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Fulltext Unique product quality considerations in vaccine development, registration and new program implementation in Malaysia

Khoo YSK, Ghani AA, Navamukundan AA, Jahis R, Gamil A

Hum Vaccin Immunother, 2020 03 03;16(3):530-538.
PMID: 31652090 DOI: 10.1080/21645515.2019.1667206

This review aims to present the unique considerations for manufacturing and the regulation of new vaccines in Muslim-populated countries such as Malaysia. Our specific objectives are to highlight vaccine production and the ingredients of concern, summarize the current mechanism for ruling and recommendations on new vaccines, outline the different steps in decision-making on incorporating a new vaccine into the National Immunization Program, describe its issues and challenges, and explore the commercial viability and challenges of producing local permissible (halal) vaccines. Through this review, we hope readers understand that alternatives are present to replace ingredients of concern in vaccines. Halal certification and introduction of a new vaccine into a program are strictly conducted and health-care providers must be prepared to educate the public on this. At the same time, it is hoped that the production of halal vaccine in Malaysia will promote self-reliance in Muslim-populated countries.
Fulltext Incidence and Prevention of Invasive Meningococcal Disease in Global Mass Gathering Events

Muttalif AR, Presa JV, Haridy H, Gamil A, Serra LC, Cané A

Infect Dis Ther, 2019 Dec;8(4):569-579.
PMID: 31471813 DOI: 10.1007/s40121-019-00262-9

INTRODUCTION: Mass gathering events involve close contact among large numbers of people in a specific location at the same time, an environment conducive to transmission of respiratory tract illnesses including invasive meningococcal disease (IMD). This report describes IMD incidence at mass gatherings over the past 10 years and discusses strategies to prevent IMD at such events.
METHODS: A PubMed search was conducted in December 2018 using a search string intended to identify articles describing IMD at mass gatherings, including religious pilgrimages, sports events, jamborees, and refugee camps. The search was limited to articles in English published from 2008 to 2018. Articles were included if they described IMD incidence at a mass gathering event.
RESULTS: A total of 127 articles were retrieved, of which 7 reported on IMD incidence at mass gatherings in the past 10 years. Specifically, in Saudi Arabia between 2002 and 2011, IMD occurred in 16 Hajj pilgrims and 1 Umrah pilgrim; serotypes involved were not reported. At a youth sports festival in Spain in 2008, 1 case of serogroup B IMD was reported among 1500 attendees. At the 2015 World Scout Jamboree in Japan, an outbreak of serogroup W IMD was identified in five scouts and one parent. At a refugee camp in Turkey, one case of serogroup B IMD was reported in a Syrian girl; four cases of serogroup X IMD occurred in an Italian refugee camp among refugees from Africa and Bangladesh. In 2017, a funeral in Liberia resulted in 13 identified cases of serogroup C IMD. Requiring meningococcal vaccination for mass gathering attendees and vaccinating refugees might have prevented these IMD cases.
CONCLUSIONS: Mass gathering events increase IMD risk among attendees and their close contacts. Vaccines preventing IMD caused by serogroups ACWY and B are available and should be recommended for mass gathering attendees.
FUNDING: Pfizer.

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