On Measles-Rubella Vaccine Halal Certification
Indonesia ranks ninth among the world’s countries with the largest volume of measles and rubella cases. These two diseases threaten the lives of millions of Indonesian children because they do not have a cure. The only option is a vaccine to develop immunity.
Indonesia ranks ninth among the world’s countries with the largest volume of measles and rubella cases.
These two diseases threaten the lives of millions of Indonesian children because they do not have a cure. The only option is a vaccine to develop immunity against the diseases.
The World Health Organisation (WHO) launched a program at the 2012 World Health Assembly to eliminate measles and rubella throughout the world by 2020. However, in Indonesia, measles and rubella remain one of the main causes of death in children under 5.
Therefore, the government implemented a mass measles and rubella (MR) immunization program. MR immunization ran from August to September 2017 in Java with a target of 35 million children. In August-September 2018, it is targeting 32 million children outside Java.
Unfortunately, the program did not run smoothly. Controversy emerged on the vaccine’s halal status. Some people refused to be vaccinated because the MR vaccine was not certified as halal.
Measles and Rubella
Measles is an acute disease caused by a highly contagious virus that is especially passed through breathing in infected bodily fluids. The symptoms of this disease include fever, reddish spots on the skin, accompanied by coughing and bloodshot eyes. Measles can trigger serious health complications such as pneumonia, brain inflammation, blindness and malnutrition that can lead to death.
Rubella frequently infects children and young adults, especially those who are highly vulnerable to infection. The rubella virus can infect pregnant women who pass it to their fetuses. The result is a childhood disease called congenital rubella syndrome, or CRS.
Infants that develop CSR will have a great risk of heart problems, hearing impairment, brain calcification and delayed development. The Health Ministry’s CRS incidence rate estimate is 0.2 per birth per year. In 2015, 979 CRS cases were reported from among 4.89 million births.
Every year, more than 11,000 suspected measles cases are reported through monitoring programs. Laboratory tests confirm 12 to 39 percent of these cases as measles infections, while 16-43 percent are confirmed rubella cases. These figures are lower than the actual numbers, as many cases are unreported.
It has been proven that the combined measles-rubella (MR) vaccine significantly reduces morbidity and mortality from the two diseases. High immunization coverage of at least 95 percent can form herd immunity and can break the chain of transmission.
However, the measles vaccine coverage of regencies/cities has been on a downward trend, falling from 45 percent in 2013 to 28 percent in 2015. The declining immunization coverage correlates with the rising incidence rate of measles.
Researches in the US show very significant results in the effectiveness of the combined measles, mumps and rubella (MMR) vaccine. From 1958 to 1962, before the vaccine was developed in 1963, 503,282 cases of measles morbidity were recorded. Following a 2000 vaccination program, the morbidity rate dropped to 81 cases, a nearly 100 percent decrease.
In 1966-1968 before vaccination, 47,745 rubella cases were recorded. Following a 2000 vaccination program, the figure fell to 152 cases, or a decrease of 99.7 percent. In 1968 before vaccination, 152,209 cases of mumps morbidity were recorded. Following a 2000 vaccination program, morbidity fell to 323 cases, or a 99.8 percent decrease. It can thus be concluded that MMR immunization is effective in saving the lives of children under 5.
Vaccine development
The rubella virus was isolated for the first time in the 1960s from the tissues of an aborted fetus, as the mother and fetus were both infected with the wild rubella virus. The isolated virus was confirmed to be the cause of CRS. The virus was tested in various cells, including engineered chicken cells and mammalian cells, but the human diploid cells (HDC) were eventually chosen and the virus was successfully weakened into a vaccine strain that proved safe for humans.
The use of HDC to grow the rubella virus was safe, free from contamination and genetically stable. The virus is isolated from the host cells and purified through a long process to produce a pure viral strain that is safe for vaccination.
The measles vaccine development technology currently uses propagation techniques using poultry/chicken embryos or HDC tissues, while developing the rubella vaccine uses only HDC for propagation.
The world’s MR vaccine strain now comes from the WHO, namely the Wistar A 27/3 rubella and Edmonstone Zagreb measles strains. These strains have undergone a long development process, from weakening, refining and finally to standardized microbiological use as a parent strain or master seed to be used throughout the world.
The MR vaccine used in Indonesia is imported from Serum International India (SII), which uses the master seed or broodstock from the WHO. The problem is that the SII produced the MR vaccine without halal certificatication from the MUI (Indonesian Ulema Council).
Indeed, the Health Ministry and the MUI later agreed to postpone the MR immunization program for people with halal concerns until the MUI issued a fatwa on the MR vaccine.
Thankfully, the MUI has issued a fatwa on the vaccine. However, several preventive steps can be taken so that a vaccine will not be subject to controversy. Among these is a study on the SII-produced MR vaccine, especially into those critical components that may raise halal issues. The key is in the use of trypsin to separate the virus from its host cells.
Trypsin, which SII uses to produce MR vaccines, is available as a porcine derivative or as recombinant porcine trypsin, the latter of which is free from all animal/human materials. In producing a vaccine, trypsin is eliminated by ultrafiltration and chromatography until no residue remains.
To control the process, a PCR (polymerase chain reaction) test can be run. The PCR method enzymatically duplicates DNA without using organic materials. Applying the PCR method prevents the replication of porcine DNA, resulting in a porcine DNA-negative MR vaccine.
The vaccine must have negative porcine residue because otherwise, the subsequent production process would not comply with safety and purity standards. As the SII-produced MR vaccine is free from porcine components, it is used in 40 member countries of the Organization of Islamic Cooperation (OIC).
In the future, the MUI should not merely refer to the fiqh (Islamic jurisprudence/law) in issuing halal certificates for vaccines, drugs or any other product that benefits many people, but also examine biotechnology development and the studies that ulema have conducted in many Islamic countries.
Sampurno, 2001-2006 Chairman, Food and Drug Monitoring Agency (BPOM); Lecturer, Pharmacy Business Administration Masters Programs, Gadjah Mada University and Pancasila University