- Email: [email protected]
New poliovirus vaccine schedules – Authors' reply
Correspondence
OPV dose.3 In a previous report, the most frequently observed vaccineassociated paralytic poliomyelitis represented the single type of poliovirus type 2 (44%) and type 3 (32%) in Russia.4 Additionally, a case of circulating vaccine-derived poliovirus type 1 with onset of symptoms was detected in Madagascar in September, 2014.5 Therefore, we believe that a sequential administration of IPV–bOPV might be safer than that of bOPV–IPV, and ask the authors to comment on this issue. We declare no competing interests.
Qian Zhang, Claire Leppold, Yueqin Shao, Yuka Mura, *Tetsuya Tanimoto [email protected] Jiading District Center for Disease Control and Prevention, Shanghai, China (QZ, YS); Minamisoma Municipal General Hospital, Fukushima, Japan (CL); Jyoban Hospital of Tokiwa Foundation, Fukushima, Japan (YM); and Navitas Clinic, Tokyo 190–0023, Japan (TT) 1
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3
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5
Asturias EJ, Bandyopadhyay AS, Self S, et al. Humoral and intestinal immunity induced by new schedules of bivalent oral poliovirus vaccine and one or two doses of inactivated poliovirus vaccine in Latin American infants: an open-label randomised controlled trial. Lancet 2016; 388: 158–69. WHO. Practical guide: inactivated poliovirus vaccine (ipv) introduction. Washington, DC: PAHO, 2014. Landaverde JM, Trumbo SP, Danovaro-Holliday MC, Cochi SE, Gandhi R, Ruiz-Matus C. Vaccine-associated paralytic poliomyelitis in the post-elimination era in Latin America and the Caribbean, 1992–2011. J Infect Dis 2014; 209: 1393–402. Ivanova OE, Eremeeva TP, Morozova NS, et al. Vaccine-associated paralytic poliomyelitis in Russian federation during the period of changes in vaccination schedule (2006–2013 yy.). Vopr Virusol 2016; 61: 9–15 (in Russian). Diop OM, Burns CC, Sutter RW, Wassilak SG, Kew OM. Update on vaccine-derived polioviruses-worldwide, January 2014–March 2015. MMWR Morb Mortal Wkly Rep 2015; 64: 640–46.
Authors’ reply Following on from our randomised controlled trial, 1 Qian Zhang and colleagues commented on the importance of the sequence of the oral poliovirus vaccine (OPV) and inactivated poliovirus vaccine (IPV) in infant immunisation schedules in the context of preventing rare but serious adverse events of OPV, such as vaccine2478
associated paralytic poliomyelitis and vaccine-derived poliovirus. They noted that the recommendation was first to give IPV followed by OPV. National choices of poliovirus vaccines and their sequence in the primary series are driven by immunogenicity, risk of wild-virus or vaccine-related polio, and vaccine cost and supply situations. On the basis of a WHO recommendation, in April, 2016, OPV-using countries considered endemic or at high risk of importation moved to a primary series of three bivalent OPV (bOPV) doses and one IPV dose; the latter given at age 14 weeks.2 In low-income countries, most cases of vaccine-associated paralytic poliomyelitis were reported as having received multiple previous doses of OPV.3 By contrast, in middle-income and high-income countries the risk of vaccine-associated paralytic poliomyelitis is 6·6 times higher in the recipients of their first dose of OPV compared with those receiving subsequent doses. 3 The choice of sequence of poliovirus vaccines in the primary series has little effect on the generation of circulating vaccinederived poliovirus. Areas at highest risk of circulating vaccine-derived poliovirus, mostly from the OPV type-2 component, are regions with low OPV coverage, and where epidemiological conditions (eg, low socioeconomic status, poor hygiene, sanitation, and crowding) favour poliovirus transmission.3,4 Given the current recommendation to introduce at least one dose of IPV in immunisation schedules with bOPV, higher immunogenicity is achieved when IPV is provided at ≥14 weeks rather than earlier, when maternal antibodies, the major factor impeding immune responses to IPV, have waned. Delaying bOPV until after IPV at 14 weeks leaves infants potentially unprotected against types 1 and 3 until they are older. As well as providing full protection, IPV after bOPV priming can boost humoral and mucosal immunity against poliovirus types 1 and 3.2,4–6
In regions such as the Americas, with high vaccination coverage and low importation risk and where vaccineassociated paralytic poliomyelitis is now the primary risk of paralytic polio, sequential schedules starting with a dose of IPV have been adapted following the global switch from trivalent OPV to bOPV. In 2015, a study in Chile reported the immunogenicity pattern of such sequential schedules.6 Following the interruption of wild-type poliovirus transmission, the planned withdrawal of all OPV and the use of IPVonly immunisation schedules should eliminate the risk of vaccine-associated paralytic poliomyelitis and vaccinederived poliovirus and sustain longterm eradication of all polioviruses. We declare no competing interests.
*Edwin J Asturias, Ananda S Bandyopadhyay, Ralf Clemens, Walter Orenstein, Ricardo Rüttimann [email protected] Department of Pediatrics, University of Colorado School of Medicine, Aurora, CO 80045, USA (EJA); Center for Global Health and Department of Epidemiology, Colorado School of Public Health, Aurora, CO, USA (EJA); Children’s Hospital Colorado, Aurora, CO, USA (EJA); Bill and Melinda Gates Foundation, Seattle, WA, USA (ASB); Global Research in Infectious Diseases, Rio de Janeiro, Brazil (RC); Emory Vaccine Center, Atlanta, GA, USA (WO); and Fighting Infectious Diseases in Emerging Countries, Miami, FL, USA (RR) 1
2
3
4
5
6
Asturias EJ, Bandyopadhyay AS, Self S, et al. Humoral and intestinal immunity induced by new schedules of bivalent oral poliovirus vaccine and one or two doses of inactivated poliovirus vaccine in Latin American infants: an open-label randomised controlled trial. Lancet 2016; 388: 158–69. WHO. Polio vaccines: WHO position paper— March, 2016. Wkly Epidemiol Rec 2016; 91: 145–68. Sutter RW, Kew OM, Cochi SL, Aylward RB. Poliovirus vaccine—live. In: Plotkin SA, Orenstein WA, Offit PA, eds. Vaccines, 6th edn. London: WB Saunders, 2013: 598–685. Bandyopadhyay AS, Garon J, Seib K, Orenstein WA. Polio vaccination: past, present and future. Future Microbiol 2015; 10: 791–808. Sutter RW, Bahl S, Deshpande JM, et al. Immunogenicity of a new routine vaccination schedule for global poliomyelitis prevention: an open-label, randomised controlled trial. Lancet 2015; 386: 2413–21. O’Ryan M, Bandyopadhyay AS, Villena R, et al. Inactivated poliovirus vaccine given alone or in a sequential schedule with bivalent oral poliovirus vaccine in Chilean infants: a randomised, controlled, open-label, phase 4, non-inferiority study. Lancet Infect Dis 2015; 15: 1273–82.
www.thelancet.com Vol 388 November 19, 2016
OPV dose.3 In a previous report, the most frequently observed vaccineassociated paralytic poliomyelitis represented the single type of poliovirus type 2 (44%) and type 3 (32%) in Russia.4 Additionally, a case of circulating vaccine-derived poliovirus type 1 with onset of symptoms was detected in Madagascar in September, 2014.5 Therefore, we believe that a sequential administration of IPV–bOPV might be safer than that of bOPV–IPV, and ask the authors to comment on this issue. We declare no competing interests.
Qian Zhang, Claire Leppold, Yueqin Shao, Yuka Mura, *Tetsuya Tanimoto [email protected] Jiading District Center for Disease Control and Prevention, Shanghai, China (QZ, YS); Minamisoma Municipal General Hospital, Fukushima, Japan (CL); Jyoban Hospital of Tokiwa Foundation, Fukushima, Japan (YM); and Navitas Clinic, Tokyo 190–0023, Japan (TT) 1
2
3
4
5
Asturias EJ, Bandyopadhyay AS, Self S, et al. Humoral and intestinal immunity induced by new schedules of bivalent oral poliovirus vaccine and one or two doses of inactivated poliovirus vaccine in Latin American infants: an open-label randomised controlled trial. Lancet 2016; 388: 158–69. WHO. Practical guide: inactivated poliovirus vaccine (ipv) introduction. Washington, DC: PAHO, 2014. Landaverde JM, Trumbo SP, Danovaro-Holliday MC, Cochi SE, Gandhi R, Ruiz-Matus C. Vaccine-associated paralytic poliomyelitis in the post-elimination era in Latin America and the Caribbean, 1992–2011. J Infect Dis 2014; 209: 1393–402. Ivanova OE, Eremeeva TP, Morozova NS, et al. Vaccine-associated paralytic poliomyelitis in Russian federation during the period of changes in vaccination schedule (2006–2013 yy.). Vopr Virusol 2016; 61: 9–15 (in Russian). Diop OM, Burns CC, Sutter RW, Wassilak SG, Kew OM. Update on vaccine-derived polioviruses-worldwide, January 2014–March 2015. MMWR Morb Mortal Wkly Rep 2015; 64: 640–46.
Authors’ reply Following on from our randomised controlled trial, 1 Qian Zhang and colleagues commented on the importance of the sequence of the oral poliovirus vaccine (OPV) and inactivated poliovirus vaccine (IPV) in infant immunisation schedules in the context of preventing rare but serious adverse events of OPV, such as vaccine2478
associated paralytic poliomyelitis and vaccine-derived poliovirus. They noted that the recommendation was first to give IPV followed by OPV. National choices of poliovirus vaccines and their sequence in the primary series are driven by immunogenicity, risk of wild-virus or vaccine-related polio, and vaccine cost and supply situations. On the basis of a WHO recommendation, in April, 2016, OPV-using countries considered endemic or at high risk of importation moved to a primary series of three bivalent OPV (bOPV) doses and one IPV dose; the latter given at age 14 weeks.2 In low-income countries, most cases of vaccine-associated paralytic poliomyelitis were reported as having received multiple previous doses of OPV.3 By contrast, in middle-income and high-income countries the risk of vaccine-associated paralytic poliomyelitis is 6·6 times higher in the recipients of their first dose of OPV compared with those receiving subsequent doses. 3 The choice of sequence of poliovirus vaccines in the primary series has little effect on the generation of circulating vaccinederived poliovirus. Areas at highest risk of circulating vaccine-derived poliovirus, mostly from the OPV type-2 component, are regions with low OPV coverage, and where epidemiological conditions (eg, low socioeconomic status, poor hygiene, sanitation, and crowding) favour poliovirus transmission.3,4 Given the current recommendation to introduce at least one dose of IPV in immunisation schedules with bOPV, higher immunogenicity is achieved when IPV is provided at ≥14 weeks rather than earlier, when maternal antibodies, the major factor impeding immune responses to IPV, have waned. Delaying bOPV until after IPV at 14 weeks leaves infants potentially unprotected against types 1 and 3 until they are older. As well as providing full protection, IPV after bOPV priming can boost humoral and mucosal immunity against poliovirus types 1 and 3.2,4–6
In regions such as the Americas, with high vaccination coverage and low importation risk and where vaccineassociated paralytic poliomyelitis is now the primary risk of paralytic polio, sequential schedules starting with a dose of IPV have been adapted following the global switch from trivalent OPV to bOPV. In 2015, a study in Chile reported the immunogenicity pattern of such sequential schedules.6 Following the interruption of wild-type poliovirus transmission, the planned withdrawal of all OPV and the use of IPVonly immunisation schedules should eliminate the risk of vaccine-associated paralytic poliomyelitis and vaccinederived poliovirus and sustain longterm eradication of all polioviruses. We declare no competing interests.
*Edwin J Asturias, Ananda S Bandyopadhyay, Ralf Clemens, Walter Orenstein, Ricardo Rüttimann [email protected] Department of Pediatrics, University of Colorado School of Medicine, Aurora, CO 80045, USA (EJA); Center for Global Health and Department of Epidemiology, Colorado School of Public Health, Aurora, CO, USA (EJA); Children’s Hospital Colorado, Aurora, CO, USA (EJA); Bill and Melinda Gates Foundation, Seattle, WA, USA (ASB); Global Research in Infectious Diseases, Rio de Janeiro, Brazil (RC); Emory Vaccine Center, Atlanta, GA, USA (WO); and Fighting Infectious Diseases in Emerging Countries, Miami, FL, USA (RR) 1
2
3
4
5
6
Asturias EJ, Bandyopadhyay AS, Self S, et al. Humoral and intestinal immunity induced by new schedules of bivalent oral poliovirus vaccine and one or two doses of inactivated poliovirus vaccine in Latin American infants: an open-label randomised controlled trial. Lancet 2016; 388: 158–69. WHO. Polio vaccines: WHO position paper— March, 2016. Wkly Epidemiol Rec 2016; 91: 145–68. Sutter RW, Kew OM, Cochi SL, Aylward RB. Poliovirus vaccine—live. In: Plotkin SA, Orenstein WA, Offit PA, eds. Vaccines, 6th edn. London: WB Saunders, 2013: 598–685. Bandyopadhyay AS, Garon J, Seib K, Orenstein WA. Polio vaccination: past, present and future. Future Microbiol 2015; 10: 791–808. Sutter RW, Bahl S, Deshpande JM, et al. Immunogenicity of a new routine vaccination schedule for global poliomyelitis prevention: an open-label, randomised controlled trial. Lancet 2015; 386: 2413–21. O’Ryan M, Bandyopadhyay AS, Villena R, et al. Inactivated poliovirus vaccine given alone or in a sequential schedule with bivalent oral poliovirus vaccine in Chilean infants: a randomised, controlled, open-label, phase 4, non-inferiority study. Lancet Infect Dis 2015; 15: 1273–82.
www.thelancet.com Vol 388 November 19, 2016