Document text
Principal Investigator: Kristin Palmsten
Organization: HEALTHPARTNERS INSTITUTE
Fiscal Year: 2023
Award: $602,839
Funding agency: Eunice Kennedy Shriver National Institute of Child Health and Human Development
The efficacy of coronavirus disease (COVID-19) vaccines available in the US is up to 95% against symptomatic COVID-19. However, pregnant and lactating individuals were excluded from initial clinical trials. COVID-19 vaccine trials are now underway in pregnant women in their second or third trimester but are not expected to conclude until 2022 or 2023, and evaluation of lactation outcomes is not planned. COVID-19 vaccines are highly effective, and mounting evidence suggests immunogenic protection for breastfed infants of mothers receiving COVID-19 vaccines. To date, there are no published studies on COVID-19 vaccine safety during pregnancy or lactation for breastfed infants, milk production and excretion, or other lactation-related outcomes. This lack of safety data threatens to undermine vaccination efforts in pregnant and lactating women. Traditional data sources used for post-licensure surveillance have limited relevance for lactation outcomes . Spontaneous reporting systems suffer from reporting bias due to their voluntary nature; their lack of a denominator of vaccinated lactating women precludes risk estimates. The CDC's V-Safe program, smart phone-based monitoring for vaccine side effects, does not capture lactation status. Ongoing health care claims-based surveillance studies also do not routinely capture lactation. Observational studies enrolling COVID-vaccinated lactating women rely primarily on self-reported outcomes and have limited generalizability. To address the need for comprehensive safety data, we propose a novel study of antenatal and postpartum COVID-19 vaccination and lactation-related outcomes in mother-infant pairs, including more than 11,000 breastfeeding dyads. We will use electronic health record data linked with state immunization data across four large health systems to study infant growth, infant heath care utilization, maternal mastitis, and breastfeeding status up to 7 months after delivery following maternal COVID-19 vaccination. Also, we will explore acute infant outcomes and abnormal infant developmental screens following maternal COVID-19 vaccination. We are uniquely positioned to overcome lack of information on lactation status and reporting and volunteer bias using routinely collected information on breastfeeding at well-child visits for a defined population. We will apply rigorous epidemiologic methods, including propensity score adjustment, to address confounding. With a focus on lactation, our study will complement other studies of COVID-19 vaccination in pregnancy and studies collecting milk samples from COVID-19-vaccinated volunteers. It will provide essential and currently unavailable evidence regarding lactation-related outcomes following perinatal COVID-19 vaccination. Findings supporting safety can reduce vaccine hesitancy, whereas results identifying a potential harm will be important for informing patient decision making. Furthermore, the novel approach and methods for studying lactation related outcomes developed through the proposed study can be adapted to efficiently evaluate the safety of drugs and vaccines currently recommended or being investigated for use in pregnant or postpartum women.
Terms: <2019-nCoV vaccine><2nd trimester><3rd trimester><Acute><Address><Age Months><Biological><Body Composition><Breast Feeding><Breast Milk><Breast fed><Breast fed infant><Breastfed><Breastfed infant><Breastfeeding><Breastmilk><CMV><COVID><COVID-19><COVID-19 affected><COVID-19 consequence><COVID-19 effect><COVID-19 impact><COVID-19 impacted><COVID-19 vaccination><COVID-19 vaccine><COVID19><COVID19 vaccination><COVID19 vaccine><CV-19><CV19><Cell Phone><Cellular Phone><Cellular Telephone><Centers for Disease Control><Centers for Disease Control and Prevention><Centers for Disease Control and Prevention (U.S.)><Clinical><Clinical Trials><CoV disease><Complement><Complement Proteins><Cytomegalovirus><Data><Data Sources><Decision Making><Dehydration><Development><Discipline of obstetrics><Dose><Electronic Health Record><Enrollment><Epidemiologic Methods><Epidemiological Methods><Epidemiological Techniques><Evaluation><Exclusion><Excretory function><Fatigue><Fever><Frequencies><Generalized Growth><Gestation><Grippe><Growth><Guidelines><HCMV><Health Care Utilization><Health system><Healthcare><Healthcare Delivery><Human><Human Milk><Human Mother's Milk><Icterus><Immunization><Individual><Infant><Infant Care><Inflammatory><Inflammatory Response><Influenza><Jaundice><Lack of Energy><Lactation><Last Trimester><Licensure><Link><Malaise><Mammary Gland Milk><Methods><Methods Epidemiology><Midtrimester><Milk><Mobile Phones><Modern Man><Monitor><Mother's Milk><Mothers><Nature><Observation research><Observation study><Observational Study><Observational research><Obstetrics><Outcome><Patient Self-Report><Patients><Perinatal><Peripartum><Population><Position><Positioning Attribute><Post-partum Women><Postpartum Period><Postpartum Women><Pregnancy><Pregnant Women><Professional Organizations><Publishing><Pyrexia><RNA vaccine><RNA-based vaccine><Recommendation><Reporting><Respiratory syncytial virus><Risk><Risk Assessment><Risk Estimate><SARS-CoV-2 vaccination><SARS-CoV-2 vaccine><SARS-CoV2 vaccine><SARS-coronavirus-2 vaccine><Safety><Salivary Gland Viruses><Sampling><Screening Result><Second Pregnancy Trimester><Second Trimester><Self-Report><Severe Acute Respiratory Syndrome CoV 2 vaccine><Severe acute respiratory syndrome coronavirus 2 vaccination><Severe acute respiratory syndrome coronavirus 2 vaccine><Survey Instrument><Surveys><System><Third Pregnancy Trimester><Third Trimester><Tissue Growth><United States Centers for Disease Control><United States Centers for Disease Control and Prevention><Vaccinated><Vaccination><Vaccines><Viral Gene Products><Viral Gene Proteins><Viral Proteins><Viral Vector><Well Child Visits><Woman><access to vaccination><access to vaccines><antenatal><antepartum><baby care><biologic><body water dehydration><breast feeding infant><breastfeeding infant><corona virus disease><corona virus disease 2019><corona virus disease 2019 vaccine><coronavirus disease><coronavirus disease 2019><coronavirus disease 2019 consequence><coronavirus disease 2019 effect><coronavirus disease 2019 impact><coronavirus disease 2019 vaccination><coronavirus disease 2019 vaccine><coronavirus disease-19><coronavirus disease-19 impact><coronavirus disease-19 vaccine><coronavirus infectious disease-19><cytokine><cytomegalovirus group><developmental><drug safety><electronic health care record><electronic health medical record><electronic health plan record><electronic health registry><electronic medical health record><enroll><excretion><expectant mother><expecting mother><febrile><febris><health and care delivery><health care><health care delivery><health care service use><health care service utilization><health delivery systems><health services delivery><healthcare service use><healthcare service utilization><healthcare utilization><hesitant to vaccination><iPhone><immunogenic><infant health care><infant healthcare><infant outcome><lactating><lactational><mRNA vaccine><mRNA-based vaccine><mastitis><maternal milk><medication safety><milk production><nCoV vaccine><nCoV-19 vaccine><nCoV19 vaccine><new approaches><newborn care><novel><novel approaches><novel strategies><novel strategy><ontogeny><perinatal period><perinatal phase><pharmaceutical safety><post-partum><pregnant><pregnant mothers><produce milk><professional association><professional membership><professional society><programs><side effect><smart phone><smartphone><surveillance study><symptomatic COVID-19><symptomatic COVID19><symptomatic coronavirus disease 2019><vaccinate against COVID-19><vaccinate against COVID19><vaccinate against SARS-CoV-2><vaccinate against coronavirus disease 2019><vaccinate against severe acute respiratory syndrome coronavirus 2><vaccination access><vaccination against COVID-19><vaccination against COVID19><vaccination against SARS-CoV-2><vaccination against Severe acute respiratory syndrome coronavirus 2><vaccination against coronavirus disease 2019><vaccination availability><vaccination hesitancy><vaccination study><vaccination trial><vaccine access><vaccine against 2019-nCov><vaccine against SARS-CoV-2><vaccine against SARS-CoV2><vaccine against SARS-coronavirus-2><vaccine against Severe Acute Respiratory Syndrome CoV 2><vaccine against Severe acute respiratory syndrome coronavirus 2><vaccine availability><vaccine for novel coronavirus><vaccine hesitancy><vaccine hesitant><vaccine safety><vaccine study><vaccine trial><virus protein><volunteer>