The Challenges in Implementation of Halal Vaccine Certification in Malaysia

The global halal pharmaceutical sector is valued at USD 132 billion by 2021. (Pharmaceuticals, 2020). This sector is seen as a high priority development area. Apart from food products, Muslim consumers are also becoming more aware of halal pharmaceuticals. They are beginning to see the potential detrimental effects created by product development, testing, and production, all of which could be deviating from the halal values. Based on this uncertainty, the public at large is increasingly questioning the sources of their pharmaceutical products. Under such circumstances, the situation of children contracting contagious diseases has been noted to be on the rise in Malaysia, especially in the last few years. As a result, health authorities are concerned that there would be parents who may reject the immunization programs for their children out of the fear that the vaccines used may infringe on some strict religious rules. (Johari Ab Latiff, 2018) A conservative Muslim may sometimes reject the inoculation over concerns that some vaccines were derived from contents of pigs or porcine, of which Muslims are forbidden to consume. Vaccines are part of the pharmaceutical products, and like all other pharmaceutical products, they can be developed using halal ingredients, which can replace the use of non halal contents or animal products and their derivatives for medication. The implementation of halal certification for vaccines is strictly bounded by Shariah law and Fatwa. Malaysia. As a Muslim country, Malaysia is widely and globally regarded as one of the pioneers in halal pharmaceuticals. This can be traced to its world first halal pharmaceutical standard which was introduced as MS 2424: Halal Pharmaceuticals – General Guidelines since 2012, with first revision in 2019. Nonetheless, from then until presently, Malaysia has not been able to provide halal certification for the vaccine products. The implementation of the halal certification for vaccine products in Malaysia may have been triggered by the use of non-halal or forbidden ingredients in the manufacturing of those vaccine products. Thus far, the Malaysian Standard of the MS 2424 is the only standard, and it is also only a general guide. There is a need to develop a more thorough manual that can be adhered to by pharmaceuticals. This necessity to certify vaccine products as halal for the context of Malaysia has thus put the Halal Certification Body, like JAKIM, to be in limbo


INTRODUCTION
Various forms of diseases that plague our society today are caused by microorganisms, such as bacteria, viruses, fungus and many more. Some of these diseases can be prevented by using early preventive treatment methods with vaccines. Such diseases are also known as vaccine-preventive diseases, among which are small pox, measles, pertussis, poliomyelitis, haemophiles influenza, tuberculosis, and others (Azizi Ayob, 2017). Vaccines were discovered over 300 years ago to prevent the spread of infectious diseases, and vaccines can also save lives. However, vaccines in the early stages of their discovery were limited to a few diseases, and their effectiveness had also been limited.
In general, using vaccines to treat diseases as a method, can be very effective if the vaccines were used among a group of people who have been exposed to the disease before. These people are then given full vaccine treatment according to the required dose at a given time. If only a handful of individuals had taken the vaccine in an area or community, then the group immunity (herd immunity) is not achievable. Group immunity is very important because access and control of the disease is very closely related to the population that has immunity to the disease. At the same time, the identified vaccines can be given to the community that has not been infected. Thus, vaccines play a role in preventing harm, in the event of disease transmission (Azizi Ayob, 2017). The concept of halal vaccines has been floating around for a few years now, but thus far, nothing concrete had emerged in support of the issue. There is, at present, limited knowledge and little relevant empirical data to suggest the possibility of producing halal vaccines globally. In Malaysia, a medicinal product that is intended for halal certification must first obtain approval from the Drug Control Authority (DCA) to market. The DCA will then mark that the product had been reviewed for safety, quality

Materials
The reference materials are the Holy al-Quran, books, articles journal, conference papers, standards, legal statutes, guidelines and relevant websites that are considered relevant to this study.
It is intended to ensure that the references referred to a reliable and accurate.

Methods
In general, qualitative methods are used in this study. Qualitative method is one of the

Non-Halal Material
A vaccine product is derived from the combination of active and excipient ingredients. These substances can be obtained from a variety of sources like animal, plants, and synthetic origin. The animal sources may be porcine, or its derivatives, dead animals, or blood (Khoo et al., 2020). All these are haram or forbidden for Muslims to consume. However, the materials are usually used as the basis in producing vaccines. The difficulty of the industry in obtaining halal ingredients could cause vaccine products to be in a state of dilemma because it is difficult to be certified as halal, as what is currently happening in Malaysia. In Islam, Muslims are required to follow the divine law, which is authoritative. The Holy al-Quran says: The excerpt above is the evidence explaining why the Muslims abstain from using haram material, or consuming porcine or its derivatives. To sum up, the first challenge in implementing halal certification for vaccines is due to the non-halal raw materials used. The current Fatwa in Malaysia seems to hold the view that vaccines produced from sources of porcine origin are not permissible.
Alternatively, porcine derivative-free vaccines are prioritized for use unless there is an urgent need to use such products.

Malaysian Standard MS 2424: 2019 is only a General Guide
The Malaysian Standard (MS) is a document developed by the consensus and approval of a recognized body. It contains rules, guidelines, or characteristics for products or methods of processing which are related. It includes the terms of administration in which compliance is not mandatory (Standards of Malaysia Act 1996 (Act 549). The Malaysian Standard MS 2424 serves as a general guideline denoting the production, handling, and storage of halal products, as has been gazetted by the Government of Malaysia. This is also inclusive of vaccine products. The issue of halal certification is central to the global acceptance of halal products. However, at present, the Malaysian halal certification body, JAKIM, does not carry a specific standard operating procedure (SOP) that can provide the halal certification of vaccine products (Johari Ab Latiff, 2018). The process to provide halal certification for vaccines or vaccine products appear to be much more complex than it is for food, cosmetics, and logistics.
Based on the MS 2424 standard, it can be identified that the content of the standard is just a mere guideline. Therefore, the standard would require a more comprehensive interpretation and implementation. Overall, the halal certification body needs to develop a specific halal certification procedure or manual for the certification of halal vaccines and product certifications. This includes the determination of relevant Fatwa as is the case of vaccines that have gone through the additional process of removing the porcine-derived ingredients, or where the impure substance has been completely transformed and changed into a new substance, different from its origin. A thorough discussion between scholars from both the religious and scientific institutions may be necessary so as to determine its permissible or forbidden status.

The Readiness of the Halal Certification Body
Another challenge in implementing the halal certification to vaccines is the readiness of the halal certification body. Although JAKIM has long been implementing halal certifications, the process for vaccines has not been smooth because the halal certification for vaccine products requires more in-depth knowledge, in particular, the vaccine products. This means that a more sophisticated technical expertise is required (Johari Ab Latiff, 2018). In addition, Malaysia is still in the midst of setting up a factory that produces halal vaccine products, and this would involve the need to obtain more information before the halal certification bodies are able to process the implementation. In this regard, JAKIM has to ensure that there are sufficient and qualified personnel available, and that training is provided. Overall, to ensure the readiness of JAKIM in producing halal certifications, it needs to work with other agencies and industries, particularly the National Pharmaceutical Regulatory Agency (NPRA), and the Ministry of Health Malaysia so as to be able to implement the halal certification for vaccine products.

The Readiness of the Industries
One of the important factors for implementing the halal certification of vaccine products is the readiness of manufacturers or industries. The pharmaceutical industry must prepare the technical details and considerations when implementing the use of halal vaccines, following the pharmaceutical standards of Good Manufacturing Practices (GMPs) (Peng et al., 2013). Following this, factory facilities must be dedicated to the halal concept so as to ensure that the ingredients used are halal.
Moreover, the pharmaceutical industry must also comply with all the standards and requirements established by the halal certification bodies and respective authorities (Johari Ab Latiff, 2018). In fact, it is very difficult for the vaccine manufacturers or the pharmaceutical industry to make any changes, no matter how small, as stated in the context, because the process involves time and cost.

CONCLUSION
As has been noted, for the purpose of implementing halal certifications for vaccine products in the context of Malaysia, as a Muslim country, some obstacles and challenges need to be resolved, either by JAKIM, other halal certification bodies and agencies, or even the pharmaceutical industry itself. The production of vaccines or vaccine products must be obtained from halal sources, either from plants or animals' origin. The halal certification body, JAKIM, needs to explain how the process is conducted by developing a thorough manual that shows the procedure for the halal certification to be approved, specific to those vaccine products. The implementation of the halal certification of vaccine products is complex. More in-depth knowledge about the products and their ingredients and sources need to be examined. The process also requires technical expertise which encompass qualified and trained personnel and know-hows. The readiness of the pharmaceutical industry in changing any of the vaccine contents, providing a halal system of the process and halal facilities may take time even though the halal certification is an important step towards making vaccine products safe for Muslims, in general.