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

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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.

MedTech

Integer plans $30 million innovation and manufacturing facility in Galway

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Integer Holdings, a medical device outsource (MDO) manufacturer, will further expand its presence in Galway with the construction of a new Medical Device Innovation and Manufacturing facility in the Parkmore East area of the city.

Plano, Texas–based Integer said the initial phase of the project will total 60,000 square feet and a $30 million investment over the coming years, with construction scheduled from 2022 to late 2023 and equipment investments continuing for another two or three years.

Integer said it has planning permission for another 87,000 square feet of expansion when needed.

This new facility is required to meet increased demand for regional research, development and manufacturing capabilities, as well as capacity for catheters and delivery systems. It adds to Integer’s 15 global manufacturing sites and current presence in Ireland, which includes an R&D centre in Galway and manufacturing facilities in Galway and New Ross, County Wexford.

Tánaiste and minister for enterprise trade & employment Leo Varadkar TD, said: “I’m really pleased to see Integer announce further investment in Galway, with the addition of a new Medical Device Innovation and Manufacturing facility. I understand that this expansion will result in 100-200 new roles in the coming years, creating excellent employment opportunities for people in the area. This collaboration between IDA Ireland and Integer is another example of the valuable work that IDA Ireland does to bring investment into the country. I wish the team every success with this expansion.”

The expansion is expected to add 100 to 200 new jobs in engineering, administration and manufacturing, plus several hundred third-party contractors in the Galway region. Integer said it has around 1,300 employees in Ireland, including 350 in Galway.

The investment is being supported by the government through the IDA Ireland.

“Integer’s planned expansion in Galway is very welcome news,” said IDA Ireland CEO Martin Shanahan.

This is an important strategic move for the company, he noted, positioning it to meet growing demand globally for its products.

“This is a significant investment by a leading medical devices company and demonstrates Integer’s continued commitment to Galway and the West Region,” he added.”

The company, which has been in Ireland for over 25 years, currently employs approximately 1,300 people in Ireland, with 350 based in Galway.

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MedTech

FDA backs Pfizer-BioNTech COVID-19 booster for Americans with high-risk illness

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The U.S. Food and Drug Administration (FDA) finally authorized on Wednesday Pfizer and BioNTech vaccine booster dose against COVID-19’s delta variant for Americans aged 65 and older with a high risk of grave illness.

While the dose will strictly involve a specific population group, boosters will be accessible to individuals between 18 and 64 years with health-threatening risks of extreme illness from the coronavirus. In parallel, the dose will be given to employees working in explicit establishments or hold certain job positions that might expose them to contracting severe COVID-19 complications, such as doctors and nurses, teachers, daycare employees, grocery workers, and people in homeless shelters.

According to the FDA’s statement, the third booster dose should be administered six months after the first two shots. 

“The FDA considered the committee’s input and conducted its own thorough review of the submitted data to reach today’s decision,” director of the FDA’s Center for Biologics Evaluation and Research, Peter Marks said in a statement.

“We will continue to analyze data submitted to the FDA pertaining to the use of booster doses of COVID-19 vaccines, and we will make further decisions as appropriate based on the data,” he added.

The FDA’s authorization will pave the way for what seems to be a complicated campaign to distribute the shots to the country’s most exposed and susceptible population, leading to potentially millions of Americans getting their vaccines at pharmacies, health clinics, and doctors’ offices.

While the administration endorsed the shots, Pfizer Inc. set safety and side effects measures by analyzing the booster’s effects in a clinical trial that involved 318 people.

During the clinical trial, the first category comprised of 306 individuals ranged between 18 and 55 years old while 12 people exceeded 65 years. The process took two months of monitoring while analyzing side effects such as pain, redness, swelling at the injection site, fatigue, headache, muscle and joint pain, and chills. 

While the third Pfizer- BioNTech shot has similar side effects to the first two shots, the FDA disclosed that a set of participants frequently suffered from swollen lymph nodes in their underarms after receiving the booster shot.

The U.S. Centers for Disease Control’s (CDC) Advisory Committee on Immunization Practice conducted a prolonged meeting on Wednesday to address collected data to analyze the effectiveness and assurance of the Pfizer-BioNTech third shot. While the committee has already studied the data, its final recommendation will be settled during its assemblage on Tuesday.

The FDA’s authorization will set the right framework for the Committee’s recommendations regarding boosters, as the CDC aims to make equitable approvals from a public health perspective, which in CDC’s advisors’ opinion should be based on preventing the intensity of the disease instead of aiming to prevent moderate infections.

As for the individuals who received a different vaccine, the FDA’s booster shot approval and the CDC’s data analysis will not refer to Moderna and Johnson & Johnson doses, as federal actions will take place in the upcoming weeks.

An FDA official, Doran Fink, engaged in CDC’s recommendatory meeting, disclosed that the federal agency does not have sufficient data to endorse the success and effectiveness of administering a Pfizer- BioNTech booster to individuals who got immunized with a different vaccine.

The FDA’s Wednesday authorization listed the U.S. as the world’s most prosperous nation to deliver booster doses, joining a league incorporating Germany, France, Israel, and the U.K.

While some public health specialists prefer if doses were sent to countries with lower vaccine rates, the Biden Administration pledged on Wednesday at a virtual COVID-19 summit to distribute an additional backup health package comprised of 500 million Pfizer doses to countries in need.

“We believe boosters have an important role in play in addressing the continued threat of this disease, alongside efforts to increase global access and uptake among the unvaccinated,” chairman and chief executive of Pfizer, Albert Bourla said in a statement.

The vagueness following the CDC’s decision will linger until its meeting on Tuesday, while the FDA’s ruling could potentially detriment the Biden Administration’s scheme to distribute booster shoots to the majority of the country’s citizens.

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MedTech

Start-up develops “world’s first” tomographic ultrasound robot

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Sydney-based medical device start-up Vexev has developed what it says is the world’s first tomographic ultrasound robot (TUR) to make diagnostics more affordable, accessible and insightful, after spending two years in stealth mode.

The primary method of diagnosis for cardiovascular disease is 2D ultrasound operated by a sonographer. Whilst 2D ultrasound is one of the most affordable imaging diagnostic modalities, and does not involve harmful radiation to the patient, it has several limitations – affordability, inconsistency and can only produce 2D scans.

Skilled sonographers are also increasingly in short demand, and their careers are often shortened by RSI due to years of operating 2D ultrasound machines.

The TUR will be tested in upcoming clinical trials at Sydney’s Eastern Suburbs Vascular Imaging, which is located at the Prince of Wales Hospital campus. The trials are supported by Australian vascular surgeons such as Dr Shannon Thomas, A/Prof Ramon Varcoe, Dr Andrew Lennox and Dr Tom Daly.

Matt Adams, senior vascular sonographer from the Australian Sonographers Association, said: “Vexev’s device has the potential to evolve the role of Vascular Sonographers, minimising low skill, high volume aspects of typical workflow. It may also assist in combating the well documented shortage of skilled Vascular Sonographers in the workforce, and high incidence of repetitive strain disorder. With extra time on their hands, this highly skilled group of healthcare professionals may have the chance to expand their scope of practice – whether that be in education, research or therapeutic intervention.”

Vexev’s technology is designed to automate the entire ultrasound procedure. Beyond increasing the efficiency and quality consistency of 2D ultrasound, the TUR aims to make diagnostics significantly more powerful by producing 3D tomographic ultrasound outputs (analogous to MRIs/CTs).

As a result, clinical settings where 2D ultrasound was previously uneconomical, such as dialysis clinics and regional clinics, can now adopt an imaging diagnostics capability. With Vexev’s device, sonographers will be able to produce 3D diagnostic outputs just like CT scan and MRI radiographers, complete more scans each day, and no longer suffer from high RSI incidence.

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