Age: 0.5
Sex: U
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Cardiac function test, Foetal exposure during pregnancy, Neonatal respiratory distress, Premature baby
Clinical narrative: Respiratory distress requiring surfactant; Baby born at 36 weeks; Foetal exposure during pregnancy; On 22-SEP-2023, this serious, initial non-interventional study safety report from the country was received from a nurse via the COVID-19  Registry and was sent to Novavax on 29-SEP-2023.  A male of 25 weeks gestation and unreported race was vaccinated with transplacental Nuvaxovid 10 ug/mL suspect Covid-19 vaccine unspecified dose on 21-JUN-2023 and suspect Covid-19 vaccine unspecified dose on 12-JUL-2023.  No medical history was reported.  The following concomitant medications were reported: vitamin D Nos and Aspirin Low (acetylsalicylic acid).  On an unspecified date in 2023, after vaccination, the individual experienced birth at 36 weeks (PT: Premature baby). On 21-JUN-2023, on date of vaccination, the individual experienced foetal exposure during pregnancy (PT: Foetal exposure during pregnancy). On 01-SEP-2023, 2 months 11 days after vaccination, the individual experienced respiratory distress requiring surfactant (PT: Neonatal respiratory distress) (Serious: Hospitalization and Medically Significant).  Relevant lab tests included: Acoustic stimulation tests (Result: "Baby passed the hearing test"; SEP-2023) and Cardiac function test (Result: "Baby's heart is fine"; SEP-2023).  At the time of reporting, the event outcome of Neonatal respiratory distress was recovered/resolved and event stop date was 09-SEP-2023; the event outcome of Premature baby was unknown; and the event outcome of Foetal exposure during pregnancy was recovered/resolved and event stop date was 01-SEP-2023.  The reporter assessed the causality between vaccine and reported events: Premature baby as Not Reported, Foetal exposure during pregnancy as Not Reported and Neonatal respiratory distress as Not Reported.  Narrative was provided as follows: This case, received on 22-Sep-2023, concerns a male neonate whose mother was a 35-year-old female participant in the post-marketing study.  Maternal medical history included body mass index high. Maternal historical condition included COVID-19 on 10-Aug-2022. Concomitant medications included prenatal vitamins, vitamin D and Adult Low Dose Aspirin (acetylsalicylic acid).  Maternal obstetrical history included 10 previous pregnancies with eight live babies and two miscarriages. The mother of neonate had no history of tobacco, e-cigarettes, alcohol or recreational drug use.  Maternal first day of the last menstrual period (LMP) was calculated to be 23-Dec-2022. The estimated delivery date (EDD) was reported to be 29-Sep-2023. Type of pregnancy was reported as singleton.  On 21-Jun-2023, at gestational age of 25 weeks and four days, the mother of the neonate received the first dose of Novavax (Nuvaxovid) vaccine for the prevention of COVID-19. Batch number reported was 5433MF001.  On 12-Jul-2023, at gestational age of 28 weeks and four days, the mother of the neonate received the first dose of Novavax (Nuvaxovid) vaccine for the prevention of COVID-19. Batch number reported was 5433MF001.  On 31-Aug-2023, the mother developed severe pre-eclampsia. The mother had severe range blood pressure and persistent headache and dizziness, was seeing spots and flashes of light.   At gestational age 36 weeks, the mother delivered a live, preterm, male neonate by cesarean section (C-section). Primary reason for C-section was reported to be severe preeclampsia with prior C-section due to which they needed to deliver as quickly as possible. The mother spent four days in hospital for the delivery. Neonate's birth weight was 7 pounds and 4 ounces, body length was 19 inches.   On the same day, after delivery, the baby was transferred to Neonatal Intensive Care Unit (NICU) due to problems with breathing as the baby experienced respiratory distress requiring surfactant. Treatment included ampicillin.   On 05-Sep-2023, the mother recovered from pre-eclampsia.    On 09-Sep-2023, the neonate recovered from respiratory distress.   The study participant did not provide causality assessment.  The case is linked with 2023-US-00113 (corresponding mother case).  Investigator's assessments: The event of Neonatal respiratory distress is serious and unexpected for the Novavax (Nuvaxovid). Temporal relationship is not suggestive. Premature birth could provide more plausible etiology for development of neonatal respiratory distress. Hence, causality is assessed as not related.; Sender's Comments: This male of an unspecified age experienced: Neonatal respiratory distress, Premature baby and Foetal exposure during pregnancy after vaccination with Nuvaxovid 10 ug/mL. The event Neonatal respiratory distress was reported as serious. The events Premature baby and Foetal exposure during pregnancy were reported as non-serious. Considering the current knowledge of the vaccine, the causal relationship between Nuvaxovid and Foetal exposure during pregnancy was assessed as related, Nuvaxovid and Premature baby and Nuvaxovid and Neonatal respiratory distress were assessed as not related. US-NOVAVAX, INC.-2023NVX-US-000001052:Mother case