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Experts want inclusion of pregnant women in clinical vaccine trials

Despite increasing support of maternal immunisation strategies in Nigeria, experts have called for the inclusion of pregnant women in clinical vaccine trials as the majority of new vaccine products are rarely considered with them in mind.

The experts say that pregnant women have unmet needs when it comes to the vaccines, however, more efforts should be made to develop vaccines specifically targeted to pregnant women to protect them and their offspring from disease outbreaks.

“The problem is that pregnant women are often left behind when it comes to vaccines, but unfortunately, they are one of the most severely impacted during outbreaks,” said Chizoba Wonodi, Nigeria country director for International Vaccine Access Center (IVAC).

“There is a lot of reticence to include pregnant women in research and this has led to a shortfall in data about how they respond to vaccines,” Wonodi said at a webinar organised by the Society of Gynaecology and Obstetrics of Nigeria (SOGON) in partnership with pharmaceutical giant Sanofi Nigeria Limited.

“It is a vicious cycle right that is perpetuated; researchers and health care providers tend to exclude pregnant women from trials, vaccinations, and tracking because fears about unknown fetal harms result in denial of access to vaccines,” she added.

Concerns over “theoretical harm” drive decisions to exclude pregnant women from interventions, Wonodi said, noting that there were about 60 to 90 percent case fatality rates concerning Ebola and that led to 100 percent loss. “This just shows that it affects a woman and her child,” she says.

“When we think about influenza, hepatitis E, Pregnant women were disproportionately affected and the offspring were also affected by Zika. Then in Lassa fever data from Nigeria, there has three to five times’ greater mortality in pregnant women in the second and third trimester.

“If pregnant women are affected disproportionately by epidemic diseases, then why should they not have the benefits of vaccines that protect against these diseases,” she asked.

Also Gbadegesin Abidoye, associate professor/ honorary Consultant, Obstetrician and Gynaecologist, Lagos State University College of Medicine/Teaching hospital said there are safe and effective vaccines that are available and have been used for more than sixty years while speaking on the topic, ‘Influenza Vaccination In pregnancy’

“There are so many causes of infant mortality; mostly preventable infectious diseases are responsible for significant maternal neonatal and young infant morbidity and mortality. This is a change in the immune response of pregnant women to allow a fetus to stay for the period it is going to stay in the womb.

He added that pregnant women are expected to have some form of immunisation to boost their immunity.

“To reduce the infant mortality rate, we need to tackle these areas by improving sanitation, access to clean drinking water, and immunisation against infectious diseases. The objective of maternal immunisation is to protect both mothers, because of morbidity,” said Abidoye.

Similarly, Beckie Tagbo, chief consultant Paediatrician and Vaccinologist, Department of Paediatrics /ICHUNTH, while speaking on the topic ‘Double-Edged Benefits of Maternal Influenza Vaccination in Pregnancy: The Role of The Obstetrician said influenza is a serious disease, especially for infants who are less than six months old.

“They have the complete loss of pediatric hospitalization, more awareness should be created on influenza vaccination, as well as research of course, and raising a vaccine optic snowball into policy decisions, ” Tagbo said.

“Vaccination is one of the best public health interventions, influenza has similar risk factors with COVID-19 and co-infection is possible. We can reduce maternal and infant mortality by vaccinating everyone indeed, we vaccinate the high-risk groups against the background, which care is a continuum and it reduces complications in the future.

“We tied to this double edge, but this is more than a double edge because it does not only benefit the mother and the infant, it benefits the society and the government.

“Doctors are in the best position to lead this change by making appropriate recommendations following the already laid out guidelines.

“It is significant mortality under-five children as the worst hits, a sense of routine diagnosis results in poor documentation, safe and effective vaccines are available on yearly basis for the optic is low.

“There is no clear policy on the back of vaccination. Let’s create awareness, sensitize, and educate, generous ongoing conversation with policymakers to achieve policy decisions for better public health impact,” said Tagbo.

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