WHAT'S NEW THIS THURSDAY: SIX ON VACCINE ASSOCIATED PARALYTIC POLIOMYELITIS

Thursday, 7th of March 2013

SIX ON VACCINE ASSOCIATED PARALYTIC POLIOMYELITIS
POISSON-MODEL ANALYSIS OF THE RISK OF VACCINE-ASSOCIATED PARALYTIC POLIOMYELITIS IN JAPAN BETWEEN 1971 AND 2000

Jpn J Infect Dis. 2008 Mar;61(2):100-3.

Source

Department of Public Health, Graduate School of Medicine, The University of Tokyo, Tokyo 113-0033, Japan. lixinh-tky@umin.ac.jp

Abstract below; full text is at http://www0.nih.go.jp/JJID/61/100.html

This study estimates the risk of vaccine-associated paralytic poliomyelitis (VAPP) in Japan between 1971 and 2000. We acquired data regarding the number of VAPP cases from the website of the Ministry of Health, Labour and Welfare, and we estimated the number of oral poliovirus vaccines (OPV) administered based on the reported immunization data. Risk was calculated as the ratio between the number of VAPP cases and the number of OPV doses administered. Both the Runs test and the Poisson model were used to analyze the occurrence of VAPP. Thirty-three cases of VAPP were recorded in Japan between 1971 and 2000; approximately one case occurred per year. There were no statistical changes in temporal trends as regards the occurrence of VAPP between 1971 and 2000. The overall risk for VAPP, including both recipient and contact VAPP, was one case per 2.0 million OPV doses administered. The risk of recipient VAPP was one per 3.7 million doses, among which the first dose posed a much higher risk of one per 2.3 million than that of the subsequent dose. These data indicated that the occurrence of VAPP is rare, but the risk has remained constant for as long as OPV has been used in Japan.

PARALYTIC POLIOMYELITIS ASSOCIATED WITH SABIN MONOVALENT AND BIVALENT ORAL POLIO VACCINES IN HUNGARY

Am J Epidemiol. 2011 Aug 1;174(3):316-25. doi: 10.1093/aje/kwr070. Epub 2011 Jun 17.

EstÃvariz CF, MolnÃ¡r Z, Venczel L, Kapusinszky B, Zingeser JA, Lipskaya GY, Kew OM, Berencsi G, CsohÃ¡n A.

Source

Global Immunization Division, Centers for Disease Control and Prevention, Atlanta, Georgia, USA. cge3@cdc.gov

Abstract below; full text is at http://aje.oxfordjournals.org/content/174/3/316.long

Historical records of patients with vaccine-associated paralytic poliomyelitis (VAPP) in Hungary during 1961-1981 were reviewed to assess the risk of VAPP after oral polio vaccine (OPV) administration. A confirmed VAPP case was defined as a diagnosis of paralytic poliomyelitis and residual paralysis at 60 days in a patient with an epidemiologic link to the vaccine. Archived poliovirus isolates were retested using polymerase chain reaction and sequencing of the viral protein 1 capsid region. This review confirmed 46 of 47 cases previously reported as VAPP. Three cases originally linked to monovalent OPV (mOPV) 3 and one case linked to mOPV1 presented after administration of bivalent OPV 1 + 3 (bOPV). The adjusted VAPP risk per million doses administered was 0.18 for mOPV1 (2 cases/11.13 million doses), 2.96 for mOPV3 (32 cases/10.81 million doses), and 12.82 for bOPV (5 cases/390,000 doses). Absence of protection from immunization with inactivated poliovirus vaccine or exposure to OPV virus from routine immunization and recent injections could explain the higher relative risk of VAPP in Hungarian children. In polio-endemic areas in which mOPV3 and bOPV are needed to achieve eradication, the higher risk of VAPP would be offset by the high risk of paralysis due to wild poliovirus and higher per-dose efficacy of mOPV3 and bOPV compared with trivalent OPV.

VACCINE-RELATED ADVERSE EVENTS IN CUBAN CHILDREN, 1999-2008.

Galindo BM, ConcepciÃ³n D, Galindo MA, PÃ©rez A, Saiz J.

Abstract below; full text is at http://www.medicc.org/mediccreview/articles/mr_237.pdf

Source

Pedro KourÃ Tropical Medicine Institute (IPK), Havana, Cuba. bgalindo@ipk.sld.cu

Abstract

INTRODUCTION Cuba has implemented an effective National Immunization Program since 1962. The schedule, administered primarily to children, comprises 11 vaccines (8 domestically produced) protecting against 13 diseases. In 1999 Cuba launched a national vaccine adverse event surveillance system to monitor and assess the safety of the immunization program, its vaccination procedures and the products administered.

OBJECTIVES Describe adverse events following vaccination reported in children aged <16 years in Cuba from 1999 through 2008.

METHODS A retrospective descriptive study was conducted of adverse events following vaccination reported from January 1999 through December 2008. Variables used: year, number of adverse events, province, type of vaccine, type and severity of adverse events (common minor, rare, severe), vaccination program errors, number of deaths, and final results of investigations of severe events. Percentages and rates per dose administered were calculated. Adverse event rates were calculated per 100,000 doses administered and by percentages of individual effects among events reported.

RESULTS A total of 45,237,532 vaccine doses were administered, and 26,159 vaccine-associated adverse events were reported (overall rate: 57.8 per 100,000 doses). The group aged 0-5 years reported the highest rate of vaccine-associated adverse events (82/100,000 doses). The DTwP vaccine exhibited the highest rate of adverse events. Common minor events were: fever (17,538), reactions at injection site (4470) and systemic side effects (2422). Rare events (by WHO definition) reported were: persistent crying (2666), hypotonic-hyporesponsive episodes (3), encephalopathy (2) and febrile seizures (112). Severe events included: anaphylaxis (2), respiratory distress (1), multiple organ failure (1), sudden death (1), vaccine-associated paralytic poliomyelitis (2), toxic shock syndrome (3), and sepsis (1). The 10 deaths and 3 cases of disability were investigated by an expert commission, which concluded that 8 of the 13 severe events were vaccination-related.

CONCLUSIONS Low rates of severe vaccine-associated adverse events observed in this study underline the low risk of vaccination relative to its demonstrated benefits in Cuba. Decision-making for the continued success of the National Immunization Program is supported by reliable information from comprehensive national surveillance with standarized reporting, along with multidisciplinary expert analysis of rare and severe adverse events and program errors.

KEYWORDS Immunization; immunization programs; vaccines; vaccination; product surveillance, postmarketing; adverse drug event; communicable disease control; Cuba.

INTRODUCTION OF INACTIVATED POLIO VACCINE (IPV) INTO THE ROUTINE IMMUNIZATION SCHEDULE OF SOUTH AFRICA

Vaccine. 2012 Sep 7;30 Suppl 3:C35-7. doi: 10.1016/j.vaccine.2012.02.056.

Schoub BD.

Source

National Institute for Communicable Diseases/National Health Laboratory Service, Private Bag X4, Sandringham 2131, South Africa. barrys@nicd.ac.za

Abstract below; full text available to journal subscribers

South Africa is currently the only country on the African continent using inactivated polio vaccine (IPV) for routine immunization in a sequential schedule in combination with oral polio vaccine (OPV). IPV is a component of an injectable pentavalent vaccine introduced nationwide in April 2009 and administered according to EPI schedule at 6, 10 and 14 weeks with a booster dose at 18 months. OPV is administered at birth and together with the first IPV dose at 6 weeks, which stimulates gut immune system producing a memory IgA response (OPV), followed by IPV to minimize the risk of vaccine associated paralytic polio (VAPP). OPV is also given to all children under 5 years of age as part of regular mass immunizations campaigns. The decision to incorporate IPV into the routine schedule was not based on cost-effectiveness, which it is not. Other factors were taken into account: Firstly, the sequence benefits from the initial mucosal contact with live(vaccine) virus which promotes the IgA response from subsequent IPV, as well as herd immunity from OPV, together with the safety of IPV. Secondly, given the widespread and increasing use of IPV in the developed world, public acceptance of vaccination in general is enhanced in South Africa which is classified as an upper middle income developing country. Thirdly, to address equity concerns because of the growing use of IPV in the private sector. Fourthly, the advent of combination vaccines facilitated the incorporation of IPV into the EPI schedule.

VACCINE-ASSOCIATED PARALYTIC POLIOMYELITIS Â IN IMMUNODEFICIENT CHILDREN, IRAN, 1995-2008

Emerging Infectious Diseases, July 2010

Abstract

To determine the prevalence of vaccine-associated paralytic poliomyelitis (VAPP) in immunodeficient infants, we reviewed all documented cases caused by immunodeficiency-associated vaccine-derived polioviruses in Iran from 1995 through 2008. Changing to an inactivated polio vaccine vaccination schedule of screening of neonates for immunodeficiencies could reduce the risk for VAPP infection

Full text is at http://wwwnc.cdc.gov/eid/article/16/7/09-1606_article.htm

RARE ADVERSE EVENTS ASSOCIATED WITH ORAL POLIOVIRUS VACCINE IN BRAZIL

Braz J Med Biol Res. 1997 Jun;30(6):695-703.

Friedrich F.

Source

Departamento de Virologia, Instituto Oswaldo Cruz, FIOCRUZ, Rio de Janeiro, Brasil.

Abstract

Oral poliovirus vaccine (OPV) developed by A. Sabin has been effectively used to control poliomyelitis in Brazil, and the last case with the isolation of a wild poliovirus strain occurred in March 1989. Although the vaccine controlled the circulation of wild strains and poliomyelitis cases associated with these strains were not detected during the last eight years, rare cases classified as vaccine-associated paralytic poliomyelitis (VAPP) have been detected. Molecular characterization studies of poliovirus strains isolated from VAPP cases and from healthy contacts have confirmed that the isolates are derived from the Sabin vaccine strains and also detected genomic modifications known or suspected to increase neurovirulence such as mutations and recombination. The molecular characterization of polioviruses isolated during the last eight years from paralysis cases classified as Guillain-BarrÃ© (GBS) syndrome and transverse myelitis (TM), and from facial paralysis (FP) cases also confirmed the vaccine origin of the strains and demonstrated mutations known to increase neurovirulence. Analysis of the epidemiologic data of these GBS, TM and FP cases demonstrated that in most of them the last OPV dose was given months or years before the onset of the disease and the isolation of the polioviruses. The temporal association between the isolation of these strains and the GBS, TM and FP suggested that the Sabin vaccine-derived poliovirus strains could also rarely trigger the diseases.