MUI: Sinovac\'s Covid-19 Vaccine is Halal
The Indonesian Ulema Council (MUI) has declared the Covid-19 vaccine holy and halal.
The Indonesian Ulema Council (MUI) has declared the Covid-19 vaccine holy and halal. Furthermore, the full fatwa for its use awaits the results of a study from the Food and Drug Monitoring Agency (BPOM) regarding the vaccine’s safety.
JAKARTA, KOMPAS — The Covid-19 vaccine produced by Sinovac, China, which the government has prepared for inoculating millions of people, has been declared halal and holy. The assessment was decided in a plenary session of the MUI’s Fatwa Commission.
For the vaccination drive to proceed, an emergency use permit from the BPOM is still pending. "Regarding the halal aspect, after a long discussion and hearing explanations from auditors, the Fatwa Commission meeting agreed that the Covid-19 vaccine made by Sinovac Lifescience, whose certification was submitted by Bio Farma, is holy and halal," said the chairman of the MUI for Fatwas, KH Asrorun Ni\'am Sholeh, at a press conference in Jakarta on Friday (8/1/2021).
The decision to declare the vaccine is halal was made after the Fatwa Commission reviewed the results of the MUI audit team. The team consisted of the Central MUI Fatwa Commission and the MUI Food, Drug and Cosmetics Assessment Institute (LPPOM), which is experienced in auditing measles and rubella vaccines.
Together with a team from the Health Ministry, PT Bio Farma and the BPOM, the MUI team visited the Sinovac factory in China to audit whether the vaccine is halal. The MUI team also conducted an audit at the Bio Farma factory, which will produce the Covid-19 vaccine from Sinovac.
The audit results were reported to the MUI Fatwa Commission for religious studies before determining the vaccine halal. The report was discussed at a plenary meeting. As a result, the Covid-19 Sinovac vaccine was declared halal and holy. "We are waiting for the final results of its thoyib (reliability). The full fatwa will be delivered after the BPOM describes the safety aspects of the vaccine," said Ni\'am.The BPOM has received the latest data on the clinical trial of the third phase of the Covid-19 Sinovac vaccine conducted by Bio Farma. This data is to demonstrate the efficacy of the vaccine as a consideration for granting emergency use permits.
Before Jan. 13
BPOM head Penny K Lukito said the advantage of the vaccine was shown by vaccine efficacy data from the percentage reduction in the incidence of disease in the group of people who were vaccinated in the third phase of the clinical trials. Measurement of immunogenicity -- the ability of the vaccine to form antibodies in the body -- is also an important parameter of the vaccine efficacy.
"Complete data on the results of the third phase of the clinical trials in Bandung for interim observation for three months is given today, and we will discuss it as soon as possible. We hope we can issue an EUA (emergency use permit) before the 13th [of January], so that vaccinations will be carried out on that date," Penny said.
The standards and requirements for the EUA of the Covid-19 vaccine are based on World Health Organization (WHO) guidelines and standards of the US Food and Drug Administration (US-FDA) and the European Medicines Agency (EMA). The requirements for EUA administration include the fact that the vaccine has clinical trial data from phases one and two as well as interim analysis data of phase three of the clinical trials related to efficacy and safety.
The EUA administration can use interim data analysis with a monitoring period of three months. Monitoring should be continued for six months. The WHO requires a minimum efficacy of 50 percent of the Covid-19 vaccine from the three months\' data.
Penny said the clinical trial of Sinovac’s CoronaVac vaccine in Bandung had the same design as the clinical trials in Brazil and Turkey, namely using vaccine recipients in the age range of 18-59 years. The clinical trial in Brazil pointed to an efficacy rate of 78 percent and the clinical trial in Turkey had an efficacy of 91.25 percent.
The data is utilized as a consideration for the formulation of the EUA for the use of the Covid-19 vaccine in Indonesia. In evaluating the issuance of EUA, the BPOM involved the National Committee for Drug Assessment and the Indonesian Technical Advisory Group on Immunization (ITAGI).
"The BPOM applies the principle of prudence, independence, integrity and transparency in making the decision on issuing distribution permits, including EUA," said Penny. A total of 1.3 million health workers as well as 17.4 million public service workers will be prioritized as the first vaccine recipients, because both of those often interact with Covid-19 sufferers.
Indonesian National Nurses Association (PPNI) chairman Harif Fadhillah said all nurses were expected to take part in the Covid-19 vaccination. Most of the nurses were ready to be inoculated.
According to an internal survey conducted by the PPNI in December 2020, as many as 82.04 percent of the 1,700 respondents were willing to be the first group to receive the vaccine. In addition, 65.00 percent of respondents wanted to become volunteers to administer the vaccination.
Penny said that, after the vaccination, the BPOM would continue to oversee the safety of the vaccine. Her agency coordinates with the Health Ministry, the National Committee and the Regional Committee for the Study and Mitigation of Post-Immunization Effects to monitor the post-immunization effects.
According to the head of the National Commission on Post-Immunization Effects (KIPI), Hindra Irawan Satari, the vaccine’s ingredients used by the government are certainly not dangerous. [The vaccine’s] safety has been monitored since the preclinical testing.
On Friday, there was an addition of 10,617 new Covid-19 cases, bringing the total number of confirmed cases to 808,340. The death rate increased by 233 people, bringing the total to 23,753 fatalities.
To detect the mutation of the coronavirus that causes Covid-19, the government formed a genomic surveillance team. According to Research and Technology Minister/Head of the National Research and Innovation Agency Bambang PS Brodjonegoro, the team aims to understand the character and mutation of SARS-CoV-2, the virus that causes Covid-19.
The Covid-19 vaccine made by Pfizer and BioNTech is likely to work against a new, highly contagious variant of the coronavirus discovered first in the UK. To fight a mutated form from South Africa, further studies are needed.
A study by Pfizer and scientists from the University of Texas Medical Branch, which has not yet been peer-reviewed but has been posted on bioRxiv, shows the vaccine is effective at neutralizing the virus with the so-called N501Y spike protein mutation.
This mutation could be responsible for greater transmissibility, according to Phil Dormitzer, a vaccine scientist at Pfizer, as quoted by Reuters. (NTA/AIK/TAN)
(This article was translated by Hyginus Hardoyo).
(The captions were translated by Kurniawan H. Siswoko)