On 19 April 2021, Prof. Ruth Karron from Johns Hopkins Bloomberg School of Public Health and Dr Judith Absalon from Pfizer, Inc. discussed the COVID-19 vaccine trials in pregnancy and the ethical framework around these studies in our webinar series “Maternal and infant immunisation in times of COVID-19.”

In her presentation on the PREVENT Guidance in the context of SARS-CoV-2, Prof. Ruth Karron considered how recommendations in the PREVENT Guidance apply to evaluation and deployment of COVID-19 vaccines for pregnant women. The PREVENT (Pregnancy Research Ethics for Vaccines, Epidemics and New Technologies) project was begun in the wake of the Zika epidemic and its devastating effect on pregnant women and their offspring. The goal of PREVENT was to develop a roadmap for the ethically responsible, socially just, and respectful inclusion of the interests of pregnant women in the development and deployment of vaccines against emerging pathogens. The PREVENT Guidance (Vaccine, 2021 Jan 3, 39(1):85-120; Epub 2019 May 3) was developed by a multi-disciplinary, international Working Group of 17 experts in bioethics, maternal immunisation, maternal-fetal medicine, paediatrics, philosophy, public health, and vaccine research and policy, in broad consultation with external experts and stakeholders, and extensive reviews of international ethics guidance and regulations regarding research with pregnant women. The Guidance contains 22 concrete recommendations organised around three key areas: public health preparedness, R&D, and vaccine delivery.

Dr Judith Absalon presented the Pfizer COVID-19 vaccine study in pregnant women. Pregnant women with COVID-19 are at risk for severe COVID-19 as well as at risk for obstetric and neonatal complications. While there are limited data on vaccine effectiveness from observational studies and safety information from post marketing surveillance systems, there are no data from well controlled clinical trials. On February 16, 2021, Pfizer initiated a phase 2/3 study to evaluate the safety, and immunogenicity of BNT162b2 in the prevention of COVID-19 in pregnant women 18 years of age and older vaccinated during 24 to 34 weeks of gestation. Safety and immunogenicity of BNT162b2 is evaluated in pregnant women and their infants.

The recording of the webinar can be accessed via this link.

The webinar series offers monthly webinars that cover topical questions relating to maternal and infant immunisation in times of COVID-19. Details about the individual sessions are communicated through the IMPRINT Newsletter.