Lineamientos Técnicos de Vacunación: Virus Sincicial Respiratorio en Personas Gestantes

Objectives

The programme seeks to prevent respiratory syncytial virus (RSV) lower respiratory tract disease, including severe disease, among infants from birth to six months by vaccinating pregnant people. RSV is identified as the leading global cause of acute lower respiratory infection in infants and as a substantial source of morbidity, mortality, longer-term sequelae and health-service demand.[1][2]Maternal immunisation is intended to expand protection during the infant period of greatest risk and to complement, rather than replace, existing monoclonal-antibody prevention for selected high-risk infants.[1][3]

• Protect infants during their first six months of life through a bivalent recombinant RSV prefusion F vaccine given during pregnancy.[4][2]
• Offer vaccination to all pregnant people from 32.0 to 36.6 weeks of gestation, a timing intended to minimise potential risk in light of an observed numerical imbalance in preterm births for which causality has not been established or excluded.[5][6]
• Promote equitable access, accurate vaccination documentation, coverage monitoring and vaccine-safety surveillance through high-quality nominal records.[7]
• Strengthen RSV prevention and control alongside epidemiological surveillance, following altered RSV seasonality in the Southern Cone and calls by the Pan American Health Organization and World Health Organization to integrate surveillance and address severe cases.[3]

Implementation

Delivery is organised as routine maternal immunisation using one intramuscular vaccine dose during a defined gestational window, supported by cold-chain procedures, supply traceability, nominal registration, post-vaccination observation and structured surveillance of maternal and infant outcomes.[2][6][7][8]The supplied material does not specify programme budgets, vaccine prices, financing sources, resource gaps or economic assumptions.[1][4][7][9]

• Administer a single 0.5 ml dose intramuscularly in the deltoid muscle between 32.0 and 36.6 weeks of pregnancy.[2][6]
• Use a vaccine dose containing 60 micrograms of stabilised prefusion F antigen from RSV subgroup A and 60 micrograms from subgroup B after reconstitution.[2]
• Store vaccine at +2°C to +8°C without freezing, and administer it immediately after reconstitution or within four hours if maintained at +15°C to +30°C.[2]
• Permit co-administration with recommended pregnancy vaccines, including acellular pertussis-containing, influenza and COVID-19 vaccines.[6]
• Provide medical treatment and appropriate supervision for acute allergic reactions following vaccination.[6]
• Maintain product traceability from origin to final destination, reporting deliveries to the relevant Global Location Number or Physical Establishment Location Code.[7]
• Record each administered dose in the Federal Nominal Vaccination Registry (NOMIVAC) or an interoperable jurisdictional nominal registry transmitting records daily, and enter the administration date, batch and vaccinator signature on the person’s vaccination card.[7]
• Monitor RSV burden through epidemiological surveillance of bronchiolitis notifications, tested samples, RSV-positive results and positivity among hospitalised cases.[10]In 2023, 218,523 bronchiolitis cases were reported through epidemiological week 48, while 13,483 of 44,842 tested samples were RSV-positive, a positivity rate of 30.07%.[10]
• Assess protection against severe infant RSV lower respiratory tract infection, for which trial efficacy was 81.8% at 90 days and 69.4% at 180 days after birth.[10][4]Assess efficacy against RSV lower respiratory tract infection more broadly, estimated at 57.1% at 90 days and 51.3% at 180 days.[5]
• Monitor maternal, fetal, neonatal and infant safety because vaccination during pregnancy can affect both the pregnant person and the fetus.[7]Use passive spontaneous reporting and active surveillance through sentinel units for adverse events of special interest.[8]
• Require health personnel caring for a person with a post-vaccination event to notify clinical events, laboratory findings, deviations from recommendations and administration errors through the Argentine Integrated Health Information System (SISA), without delaying notification for investigation or classification.[8]
• Monitor pregnancy outcomes including preterm birth, placental abruption, gestational hypertension, pre-eclampsia, oligohydramnios, thrombotic events and fetal death, and monitor newborn outcomes through six months including prematurity, low birth weight, neonatal death, jaundice, sepsis, respiratory distress, congenital malformations and cardiac abnormalities.[8]
• Report serious events supposedly attributable to vaccination or immunisation within 48 hours and non-serious events within seven days, including events identified outside those timeframes.[8][9]Classify as serious events causing death, imminent life risk, hospitalisation or prolonged hospitalisation, persistent or significant disability, or suspected congenital anomaly, stillbirth or abortion.[9]

Monitoring & Evaluation

Monitoring combines respiratory syncytial virus (RSV) disease surveillance, vaccination registration, vaccine-safety surveillance and time-bound adverse-event reporting. RSV surveillance includes bronchiolitis notifications, numbers of samples tested, RSV-positive results and positivity among hospitalised cases.[10]Maternal immunisation records are intended to support coverage monitoring, equitable access and vaccine-safety surveillance.[7]

• Monitor RSV burden and vaccine impact using severe lower respiratory tract infection outcomes in infants. Reported vaccine efficacy against severe RSV lower respiratory tract infection was 81.8% at 90 days after birth and 69.4% at 180 days.[4]Efficacy against RSV lower respiratory tract infection of any severity was 57.1% at 90 days and 51.3% at 180 days, respectively.[5]
• Track epidemiological burden through reported bronchiolitis and laboratory testing. Between epidemiological weeks 1 and 48 of 2023, Argentina reported 218,523 bronchiolitis cases, a cumulative incidence of 14,978.3 per 100,000 inhabitants; 44,842 samples were tested for RSV, of which 13,483 were positive, representing 30.07% positivity.[10]
• Register administered doses in the Federal Nominal Vaccination Registry (NOMIVAC), or interoperable jurisdictional nominal registries that transmit records daily. Record the administration date, vaccine batch and vaccinator’s signature on the individual vaccination card.[7]
• Maintain vaccine traceability from origin to final destination, including reporting deliveries to the relevant Global Location Number or Physical Establishment Location Code.[7]
• Conduct passive surveillance through spontaneous reports of events supposedly attributable to vaccines and immunisations, and active surveillance through sentinel units for adverse events of special interest.[8]
• Require health personnel to notify clinical events, laboratory findings, departures from recommendations and administration errors through the Argentine Integrated Health Information System (SISA). Investigation and classification should not delay notification.[8]
• Monitor maternal, fetal, neonatal and infant outcomes, including preterm birth, placental abruption, gestational hypertension, pre-eclampsia, fetal death, low birth weight, neonatal death, jaundice, sepsis, respiratory distress, congenital malformations and cardiac abnormalities through six months after birth.[8]
• Report serious events within 48 hours and non-serious events within seven days, including events identified after those timeframes.[8][9]Classify events as serious when they result in death, imminent risk to life, hospital admission or prolonged hospitalisation, persistent or significant disability, suspected congenital anomaly, stillbirth or suspected abortion.[9]
• Monitor safety findings relevant to programme implementation, including the numerical imbalance in preterm births observed in the trial, for which available data were insufficient to establish or exclude a causal relationship.[5]

Costing & Financing

No vaccine price, procurement cost, programme budget, allocation, funding source, resource-mobilisation mechanism, funding gap or economic assumption is specified in the supplied extracts.[1][3][10][4][5][2][9]

• Provide operational resources described in the extracts, including refrigerated storage, vaccination registration systems, traceability arrangements and safety-surveillance reporting mechanisms, but without stated financial values or funding arrangements.[2][7][8]