Why India Cannot Delay Vaccinating Pregnant Women Against Covid-19

Kalyani Agrahari, 27, an assistant teacher, was assigned to poll duty in eastern Uttar Pradesh's Jaunpur block during the April 2021 state panchayat elections. Eight months pregnant with her first child and advised bed-rest by her doctor, Kalyani asked to be excused from the 12-hour duty at the poll booth that was 32 km from her home.

The district administration not only turned down her application but also threatened her with disciplinary action if she did not report for work. Kalyani, who had been appointed to the job just four months before, had no option but to comply.

On the evening of April 15, when she returned home from the poll booth, she complained of fever and body ache. When her temperature did not subside for three days, her family tried to get her hospitalised. She was turned down by eight hospitals that said they had no free beds. In the meanwhile, she had tested positive for Covid-19 and was finally admitted to Mahila Chikitsalaya (Women's hospital) in Jaunpur. She died on April 24, two days before her third wedding anniversary.

"June 10 was supposed to be her delivery date, didi died much before," her younger sister, Rani Agrahari, 22 told IndiaSpend. Blaming the administration for forcing Kalyani to report to work despite her vulnerable state, her father Suresh Kumar said that she had been in good health through her pregnancy except for fatigue, for which she was on medication.

The same month, Dimple Arora Chawla, 34, a Delhi-based dentist who was seven-months pregnant and Covid-positive, was rushed to a hospital when her oxygen levels started dipping after 10 days of illness. She was administered remdesivir and plasma therapy and underwent an emergency Cesarean section but the baby was born dead and the next day Dimple, mother also to a three-year-old son, succumbed.

Chawla had been particular about Covid precautions, never stepping out without a mask and personal protective equipment, and would even get herself tested for the infection every 3-4 months, said her husband Ravish Chawla to the UK-based The Independent. In a video he released after her death to spread awareness about the disease, she can be seen urging people to take the virus seriously and remain masked.

The second wave of the pandemic has affected pregnant women much more severely than the first and also caused more maternal deaths, said the gynaecologists and obstetricians we interviewed across the country. But despite their heightened vulnerability, India's vaccine policy does not allow pregnant women to be vaccinated and this needs to change, they said. The risks from Covid are far higher than the risks from vaccines, as we detail later.

Women who contract Covid-19 during pregnancy are over 50% more likely to experience complications such as premature birth and pre-eclampsia, more likely to require intensive care and are more at risk of death, said an INTERCOVID study in the journal JAMA Pediatrics published in April 2021. The study, which included 2,100 pregnant women across 18 countries, also found that while maternal death was low among women with Covid (1.6%), they were 22 times more likely to die than uninfected women. Pre-existing conditions such as obesity, diabetes, hypertension and chronic cardiac and respiratory disease worsened Covid complications among pregnant women.

The findings of the INTERCOVID study are in line with the study of 703 health centres in the US which found that the risk of death among women with a Covid diagnosis at delivery was 17 times more than those not infected. The risk of sepsis was 14 times higher, of mechanical ventilation 13 times, and of shock five times, as per the study.

There have been no definitive findings on the subject in India but anecdotal evidence suggests similar risks for Covid-infected pregnant women, we found.

Maternal deaths are rare and its indicator, the maternal mortality ratio, is calculated per 100,000 live births. India's maternal mortality ratio is 113, according to the latest Sample Survey registration system (2016-18), down from 212 in 2007-09 and 327 in 1999-2001.

In the first wave, most pregnant women who contracted Covid reported higher complication incidence than in pre-pandemic times but they delivered successfully, said Alpesh Gandhi, president of the Federation of Obstetric and Gynaecological Societies of India (FOGSI). But in the ongoing wave, the threat to their lives has become more acute, he said.

In April 2020, the federation started a registry of all pregnant women infected with Covid-19 as did the Indian Council of Medical Research in May 2020. But the data remain incomplete because health centres are struggling with heavy workloads and will not be in a position to collate the exact numbers till later, said Gandhi. "We expect to see a 7-8 times higher maternal mortality due to Covid-19 in 2021 compared to pre-pandemic times and four times higher mortality than the first wave," he told IndiaSpend.

One reason for the higher disease severity in pregnant women could be because the second wave in India has seen far more cases (peaking with 400,000 new cases in May 2021) compared to the first (peaking with 97,000 new cases in September 2020), and this includes the country's younger population.

However, it is also important to remember that not all pregnant women will have complications or adverse outcomes, pointed out Ruma Satwik, a Delhi-based gynaecologist who works at a tertiary care centre. "About 80% pregnant women will be asymptomatic or with mild symptoms," said Satwik.

Pregnancy as a condition reduces the body's immune response because it has to accept the foetus itself to start with, said Satwik. In normal times, most maternal deaths have been because of excessive blood loss due to haemorrhage or uncontrolled hepatitis, but now pregnant women with moderate-to-severe disease Covid symptoms are also dealing with pneumonia, she said.

Most complications in the second wave are being reported in the third trimester because, with the pregnancy progressing, the uterus expands upwards and pushes against the diaphragm and this reduces the capacity of the lungs, she said.

"The situation is very bad--in the first wave, Kerala had seen only seven maternal deaths but the figure is 4-5 times the numbers this time around," said V.P. Paily, senior obstetrician and the state coordinator for Confidential Review of Maternal Deaths, a maternal death auditing process undertaken by Kerala Federation of Obstetrics and Gynaecology (KFOG).

"We were hoping that when the disease prevalence comes down, the maternal deaths will come down but even now we haven't seen signs of that," he said, adding that the disease severity is higher this wave. "Lung involvement--the way it affects oxygen saturation--is much more in this wave, it was much milder in the previous wave."

Doctors are seeing more incidents of moderate-to-severe cases of Covid among pregnant women with a greater need for ICU admission and ventilation compared to the last wave, said Ruma Satwik. At their centre there were no Covid-related deaths in the last wave, but there have been a few the last month, she said.

Late or multiple pregnancies and diabetes raised the risk for Covid-related complications, Paily said.

At Mumbai's B.Y. Nair Hospital, the city's referral centre for Covid-infected pregnant women, there have been 33 maternal deaths and of them, 8-10 were in the first wave and the rest in the second, said Ganesh Shinde, professor and head of gynaecology at the hospital. Most fatalities were among women who came to the hospital with severe lung involvement and nothing much could be done to save them, he said.

Since April 2020, the centre has conducted 1,059 deliveries, and 90 women with moderate-to-severe disease needed ICU care, Shinde said.

The INTERCOVID study cited earlier also found that infants born to infected women were more likely to require neonatal intensive care, mostly due to premature birth. The study, however, showed that infected pregnant women who were asymptomatic were at the same risk as uninfected pregnant women.

Observing Covid hygiene protocols--double masking, social distancing and frequent hand-washing--is the best way to ensure a safe pregnancy, said Alpesh Gandhi. But vaccination would be even more effective and this must be allowed, said Paily.

Pregnant and lactating women were not part of any clinical trial for Covid vaccines and hence most countries kept them out of their immunisation drives. This has changed as more vaccination data became available, and more medical bodies started advocating for vaccinating pregnant women. Clinical trials on the safety of vaccines for pregnant women too are currently under way.

Experts believe that vaccines, given their basic mechanism, are not risky for pregnant women. Animal studies of mRNA vaccines (Pfizer, Moderna) and Jannsen's viral vector vaccine showed no additional risk for pregnant animals or their babies. The Centers for Disease Control and Prevention in the US created a V-safe registry to monitor pregnant women who had been vaccinated. The preliminary results showed that 3,958 women who had been vaccinated showed no additional risk from the mRNA vaccines.

The World Health Organization recommends Covid vaccination for women with high-risk exposure to Covid or comorbidities that puts them at risk.

"The odds of getting adverse effects from vaccinations are far lower than of getting infected with Covid. In this situation, vaccination for pregnant women, who are at high risk of complications, should be prioritised," said Yamini Sarwal, lead author of a yet-to-be published study on prioritising pregnant women for Covid vaccinations, and also the chief medical officer at the Vardhman Mahavir Medical College in Safdarjung Hospital, New Delhi.

Given that vaccines protect both the mother and the foetus--to whom the antibodies get transferred--Covid vaccination should be made a part of the routine antenatal protocol, the report said.

This is also what FOGSI had advocated for pregnant and lactating women in April 2021 itself, noting that the benefits of vaccines outweigh the risks.

On May 13, 2021, the National Technical Advisory Group on Immunisation had recommended Covid vaccination for both pregnant and lactating women. But the Ministry of Health and Family Welfare allowed only lactating women to be vaccinated, deferring the decision on pregnant women.

The study we cited above also found that only nine of 20 countries with high Covid burdens have allowed vaccination for pregnant women. The U.S. and the U.K. have prioritised pregnant women for vaccination, it said, while Brazil, France, Italy, Argentina, Spain, Mexico and Netherlands include them in their vaccination drive.

India, Turkey, Russia, Germany, Poland, Columbia, Iran, Ukraine, Peru and Indonesia do not allow pregnant women to be vaccinated.

The study also found that among 20 countries with high rates of infant and maternal mortality, only four allow Covid vaccination for pregnant women. India and Indonesia, with one-fifth of the world's population, high Covid burdens, and maternal and infant mortality, do not currently include pregnant women in their immunisation drives.

Some 27 million Indian women get pregnant every year, said Alpesh Gandhi of FOGSI. "We are hopeful that the government of India will take a decision on this soon so that more pregnant women can be protected," he said.

This copy was published in a special arrangement with IndiaSpend.