Avril Lavigne once sang, “Tell me, why’d you have to go and make things so complicated?” Since that was from her 2002 album Let Go, chances are she was not singing to the Zika virus…unless she knew something that we didn’t at the time. But nowadays her Complicated song could certainly apply to nearly everything about the Zika virus…including the Zika vaccines that are currently under development.
I’ve previously written about how the Zika virus has turned out to be a trickier than initially thought. But what’s so complicated about Zika vaccines besides the fact that vaccine development in general is complicated? Well, the biggest risk of Zika infection is to pregnant women, because the virus can cause devastating birth defects in the fetus. Therefore, pregnant women could certainly use a Zika vaccine for protection, but…. Don’t we usually avoid testing vaccines or other medications on pregnant women, because of potential risk to the fetus and the woman and the many changes a body undergoes while pregnant? A pregnant woman is not the same as a non-pregnant woman in many ways physiologically. A two-weeks pregnant woman is not the same as 2-months pregnant woman. One pregnant woman is not the same as another pregnant woman. These physiologic changes and ethical issues make Zika vaccine development and testing more…complicated, as Lavigne sang, “Uh huh, uh huh. That’s the way it is.” Time to call in the ethics experts.
That’s what the Wellcome Trust did in supporting the formation of the “Ethics Working Group on Zika Virus Research & Pregnancy.” Consider this a Justice League of ethics, vaccine, infectious disease, Zika, and OB/GYN experts that included Ruth Faden, PhD, MPH, Founder and former Director of the Johns Hopkins Berman Institute of Bioethics and the inaugural Philip Franklin Wagley Professor of Biomedical Ethics at Johns Hopkins University, Annie Lyerly, MD, MA, Professor of Social Medicine at the University of North Carolina, and Maggie Little, BPhil, PhD, Director of the Kennedy Institute of Ethics and Professor of Philosophy at Georgetown University. The website lists other members of the Working Group. Their role was to provide guidance to the scientific, health, and policy communities on how to proceed with Zika vaccine development, testing, and roll-out (if and when it occurs) with regards to pregnant women and women of child-bearing age.
Here’s another complication. There isn’t just one Zika vaccine candidate. As Dr. Faden explained, “There are about 40 Zika vaccines in the pipeline. Not all are equally suitable for use in pregnancy, and not every Zika virus vaccine needs to be acceptable for use in pregnancy, but every effort should be made to ensure some of the vaccines developed can be used by pregnant women at risk of Zika infection.” Vaccine development for an emergency such as an outbreak or epidemic of a novel virus is a bit like the movie Cannonball Run, a rather scattered and frantic race. Different groups are trying to get a Zika vaccine to market. Each is using a different approach. Many will end up failing. You don’t know which may succeed, if any, and you aren’t quite sure what the vaccine will look like if and when it gets to market. Complicated. Here’s a previous CBS News Report on some of the candidate vaccines:
Thus, all of the scientists, laboratories, research centers, companies, policy makers, healthcare facilities, healthcare administrators, government agencies, and public health officials involved in this massive race need guidance. Otherwise it could descend into some chaos (if there is such a thing as “some” chaos). Therefore, months of reviewing available research studies and ethics guidelines, interviewing experts, and complicated discussions resulted in the following guidance from the Ethics Working Group: “Pregnant Women & the Zika Virus Vaccine Research Agenda: Ethics Guidance on Priorities, Inclusion, and Evidence Generation.”
They divided their recommendations into those for any Zika vaccine developed for pregnant women, those developed for non-pregnant women of childbearing age, and other Zika vaccines not for use during pregnancy. This included guidance on how to ensure that pregnant women are a priority population for Zika vaccines, enough financial resources are available for Zika vaccine development, proper data is collected, analyzed, and interpreted on the safety and efficacy of vaccines, and pregnant women have appropriate access to and information on the Zika vaccines.