Pfizer asks US FDA to authorize booster shots for all adults 18 years old and over
November 10, 2021, 1:09 am

Pfizer asks US FDA to authorize booster shots for all adults 18 years old and over

COVID in USA-Stores closed/Pixabay

The Xinhua reported that drug makers Pfizer and BioNTech said on Tuesday that they had asked the U.S. Food and Drug Administration (FDA) to authorize booster shots of their COVID-19 vaccine for all adults 18 years old and over, seeking to broaden who is eligible for a third shot.

The move came as part of a long-running debate among experts over who should be eligible for booster shots. An FDA advisory panel voted against a request for all adults to have a booster in September, in what was "a blow to the (Joe) Biden administration's earlier announcement of widespread shots," said The Hill.

Currently, people who get the Pfizer/BioNTech or Moderna COVID-19 vaccines six months ago or longer may get a booster if they are 65 or older; at risk of severe COVID-19 from a breakthrough infection because of a medical condition such as diabetes, kidney disease or pregnancy; or at risk because of living conditions or work.

Vaccination center-COVID vaccines/Pixabay

The companies said the submission was based on results of a Phase 3 trial involving more than 10,000 participants. It found boosters were safe and had an efficacy of 95 percent against symptomatic COVID-19 compared with the two-dose vaccine schedule in the period when the highly transmissible Delta was the dominant strain.

The new request from Pfizer and BioNTech came as "federal health officials have made clear their concern about waning immunity as the nation heads into the winter months," reported CNN. The Pfizer/BioNTech vaccine itself was already authorized for use in people from ages 5 to 15, and approved for people aged 16 and older.

The FDA has not scheduled a meeting of its independent advisory committee for November, suggesting the agency may make a decision on the Pfizer-BioNTech on its own without seeking external advice, reported National Public Radio (NPR).

On Tuesday, the U.S. Centers for Disease Control and Prevention updated that 224,257,467 people have received at least one dose of COVID-19 vaccine, making up 67.5 percent of the whole U.S. population; fully vaccinated people stood at 194,168,611, accounting for 58.5 percent of the total. A total of 25,368,545 people, or 13.1 percent of fully vaccinated group, have received booster shots.

Source: xinhua

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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.