By Teresa Acosta
Pregnant people should be included in early clinical trials of pandemic vaccines. Excluding this subset of the population is detrimental to everyone.
According to The Centers for Disease Control and Prevention, there is an increased risk of severe illness and pregnancy complications from COVID-19 for pregnant people.
The CDC also said of the 125,000 laboratory-confirmed COVID-19 cases in pregnant people, more than 22,000 were hospitalized and 161 have died throughout the pandemic.
When Moderna and Pfizer began the clinical trials for COVID-19 vaccines, the companies required a commitment from women of childbearing age to use birth control and required proof of a negative pregnancy test.
This decision has led to a delayed recommendation by the CDC for those wanting to become pregnant, those who are pregnant, and those breastfeeding to get vaccinated— losing precious time and research efforts in the process.
The recommendation statement and data release occurred only a few months ago, in early August.
There are regulations and guidelines put in place for pregnant people in clinical trials. Some include testing for safety and toxicity on pregnant animals first and then on people in the late stages of pregnancy. This is when the fetus is in the final stages of growth and development.
These should absolutely be followed. Guidelines should be followed in a timely manner similar to what other areas of the population are afforded.
Understandably, protecting pregnancy from undue risk is important. This should not be used as an excuse to exclude those who are pregnant from potentially life-saving research.
In a recent article by the Los Angeles Times, Diana Bianchi, head of the Eunice Kennedy Shriver National Institute of Child Health and Human Development, said, “It’s a very paternalistic attitude, and we are trying to change the culture, to protect pregnant people through research, instead of from research.”
Bianchi is a part of a cohort of researchers who work to further the inclusion of pregnant people in clinical research.
This misstep of exclusion by vaccine companies will hopefully serve as an example of what not to do in pandemic vaccine research.