TCV vaccines

Evidence from randomized trials, systematic reviews and post-licensure surveillance indicates a favourable TCV safety profile.^{Go to footnote 11, Go to footnote 22, Go to footnote 33} Common reactions are generally mild and transient and include injection-site pain, fever, headache and malaise.^{Go to footnote 11, Go to footnote 22, Go to footnote 33} A 2025 Cochrane review of 19 studies involving 394 790 participants found little to no difference in overall adverse events between TCV and comparator vaccines or placebo (RR 0.91, 95% CI: 0.76–1.09), and no increase in serious adverse events among TCV recipients (RR 0.83, 95% CI: 0.71–0.97), although some comparisons included few events.^{Go to footnote 44} 

WHO safety reviews and pharmacovigilance data have not identified a new safety signal; passive reporting cannot establish causality. Repeat or booster dosing has also been well tolerated, with no observed vaccine-related serious adverse events, although booster studies were not powered to detect rare events.^{Go to footnote 11, Go to footnote 22, Go to footnote 33}