In a letter to all the states and union territories, the Union ministry of health has advised not administering the COVID-19 vaccine to pregnant and lactating women as “they have not been part of any anti coronavirus vaccine clinical trial so far”
The COVID-19 vaccination is set to kick-off in India tomorrow, January 16, with the healthcare and frontline workers as the first priority for administering the vaccine. Meanwhile, the Union ministry of health and family welfare has said that pregnant and lactating women should not be administered the COVID-19 vaccine, for now.
In a letter dated January 14 to all the states and union territories, Manohar Agnani, additional secretary, health ministry, mentioned that vaccination during pregnancy and for lactating mothers is ‘not recommended’ for both Covishield vaccine of the Serum Institute of India, and Covaxin of Bharat Biotech. Both these vaccines have been officially approved by the Drug Controller General of India (DCGI) for immunisation against the COVID-19 pandemic. However, bioethics researchers and public health experts have been warning against the approval to the Covaxin without completion of phase 3 trials.
The ministry’s letter notes that “interchangeability of COVID-19 vaccines is not permitted and pregnant and lactating women should not be administered the shots as they have not been part of any anti coronavirus vaccine clinical trial so far”.
Even though pregnant women form the ‘high-risk category’, the World Health Organization does not recommend giving them COVID-19 vaccine due to insufficient safety data on pregnant women.
However, the American College of Obstetricians and Gynecologists, (ACOG), a professional association of physicians specialising in obstetrics and gynaecology in the United States, in a report published in December last year, said pregnant women can be vaccinated. The group also noted that even though the vaccine has not been tested on pregnant women, it expects the safety profile would be similar to other groups.
Three days back, on January 12, Gaon Connection reported about the divided opinion in the country on getting the pregnant women vaccinated for COVID-19.
The health experts differ about the risk of vaccinating pregnant women. Lucknow-based gynaecologist Neelam Gupta said that pregnant women need to get priority as the risk of contracting the virus for this section of population is high, and they may go in for pre-term (premature) delivery. However, Kolkata-based gynaecologist Soumitra Kumar said that for now there was no need to vaccinate pregnant women as there was insufficient data on the risks and safety of the COVID-19 vaccine.
A recent Gaon Connection survey across 16 states and one union territory showed only 15.3 per cent of rural respondents suggested prioritising pregnant women for COVID vaccination.
Meanwhile, following the death on December 21 last year of a volunteer, nine days after a trial dose of Bharat Biotech’s Covaxin, other volunteers have raised questions on the way in which the trial was conducted. They alleged facing several health issues post receiving the vaccine dose, such as headaches, dizziness, loss of appetite, vomiting, backache, breathlessness and abdominal pain.
In another nationwide survey by Gaon Connection, released last August, it was found that nearly half (42 per cent) of the rural households with pregnant women did not undergo regular checkups and routine vaccination due to the COVID-19 pandemic and lockdown.