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Official: EU agency to confirm AstraZeneca blood clot link

Associated Press

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AstraZeneca blood clot

A top official at the European Medicines Agency says there’s a causal link between AstraZeneca’s coronavirus vaccine and rare blood clots, but that it’s unclear what the connection is and that the benefits of taking the shot still outweigh the risks of getting COVID-19.

Marco Cavaleri, head of health threats and vaccine strategy at the Amsterdam-based agency, told Rome’s Il Messaggero newspaper on Tuesday that the European Union’s medicines regulator is preparing to make a more definitive statement on the topic this week.

Asked about Cavaleri’s comments, the EMA press office said its evaluation “has not yet reached a conclusion and the review is currently ongoing.” It said it planned a press conference as soon as the review is finalized, possibly Wednesday or Thursday.

Based on the evidence so far, Cavaleri said there’s a clear association between the AstraZeneca vaccine and the dozens of rare blood clots that have been reported worldwide amid the tens of millions of AstraZeneca shots that have been given out.

“It is becoming more and more difficult to affirm that there isn’t a cause-and-effect relationship between AstraZeneca vaccines and the very rare cases of blood clots associated with a low level of platelets,” Cavaleri was quoted as saying.

AstraZeneca did not immediately respond to a request for comment. Late in the day, however, the pharmaceutical company and Oxford University, which developed the vaccine, announced they were pausing the trial of their jabs in children while British regulators investigate the potential blood clot link in adults.

“Whilst there are no safety concerns in the pediatric clinical trial, we await additional information” from the British regulator, an Oxford spokesperson said in a statement.

In Geneva, the World Health Organization said its experts were also evaluating a possible link between the AstraZeneca vaccine and rare blood clots — and that it might have a “fresh, conclusive assessment” before Thursday.

In March, more than a dozen countries, including Germany, suspended using AstraZeneca over the blood clot issue. Most EU nations restarted on March 19 — some with age restrictions — after the EMA said the benefits of the vaccine outweighed the risks of not inoculating people against COVID-19. At the time, the EMA recommended the vaccine’s leaflet be updated with information about the rare clots.

Any further doubts about the AstraZeneca vaccine would be a setback for the shot, which is critical to Europe’s immunization campaign and a linchpin in the global strategy to get vaccines to poorer countries. The AstraZeneca vaccine is cheaper and easier to use than rival vaccines from Pfizer and Moderna and has been endorsed for use in over 50 countries, including by the 27-nation EU and the World Health Organization. U.S. authorities are still evaluating the vaccine.

Cavaleri said while EMA was prepared to declare a link, further study was still needed to understand why and how the phenomenon occurs.

He said the rare blood clots, including some in the brain, coupled with a low level of blood platelets that may make people at risk of serious bleeding, “seem to be the key event to study further.” Cavaleri promised more details soon, adding: “In the coming hours, we will say that the link is there, how this happens we still haven’t figured out.”

Cavaleri said the biological mechanism for how the vaccine might be causing the rare clots was still unknown and if it was linked to how the shot is made, other vaccines with similar technologies might also need to be evaluated.

He stressed the risk-benefit analysis remained positive for the AstraZeneca jab, even for young women who appear to be more affected by the clots.

“Let’s not forget that young women also end up in intensive care with COVID. So we need to do very meticulous work to understand if the risk-benefit analysis remains for all ages,” he was quoted as saying.

He ruled out a preventive therapy to address the rare blood clots, saying there is still too much unknown about the phenomenon.

Even after the March 19 restart, the Dutch and German governments suspended the jabs for people under 60 and some Europeans have been shying away from getting a shot.

Romania’s national vaccination committee’s chief, Valeriu Gheorghita, said Tuesday that since March, 207,000 people in Romania had canceled their AstraZeneca vaccine appointments and another 92,000 simply didn’t show up.

“It is a high percentage, a third of people scheduled who did not show up,” Gheorghita told reporters.

British Prime Minister Boris Johnson declined to be drawn directly into the latest warnings about the vaccine but urged people to look at the advice from Britain’s independent Medicines and Healthcare Regulatory Agency.

“Their advice to people is to keep going out there, get your jab, get your second jab,” he said during a visit Tuesday to an AstraZeneca facility in Macclesfield, in northwest England.

Last week, Britain’s MHRA said seven people had died in the U.K. due to blood clots after getting the AstraZeneca jab. It said it wasn’t clear if the shots are causing the clot and that it was undertaking a “rigorous review” into the reports. The agency said it had identified 30 blood clot cases out of 18.1 million AstraZeneca jabs given by March 24.

Adam Finn, a professor of pediatrics at the University of Bristol, said the latest surge of COVID-19 cases that is filling up hospitals across Europe should prompt people to get vaccinated as soon as possible.

“If you are currently being offered a dose of Oxford-AstraZeneca vaccine, your chances of remaining alive and well will go up if you take the vaccine and will go down if you don’t,” he said.


ROME (AP) — By NICOLE WINFIELD and PAN PYLAS

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EU throws weight behind Pfizer-BioNTech and new technology

Associated Press

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EU throws weight behind Pfizer-BioNTech and new technology

In a stinging rebuke to pharma giant AstraZeneca Wednesday, the European Union announced plans to negotiate a massive contract extension for Pfizer-BioNTech’s COVID-19 vaccine insisting the 27-nation bloc had to go with companies that had shown their value in the pandemic.

“We need to focus on technologies that have proven their worth,” said EU Commission President Ursula von der Leyen. She also announced that America’s Pfizer and Germany’s BioNTech would provide the EU with an extra 50 million doses in the 2nd quarter of this year, making up for faltering deliveries of AstraZeneca.

In contrast to the oft-criticized Anglo-Swedish company, von der Leyen said Pfizer-BioNTech “has proven to be a reliable partner. It has delivered on its commitments, and it is responsive to our needs. This is to the immediate benefit of EU citizens.”

Exacerbating the problems for AstraZeneca, Denmark decided Wednesday not to resume use of its vaccine, after putting it on hold last month following reports of rare blood clots in some recipients. The bulk of the shots given in the Scandinavian country so far have been the Pfizer-BioNTech vaccine.

The Johnson & Johnson jab, which uses the same base technology as AstraZeneca, hit a snag this week when U.S. regulators recommended a “pause” in administering Johnson & Johnson shots. Deliveries in the EU have been suspended.

AstraZeneca was supposed to be the workhorse of the EU’s vaccine drive this year — a cheap and easy-to-transport shot to break the pandemic’s back. Yet, the EU said that out of 120 million doses promised for the 1st quarter, only 30 million were delivered, and, of the 180 million expected, now there are only 70 million set for delivery in the 2nd quarter.

Because of that shortfall, the EU has come under crushing pressure as, even though it it is a major producer and exporter of vaccines, it cannot get its vaccinations even close to the levels of the United Kingdom and the United States.

The Our World in Data site said 47.5% of people in the U.K. have received at least one dose of COVID-19 vaccine, compared to 36.6% in the U.S. and 16.4% in the EU.

Now, Pfizer-BioNTech could well become the key to beat the pandemic on the continent.

With 200 million doses already earmarked for the bloc this quarter from Pfizer-BioNTech. the 50 million additional deliveries will be especially welcomed by EU nations dealing with supply delays and concerns over rare blood clots potentially linked to the Oxford-AstraZeneca vaccine.

Von der Leyen said the EU will start negotiating to buy 1.8 billion doses of the Pfizer-BioNTech vaccine through 2023.

“It will entail that not only the production of the vaccines, but also all essential components, will be based in the EU,” von der Leyen said.

The European Commission currently has a portfolio of 2.3 billion doses from half a dozen companies and is negotiating more contracts.

Von der Leyen expressed full confidence in the technology used for the Pfizer-BioNTech vaccine, which is different from that behind the Oxford-AstraZeneca vaccine.

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.

Astra Zeneca’s is made with a cold virus that sneaks the spike protein gene into the body. It’s a very different form of manufacturing: Living cells in giant bioreactors grow that cold virus, which is extracted and purified.

Von der Leyen said Europe needs to have a technology that can boost immunity, tackle new variants and produce shots quickly and massively. “mRNA vaccines are a clear case in point,” she said.

The planned negotiations with Pfizer left in the middle what the EU would do about any new contracts with AstraZeneca. “Other contracts, with other companies, may follow,” said von der Leyen.


BRUSSELS (AP) — By RAF CASERT Associated Press
Jan M. Olsen contributed from Copenhagen.

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UK NHS Cancer backlog treated by digital tools, says report

Karim Hussami

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digital app

A report from ORCHA (The Organisation for the Review of Care and Health Apps), an NHS partner and a leading authority on health app trends and usage, says that MedTech digital tools can be part of the solution to the backlog in cancer services.

The report adds that patients must be supported by healthcare staff in their choice of apps and be extremely wary of poor-quality tools which could damage their health.

“There are excellent apps or digital tools supporting cancer patients. These have been developed with clinicians, rigorously reviewed and frequently updated. Apps such as these can be embedded into cancer services to provide tremendous support to patients and ease the healthcare system at a time of tremendous backlog,” former NHS clinician and founding CEO of ORCHA, Liz Ashall-Payne, said.

“For example, BELONG, Beating Cancer Together gives users access to oncologists, radiologists and doctors to answer questions and notifies users of available clinical trials around the world. Vinehealth Cancer Companion helps patients monitor their symptoms and track their medication,” he noted.

Around 40,000 fewer people started cancer treatment in 2020 due to COVID-19, putting potential pressure on services for years to come.

“We believe there is massive potential for intelligent apps such as these both to help patients and provide excellent returns on investment to the NHS,” Liz added.

According to ORCHA research, 3,603 digital tools in forms of apps to support cancer can be found in app stores. Worryingly, 74 percent of these have not been updated in the last 18 months. This means the vast majority have not kept pace with medical, data or usability guidelines.

Amongst the apps updated within 18 months, ORCHA reviewed 190 of the most downloaded, testing them against more than 350 health standards and measures including elements of the NICE framework. This diligence revealed that only 24.7 percent of the apps reviewed meet minimum quality thresholds.

Liz Ashall-Payne, said: “These statistics are deeply concerning, given how easy it is for vulnerable patients and care providers to search app stores and stumble across apps which may give poor or outdated advice or blatantly misuse their private data.”

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Wearable tech start-up aims to tackle head injuries in sport

Karim Hussami

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Wearable tech start-up

An Edinburgh-based business recently launched a Kickstarter campaign to help move into production of a technology to safeguard athletes against head injuries.

Based at the Edinburgh Business School (EBS) Incubator within Heriot-Watt University, the technology has been developed by start-up company HIT. The concept is wearable tech which measures and tracks head impact force in sport and recreational activities and is set to aid research and support informed decisions on the risk of brain injury.

Founder Euan Bowen, an avid rugby player, was inspired to develop the technology a teammate was injured. With brain injuries rarely reported, Bowen spotted a gap in the market for sportspeople to track brain health.

Bowen explained: “I found little technology available to monitor head impact, despite the severity of the issue across different sports.

“As a member of a rugby club in Edinburgh, I began researching and developing a project, working closely with the team to develop an initial prototype.”

Featuring a unique impact sensor, wearable across multiple sporting and activity applications, the device universally clips onto any helmet or halo headband, detecting g-force and recording impact via a companion app.

Using a traffic light system, the app records data and acts as an early warning notification for the user regarding the level of impact force recorded – highlighting the caution required in continued exercise.

“High impact sports are focusing increasingly on concussion mitigation with the Field – ‘Football’s Influence on Lifelong Health and Dementia Risk’ – study recently finding that former professionals are three and a half times more likely to die of dementia than the general population,” Bowen noted.

Kallum Russell, manager of the EBS Incubator said: “HIT Impact is a much-needed technology to track and support the current efforts to increase sports safety at a time when governing bodies across high impact sports are increasingly focused on minimizing head trauma.”

The current parliamentary inquiry into concussion recently heard evidence about the long-term implications of repetitive head trauma on sports people with MPs asking how sports could be made safer.

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