The impact of COVID-19 on pregnancy and therapeutic drug development

Abstract

Emerging data show that pregnant women with COVID-19 are at significantly higher risk of severe outcomes compared with non-pregnant women of similar age. This review discusses the invaluable insight revealed from vaccine clinical trials in women who were vaccinated and inadvertently became pregnant during the trial period. It further explores a number of clinical avenues in their management and proposes a drug development strategy in line with clinical trials for vaccines and drug treatments for the drug development community. Little is known of the long-term effects of COVID-19 on the mother and the baby. Our hypothesis that COVID-19 predisposes pregnant women to pre-eclampsia or hypertensive disorders during pregnancy is supported by a clinical study, and this may also adversely impact a woman's cardiovascular disease risk later in life. It may also increase a woman's risk of pre-eclampsia in subsequent pregnancy. This is an ever-evolving landscape, and early knowledge for healthcare providers and drug innovators is offered to ensure benefits outweigh the risks. COVID-19 mRNA vaccines appear to generate robust humoral immunity in pregnant and lactating women. This novel approach to vaccination also offers new ways to therapeutically tackle disorders of many unmet medical needs. LINKED ARTICLES: This article is part of a themed issue on The second wave: are we any closer to efficacious pharmacotherapy for COVID 19? (BJP 75th Anniversary). To view the other articles in this section visit http://onlinelibrary.wiley.com/doi/10.1111/bph.v179.10/issuetoc.

Keywords: COVID-19; cardiovascular diseases; clinical trials; drug development; pre-eclampsia; pregnancy; vaccines.

FIGURE 1

Diagram to illustrate the recommendations for inclusion of pregnant women in vaccine and drug development during the COVID‐19 pandemic. Vaccine and drug development during the COVID‐19 pandemic has accelerated, with phases overlapping and at‐risk vaccine production during clinical trials. Developmental and reproductive studies should take place as early as possible in the clinical development programme, ideally during preclinical evaluation of diverse animal models. Target product profile (TPP) for the product lead (candidate ID) should be discussed and developed with regulatory bodies during preclinical phase. Inclusion of pregnant women in Phase III with rolling review by data monitoring and safety committees, as well as post‐marketing studies, will provide clinicians with the data needed to make evidence‐based decisions

FIGURE 2

Recommendations for vaccine and drug development and accessibility for pregnant patients with COVID‐19. Data on COVID‐19 vaccine and treatment should be monitored, and the developmental and reproductive toxicity (DART) data should be made available