The World Health Organization (WHO) had previously issued guidance recommending that pregnant women should not receive the Moderna Inc. vaccine unless the individual is at high risk of exposure or having a severe case.
It now has reversed that. In its updated guidance, WHO stated the following: “Pregnant women are at higher risk of severe COVID-19 compared with women of childbearing age who are not pregnant, and COVID-19 has been associated with an increased risk of preterm birth. The available data on mRNA-1273 vaccination of pregnant women are insufficient to assess vaccine efficacy or vaccine-associated risks in pregnancy. However, it should be noted that the mRNA-1273 vaccine is not a live virus vaccine, and the mRNA does not enter the nucleus of the cell and is degraded quickly. Developmental and reproductive toxicology (DART) studies in animals have not shown harmful effects in pregnancy.”
There are further studies planned in pregnant women in the coming months, WHO said. “As data from these studies become available, recommendations on vaccination will be updated accordingly,” the guidance reads. “In the interim, WHO recommends not to use mRNA-1273 in pregnancy, unless the benefit of vaccinating a pregnant woman outweighs the potential vaccine risks, such as in health workers at high risk of exposure and pregnant women with comorbidities placing them in a high-risk group for severe COVID-19. Information and, if possible, counselling on the lack of safety and efficacy data for pregnant women should be provided. WHO does not recommend pregnancy testing prior to vaccination. WHO does not recommend delaying pregnancy following vaccination.”
Clinical trials for the Moderna vaccine or the one developed by Pfizer Inc. and BioNTech SE did not include women who are pregnant.
When WHO issued the guidance recommending that pregnant women should not receive the vaccine, it provoked immediate response from leading health care associations in women’s health, particularly the American College of Obstetricians and Gynecologists (ACOG), and the Society for Maternal Fetal Medicine (SMFM), which issued a joint statement.
“ACOG and SMFM continue to stress that both COVID-19 vaccines currently authorized by the U.S. Food and Drug Administration should not be withheld from pregnant individuals who choose to receive the vaccine,” the statement read. “ACOG’s and SMFM’s current guidance on the COVID-19 vaccine in pregnant patients remains in place.
“Despite efforts by ACOG and SMFM to advocate for their inclusion, clinical trials that informed the emergency use authorization (EUA) of the vaccines did not include pregnant individuals,” they stated. “However, preliminary developmental and reproductive toxicity (DART) studies for both the Pfizer-BioNtech and Moderna vaccines are encouraging, with no safety signals reported. DART animal studies provide the first safety data to help inform the use of these vaccines in pregnancy until there are more data in this specific population. These studies do not indicate any adverse effects on female reproduction or fetal/embryonal development. ACOG and SMFM strongly urge manufacturers and federal agencies to collect and report data regarding the use of these vaccines in pregnancy.
“Data have demonstrated that symptomatic pregnant individuals with COVID-19 are at increased risk of more severe illness and death compared with nonpregnant peers,” the statement continues. “Many pregnant individuals have medical conditions known to put them at further increased risk of severe illness and complications. Therefore, given clear evidence of the dangers of COVID-19 in pregnancy, an absence of data demonstrating adverse effects associated with the vaccine in pregnancy, and in the interest of patient autonomy, ACOG and SMFM recommend that pregnant individuals be free to make their own informed decisions regarding COVID-19 vaccination.”
On February 10, the National Institutes of Health (NIH) issued a media advisory calling for greater inclusion of pregnant and lactating people in COVID-19 vaccine research. The advisory was based on a viewpoint by Diana W. Bianchi, M.D., director of the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), part of the NIH, and colleagues, which appears in JAMA Network.
“The conflicting information being provided to pregnant individuals stems from long-standing obstacles to the inclusion of pregnant and lactating people in clinical research,” the authors write. “The data provided by the manufacturers in the Emergency Use Authorizations for both the Pfizer and Moderna vaccines described the specific exclusion of pregnant people; those who became pregnant during the trials (n = 36) provided very limited data to inform evidence of safety and effectiveness in this population.”
The full viewpoint can be accessed and read at the link provided above.