From January 16, India will start the COVID19 vaccination drive. To begin with, 30 million healthcare staff and frontline workers are to be vaccinated, for free. This would be followed by the 50-year plus population. The Centre had said last year that about 250-300 million people would be vaccinated by September 2021. 

On January 3, the Drugs Controller General of India approved the Serum Institute of India’s Oxford COVID-19 vaccine Covishield, and Bharat Biotech’s Covaxin for emergency use in the country. However, for now, there is no clarity on whether pregnant women, who, the World Health Organization (WHO) says are also a high-risk category, should be vaccinated. 

Recently, the American College of Obstetricians and Gynecologists said in its report that pregnant women can be vaccinated for COVID-19, but WHO does not recommend that due to insufficient data on pregnant women and the vaccine. India is not vaccinating pregnant women for now.

To get an opinion of rural citizens on the corona vaccine, Gaon Connection recently conducted a survey on COVID-19 Vaccine and Rural India, as part of which 6,040 households across 60 districts in 16 states and one union territory were asked whom they thought should the government be vaccinating first on priority basis. 

Respondents had the option of multiple choices. Only 15.3 per cent of rural respondents suggested prioritising pregnant women for COVID vaccination. This, when 43.5 per cent of surveyed households chose doctors and nurses, 34.8 per cent chose frontline health workers and 21 per cent chose populations above 60 years. 

Lucknow-based gynaecologist Neelam Gupta suggested to Gaon Connection that pregnant women should be in the priority list too, “after healthcare and frontline workers and the elderly and those with comorbidities”.

Meanwhile, health experts differ about the risk of vaccinating pregnant women. Gupta believes pregnant women need to get priority as the risk for contracting the virus for this population is more, and they may go in for preterm (premature) delivery. However, Kolkata-based gynaecologist Soumitra Kumar said there was no need as of now to vaccinate pregnant women as there is not enough data on the risks and safety of vaccination.

GC Survey on COVID19 vaccine

The Gaon Connection Survey found that only 5.6 per cent of rural families were willing to pay for the coronavirus vaccine for pregnant women in their households. This, when Rajesh Bhushan, Union health secretary, said that more than one-third (37 per cent) of COVID-19 cases were of women.

When respondents were asked who they would vaccinate first if they had to pay for the vaccine, the three most selected options were — old parents (33.3 per cent), kids (26.5 per cent) and breadwinner (16 per cent). 

“Indian tradition prohibits giving new medicines to pregnant women. This could be the reason behind such low percentages for pregnant women,” K Suresh Kishan Rao, public health specialist who has been associated with the country’s immunisation programme, told Gaon Connection.

Among the meagre numbers of households who wanted to pay for a vaccine for pregnant women, the highest of over 10 per cent was in the East-northeast zone (West Bengal, Odisha, Assam, and Arunachal Pradesh). However, this figure stood at only two per cent in the North zone (Punjab, Haryana, Jammu & Kashmir, Himachal Pradesh, Uttar Pradesh, Jharkhand, and Bihar), the lowest in the country.

“Such a huge difference could be attributed to the education level and awareness in these two zones. Households in the East-northeast are more aware pertaining to coronavirus health concerns. But in the North, even general knowledge about health is less,” said Kumar.

For and against vaccinating pregnant women

“Through the media, people hear the elderly and kids are more vulnerable to COVID. But nobody talks about risks of coronavirus to pregnant women. They are not counted. But, pregnant women who contract the virus are at a very high risk,” said Gupta. “If she gets COVID during pregnancy, when her immunity is already low, chances of multiple organs getting affected increases. In the worst case, she can die,” she warned.

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 noted that pregnancy may increase the risk of severe COVID-19, ICU admission, need for ventilation and death. And, conditions such as Type 2 diabetes may amplify that risk.

The ACOG 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. But it added as a caveat that “there are no safety data specific to mRNA (Messenger RNA vaccines to protect against infectious diseases) vaccine use in pregnant or lactating individuals and the potential risks to a pregnant individual and the foetus are unknown”.

Commenting on mRNA COVID vaccines, Gupta said: “Any live vaccine is not advisable in pregnancy. In our country, we have mRNA vaccine, which is a dead vaccine. The side effects of vaccinating pregnant women, if any, can be treated. We should weigh the benefits,” she said.

On the other hand, Kumar, who has been practising in West Bengal for the past 30 years felt that  “pregnant women should not be vaccinated unless we have all the data from rigorous trials that include them. I have seen pregnant women respond better in a COVID situation.” 

Need to include pregnant women in clinical trials

On January 7, Bharat Biotech announced “successful completion” of volunteer enrolment (25,800 volunteers) for Phase-3 clinical trials for Covaxin. 

Experts said these trials did not include pregnant women. “All the vaccines in the trial phase in our country have not considered pregnant women,” informed Gupta.

As per The Lancet Global Health report 2020, inclusion of pregnant women in clinical treatment trials is urgently needed to identify effective COVID-19 treatment for this population. This would allow evaluation of effective therapies that might improve maternal health, pregnancy and birth outcomes, and avoid the delay of developing treatment recommendations for pregnant women.

Interestingly, a 2014 report of WHO, in general, many vaccines given during pregnancy did not undergo formal clinical trials in pregnant people — safety and efficacy data are often gathered through animal and observational studies.

“We do not have any evidence as to how COVID vaccines may act on pregnant women. For people to understand that this vaccine would be safe, the government needs to guarantee that. Awareness programmes and selective trials, both in urban and rural populations, are needed,” said Kishanrao.

In another survey, released last August by Gaon Connection, it was found that nearly half (42 per cent) of the rural households with pregnant women did not undergo regular checkups and routine vaccination. This also remains a big concern as it is expected to have wide ranging impacts.