by Michael Pfleiderer
Vaccines have one of the highest live saving potentials amongst all medicinal products licensed around the globe. Numerous novel vaccines have been developed in the past and numerous others are under development. Availability of these vaccines further contributes to the significant reduction of morbidity and mortality caused by infectious agents. Most importantly, a wide range of vaccines against emerging and re-emerging infectious diseases have been developed during the past years. Some of these vaccines are already licensed others are at various stages of their pharmaceutical and clinical development. One commonality of all these vaccines is that they are developed for all age and risk categories except pregnant women. Although some vaccines are specifically recommended for use in pregnancy such as influenza, pertussis and tetanus vaccines justified by decades of experience regarding the safe use of those vaccines during pregnancy, access to novel vaccines is generally blocked for pregnant women. The main reason for that dilemma is that pregnant women are generally not included in clinical studies conducted with novel vaccines. Few exceptions exist e.g. for RSV, CMV and group B streptococcal candidate vaccines. However, for the most urgently needed vaccines as specified in WHO’s updated blueprint list of priority diseases no specific development programs are foreseen for making these vaccines accessible to pregnant woman. The main reason for this reluctance is that ethicists, scientist and regulators have no tools and standards ready at hand according to which a common understanding on the acceptability of conducting clinical studies with novel vaccines in pregnant women could be reached. In most instances, unknown risks and benefits inherent to novel vaccine construct are the pivotal blocking element although the risks are obvious of being exposed and getting infected in an outbreak scenario putting the lives of both the mother and the unborn baby in jeopardy.
In order to overcome this dilemma the Pregnancy Research Ethics for Vaccines, Epidemics, and New Technologies (PREVENT) Working Group has recently released a new guidance document: “Pregnant Women & Vaccines Against Emerging Epidemic Threats: Ethics Guidance for Preparedness, Research, and Response.” The PREVENT Working Group acts as a multidisciplinary, international team of 17 experts specializing in bioethics, maternal immunization, maternal-fetal medicine, obstetrics, pediatrics, philosophy, public health, and vaccine research and policy — in consultation with a variety of external experts and stakeholders.
The aforementioned guidance provides 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 (vax.pregnancyethics.org).
The guidance makes concrete recommendations for a range of actors, including global and national policymakers, regional and national regulatory authorities, funders and sponsors, vaccine manufacturers, research institutions, trial networks and research groups, individual researchers, oversight bodies, ethics review committees, community advisory boards, and civil society organizations.
The guidance document is accompanied by a social media toolkit for simplified use which also includes a short video and some suggested posts. As such it is intended to widely distribute the document in order to seek global concurrence on mechanisms facilitating investigation and use of novel vaccines in pregnant women.
Biopharma Excellence has deeply been involved in these activities and will be pleased to assist you in taking your vaccine development forward particularly endeavoring mutual scientific and regulatory agreement as regards the investigation in pregnant women. Do not hesitate to contact us for more information.