Explained | Should pregnant and lactating women and children be vaccinated against COVID-19?

What is the view of experts on immunisation against COVID-19 for these sections, and where does India stand?

Updated - November 30, 2021 06:31 pm IST

Published - May 23, 2021 03:45 am IST

corona virus covid-19 vaccine,injection, vaccine bottle, vector illustration

corona virus covid-19 vaccine,injection, vaccine bottle, vector illustration

The story so far : Over four months after the COVID-19 vaccination drive was launched, India has administered around 19 crore doses of Covishield and Covaxin so far. But it is yet to open up vaccination for pregnant women and children. On May 19, the Union Ministry of Health and Family Welfare accepted fresh recommendations from the National Expert Group on Vaccine Administration for COVID-19 (NEGVAC) for vaccinating lactating mothers. The country is yet to study the safety and efficacy of the two existing vaccines in the paediatric population, with the Drugs Controller General of India recently giving the nod to Bharat Biotech to conduct clinical trials of Covaxin in the 2-18 years age group.

Why should pregnant and lactating women be vaccinated against COVID-19?

“Vaccinating pregnant women against COVID-19 is extremely important. The second wave is worse than the first wave. The impact is more in terms of the overall numbers,” said Dr. Jaishree Gajaraj, senior consultant, Obstetrics and Gynaecology, MGM Healthcare, Chennai, adding that based on observations by obstetricians in Chennai, roughly one in three pregnant women tested positive for COVID-19. “This is a high number, and it is important to do something to protect them as the disease burden in pregnancy is high,” she said.


The Federation of Obstetric and Gynaecological Societies of India (FOGSI), in a statement last month, said protection should be extended to pregnant and lactating women. “The very real benefits of vaccinating pregnant and lactating women seem to far outweigh any theoretical and remote risks of vaccination,” it said.

Pregnant women are a vulnerable population, said Dr. Gajaraj, adding, “There is some kind of immunological compromise in pregnant women. The disease could be severe, as we have noticed in the second wave.”

For lactating women, FOGSI stated that there were no known adverse effects on neonates who are breastfeeding. “In fact, there is a passage of protective antibodies to the child, which may be a beneficial effect.”

Do we have data to assess the risks or benefits?

According to the World Health Organization, while pregnancy brings a higher risk of severe COVID-19, at present, very little data is available to assess vaccine safety in pregnancy. There is no evidence that suggests vaccination would cause harm during pregnancy.

“To date, none of the clinical trials have included pregnant and lactating women for obvious reasons as no ethics board will give the nod. Preliminary information from the United States, which has been vaccinating since last year, is that the immune response has been good in pregnant women, irrespective of the type of vaccines. Antibodies were found in the umbilical cord and breastmilk that could give protection for the newborn,” said Dr. Gajaraj.


Can children be vaccinated?

Across the globe, several studies have begun to examine the safety and efficacy of COVID-19 vaccines in children. The United States has started vaccination for children above 12 years of age.

Also read | Belagavi hospital begins clinical trials for COVID-19 vaccine on children

Dr. Rema Chandramohan, professor of paediatrics, Institute of Child Health and Hospital for Children, Chennai, said, “The paediatric population is less affected during this pandemic. Since adults are either infected or vaccinated, children will become vulnerable in the next wave. Initially, it was thought that children will not be affected due to the absence of ACE2 receptor in the lungs but we do see several children with the infection, who are mostly asymptomatic, and some with typical symptoms of COVID-19. There are two ways that COVID-19 presents in children — as viral fever and as a multisystem inflammatory syndrome. Vaccinating children against COVID-19, therefore, becomes necessary.”

How is it different from vaccinating adults?

“When a vaccine against COVID-19 for children is being developed, the vaccine developer should keep in mind the effect of the vaccine on children, and how safe the vaccines are in children. The benefits should outweigh the risks to a great extent. There should be sufficient safety trials before rolling out the vaccines for children,” said Dr. Chandramohan.

The results of trials abroad among 12-year- to 17-year-olds have demonstrated the safety of vaccines, said Dr. Chandramohan, adding: “We cannot extrapolate studies done in adolescents and adults as every aspect is different in children — the dose, weight of the child, muscle mass matters. We need to look at the minimal dose required which will give maximum benefit/response in addition to having minimal side effects and maximum safety profile in children to call it an effective vaccine.”

What lies ahead?

Vaccination of pregnant women is something that needs immediate attention. There are a lot of debates on the safety of vaccines in pregnancy. “Being a killed vaccine, there is no real expectation of adverse effects with Covaxin. There have been some reports of coagulation and blood clotting problems with Covishield, especially in the younger population less than 30 years of age. The rare occurrence of these adverse effects should not be a deterrent to offer the much-needed protection … Concerns regarding the severity of COVID-19 infection in pregnancy far outweigh the remote possibility of side-effects,” said Dr. Gajaraj. Noting that there was only a theoretical risk of adverse events, she said informed consent could be obtained from women before vaccination. “Usually, vaccines are avoided in the first 12 to 13 weeks of pregnancy due to organogenesis. Vaccines, including the flu shot, are generally given after 26 weeks to protect the neonates, too. But this is a pandemic, and we could give the vaccination at any time during the pregnancy to protect the mother.”

“Once we have a vaccine for children, we should look at how it can be included in the vaccination schedule without interfering with the regular schedule. Coronavirus is highly mutated, and so, like influenza, children may need regular booster doses,” Dr. Chandramohan noted.

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