Vaccination of pregnant women against COVID‐19 in India and Indonesia: Moving beyond the opt‐in to the opt‐out option

Synopsis

In view of the continued threat of COVID‐19, and to synergize with routine antenatal care, COVID‐19 vaccination should become a default part of routine antenatal care with an opt‐out option.

Amid rising concerns voiced by health professionals, ¹ gender experts, ² researchers, ³ and the press on allowing vaccination for pregnant women against COVID‐19, and 167 days after the start of the campaign, the government of India on July 2, 2021, provided approval for the vaccination of pregnant women against COVID‐19. ⁴

Earlier, on May 28, 2021, the National Technical Advisory Group on Immunization had recommended vaccination for pregnant women subject to safety precautions. The group remarked, “considering the current situation of the pandemic, pregnant women should not be excluded from vaccination because exposure probability is very high and therefore the benefit far outweighs the risk”; however, the group also suggested that pregnant women should be fully informed about the fact that “the long‐term adverse reactions and the safety of the vaccine for fetus and child are not yet established… The vaccine may be provided at any time during pregnancy.” ⁵ In an early advisory, the Indian Research Body (ICMR) had issued “Guidance for Management of Pregnant Women in COVID‐19 Pandemic,” merely recommending infection prevention and control measures. ⁶ Lactating women were allowed to receive COVID‐19 vaccinations in May 2021. ⁷

Since pregnant women are at higher risk of severe COVID‐19 infection, a decision on vaccinating them was necessary. Even though no evidence existed to suggest vaccination would cause harm during pregnancy, little data on the safety of the vaccine was available. ⁸ The argument regarding the safety of the COVID‐19 vaccine in pregnant women was largely settled with regards to mRNA vaccines and remained inclusive for those vaccines derived from adenovirus agents. The evidence pertaining to the immunogenicity of the COVID‐19 mRNA vaccine in pregnant women and transport of such antibodies to infant cord blood and breast milk made a convincing and sound argument regarding safety and efficacy for newborns. ⁹ Agencies and associations around the world, like the Center for Disease Control and Prevention, American College of Obstetrics and Gynecology, Joint Committee on Vaccination and Immunisation have all called for vaccination of pregnant women against COVID‐19.

Now, weighing the risk‐reward balance, the decision to allow pregnant women to receive the COVID‐19 vaccine is a judgmental call taken without irrefutable evidence on safety, especially regarding adenovirus vaccines. However, this decision is based on the preponderance of probability and likely benefit that a mass use and protection of pregnant women is likely to offer, especially given that COVID‐19 infection is more severe in pregnancy. Recently, Indonesia which faces the dual burden of COVID‐19 infection as well as high maternal and under five mortality, like India, has also allowed vaccination of pregnant and lactating women. ¹⁰

This decision has huge public health implications around the world since only a handful of countries (12 of the most COVID‐19 affected countries, and 6 countries with high child and maternal mortality) allow COVID‐19 vaccination of pregnant women. The policy change in India should now trigger action from other countries that are the facing the dual burden of high COVID‐19 cases and high maternal and child mortality.

As of yet, neither India nor Indonesia have made COVID‐19 vaccination part of routine antenatal care. In India, the decision to opt‐in for vaccination is left to the pregnant woman after informing her about the pros and cons of vaccination. ¹¹ While this approach may be acceptable for countries where the incidence and effects of COVID‐19 and/or maternal and child mortality are less prevalent, in countries like India and Indonesia, COVID‐19 vaccination should be part of routine antenatal care protocols.

The authors of the present study welcome this bold decision and commend the governments of India and Indonesia for taking this timely step. In order to protect all pregnant women and their newborns, we call for inclusion of COVID‐19 vaccination as a part of routine antenatal care. Such a step will help to improve antenatal coverage, of which rates have slipped during the pandemic, and also help newborns, thus contributing to and improving the unfinished child survival revolution occurring in large parts of the world.

A close vigilance on the adverse effects of COVID‐19 vaccinations in pregnant women should be established to take more precise decisions on the best time for vaccination and the optimal interval duration between two doses. A national vaccine tracking platform should be tailored to track pregnant women, especially for the purposes of looking out for any side effects which are experienced by mothers and/or their children.

A total of 30 736 pregnant women die every year in India (birth rate of 20, maternal mortality ratio (MMR) of 113). Of the cumulative 399 000 deaths due to COVID‐19 in India from February 2020 to June 2021, it is reasonable to assume that 2% of this total (approximately 8000) were pregnant women, comprising one fifth of usual maternal deaths. The recent decision on allowing vaccination of pregnant women, along with its zealous implementation, will help track any rise in the incidence of maternal mortality in India—for instance, the Ebola epidemic in Africa lead to a 75% increase in maternal mortality across various countries. ¹⁰

The decision to allow vaccination of pregnant women against COVID‐19 is a step towards achieving target 3.1 of the Sustainable Development Goals, which aims to reduce the global MMR to <70 per 100 000 live births.

CONFLICTS OF INTEREST

The authors have no conflicts of interest.

AUTHOR CONTRIBUTIONS

YS and RS together conceptualized the idea. YS and TS searched the literature and wrote the original draft. RS edited the draft and gave final shape to the manuscript. All authors contributed to and approved of the final version of the manuscript.