From the Guidelines
The IRB is not approving the introduction of a new Pneumovax trial in pregnant women primarily because pregnancy represents a vulnerable population requiring special protection in research, and without substantial prior safety data, testing a new vaccine directly in pregnant women would violate ethical research principles. The potential risks to fetal development and pregnancy outcomes would be a significant concern, as noted in a review of current evidence and recommendations on maternal vaccination 1. While pneumococcal vaccinations can be used in pregnancy if protection of the woman is considered necessary, as stated in the American Journal of Obstetrics and Gynecology 1, a completely new formulation would require extensive pre-clinical and non-pregnant human testing before being considered for pregnant women. Some key points to consider include:
- The safety of polysaccharide vaccines in pregnancy, though there is little evidence that this affects the colonization rates or disease incidence in infants born to vaccinated mothers 1
- The general recommendations on immunization, which state that there is no convincing evidence of risk from vaccinating pregnant women with other inactivated virus or bacteria vaccines or toxoids 1
- The IRB's primary responsibility is to protect research subjects from undue harm, and this responsibility takes precedence over the potential benefits of the vaccine. Given the lack of substantial prior safety data on the new vaccine formulation, the IRB's decision to not approve the trial is justified to prioritize the safety and well-being of the pregnant women and their fetuses.
From the FDA Drug Label
Available human data from clinical trials of PNEUMOVAX 23 in pregnancy have not established the presence or absence of a vaccine-associated risk. The FDA drug label does not answer the question.
From the Research
Institutional Review Board (IRB) Approval Process
The IRB may not be approving the introduction of a new Pneumovax (pneumococcal vaccine) trial in pregnant women due to several reasons, including:
- Regulatory issues: Pregnant women are often classified as a "vulnerable" population, which can lead to a presumption of exclusion from clinical research 2.
- Lack of evidence: There is a lack of evidence on the safety and effectiveness of drugs, including vaccines, in pregnant women, which can make it difficult for IRBs to approve research involving this population 3.
- Risk assessment: IRBs may be cautious when assessing the risk of research involving pregnant women, even if the research poses minimal risk of harm to the fetus 4.
- IRB decision-making: IRB members may have varying interpretations of "minimal risk" and may be influenced by different factors when making decisions about research involving pregnant women 4.
IRB Challenges and Limitations
IRBs face several challenges and limitations, including:
- Inconsistencies in review and application of federal regulations 5.
- Time-consuming and burdensome review process without clear evidence of effectiveness at protecting human subjects 5.
- Deception and "IRB shopping" practices that can undermine the integrity of the IRB process 6.
- Need for guidance and resources to develop and test review and oversight models that provide adequate and respectful protections of participant rights and welfare 5.
Pregnancy Research and IRB Approval
To promote ethically responsible and scientifically sound research during pregnancy, it is essential to:
- Reclassify pregnant women from a "vulnerable" population to a scientifically "complex" population and change the presumption of exclusion to one of inclusion 2.
- Develop a pregnancy-focused research agenda that addresses pressing clinical needs and encourages important new research areas 2.
- Provide guidance for IRBs to support fair inclusion, rather than routine exclusion, of pregnant women in clinical research 3.