世界卫生组织全球疫苗安全咨询委员会第49次会议报告，2025年11月27日至28日

an independent expert advisory body to the Director-General of the World Health Orga- nization (WHO), as well as to WHO’s collaborating centres and Member States, on The main objectives of the November 2025 GACVS meeting were to provide updates through global pharmacovigilance data and dedicated reviews of myocarditis, preg-nancy outcomes and other adverse events of special interest (AESI). The most recent updates reaffirmed that the benefits of vaccination outweigh the risks across all groupsand advised continued monitoring for younger males and follow-up of persons whohave reported vaccine-associated myocarditis. Many individuals have received three or more doses of COVID-19 vaccine. Some adverse events – such as myocarditis – seem to occur mainly after the second dose of mRNACOVID- 19 vaccines. However, the outcomes were less severe in persons who developedmyocarditis after vaccination compared to those unvaccinated and following infections, recommended continued vaccination for high-priority groups while acknowledging thatgaps remain in the evidence on the safety of repeated dosing, long-term outcomes, and in subgroups such as children and pregnant women.As of October 2025, for all COVID-19 vaccines, there were only 32 cases of perturbationof fetal development in EudraVigilance, of which most were reported with the originalvaccine strains. An analysis of safety of protein-based COVID-19 vaccines by the UppsalaMonitoring Centre (UMC) showed that as of November 2025 there were almost 6 millionreports for all COVID-19 vaccines in UMC’s VigiBase. Of these, 16 548 reports concerned outcome. Most reports were for the variant NVX CoV 2373 and most deaths were oldervaccinees aged 75 years or more.GACVS reviewed findings from the Scandinavian collaboration called SCOPE (Scandi-navian studies ofCOvid-19 in PrEgnancy). Findings showed no increased risk ofadverse pregnancy, maternal or neonatal outcomes after mRNA COVID-19 vaccinationin pregnancy in Denmark, Norway and Sweden. As of September 2025, the recommen-dation for vaccination in pregnancy was revised to apply only to specific high-riskgroups.A case-control study by SCOPE of all women with a miscarriage before 14 weeks andall women with a primary care-based confirmation of an ongoing pregnancy in the first trimester revealed no evidence of increased risk of early pregnancy loss after COVID-19 vaccination. A further investigation of COVID-19 infection and vaccination with mRNA vaccines during the firsttrimester of pregnancy and the risk of congenital anomalies, in a population-based cohort of 150 000 live-born infantsin Denmark, Norway and Sweden, showed no increased risk of major congenital anomalies among infants whose A SCOPE investigation of the association between COVID-19 vaccination and several pregnancy outcomes amonga cohort of almost 160 000 singleton pregnancies between January 2021 and 2022 in Norway and Sweden showedthat vaccination against COVID-19 during pregnancy was not associated with any of the studied adverse pregnancyoutcomes. In another SCOPE study of COVID-19 vaccination during pregnancy and the risk of severe postpartum Finally, SCOPE investigated neonatal outcomes after COVID-19 vaccination with mRNA vaccine during pregnancy ina cohort of almost 200 000 infants in Norway and Sweden. Again, no increased odds were found of any adverse In consideration of the evidence presented, GACVS members agreed the following: Repeated-dose safety (including boosters with variant-containing vaccines): Current evidence remains reassuring,with no new safety signals recently identified.Safety of protein-based vaccines:While generally well tolerated, reported adverse events include a proportion ofserious individual case safety reports (ICSRs) in the global database. Several potential signals (e.g. tinnitus, anti-body-dependent enhancement, thrombosis) require further evaluation. Additional data collection and analysisare therefore recommended to strengthen the evidence base for these vaccines.Long-term outcomes of known risks (e.g. myocarditis, pregnancy outcomes): Myocarditis continues to occurpredominantly in younger adults, typically with mild-to- moderate severity and most frequently after the second Subgroup-specific safety (children, young males, older adults, immunocompromised individuals, pregnant women):Evidence to date shows no harmful effects of mRNA COVID-19 vaccination during pregnancy, including noincrease in congenital anomalies, adverse perinatal outcomes, or some post-natal complications. Some studies Safety monitoring during the transition to endemic COVID-19 vaccination: Continued vigilance is required, partic-ularly regarding more recent variant-adapted vaccines which remain safe on the basis of current data. Enhancedmonitoring of protein-based vaccines is important given the comparatively limited evidence and the presence of Updated criteria for WHO Vaccine Safety Net members As a result of the spread of false