Joint evaluation of marketing authorization files of inactivated polio vaccines in countries of the Eastern Mediterranean Region.

BACKGROUND: In 2012, the World Health Assembly declared ending polio a "programmatic emergency for global public health". In response, the Global Polio Eradication Initiative developed "The Polio Eradication and Endgame Strategic Plan 2013-2018" to address the eradication of all types of poliomyelitis. AIMS: The World Health Organization invited selected countries in the Eastern Mediterranean Region to take part in a joint evaluation of the marketing authorization files of candidate standalone inactivated poliovirus vaccines (IPVs), aimed to facilitate the evaluation process and expedite the timelines for registration. METHODS: This report describes the planning, organization and execution of the joint meeting among 6 countries of Eastern Mediterranean Region. RESULTS: Participants prepared a joint list of questions and concerns which was shared and discussed with the respective manufacturers on the last day of the review. Manufacturer provided answers to the questions. The questions that could not be responded to immediately by the manufacturer remained to be addressed after the meeting directly between the manufacturer and the national regulatory authoritys. A final joint evaluation report was prepared before the end of the meeting by the participating countries. CONCLUSIONS: The report focuses on the benefits of the exercise and highlights its shortcomings as a sole strategy to secure the timely registration of the vaccine in target countries. We discuss additional aspects to be addressed to effectively accelerate registration, and hence access to priority vaccines.

Introduction of Inactivated Polio Vaccine, Withdrawal of Type 2 Oral Polio Vaccine, and Routine Immunization Strengthening in the Eastern Mediterranean Region.

The Global Polio Eradication Initiative has reduced the global incidence of polio by 99% and the number of countries with endemic polio from 125 to 3 countries. The Polio Eradication and Endgame Strategic Plan 2013-2018 (Endgame Plan) was developed to end polio disease. Key elements of the endgame plan include strengthening immunization systems using polio assets, introducing inactivated polio vaccine (IPV), and replacing trivalent oral polio vaccine with bivalent oral polio vaccine ("the switch"). Although coverage in the Eastern Mediterranean Region (EMR) with the third dose of a vaccine containing diphtheria, tetanus, and pertussis antigens (DTP3) was ≥90% in 14 countries in 2015, DTP3 coverage in EMR dropped from 86% in 2010 to 80% in 2015 due to civil disorder in multiple countries. To strengthen their immunization systems, Pakistan, Afghanistan, and Somalia developed draft plans to integrate Polio Eradication Initiative assets, staff, structure, and activities with their Expanded Programmes on Immunization, particularly in high-risk districts and regions. Between 2014 and 2016, 11 EMR countries introduced IPV in their routine immunization program, including all of the countries at highest risk for polio transmission (Afghanistan, Pakistan, Somalia, and Yemen). As a result, by the end of 2016 all EMR countries were using IPV except Egypt, where introduction of IPV was delayed by a global shortage. The switch was successfully implemented in EMR due to the motivation, engagement, and cooperation of immunization staff and decision makers across all national levels. Moreover, the switch succeeded because of the ability of even the immunization systems operating under hardship conditions of conflict to absorb the switch activities.

Genetic variability of genotype 1 hepatitis C virus isolates from Tunisian haemophiliacs.

This paper reports hepatitis C virus (HCV) prevalence, genotypes and phylogenetic characteristics in 95 haemophilic Tunisian patients. The studied population included 3 groups of patients according to their date of birth: before 1985 when inactivation procedures for clotting factors was introduced, between 1985 and 1994 when systematic anti-HCV screening of Tunisian blood donors was introduced and after this date. HCV infection was assessed by serological and molecular commercial tests. Genotypes were determined using the INNO-LiPA HCV test and by partial sequencing in the NS5b genomic region. Phylogenetic analyses were performed by comparing NS5b sequences of Tunisian haemophiliacs to published sequences. HCV infection was detected in 50.5% of cases with a significant decrease according to age. Subtype la was the most prevalent followed by subtype 1b (52.6% vs 44.7%); it was more frequent among haemophiliacs born before 1985. NS5b sequences were different from those obtained from non-haemophilic Tunisian patients and showed nucleic affiliation with HCV isolates from the USA. These findings suggest an infection through clotting factors imported to Tunisia and frequently manufactured from US blood donors. In contrast, subtype 1b showed approximately the same distribution among patients born before and after 1985; NS5b sequences from haemophiliacs were randomly distributed among other Tunisian sequences, favouring a transmission through cryoprecipitates prepared from Tunisian blood donors.

[Not Available]. / Réactions systémiques après traitement endovésical par le BCG : à propos de 4 cas.

Local Bacillus Calmette-Guerin (BCG) immunotherapy is an effective and widely used treatment for superficial bladder carcinoma. Local side effects are frequent, whereas systemic side effects are rare, but more serious. We report four cases of systemic BCG reaction. Although uncommon, this infectious complication of BCG therapy should always be considered in the appropriate clinical setting. The best approach to minimize this complication is a strict compliance with precautions and a close and rigorous surveillance of this drug.

[Systemic BCG reactions after intravesical BCG therapy. A report of four cases]. / Réactions systémiques après traitement endovésical par le BCG: à propos de 4 cas.

Local Bacillus Calmette-Guerin (BCG) immunotherapy is an effective and widely used treatment for superficial bladder carcinoma. Local side effects are frequent, whereas systemic side effects are rare, but more serious. We report four cases of systemic BCG reaction. Although uncommon, this infectious complication of BCG therapy should always be considered in the appropriate clinical setting. The best approach to minimize this complication is a strict compliance with precautions and a close and rigorous surveillance of this drug.

Effective vaccine safety systems in all countries: a challenge for more equitable access to immunization.

Serious vaccine-associated adverse events are rare. To further minimize their occurrence and to provide adequate care to those affected, careful monitoring of immunization programs and case management is required. Unfounded vaccine safety concerns have the potential of seriously derailing effective immunization activities. To address these issues, vaccine pharmacovigilance systems have been developed in many industrialized countries. As new vaccine products become available to prevent new diseases in various parts of the world, the demand for effective pharmacovigilance systems in low- and middle-income countries (LMIC) is increasing. To help establish such systems in all countries, WHO developed the Global Vaccine Safety Blueprint in 2011. This strategic plan is based on an in-depth analysis of the vaccine safety landscape that involved many stakeholders. This analysis reviewed existing systems and international vaccine safety activities and assessed the financial resources required to operate them. The Blueprint sets three main strategic goals to optimize the safety of vaccines through effective use of pharmacovigilance principles and methods: to ensure minimal vaccine safety capacity in all countries; to provide enhanced capacity for specific circumstances; and to establish a global support network to assist national authorities with capacity building and crisis management. In early 2012, the Global Vaccine Safety Initiative (GVSI) was launched to bring together and explore synergies among on-going vaccine safety activities. The Global Vaccine Action Plan has identified the Blueprint as its vaccine safety strategy. There is an enormous opportunity to raise awareness for vaccine safety in LMIC and to garner support from a large number of stakeholders for the GVSI between now and 2020. Synergies and resource mobilization opportunities presented by the Decade of Vaccines can enhance monitoring and response to vaccine safety issues, thereby leading to more equitable delivery of vaccines worldwide.