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COVID-19 current vaccine safety status and insights
-- Since 2021, GACVS has regularly reviewed the safety of COVID-19 vaccines, including through global pharmacovigilance data and dedicated reviews of myocarditis, pregnancy outcomes and other adverse events of special interest (AESI).
-- The most recent updates reaffirmed that the benefits of vaccination outweigh the risks across all groups and advised continued monitoring for younger males and follow-up of persons who have 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 mRNA COVID- 19 vaccines.
-- However, the outcomes were less severe in persons who developed myocarditis after vaccination compared to those unvaccinated and following infections, including SARS- CoV-2.
-- Also, children under six months of age seem to be at higher risk of severe COVID-19 infection along with people over the age of 65 years.
-- WHO has recommended continued vaccination for high-priority groups while acknowledging that gaps 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 perturbation of fetal development in EudraVigilance, of which most were reported with the original vaccine strains.
-- An analysis of safety of protein-based COVID-19 vaccines by the Uppsala Monitoring Centre (UMC) showed that as of November 2025 there were almost 6 million reports for all COVID-19 vaccines in UMC’s VigiBase.
-- Of these, 16 548 reports concerned updated COVID-19 vaccine variants; among these were 5085 reports for updated protein-subunit vaccines.
-- Around 17.4% of these were serious, and 50 reported a fatal outcome.
-- Most reports were for the variant NVX CoV 2373 and most deaths were older vaccinees aged 75 years or more.
-- GACVS reviewed findings from the Scandinavian collaboration called SCOPE (Scandinavian studies of COvid-19 in PrEgnancy).
-- Findings showed no increased risk of adverse pregnancy, maternal or neonatal outcomes after mRNA COVID-19 vaccination in pregnancy in Denmark, Norway and Sweden.
-- As of September 2025, the recommendation for vaccination in pregnancy was revised to apply only to specific high-risk groups.
-- A case-control study by SCOPE of all women with a miscarriage before 14 weeks and all 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 first trimester of pregnancy and the risk of congenital anomalies, in a population-based cohort of 150 000 live-born infants in Denmark, Norway and Sweden, showed no increased risk of major congenital anomalies among infants whose mothers were vaccinated against COVID-19 during the first trimester.
-- A SCOPE investigation of the association between COVID-19 vaccination and several pregnancy outcomes among a cohort of almost 160 000 singleton pregnancies between January 2021 and 2022 in Norway and Sweden showed that vaccination against COVID-19 during pregnancy was not associated with any of the studied adverse pregnancy outcomes.
-- In another SCOPE study of COVID-19 vaccination during pregnancy and the risk of severe postpartum haemorrhage, including more than 300 000 single-term deliveries in Denmark, Norway and Sweden, no evidence was found of an association between COVID-19 vaccination at any time during pregnancy and severe postpartum hemorrhage.
-- Finally, SCOPE investigated neonatal outcomes after COVID-19 vaccination with mRNA vaccine during pregnancy in a cohort of almost 200 000 infants in Norway and Sweden.
-- Again, no increased odds were found of any adverse neonatal outcomes and neonatal mortality.
-- 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 of serious individual case safety reports (ICSRs) in the global database. Several potential signals (e.g. tinnitus, antibody-dependent enhancement, thrombosis) require further evaluation. Additional data collection and analysis are therefore recommended to strengthen the evidence base for these vaccines.
- Long-term outcomes of known risks (e.g. myocarditis, pregnancy outcomes):
* Myocarditis continues to occur predominantly in younger adults, typically with mild-to- moderate severity and most frequently after the second dose. Longer follow-up studies are needed to define the long-term prognosis and risks of revaccination in affected individuals.
- 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 no increase in congenital anomalies, adverse perinatal outcomes, or some post-natal complications. Some studies even suggest lower odds of intracranial haemorrhage, cerebral ischaemia and neonatal mortality among infants of vaccinated mothers.
- Safety monitoring during the transition to endemic COVID-19 vaccination:
* Continued vigilance is required, particularly regarding more recent variant-adapted vaccines which remain safe on the basis of current data. Enhanced monitoring of protein-based vaccines is important given the comparatively limited evidence and the presence of identified risks that warrant further investigation.
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Source:
Link: https://www.who.int/publications/journals/weekly-epidemiological-record
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