NIH calls for inclusion of pregnant mothers in clinical research of Covid-19 vaccines

Kampala, Uganda | THE INDEPENDENT | The National Institute of Health-NIH is calling upon researchers to involve pregnant mothers while studying COVID-19 vaccines. This follows a just-published study by the Institute that shows pregnant people are at increased risk of hospitalization and have a 3-fold adjusted relative risk of needing intensive care and mechanical ventilation compared with age-matched non-pregnant individuals.

According to Dr Diana Bianchi, the Director of the National Institute of Child Health and Human Development at NIH, manufacturers of all the currently available vaccines that have so far been administered to people in ten countries across the globe excluded pregnant and lactating women from clinical trials putting clinicians and pregnant women in a tricky situation to make real-time decisions now about the vaccine based on little or no scientific evidence that applies specifically to them.

On Wednesday, the World Health Organisation (WHO) gave the Oxford/Astrazeneca COVID-19 vaccine emergency use validation making it the second vaccine candidate to be approved after the Pfizer BioNtech last month.  Both vaccines are not recommended for use by pregnant and lactating mothers.

“Pregnant women are not supposed to be vaccinated if it can be avoided since the risk the vaccine presents to expectant mothers is unknown”, read in part the recommendations by the WHO Scientific Advisory Group on Emergencies (SAGE) yesterday as they approved the use of AstraZeneca.

Bainchi says that this conflicting information being provided to pregnant individuals stems from long-standing obstacles to the inclusion of pregnant and lactating people in clinical research.

“The data provided by the manufacturers in the Emergency Use Authorizations for both the Pfizer and Moderna vaccines described the specific exclusion of pregnant people.  Those who became pregnant during the trials provided very limited data to inform evidence of safety and effectiveness in this population”.

She warns in a press release that the continued exclusion of this key group in scientific research is risky since pregnant people need to be protected through research rather than from research.

However, research shows pregnant people with laboratory-confirmed severe or critical COVID-19 disease have a higher risk of caesarean delivery, excessive bleeding after delivery also called postpartum haemorrhage, hypertensive disorders of pregnancy and preterm birth.

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