Pneumococcal Vaccines for Preventing Otitis Media

A Cochrane review [Abstract] 1 included 11 RCTs with a total of 60 733 children (range 74 to 37 868 per study). 7- to 11-valent pneumococcal conjugate vaccines (PCV) (with different carrier proteins) were compared with control vaccines (meningococcus type C vaccine in 3 trials, and hepatitis A or B vaccine in 8 trials). In seven trials (n=59 415) PCVs were administered in early infancy, while 4 trials (n=1 318) included children aged one year and over who were either healthy or had a history of respiratory illness. The results were not pooled due to heterogeneity between studies.

PCV administered in early infancy

• PCV7: The effect of a licenced 7-valent PCV with CRM197 as carrier protein (CRM197-PCV7) on all‐cause AOM varied from −5% (95%CI −25% to 12%) RRR in high-risk infants (1 trial, n=944) to 6% (95% CI −4% to 16%; 1 trial, n=1 662) and 6% (95% CI 4% to 9%; 1 trial, n=37 868) RRR in low-risk infants. PCV7 with the outer membrane protein complex of Neisseria meningitidis serogroup B as carrier protein (OMPC-PCV7) was not associated with a reduction in all‐cause AOM (RRR −1%, 95% CI −12% to -10%; one trial, n1 666). CRM197-PCV7 and OMPC-PCV7 were associated with 20% (95% CI 7% to 31%) and 25% (95% CI 11% to 37%) RRR in pneumococcal AOM, respectively (2 trials, n=3 328) and CRM197-PCV7 with 9% (95% CI −12% to 27%) to 10% (95% CI 7% to 13%) RRR in recurrent AOM (2 trials, n=39 530).
• PHiD-CV10/11: The effect of a licenced 10-valent PCV conjugated to protein D, a surface lipoprotein of Haemophilus influenzae, (PHiD-CV10) on all-cause AOM varied from 6% (95% CI −6% to 17%; 1 trial, n=5 095) to 15% (95% CI −1% to 28%; 1 trial, n= 7 359) RRR in healthy infants. PHiD-CV11 was associated with 34% (95% CI 21% to 44%) RRR in all-cause AOM (1 trial, n=4 968). PHiD-CV10 and PHiD-CV11 were associated with 53% (95% CI 16% to 74%) and 52% (95% CI 37% to 63%) RRR in pneumococcal AOM (2 trials, n= 12 327) and PHiD-CV11 with 56% (95% CI −2% to 80%) RRR in recurrent AOM (1 trial, n= 4 968).

PCV administered at later age

• PCV7: There was no beneficial effect on all-cause AOM of administering CRM197-PCV7 in children aged 1 to 7 years with a history of respiratory illness or frequent AOM (2 trials, n= 457) and CRM197-PCV7 combined with a trivalent influenza vaccine in children aged 18 to 72 months with a history of respiratory tract infections (1 trial, n= 597 children).
• CRM197-PCV9: In one trial (n=264) with 264 healthy day-care attendees aged 1 to 3 years, it was associated with 17% (95% CI −2% to 33%) RRR in parent-reported all-cause OM.

Adverse events

• Nine studies reported on adverse effects (n=77 389). Mild local reactions and fever occurred more frequently in PCV than in control vaccine groups: redness (< 2.5 cm): 5% to 20% versus 0% to 16%; swelling (< 2.5 cm): 5% to 12% versus 0% to 8%; and fever (< 39 °C): 15% to 44% versus 8% to 25%. More severe redness (> 2.5 cm), swelling (> 2.5 cm), and fever (> 39 °C) occurred less frequently (0% to 0.9%, 0.1% to 1.3%, and 0.4% to 2.5%, respectively) in children receiving PCV, and did not differ significantly between PCV and control vaccine groups. Pain or tenderness, or both, was reported more frequently in PCV than in control vaccine groups: 3% to 38% versus 0% to 8%. Serious adverse events judged to be causally related to vaccination were rare and did not differ significantly between groups, and no fatal serious adverse event judged causally related to vaccination was reported.

References

• de Sévaux JL, Venekamp RP, Lutje V et al. Pneumococcal conjugate vaccines for preventing acute otitis media in children. Cochrane Database Syst Rev 2020;(11):CD001480. [PubMed]