VOI - Voice of Indonesia | RRI - Radio Republik Indonesia

Britain’s medicine regulator said anyone with a history of anaphylaxis to a medicine or food should not get the Pfizer-BioNTech COVID-19 vaccine, giving fuller guidance on an earlier allergy warning about the shot.

Starting with the elderly and frontline workers, Britain began mass vaccinating its population on Tuesday, part of a global drive that poses one of the biggest logistical challenges in peacetime history.

The Medicines and Healthcare Products Regulatory Agency (MHRA) said there had been two reports of anaphylaxis and one report of a possible allergic reaction since the rollout began.

“Any person with a history of anaphylaxis to a vaccine, medicine, or food should not receive the Pfizer BioNTech vaccine,” MHRA Chief Executive June Raine said in a statement.

“Most people will not get anaphylaxis and the benefits in protecting people against COVID-19 outweigh the risks... You can be completely confident that this vaccine has met the MHRA’s robust standards of safety, quality, and effectiveness.”

Anaphylaxis is an overreaction of the body’s immune system, which the National Health Service describes as severe and sometimes life-threatening.

The fuller guidance, clarifying that the main risk was from anaphylaxis specifically, was issued after consulting experts on allergies. The MHRA had initially advised anyone with a history of a “significant allergic reaction” not to take the shot.

Pfizer and BioNTech said they were supporting the MHRA’s investigation.

Last week, Britain’s MHRA became the first in the world to approve the vaccine, developed by Germany’s BioNTech and Pfizer, while the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) continue to assess the data.

A top U.S. official said on Wednesday that Americans with known severe allergic reactions may not be candidates for Pfizer’s COVID-19 vaccine until more was understood about what had happened.

Canada’s health ministry said it would look at the reported adverse reactions in Britain, but said adverse events were to be expected and would not necessarily change the risk/benefit of the shot after the country approved the vaccine.

ALLERGIC REACTION

MHRA chief Raine told lawmakers such allergic reactions had not been a feature of the Pfizer’s clinical trials.

Pfizer has said people with a history of severe adverse allergic reactions to vaccines or the candidate’s ingredients were excluded from their late stage trials, which is reflected in the MHRA’s emergency approval protocol.

However, the allergic reactions may have been caused by a component of Pfizer’s vaccine called polyethylene glycol, or PEG, which helps stabilise the shot and is not in other types of vaccines.

Imperial College London’s Paul Turner, an expert in allergy and immunology, who has been advising the MHRA on their revised guidance, told Reuters: “As we’ve had more information through, the initial concern that maybe it affects everyone with allergies is not true.”

“The ingredients like PEG which we think might be responsible for the reactions are not related to things which can cause food allergy. Likewise, people with a known allergy to just one medicine should not be at risk,” Turner told Reuters.

The EMA said in an email that all quality, safety and efficacy data would be taken into account in assessing the vaccine, including data generated outside the EU.

In the United States, the FDA released documents on Tuesday in preparation for an advisory committee meeting on Thursday, saying the Pfizer vaccine’s efficacy and safety data met its expectations for authorization.

The briefing documents said 0.63% of people in the vaccine group and 0.51% in the placebo group reported possible allergic reactions in trials, which Peter Openshaw, professor of experimental medicine at Imperial College London, said was a very small number.

“The fact that we know so soon about these two allergic reactions and that the regulator has acted on this to issue precautionary advice shows that this monitoring system is working well,” he said.

However, Gregory Poland, a virologist and vaccine researcher with the Mayo Clinic in Rochester, Minnesota, said that the MHRA and NHS had overreacted initially.

“I would not have broadened to the degree they did,” he said.

“It’s reasonable to let the world know about this, and to be aware of it in terms of people who have had reactions like this to vaccines. I think to say medicines, foods or any other allergies is past the boundary of science.” (Reuters)

The Corruption Eradication Commission (KPK), National Counterterrorism Agency (BNPT), National Narcotics Agency (BNN), and Pancasila Ideology Education Agency (BPIP) are on the same page to exchange information and data under the endeavors to prevent corruption.

To this effect, leaders of four state agencies inked a memorandum of understanding (MoU) at the KPK Red-and-White Building here on Thursday.

The leaders of state agencies are KPK Chief Firli Bahuri, BNPT Chief Boy Rafli Amar, BNN Chief Heru Winarko, and BPIP Chief Yudian Wahyudi.

KPK Chief Bahuri affirmed that through the exchange of information, the four state agencies will prevent corruption crimes, organize education and training, conduct assessment and research, and provide people as sources and experts.

"The other scopes we have agreed upon cover (the prevention of) corruption, terrorism, narcotics (abuse), and narcotics precursors as well as instilling Pancasila values by observing their respective authority in accordance with the law," Bahuri noted in a statement released on Tuesday.

"The KPK is keen to eradicate corruption. If the values of Pancasila can be instilled (in everyone), nobody will commit corrupt acts," he affirmed.

The KPK is optimistic that the MoU between the four state agencies would be one of the several joint efforts to fulfill duties and functions of each agency in keeping with the public interest.

Hence, the state budget fund can be utilized optimally to boost the people's welfare and reduce potential irregularities that trigger suffering among people, he stated. (Antaranews)

Coordinating Political, Legal, and Security Affairs Minister, Mahfud MD, highlighted at a meeting with Secretary General of the World Moslem League that Indonesia is a laboratory of pluralism and tolerance.

"Indonesia is the most effective laboratory of pluralism and tolerance in the world, as a country with the largest Muslim population in the world and with a very complete variety of religions and religious schools. Everyone can live side by side," Mahfud MD stated at a meeting with Secretary General Syech Abdul Karim Al Issa of the World Moslem League in Riyadh, Saudi Arabia, on Tuesday (December 8), as cited from the statement received here, Wednesday.

During the 90-minute-long meeting, Mahfud MD and Al Issa stressed on the significance of implementing moderation of Islam, or Wasathiyyah Islam, among Muslims globally.

Inclusiveness has become an important aspect in the lives of people in nations and countries, taking into account the diverse religions and beliefs embraced by humans globally.

Muslims were urged to not become trapped in either radical extremism or liberalism and instead adopt a moderate outlook and serve as the agents of peace.

Mahfud MD believed that the concept of moderate Islam is pertinent to Muslims in Indonesia, as the country is home to a plethora of religions and beliefs.

Meanwhile, Secretary General Abdul Karim Al-Issa expressed pride over the mainstreaming of moderate Islam by Indonesian Muslims.

"Some time ago, I visited Indonesia and officially opened the Museum of the History of the Prophet Muhammad and delivered lectures at various places. Muslims there really reflect the awareness that humans are created differently but have the same position in life together. Indonesian Muslims follow the Medina Charter made by the Prophet Muhammad himself," Al-Issa stated.

The coordinating minister and secretary general then agreed to cooperate in spreading Wasathiyyah Islam through their networks. (Antaranews)

State-owned oil and gas company PT Pertamina (Persero) has developed a coal gasification project to produce an alternative source of energy to curb the imports of liquefied natural gas (LNG) since Indonesia has copious resources.

"We are striving to reduce the import of fuel oil and LPG to optimize local natural resources as raw material for energy production. Thus, it could reduce imports and the deficit in trade balance. With abundant resources in Indonesia and supported by the right technology, the coal-to-dimethyl ether gasification project to replace LPG will not become an environmental issue in Indonesia. The key is on the choice of technology," Pertamina's President Director, Nicke Widyawati, stated here on Wednesday.

However, Widyawati stressed on the urgency to develop an apt technology for the program to lower environmental impacts.

The company has inked an agreement with Bomba Group through the latter's subsidiary PT Berkah Bomba Energi in order to gasify coal into dimethyl ether.

CEO of PT Berkah Bomba Energi Todotua Pasaribu echoed the company’s support to the government's efforts to lower dependence on LPG imports and develop energy resilience through diversification in the energy business.

"We are committed to developing the project in order to support regional development, especially in the southern Sumatra region," he stated.

Bomba Group has other business units in coal, plantation, power plant, and property in South Sumatra.

Director General of Coal of the Energy and Mineral Resources Ministry Ridwan Djamaluddin stated that the cooperation held strategic importance since Indonesia had abundant low-calorie coal resources.

"We are optimistic that the program would offer us a competitive advantage. We are also striving to attract more investment to create a multiplier effect," Djamaluddin remarked. (Antaranews)