EU drug regulator recommends authorizing vaccine for monkeypox
July 22, 2022, 4:31 pm

EU drug regulator recommends authorizing vaccine for monkeypox

Monkeypox is caused by monkeypox viruses, a type of Orthopoxvirus. Of the 2-types in humans, the West African type causes a less severe disease than the Central African (Congo Basin) type. It may spread from handling bushmeat, animal bites or scratches, body fluids, contaminated objects, or other close contact with an infected person - Photo: Twitter

The European Medicines Agency said Friday (July 22) that the smallpox vaccine made by Bavarian Nordic should also be authorized against monkeypox, as the outbreak of the once-rare disease continues to sicken people across the continent, the Alarabiya English reported, citing the Associated Press.

The European Union drug regulator said its recommendation was based on animal studies that suggest the vaccine protects non-human primates from monkeypox.

It is up to the EU’s executive arm, the European Commission, to formally approve the vaccine based on the EMA’s recommendation.

The EMA said: “To confirm the effectiveness of the vaccine against monkeypox, the company will collect data from an observational study that will be carried out during the ongoing monkeypox outbreak in Europe.”

It added that the vaccine’s safety profile was “favorable” and the benefits of its use during the ongoing monkeypox outbreak outweighed the risks, noting mostly mild to moderate side effects.

Monkeypox is an infectious viral disease that can occur in both humans and some other animals. Symptoms include fever, swollen lymph nodes, and a rash that forms blisters and then crusts over. The time from exposure to onset of symptoms ranges from 5-to-21 days. The duration of symptoms is typically 2 to 4 weeks - Photo: Twitter

The vaccine, known as Imvanex in Europe but sold as Jynneos in the United States, was already cleared for use against monkeypox by American regulators.

Of the more than 15,000 monkeypox cases reported worldwide, nearly 70 percent are in Europe, with more than 30 countries across the continent affected. Doses of the Bavarian Nordic vaccine are extremely limited.

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Most of the world’s supply has already been bought by countries and regions including Britain, Canada, the EU and the US.

None have gone to Africa, where a more severe version of monkeypox has killed dozens of people. No monkeypox deaths have been reported in rich countries.

People who catch monkeypox often experience symptoms that include fever, body aches, a rash and lesions; most recover within weeks without needing medical attention.

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Authorities in numerous countries, including Britain, Germany and the US, have offered the vaccine to health workers and those at high risk of being infected by monkeypox.

In the US, soaring demand for the monkeypox vaccine caused the appointment system to crash in New York City, one of many places where supplies have run out almost immediately after they arrived.

Source: alarabiyaenglish

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BENEFIT, the Kingdom’s innovator and leading company in Fintech and electronic financial transactions service, held its Annual General Meeting (AGM) at the company’s headquarters in the Seef District.
During the meeting, shareholders approved all items listed on the agenda, including the ratification of the minutes of the previous AGM held on 26 March 2024. The session reviewed and approved the Board’s Annual Report on the company’s activities and financial performance for the fiscal year ended 31 December 2024, and the shareholders expressed their satisfaction with the company’s operational and financial results during the reporting period.
The meeting also reviewed the Independent External Auditor’s Report on the company’s consolidated financial statements for the year ended 31 December 2024. Subsequently, the shareholders approved the audited financial statements for the fiscal year. Based on the Board’s recommendation, the shareholders approved the distribution of a cash dividend equivalent to 10% of the paid-up share capital.
Furthermore, the shareholders endorsed the allocation of a total amount of BD 172,500 as remuneration to the members of the Board for the year ended 31 December 2024, subject to prior clearance by related authorities.
The extension of the current composition of the Board was approved, which includes ten members and one CBB observer, for a further six-month term, expiring in September 2025, pending no objection from the CBB.
The meeting reviewed and approved the Corporate Governance Report for 2024, which affirmed the company’s full compliance with the corporate governance directives issued by the CBB and other applicable regulatory frameworks. The AGM absolved the Board Members of liability for any of their actions during the year ending on 31st December 2024, in accordance with the Commercial Companies Law.
In alignment with regulatory requirements, the session approved the reappointment of Ernst & Young (EY) as the company’s External Auditors for the fiscal year 2025, covering both the parent company and its subsidiaries—Sinnad and Bahrain FinTech Bay. The Board was authorised to determine the external auditors’ professional fees, subject to approval from the CBB, and the meeting concluded with a discussion of any additional issues as per Article (207) of the Commercial Companies Law.
Speaking on the company’s performance, Mr. Mohamed Al Bastaki, Chairman BENEFIT , stated: “In terms of the financial results for 2024, I am pleased to say that the year gone by has also been proved to be a success in delivering tangible results. Growth rate for 2024 was 19 per cent. Revenue for the year was BD 17 M (US$ 45.3 Million) and net profit was 2 Million ($ 5.3 Million).

Mr. Al Bastaki also announced that the Board had formally adopted a new three-year strategic roadmap to commence in 2025. The strategy encompasses a phased international expansion, optimisation of internal operations, enhanced revenue diversification, long-term sustainability initiatives, and the advancement of innovation and digital transformation initiatives across all service lines.
“I extend my sincere appreciation to the CBB for its continued support of BENEFIT and its pivotal role in fostering a stable and progressive regulatory environment for the Kingdom’s banking and financial sector—an environment that has significantly reinforced Bahrain’s standing as a leading financial hub in the region,” said Mr. Al Bastaki. “I would also like to thank our partner banks and valued customers for their trust, and our shareholders for their ongoing encouragement. The achievements of 2024 set a strong precedent, and I am confident they will serve as a foundation for yet another successful and impactful year ahead.”
Chief Executive of BENEFIT; Mr. Abdulwahed AlJanahi commented, “The year 2024 represented another pivotal chapter in BENEFIT ’s evolution. We achieved substantial progress in advancing our digital strategy across multiple sectors, while reinforcing our long-term commitment to the development of Bahrain’s financial services and payments landscape. Throughout the year, we remained firmly aligned with our objective of delivering measurable value to our shareholders, strategic partners, and customers. At the same time, we continued to play an active role in enabling Bahrain’s digital economy by introducing innovative solutions and service enhancements that directly address market needs and future opportunities.”
Mr. AlJanahi affirmed that BENEFIT has successfully developed a robust and well-integrated payment network that connects individuals and businesses across Bahrain, accelerating the adoption of emerging technologies in the banking and financial services sector and reinforcing Bahrain’s position as a growing fintech hub, and added, “Our achievements of the past year reflect a long-term vision to establish a resilient electronic payment infrastructure that supports the Kingdom’s digital economy. Key developments in 2024 included the implementation of central authentication for open banking via BENEFIT Pay”
Mr. AlJanahi concluded by thanking the Board for its strategic direction, the company’s staff for their continued dedication, and the Central Bank of Bahrain, member banks, and shareholders for their valuable partnership and confidence in the company’s long-term vision.