When counseling pregnant women on whether to get the coronavirus disease 2019 (COVID-19) vaccine, pharmacists should consider recommendations on other vaccinations and what researchers already know about vaccines given during pregnancy.

A new article published in JAMA outlined these considerations and described how the available safety and efficacy data, basic science of mRNA vaccines, and the history of successful vaccine administration in pregnant women could demonstrate potential benefits of COVID-19 prevention. Although researchers do not yet know what level of protection the COVID-19 vaccine could provide infants when administered to mothers during pregnancy, the researchers believe there is potential for protection.

Vaccines such as those for influenza and whooping cough have been proven to be lifesaving for women and newborns when administered during pregnancy, according to the study. For example, the pertussis vaccine reduced whooping cough by 85% compared with waiting to administer until after pregnancy. Similarly, influenza vaccination during pregnancy reduced both mother and infant influenza by 20% and 30%, respectively.

Because pregnant women have been excluded from COVID-19 vaccine clinical trials due to liability and safety concerns, the investigators said guidance issued by professional organizations on the topic has been limited. Therefore, clinicians should counsel patients based on the benefits of other vaccines used during pregnancy, evidence from COVID-19 vaccine trials in non-pregnant patients, and basic vaccine science suggesting safety for the fetus, according to the study authors.

“We still need granular data on safety in pregnancy and data that shows no adverse pregnancy outcomes,” said co-author Emily Adhikari, MD, in a statement.

The press release noted that both the American College of Obstetricians and Gynecologists and the Society for Maternal-Fetal Medicine have advocated for making COVID-19 vaccines available to pregnant and lactating women. Similarly, their statements argued that the vaccine could have important benefits based on knowledge from other vaccines administered during pregnancy.

On January 26, 2021, the World Health Organization recommended against vaccinating pregnant women with the Moderna vaccine except in select circumstances, but they revised the statement to include more permissive language a few days later. Their recommendations now support offering the vaccine to pregnant women who are at high risk of exposure or with comorbidities, in consultation with their health care provider.

Still, the study authors noted that the original recommendation caused significant anxiety despite no concerning data made available.

“I am very supportive of any woman who decides to get the vaccine,” Adhikari said in the press release. “I fully support that woman’s choice. I understand if a woman decides she’s not ready for the vaccine, but I also think it’s an opportunity for education about vaccines in general.”

Adhikari has previously published a study of 3374 pregnant women, including 252 who had contracted COVID-19 during pregnancy and 3122 who tested negative. They found no increase in adverse pregnancy outcomes overall, although preterm births increased among the 5% of pregnant women who were hospitalized for COVID-19 respiratory illness.

With these concerns in mind, the article reviews how the major risks to pregnancy are from maternal respiratory illness due to COVID-19 and urges prevention measures as a key to ensure safety.

“Women who are pregnant, who have severe respiratory distress, who need significant oxygen support—some intubated for months—have most risk to the pregnancy,” said co-author Catherine Y. Spong, MD, in the press release.

Adhikari said the team is doing ongoing data collection but has not yet demonstrated that the vaccine is safe in pregnant women, does not result in harm, and results in no difference in pregnancy outcomes. These findings should help establish an evidence basis that will allow clinicians to feel more comfortable counseling patients on the COVID-19 vaccine, according to the study authors.

REFERENCE
History of vaccines offers lessons on COVID-19 for pregnant women [news release]. EurekAlert; February 8, 2021. https://www.eurekalert.org/pub_releases/2021-02/usmc-hov020821.php Accessed February 17, 2021.