Roopali Bansal Pareek worked as a radiologist at Sion Hospital when COVID-19 cases were surging, especially in Dharavi. She says she would have taken the vaccine had she not conceived in June last year. Pic/Sameer Markande

Last month, when India launched the world’s largest COVID-19 vaccination drive, opening up the first phase for frontline medical workers, Pareek missed her chance to get a shot. All her family members, however, became COVID-19 vax beneficiaries. “I don’t want to take the vaccine yet. We don’t know enough about the long-term effects of COVID-19 yet. So far, it is looking like it may be similar to the influenza virus, which is not so serious if it happens to an expectant mother. But, who is to say that it won’t end up being like one of the other more serious viral infections we know of such as the TORCH infections? These include toxoplasmosis, other (e.g., syphilis, HIV), rubella, cytomegalovirus (CMV), and herpes simplex virus; it spreads through your blood to your baby. And the damage to the child is irreversible. I would have definitely taken the vaccine had I not been pregnant. But with the limited data and studies regarding it’s safety for the baby, I don’t want to risk it with my pregnancy or when I begin lactating atleast,” Pareek explains.

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The Coronavirus vaccine has presented a dilemma for pregnant women across the world. As approved vaccine candidates make their way from production centres to frontline workers in nursing homes and hospitals across the globe, people who are pregnant, breast-feeding, or trying to conceive must contend with the lack of data available on how these will affect them, the developing foetus, or infant.

Dr Shirish Malde

Since the pandemic started, the World Health Organization (WHO) said it could not recommend vaccination in pregnant women “at this time” because of insufficient data. In a major U-turn, however, the WHO on January 29, while updating guidelines on the US-funded Moderna vaccine, said that, based on the data at hand, “we don’t have any...reason to believe there will be specific risks that would outweigh the benefits of vaccination for pregnant women.” The WHO said that pregnant women in risk groups, such as those employed in healthcare, or with comorbidities, may get the jab after consulting their doctor. The previous version of the recommendations featured a stronger wording: “the use of this vaccine in pregnant women is currently not recommended unless they are at risk of high exposure.”

Dr Shirish Malde, a clinical sexologist and president of the Family Association of India (FPAI), Mumbai chapter, sees no danger, though. Primary data, which indicates efficacy and toxic side effects of vaccines, is not pointing towards any major risk for people. Whether it is Covishield, which contains the genetic material of the SARS-CoV-2 virus spike protein, or Covaxin, which destroys the pathogen’s ability to replicate, the immunological response to these vaccines has been more or less well within normal limits of metabolism. The vaccines are not altering your body in any way; maybe that is why the WHO thought that excluding pregnant women will not be a good idea anymore. Therefore, I think we could advise expectant mothers to take a jab.”

Ruhita Choughule, who is due for delivery this month, says she will wait before she decides on taking the vaccine due to lack of sufficient research available from across the world. Pic/Nimesh Dave

Malde thinks after healthcare workers, India should give the vaccine to senior citizens, diabetic patients and pregnant women on priority. “We are a country with a diabetic epidemic; there is a large number of people who should be put on priority. Even the medical fraternity is thinking whether to give pregnant women the vaccine before the remaining population,” he adds.

At present, the Government of India and the Ministry of Health and Family Welfare (MOHFW) advise against getting a COVID-19 vaccine during pregnancy and while breastfeeding. However, these guidelines may change if we get conclusive evidence that there is no risk to mother or child.

Dr Ashwini Bhalerao Gandhi and Dr Dinesh Dhodi

Borivli-based Ruhita Choughule is due to give birth this month. She, too, is uncomfortable taking the vaccine at the moment. “I have heard mixed reviews from people who have taken the jab since India started the vaccination programme. There are some who showed side effects, too. If normal people are expressing discomfort, should a pregnant woman take the risk?,” wonders Choughule, who works as a sales manager and is currently on maternity leave. Choughule, who is due to have her first baby after eight years, says she and her husband had been working towards reaching a place of financial stability. “Last year, despite the pandemic, we thought maybe it’s time we have a baby. While there are no complications in my pregnancy despite me being in my mid-30s, I don’t want to take a chance.”

In previous outbreaks of other Coronavirus infections, such as severe acute respiratory syndrome and Middle East respiratory syndrome, serious complications were reported in pregnant women. During the 2009 influenza A H1N1 pandemic, pregnant women accounted for five per cent of US deaths, while representing only one per cent of the US population. However, despite more than 18 million reported cases of COVID-19 worldwide, understanding the effect of SARS-CoV-2 on pregnant women, foetuses, and infants is incomplete. A study published in The Lancet in August 2020 titled, Inclusion of pregnant women in COVID-19 vaccine development, states: “A comprehensive document published by the Pregnancy Research Ethics for Vaccines, Epidemics, and New Technologies Working Group in 2019 provided ethical guidance for preparedness, research, and response for pregnant women and vaccines against emerging epidemic threats. The document identified a number of specific strategies to promote the ethically responsible, socially just, and respectful inclusion of the interests of pregnant women in the development and deployment of vaccines against emerging pathogens. The WHO Scientific Advisory Group of Experts welcomed this initiative and suggested it should be extended to include lactating women.”

Why then were pregnant animals not used in COVID-19 vaccine trials is a question many are asking. “Since the immune response to vaccination in pregnant women cannot be assumed from that of non-pregnant women and because the assessment of safety of vaccination in pregnancy is unique, pregnant women should be included in appropriately designed vaccine trials,” the study added.
 
Dr Dinesh Dhodi of JJ Hospital, who is also the co-investigator of vaccine trials, says Covaxin is safe for use, but the team is still waiting for an interim report on its efficacy next month. “As the co-investigator, I ensure that the trial goes as per protocol, in terms of monitoring, follow ups, etc. In one month, we called over 476 volunteers, of which 436 were successfully enrolled for trials in Mumbai. This one-year trial, which is ongoing, includes a total of seven RT-PCR tests. While the final result on Covaxin is not out, we are waiting for an interim report to come next month.”

Dhodi says that it is not just during COVID-19 vaccine trials that pregnant women were excluded. It is, in fact, a norm for any drug trial across the world. “In every trial, pregnant women are not included, until it is a purely pregnancy-related condition that is being tested. This is because there is a lot of requirement from volunteers like follow-ups, regular check-ups, etc. A pregnant woman cannot dedicate that much time. In addition to this, if something does go wrong in the pregnancy, the trial will fail. Right now, we don’t know if the foetus will experience any adverse effects of the vaccine. The health ministry is yet to issue a guideline and we should wait for it,” he thinks. 

A lot of countries are now recommending that women take the vaccine before conceiving. Malde welcomes this alternative. “If the time of your future baby’s birth does not bother you, or you can afford to delay conception, it would be ideal to wait and get the vaccine dose when you can. However, this is a great alternative for the learned class. If you sit and try to change people’s mindset, in a country like ours, where daily 60,000 children are born, it is difficult to expect people to follow suit. The birth rate in hospitals in Mumbai has more or less remained unaltered despite the pandemic. The pregnancy rate has remained the same in the lockdown.”
 
Since at least the mid-1990s, representatives of medical societies and leading research institutions—the American College of Obstetricians and Gynecologists, the Society for Maternal-Fetal Medicine, the National Institutes of Health, and the National Academy of Medicine—have advocated for the inclusion of pregnant and lactating women in vaccine trials, including those for the Coronavirus. “If we don’t have vaccines that are proven to be safe and effective in pregnant women, we don’t have a vaccine for healthcare workers,” Emily Erbelding, the director of the Division of Microbiology and Infectious Diseases at the National Institute of Allergy and Infectious Diseases, said at a September 2020 workshop by the FDA on pregnant women and COVID-19.

Dr Ashwini Bhalerao Gandhi, consultant gynaecologist at PD Hinduja Hospital, agrees, and asks soon-to-be mothers to wait this one out. “The Royal College of Obstetricians and Gynaecologists (RCOG) issued guidelines in January this year for pregnant women. It says that if you are eligible for and have been offered a COVID-19 vaccine, the decision whether to have the vaccination is your choice. You can either take the vaccine or wait for more information to come on it. I personally feel that women who are eligible for the vaccination should consider discussing any concerns they have with their healthcare professionals. Unless you are at a high risk of contracting the virus, for instance if you are a healthcare worker, then you may want to take a vaccine shot, with risk. Maybe two years down the line, researchers will be able to tell us better if these vaccines are safe. I’d suggest that you take a jab and after four months, try to make a baby,” she concludes.
 

What are the risks of vaccination?

. COVID-19 vaccines have been given to large numbers to ensure they meet stringent standards of effectiveness and safety.

. Insufficient evidence is available for pregnant women, although the data does not indicate any safety concern or harm to pregnancy. More information may come from studies in the future.

. We do not know whether the vaccine works as well in pregnancy.

. We do not know whether there are unique downsides in pregnancy, like different side effects, an increased risk of miscarriage or problems with the baby’s development.

. Side effects from the vaccine are common. These do not affect pregnancy, but may include: injection site reactions (sore arm), fatigue, headache, muscle pain, fever, chills and joint pain.

Notification by RCOG