Increasing calls to vaccinate pregnant women against COVID-19

Amid an increase in COVID-19 cases and deaths across the globe, there are growing calls to prioritize pregnant women for vaccination.

While there’s no evidence showing that pregnant women are more susceptible to COVID-19 infection, there is evidence suggesting that pregnant women with COVID-19 are at higher risk of developing severe disease compared to other women of reproductive age.

A study published in JAMA in April 2021 that enrolled pregnant women with and without COVID-19 from 18 countries found that pregnant women were more likely to suffer adverse outcomes from COVID-19, including mortality, preeclampsia, and preterm birth.

Although global estimates are currently unavailable, and data is sparse for national estimates of maternal deaths due to COVID-19 in low- and middle-income countries, organizations in countries such as Indonesia, Bangladesh, and South Africa have appealed to their governments to open up vaccinations for this section of the population.

Indonesia has recently done so, supporting the vaccination of pregnant women in their second trimester of pregnancy. COVID-19 vaccinations are also now open to children aged 12-17 years old. Edhie Rahmat, executive director at Project HOPE in the country, said the decision came after concerns over reported deaths of pregnant women and children in recent months.

In the regencies of Grobogan and Banyumas in the province of Central Java, there have been a total of 85 maternal deaths in 2021 as of last week, more than double compared to that of 2020, he said, pertaining to data from hospitals and health centers the organization is supporting in these areas.

“Pregnant women and children under 18 were not prioritized because ... most deaths are among old people and those with co-morbidity, and it has been revealed in the last three months that deaths among pregnant women and children are concerning,” Rahmat told Devex. While vaccine supply was likely a factor, he said safety was the main consideration for not including these populations at the outset of the country’s vaccination drive.

Should pregnant women get the jab?

The World Health Organization recommends vaccinating pregnant women where the benefits outweigh the risks. That means pregnant women with heightened exposures to COVID-19, such as health workers and those with comorbidities, stand to benefit from being vaccinated.

WHO’s advice is that vaccination for pregnant women should be considered case-by-case, and upon consultation with a health care provider. Pregnant women should be counseled about the risks of vaccinating against COVID-19 during pregnancy, its benefits in relation to the local epidemiological context, but also that there is currently limited data on the vaccines’ safety for pregnant women.

But data from the COVID-19 Maternal Immunization Tracker show that, of the countries with publicly available policies on COVID-19 vaccination, 39 countries allow vaccinations for all pregnant women. A total of 35 countries are not recommending vaccination for pregnant women, 16 are recommending it with some exceptions, while only 33 are permitting it for pregnant mothers who are considered high-risk such as health workers and those with underlying medical conditions.

Individual countries, however, may limit or declare preference for certain vaccines based on data or supply.

In Indonesia, the Ministry of Health recommended the Sinovac, Pfizer, and Moderna vaccines for pregnant women, when available. In Malaysia, there seems to be a preference for an mRNA-based COVID-19 vaccine.

A government document cites current data on COVID-19 vaccinations, stating that mRNA-based vaccines from Moderna and Pfizer “did not identify any safety concerns for the vaccinated women or for their babies.” mRNA-based vaccines are often considered the safest as they do not make use of live — nor weakened — viruses.

In Seychelles, one of the countries with the highest number of fully vaccinated individuals against COVID-19 globally, women planning to get pregnant, currently pregnant, or breastfeeding are not recommended to receive the Sinopharm jab.

Why the various policies?

The variation of policies across countries is likely due to a lack of clear-cut evidence on the effect of COVID-19 vaccines on pregnant women as data is still being gathered. It could also be attributed to individual countries’ different assessments of benefits and risks, said Helga Fogstad, executive director at the Partnership for Maternal, Newborn and Child Health.

“When you don't know the total effect, you don't want to expose the woman or the fetus to these risks and so therefore you play it safe and say, ‘OK, we don't know enough so we have to wait.’ And there are countries that have then chosen that,” she elaborated.

The situation is very dynamic, so countries are changing their policies based on the latest evidence, she said. But there are studies underway to assess vaccines’ risk-benefit profile for pregnant and breastfeeding mothers, including by the respective vaccine manufacturers.

Supply also plays a factor, with most countries’ immunization drives focused on priority groups such as the elderly and those with comorbidities due to limited supplies, Dan Irvine, senior director of health and nutrition at World Vision International, told Devex.

And while donations are helping augment supplies in low and middle-income countries, it creates challenges too.

“[W]hereas many donor countries have the luxury of approving/regulating vaccines manufactured in their own country, or a small number of vaccines against which they can provide complete population coverage, many developing countries need to approve/regulate vaccines donated from multiple sources, making their work more complex,” Irvine said, adding that, “[The] geopolitical nature of vaccine donations also creates apprehensions and confusion in populations already challenged with routine hesitancy concerns.”

The lack of readily available data concerning the vaccines’ effects on women stems from their non-inclusion early on in clinical trials. Including them presents additional complexities that Irvine said “developers fear can create delays in their trials.”

The exclusion of pregnant women in clinical trials isn’t unique to those for the COVID-19 vaccine, and reflects a historic pattern of “protection by exclusion.” Yet that creates a dilemma when therapies are finally introduced in the general population and questions about safety arise. Recent, however, recommendations on how to safely and ethically include pregnant and lactating women in clinical research.

An appeal for mothers

In countries that have seen an increase in COVID-19 cases and deaths in recent months, national organizations have appealed to their governments to expand vaccination to all pregnant and lactating women.

In South Africa, the South African Society for Obstetricians and Gynaecologists has asked the government to include all women of reproductive age for COVID-19 vaccinations, and they are hoping this will happen by September 2021. Currently, vaccination only covers those who are 35 years of age and older, and/or working in the essential services sector, such as the police, teachers, and health care workers.

Meanwhile, the Bangladeshi government is in the final stages of identifying procedures for vaccinating pregnant and lactating women, and organizations are hopeful that implementation will begin soon.

Professor Ferdousi Begum, president of the South Asian Federation of Obstetrics & Gynaecology based in Dhaka, said they had appealed to the government to allow COVID-19 vaccinations for pregnant and lactating women after evaluating available evidence, recommendations, and best practices in other countries.

“There is no definite data on deaths of pregnant women with COVID-19. [B]ut in the last month, the number of infections and deaths were highest in comparison to earlier part of the year and last year,” she told Devex via email.

At the moment, there is little evidence to help discern precisely where maternal deaths due to COVID-19 may be rising. But the existing evidence points to what many in the global health community have long feared: Maternal outcomes are worsening in LMICs, as well as among the most vulnerable populations even in high-income countries.

About 88% of pregnant women who died during the first wave of the pandemic in the U.K. were from black and minority ethnic groups, Fogstad said, reiterating the need to ensure that women and their newborns are safeguarded in national policies.

“During World War II, even when resources were really down to nothing, women and children were prioritized, their health was prioritized, and this gave a lot of return on investment. So I think there's no excuse, even in crises or in low-income settings … you need to have a policy in place that is explicit about their needs,” she added.