT IF I AM PREGNANT?
If you are pregnant, you should not get the vaccine as the safety of the vaccine has not been studied in pregnant women.”

Covishield:
“4.6 Fertility, pregnancy and lactation
Pregnancy
There is a limited experience with the use of ChAdOx1 nCoV-19 Corona Virus Vaccine (Recombinant) in pregnant women.  Preliminary animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryofetal development, parturition or postnatal development; definitive animal studies have not been completed yet. The full relevance of animal studies to human risk with vaccines for COVID-19 remains to be established. Administration of COVISHIELD™ in pregnancy should only be considered when the potential benefits outweigh any potential risks for the mother and fetus.
Breastfeeding
It is unknown whether Covishield is excreted in human milk.”

Sputnik V:
WHAT IF I AM PREGNANT OR BREASTFEEDING?
The product is not for use during pregnancy, since its effectiveness and safety during this period have not been studied.”

Furthermore, RTI CDSCO/R/T/21/00670 filed on 27.7.21 says the following:

“CDSCO has not granted permission to conduct clinical trials on pregnant women and breast feeding women.”

This is a grave mistake on the part of the Government to hastily declare these experimental vaccines safe, without having the required safety studies done.

Please find the full copy of the IA below:

Supporting Annexures:

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