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Indonesia ready to start using AstraZeneca after suspension

BPOM declares dual-dose vaccine safe for inoculations

Ardila Syakriah (The Jakarta Post)
Jakarta
Mon, March 22, 2021 Published on Mar. 21, 2021 Published on 2021-03-21T20:12:50+07:00

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Indonesia ready to start using AstraZeneca after suspension

I

ndonesia is ready to roll out the COVID-19 vaccine made by British-Swedish firm AstraZeneca after a brief delay over blood clot concerns, as the country’s drug regulator and top Muslim clerical body have approved its use.

The Food and Drug Monitoring Agency (BPOM) announced that the vaccine was safe to use, a day after its European Union counterpart, the European Medicines Agency (EMA), had said that its benefits in preventing hospitalizations and deaths outweighed the risk of its side effects. The EMA said the vaccine was not associated with an increase in the overall risk of blood clots.

The BPOM had reviewed the vaccine alongside several other institutions, like the National Commission on Post-Immunization Accidents (Komnas KIPI) and Indonesia's Technical Advisory Group on Immunization (ITAGI), BPOM spokesperson Lucia Rizka Andalusia said, adding that it had also consulted with the World Health Organization and studied investigation reports from drug regulators of other countries.

“COVID-19 case numbers are still high. There may be adverse events [from the vaccines], but the risks of dying of COVID-19 are far higher. That's why the people should still get the vaccine as scheduled,” Lucia told a press briefing on Friday.

Read also: Indonesia delays rollout of AstraZeneca vaccine

The dual-dose AstraZeneca vaccine can be used for people aged 18 years and above with an interval of between eight and 12 weeks. It has an overall efficacy of 62.1 percent and adverse events from the trials are mild to moderate, starting from pains around the injection area to fever, according to Rizka.

More than 70 countries have authorized the vaccine for emergency use, the firm said, as the WHO has also granted it emergency use listing, allowing it to be distributed to over 100 countries through the multilateral initiative COVAX facility. Indonesia is among the recipients from the facility, having received 1.1 million doses on March 8 and expecting another 10 million doses.

As countries recently halted its use, the WHO has called for continuation, saying that "venous thromboembolism is the third-most common cardiovascular disease globally."

Following its investigation, the EMA said around 20 million people in the United Kingdom and European countries had received the vaccine as of March 16, and that the agency had reviewed only seven cases of blood clots in multiple blood vessels and 18 cases of clots in the vessels draining blood from the brain, leading to nine deaths.

The events reported upon vaccination were lower than what would be expected in the general population, it said, noting however that further analysis might be necessary for very rare cases of unusual blood clots found in women under 55 years of age.

Read also: WHO experts say countries should keep using AstraZeneca jab

The Indonesian Ulema Council (MUI) has issued an edict strongly recommending its use, although its edict department head Asrorun Niam Sholeh made a point to note it was haram, or forbidden in Islam, because it was processed with pork-derived trypsin.

He said the vaccine could be administered due to the emergency situation, the fatal risk if people are not vaccinated, the insufficient supply of halal vaccines and assurances of its safety from the authorities.

"The government must work on securing halal and pure vaccines [...]. Indonesian Muslims must participate in the COVID-19 vaccination program," he said during the Friday briefing.

A widely-circulating statement reported to be from AstraZeneca Indonesia showed that the firm said the vaccine did not contain any products from animal, let alone pigs, as it had been allowed for use in Muslim countries and by Islamic boards abroad, according to news reports. AstraZeneca Indonesia was not immediately available for comment.

A written statement circulated by the COVID-19 handling and national economic recovery team on Sunday cited Airlangga University epidemiologist M. Atoillah Isfandi, who said the porcine trypsin was only used in the early stage of the vaccine development and was not contained in the end product, hence it should be halal.

Read also: Indonesia receives first AstraZeneca vaccines under COVAX facility

Epidemiologist Dicky Budiman was worried that the recent suspension of the use of AstraZeneca's vaccine and its haram status might lead to vaccine rejection among Indonesians.

"Their risk communication strategy will surely affect [vaccine rejection]. There must be improvement in the future on how the MUI, the Health Ministry and the BPOM need to first collaborate on choosing which vaccines should be used," he said.

He said there should not be a repeat of what happened with the measles vaccine in 2018, when a fatwa declaring it haram had driven people away from vaccination, and with the meningitis vaccine when it was deemed haram years ago, leading to the doses already in the country to be sent to other countries.

The Health Ministry will work with the MUI and its local councils as well as local administrations to boost people's confidence in the AstraZeneca vaccine, according to ministry spokesperson Siti Nadia Tarmizi. The vaccine would be used on the second- priority group in regions set to accelerate their vaccination programs, such as Bali to support its tourism.

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