FDA Accepts sNDA for Jardiance as Potential Treatment for Chronic Kidney Disease
January 26, 2023 02:12pm
By Ashley Gallagher, Assistant Editor
As COVID-19 vaccination continues across the United States, many states have begun vaccinating vulnerable individuals and have included pregnant patients in the eligibility criteria.
Evidence suggests that newborns may have some protection against coronavirus disease 2019 (COVID-19) from maternal vaccination.
Pregnant individuals are at an increased risk of severe coronavirus disease 2019 (COVID-19), and pregnancy-related complications such as preterm birth can occur.1 As COVID-19 vaccination continues across the United States, many states have begun vaccinating vulnerable individuals and have included pregnant patients in the eligibility criteria. There is limited data available on COVID-19 vaccines in pregnant patients. Since COVID-19 vaccines are not live, major safety issues are not expected in pregnant patients.2
Influenza and Tdap vaccination during pregnancy is recommended by the CDC to protect mothers and their newborns (by passing antibodies during pregnancy), and this has been well studied.3 The American College of Obstetricians and Gynecologists recommends that COVID-19 vaccines not be withheld from patients, and they can be administered at any setting.4 Growing evidence suggests that COVID-19 vaccination in pregnant women is safe and may provide protection in newborns.5-7
The first reported US case of a newborn with detectable COVID-19 antibodies after the mother received 1 dose of the Moderna COVID-19 vaccine was published on the preprint server medRxiv.5 A South Florida health care worker, who was not previously infected with COVID-19, received her first dose of the Moderna COVID-19 vaccine at 36 weeks pregnant and delivered a healthy full-term baby girl 3 weeks later.5,6 SARS-CoV-2 IgG antibodies were detected in the newborn’s cord blood sample.5 The mother received her second dose of the Moderna vaccine post-partum, 28 days after her first dose while breastfeeding.5 It is unknown how long the antibody protection will last in the newborn, and future studies should evaluate the timing of vaccination during pregnancy for optimal protection.5
Public Health Implications
The case report provides important information about COVID-19 vaccination during pregnancy.One recent study in Israel, found COVID-19 antibodies in all 20 pregnant women and their newborns.7 All pregnant women received 2 doses of the Pfizer COVID-19 vaccine during their third trimesters.7
Pfizer and BioNTech began evaluating the safety and efficacy of their COVID-19 vaccine in approximately 4000 pregnant women in a global phase 2/3 randomized, placebo-controlled study.8 Two doses of the vaccine will be administered 21 days apart during 24-34 weeks’ gestation, and the study will assess safety in infants of vaccinated pregnant women and the transfer of COVID-19 antibodies.8 Additionally, infants will be monitored through approximately 6 months of age.8
As of March 15, 2021, over 51,000 v-safe (smartphone tool for health check-ins after COVID-19 vaccination) participants reported they were pregnant at the time they were vaccinated.9 The CDC is currently analyzing the data, and individuals can also sign up for the v-safe COVID-19 Vaccine Pregnancy Registry.9 To date, no safety concerns have been identified in pregnant patients who have been vaccinated.