COVNEO AND PREGVAX
CovNeo – THE IMPACT OF COVID-19 IN NEONATES
SARS-CoV-2 in pregnant women is at risk of causing poor pregnancy outcomes, including low birth weight, miscarriage, stillbirth, increased perinatal and neonatal morbidity, admission to an intensive care unit for infants or a neonatal intensive care unit (NICU), and mortality was observed in newborns born to women with severe symptoms during pregnancy[1-4]. The COVID-19 study in pregnant women or COVID-19 in Pregnancy (CovPreg) detected 35% of the 956 mothers experiencing COVID-19 during pregnancy and assessed the adverse impact of the pandemic on pregnancy outcomes, such as decreased birth weight [results not yet published]. From the results of our other study, THRIVE-GEN, we monitored the baby’s growth and development and found delays in growth and development, a home environment that did not support growth and stress in the family. With limited knowledge about the biomedical and maternal psychosocial effects of the COVID-19 pandemic on neonatal health and efforts to control COVID-19 in the newborn population, we conducted a study of the impact of COVID-19 during pregnancy on newborns or also known as COVID-19 in Neonates (COVNEO).
The COVNEO study is a longitudinal cohort study involving 1000 pairs of pregnant women and newborns who live in East Lombok, West Nusa Tenggara Province, and agree to participate voluntarily. This study has been ongoing since November 2021 and is still ongoing and is expected to be completed in 2023. The objectives of this study are (1) to assess the incidence and prevalence of COVID-19 in newborns up to 12 months of age, (2) to determine immune status maternal response to COVID-19 during pregnancy and potential transfer of immunity to infants, (3) assessing immune retention of COVID-19 in newborns up to 12 months of age, (4) assessing social and stress factors associated with COVID-19 against child growth and development, and (5) supporting local government programs in monitoring the health of pregnant women and newborns during the COVID-19 pandemic in order to reduce maternal and infant mortality. During the study, the beneficiary mothers received regular basic health monitoring and examinations through local health facilities in addition to continuing health services and education related to COVID-19 through home visits and teleconsultation. Immune testing against COVID-19 is carried out on pregnant women in the third trimester of pregnancy, while for infants, antibody and active infection checks are carried out when babies are 0-7 days old (maximum 28 days), 6 months, and 12 months. We also conducted an assessment of infant growth and development, maternal stress, and assessment of family parenting at 6 and 12 months of age. To date, we have detected the potential for transfer of maternal antibodies, the potential for antibody persistence up to the first 6 months, and the presence of COVID-19 cases in neonates and infants at 6 months. The findings from this study are expected to increase awareness of mothers and families regarding the COVID-19 pandemic, provide recommendations for preventing COVID-19 in infants through vaccination, and provide recommendations regarding how to mitigate factors that affect infant growth and development during a pandemic.
PregVax – Characterization of the Safety and Protection of the COVID-19 Vaccine Against Pregnant Women and Neonates
COVID-19 in pregnancy is associated with an increase in undesirable events for pregnant women and infants, such as maternal mortality, preeclampsia and eclampsia, premature birth, and severity in infants. Although primary vaccination coverage is currently at 80%, the COVID-19 vaccination rate during pregnancy is still low due to public concerns about the effectiveness and safety of the vaccine. PregVax is a longitudinal cohort study to significantly assess the safety and effectiveness of the approved COVID-19 vaccines for pregnant women, namely CoronaVac, Moderna, or Pfizer, in inducing immunity and common body reactions in 9000 pregnant women in the context of routine antenatal care. . This assessment includes the impact of a booster vaccine (dose 3) of a kind to be administered to a subgroup of 4500 pregnant women and follow-up of potential vertical (mother-to-infant) transfer of immunity in 9000 newborns up to 6 months of age. PregVax respondents will also receive continuous pregnancy monitoring via Whatsapp API automated messages and improved routine antenatal services such as free health check-ups and ultrasounds. Specifically, the objectives of this activity are (1) to determine the effectiveness of the COVID-19 vaccine by administering 2 and 3 doses of the COVID-19 vaccine, as well as to assess the SARS-CoV-2 variant on active exposure and duration of immune protection (i.e. antibodies) received. the baby of the mother while pregnant or breastfeeding; (2) to assess the safety and ability of the COVID-19 vaccine to induce general immune and body reactions; (3) assessing the number of responses and resistance of the immune system, both antibodies and immune cells, which are specific to viral body parts in pregnant women and if possible in infants at 6 months of age.
[1] Villar J, Ariff S, Gunier R et al. Maternal and Neonatal Morbidity and Mortality Among Pregnant Women With and Without COVID-19 Infection. JAMA Pediatr. 2021;175(8):817. doi:10.1001/jamapediatrics.2021.1050
[2] Vouga M, Favre G, Martinez-Perez O et al. Maternal outcomes and risk factors for COVID-19 severity among pregnant women. Sci Rep. 2021;11(1). doi:10.1038/s41598-021-92357-y
[3] M., Papaioannou, M., Petta, A., Routsi, E., Farmaki, M., Vlahos, N., & Siristatidis, C. (2021). Maternal and neonatal characteristics and outcomes of covid-19 in pregnancy: An overview of systematic reviews. In International Journal of
Environmental Research and Public Health (Vol. 18, Issue 2).[4] D. Di Mascio et al., “Outcome of coronavirus spectrum infections (SARS, MERS, COVID-19) during pregnancy: a systematic review and meta-analysis”, American Journal of
Obstetrics & Gynecology MFM, vol. 2, no. 2, p. 100107, 2020. Available: 10.1016/j.ajogmf.2020.100107.