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EU signs new deal with Pfizer-BioNTech, Hungary opts out

Associated Press

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EU signs new deal with Pfizer-BioNTech

The European Union’s executive arm on Thursday finalized a third vaccine contract with Pfizer and BioNTech through 2023 for an additional 1.8 billion doses of their COVID-19 shot to share between the bloc’s countries except for Hungary, which opted out of the deal.

The European commission said the contract, which was agreed on behalf of all 27 EU countries earlier this month, will allow the buying of 900 million doses of the current shots and of a serum adapted to the virus’ variants, with an option to purchase an extra 900 million shots.

Although EU nations agreed to keep on with their strategy of buying doses collectively, Hungary decided not to be part of the new purchase agreement that followed previous agreements with the two companies for 600 million shots.

“Therefore it will not be covered by the contract,” EU Health Commissioner Stella Kyriakides said following a meeting with health ministers from the region. “All other member states will have the opportunity to purchase vaccines under the new contract.”

Hungary is using vaccines from China and Russia in addition to Western jabs. About 40% of Hungary’s population has received at least one dose of vaccine, the second-highest vaccination rate in the EU.

The signature of the new agreement comes less than a week before a court hearing in Brussels pitting the Commission against the pharmaceutical company AstraZeneca, which is accused by the EU of failing to deliver the promised number of doses of its own vaccine.

The Commission said that the deal with Pfizer-BioNTech stipulates that the production of doses must be based in the EU and that essential components are sourced from the region. “From the start of the supply in 2022, the delivery to the EU is guaranteed,” the Commission said.

AstraZeneca’s contract with the EU foresaw an initial 300 million doses for distribution among member countries, with an option for a further 100 million. The doses were expected to be delivered throughout 2021 but only 30 million were sent during the first quarter. According to the Commission, the company is set to provide only 70 million doses in the second quarter, rather than the 180 million it had promised.

In sharp contrast with the tense nature of its relationship with AstraZeneca, the Commission highlighted its “well-established cooperation” with BioNTech and Pfizer guaranteeing that “timely deliveries of the doses are ensured.”

The Commission said that under the new deal EU countries will have the possibility to donate some of their allocated doses to non-EU countries or through the U.N-backed effort known as COVAX, which is providing vaccines to low- and middle-income countries.

Kyriakides said the EU is now prioritizing vaccine technologies “that have proven their worth, like mRNA vaccines.”

The active ingredient in the Pfizer-BioNTech shot is messenger RNA, or mRNA, which contains the instructions for human cells to construct a harmless piece of the coronavirus called the spike protein. The human immune system recognizes the spike protein as foreign, allowing it to mount a response against the virus upon infection.

“But we keep our options open,” Kyriakides said. “The past months have clearly demonstrated the need to have access to a broad portfolio of vaccines and different technologies, as well as reliable partners. As the pace of vaccination increases every day and work on effective therapeutics intensifies, we can look ahead with more optimism and confidence.”

EU Commission president Ursula von der Leyen told an event organized by Germany’s WDR public television that, by the end of this week, 260 million doses of vaccine will have been delivered in Europe. She acknowledged that countries such as the U.S. and U.K. were faster to start with, but said “that has been put into perspective over time.”

After its much-criticized slow start, she said the bloc’s COVID-19 vaccination drive is a success.

“Yes, there was a lot of criticism of the European Union at the beginning,” she said in comments broadcast Thursday. “What counts in the end is that the European Union reliably delivers vaccines to its 450 million citizens day by day, and that we can say we got there together as a community. Measured by that, our European vaccination campaign is a success.”


BRUSSELS (AP) — By SAMUEL PETREQUIN Associated Press

Geir Moulson in Berlin contributed to this report.

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MedTech

AI cancer diagnosis platform receives FDA Designation

Karim Husami

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AI cancer diagnosis

The U.S. Food and Drug Administration (FDA) granted Breakthrough Device Designation to Ibex Medical Analytics, a specialist in AI-powered cancer diagnostics, which will help fast track the clinical review and regulatory approval of its platform.

Granting such approval is given to technologies that have the potential to provide more effective treatment or diagnosis of life-threatening diseases.

The designation enables close collaboration with, and expedited review by the FDA, and provides formal acknowledgement of the Galen platform’s utility and potential benefit as well as the robustness of Ibex’s clinical program.

Oncology treatments

According to the National Cancer Institute, approximately 39.5 percent of men and women will be diagnosed with cancer at some point during their lifetimes (based on 2015–2017 data).

“In 2020, an estimated 16,850 children and adolescents ages 0 to 19 will be diagnosed with cancer and 1,730 will die of the disease,” the institute noted.

An estimated 1,806,590 new cases of cancer will be diagnosed in the United States in 2020, it noted, and 606,520 people will die from the disease.

“Oncology treatments have made great strides, but to save more lives it is also essential to see technological advances in cancer diagnostics. Enhancing the accuracy of cancer diagnosis and improving the efficiency for the pathologist is paramount to improving quality and affordability of cancer care,” David Shulkin, MD, advisor to Ibex Medical Analytics said.

AI cancer diagnosis platform role

“Ibex’s AI platform has demonstrated success in helping pathologists worldwide improve care for patients with cancer. This FDA designation is an important step forward in making this technology broadly available in the United States,” David added.

That said, pathologists play an important role in the detection and diagnosis of disease, with their assessment being vital for correct treatment decisions in cancer care.

However, a rise in cancer prevalence and advances in personalized medicine have resulted in growing diagnostic complexity that significantly increases pathologists’ workloads.

As such, Ibex’s Galen platform uses Strong AI algorithms to help pathologists improve the quality of cancer diagnosis, implement real-time quality control, reduce diagnosis time, and boost productivity. It has already demonstrated outstanding outcomes in clinical studies and is deployed in labs worldwide where it is used as part of everyday clinical practice.

Joseph Mossel, chief executive officer and co-founder of Ibex Medical Analytics, said: “We are honored to have been granted the Breakthrough Device Designation. Ibex is committed to providing world class tools for pathologists to ensure every patient receives a timely and correct diagnosis, while supporting pathology labs and health systems to increase efficiency and accuracy. Our Strong AI technology is already in clinical use globally, making a real impact on patient care. We are proud to work closely with the FDA and look forward to continuing to collaborate with the agency as we accelerate our clinical program in the United States.”

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MedTech

Russia’s Sputnik V vaccine shows 94% efficacy in Bahrain

Inside Telecom Staff

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Sputnik-V

Controversy has been the main headline stuck to Russia’s Sputnik V COVID-19 vaccine, with many countries either doubting its efficacy levels or brushing it off due to political tensions between western countries and Russia.

In parallel, Russia hasn’t done a good job marketing the drug since it was named after the Soviet Union’s and the world’s first artificial satellite launched into space back in 1957.

But still the Russian vaccine persisted and remains to be administered to people all around the world as we speak.

With that in mind, the Russian Direct Investment Fund (RDIF, Russia’s sovereign wealth fund) announced on Thursday data of the Ministry of Health of the Kingdom of Bahrain on the Russian Sputnik V coronavirus vaccine confirming its safety and high efficacy during the vaccination campaign in the country.

The efficacy study was conducted in Bahrain in accordance with WHO guidelines involving more than 5,000 subjects. Overall efficacy beyond 14 days after administering the second dose was estimated at 94.3 percent.

Analysis is based on the data collected between February and early May 2021.

“Sputnik V has demonstrated efficacy of 94.3 percent and high safety confirming the data collected in a number of other countries where it is used to protect the population against coronavirus. The Russian vaccine is an important part of Bahrain’s diversified national portfolio. Use of Sputnik V is making a significant contribution in mitigating the spread of coronavirus, resuming normal life and economic activity,” Kirill Dmitriev, CEO of the Russian Direct Investment Fund (RDIF), said in a statement.

The data of the Ministry of Health also demonstrates that 98.6 percent of all COVID-19 cases 14 days after receiving the second dose were mild among those vaccinated with Sputnik V.

Vaccination data indicates high safety of Sputnik V:

  • No serious adverse events associated with vaccination;
  • No deaths related to the vaccination;
  • No cerebral vein thrombosis (CVT) cases after vaccination.

“Our data has confirmed the high efficacy and safety of Sputnik V during its use in Bahrain. This vaccine is one of a number of approved vaccines made available free of charge to citizens and residents in the Kingdom. Sputnik V continues to play an important role in the Kingdom’s ongoing and successful vaccination campaign, with 81 percent of the eligible population vaccinated so far,” Faeqa Saeed Al-Saleh, Bahrain’s Minister of Health, highlighted. 

Sputnik V has a number of key advantages:

  • Efficacy of Sputnik V is 97.6 percent based on the analysis of data on the coronavirus infection rate among those in Russia vaccinated with both components of Sputnik V from December 5, 2020, to March 31, 2021;
  • The vaccine is based on a proven and well-studied platform of human adenoviral vectors, which cause the common cold and have been around for thousands of years.
  • Sputnik V uses two different vectors for the two shots in a course of vaccination, providing immunity with a longer duration than vaccines using the same delivery mechanism for both shots.
  • The safety, efficacy, and lack of negative long-term effects of adenoviral vaccines have been proven by more than 250 clinical studies over two decades.
  • There are no strong allergies caused by Sputnik V.
  • The storage temperature of Sputnik V at +2+8 C means it can be stored in a conventional refrigerator without any need to invest in additional cold-chain infrastructure.
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MedTech

Orange, AXA acquire majority stake in Moroccan HealthTech company

Inside Telecom Staff

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HealthTech

Orange Middle East and Africa and AXA CIMA entities led by AXA Assurance Maroc announced on Monday a joint agreement to acquire a majority stake in DabaDoc, the Moroccan HealthTech company digitalizing access to healthcare in Africa, alongside the company’s founders.

DabaDoc – which was founded by Zineb Drissi-Kaitouni and Driss Drissi-Kaitouni earlier in 2014 – has developed solutions that are used by thousands of healthcare professionals in Morocco, Tunisia, and Algeria.

The agreement will allow both French companies to accelerate DabaDoc’s growth using their vast investment portfolios and network, particularly in Sub-Saharan Africa; the transaction is expected to close in the third quarter of 2021.

“As a responsible operator on the continent, we want to contribute to this major social challenge, especially during a pandemic. The deployment of this type of solution in the countries where we are present will greatly facilitate populations’ access to healthcare services, which is essential to the continent’s development,” Alioune Ndiaye, CEO of Orange Middle East and Africa, said in a joint statement.

With this acquisition, the French telco confirms its ambition of leading the line in multi-services digital operator in the region. Through its partnership with DabaDoc and relying on AXA’s globally recognized expertise in healthcare, Orange is positioned as a key player in HealthTech.

In parallel, this acquisition wouldn’t be the first investment AXA Assurance has placed in DabaDoc – with the first being in 2018 – but rather sends a message that the insurance company is looking to consolidate its partnership with the company to accelerate the digitalization and integration of its customers’ healthcare journey.

AXA will also aim to facilitate its policyholders’ interactions with healthcare professionals, notably via DabaDoc’s appointment booking and remote consultation infrastructure and network.

“This is one of the Group’s strategic priorities as part of the Driving Progress 2023 plan. This ambition is even stronger as we are facing an unprecedented health crisis. Through this partnership, we therefore aim to enable patients to access a better healthcare journey in Morocco and to support DabaDoc through its development in the CIMA countries as well,” Meryem Chami, CEO of AXA Assurance Maroc and AXA CIMA, highlighted.

In cementing this tri-party partnership, DabaDoc will benefit from the broad experience of AXA, one of the global leaders in health insurance, and Orange’s technological expertise and payment solutions to enable digital solutions to be developed that rapidly scale and benefit patients and the entire African healthcare ecosystem.

“Orange’s investment in DabaDoc and AXA’s renewed investment will strengthen DabaDoc’s growth ambitions through Orange and AXA’s presence in Africa and the Middle East. The pandemic has strengthened our belief that the digitalization of healthcare services is essential and inevitable,” Zineb Drissi-Kaitouni, co-founder and CEO of DabaDoc, noted in the statement.

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