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AstraZeneca: US data shows vaccine effective for all ages

Associated Press

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AstraZeneca US data shows vaccine effective for all ages

AstraZeneca’s COVID-19 vaccine provided strong protection against sickness and eliminated hospitalizations and deaths from the disease across all age groups in a late-stage study in the United States, the company announced Monday.

AstraZeneca said its experts did not identify any safety concerns related to the vaccine, including finding no increased risk of rare blood clots identified in Europe.

Although AstraZeneca’s vaccine has been authorized in more than 50 countries, it has not yet been given the green light in the U.S. — and has struggled to gain public trust amid a troubled rollout. The study comprised more than 30,000 volunteers, of whom two-thirds were given the vaccine while the rest got dummy shots.

In a statement, AstraZeneca said its COVID-19 vaccine was 79% effective at preventing symptomatic COVID-19 and was 100% effective in stopping severe disease and hospitalization, though it has not yet published full data. Investigators said the vaccine worked across all ages, including older people — something experts wanted better data on. Two doses of the AstraZeneca vaccine were given to people four weeks apart.

“These findings reconfirm previous results observed,” said Ann Falsey, of the University of Rochester School of Medicine, who helped lead the trial. “It’s exciting to see similar efficacy results in people over 65 for the first time.”

The AstraZeneca shot is a pillar of a U.N.-backed project known as COVAX that aims to get COVID-19 vaccines to poorer countries, and it has also become a key tool in European countries’ efforts to boost their sluggish vaccine rollouts.

Dr. Paul Hunter, a professor of medicine at the University of East Anglia, said the results were reassuring but that more details were needed to back up AstraZeneca’s claim that the vaccine was completely effective at preventing severe disease and hospitalization.

”It would be good to know how many severe cases occurred in the control group and so what the confidence intervals are for this 100% figure,” said Hunter, who was not connected to the study. “But this should add confidence that the vaccine is doing what it is most needed for.”

The early findings from the U.S. study are just one set of information AstraZeneca must submit to the Food and Drug Administration. An FDA advisory committee will publicly debate the evidence behind the shots before the agency decides whether to allow emergency use of the vaccine. In the past, the time between a company revealing efficacy data and a shot being authorized in the U.S. has been about a month.

Stephen Evans, of the London School of Hygiene & Tropical Medicine, said the new data is important for two reasons: The findings will reassure the FDA, which is reluctant to rely on data obtained outside the United States, but they could also boost confidence more broadly in the shot.

“The benefits of these results will mainly be for the rest of the world where confidence in the AZ (AstraZeneca) vaccine has been eroded, largely by political and media comment,” he said.

Scientists had hoped the U.S. study would clear up some of the confusion about just how well the shots really work, particularly in older people. Previous research suggested the vaccine was effective in younger populations, but there was no solid data proving its efficacy in those over 65, often those most vulnerable to COVID-19.

Britain first authorized the vaccine based on partial results from testing in the United Kingdom, Brazil and South Africa that suggested the shots were about 70% effective. But those results were clouded by a manufacturing mistake that led some participants to get just a half dose in their first shot — an error the researchers didn’t immediately acknowledge.

Then came more questions, about how well the vaccine protected older adults and how long to wait before the second dose. Some European countries including Germany, France and Belgium initially withheld the shot from older adults and only reversed their decisions after new data suggested it was offering seniors protection.

AstraZeneca’s vaccine development was rocky in the U.S., too. Last fall, the FDA suspended the company’s study for an unusual six weeks, as frustrated regulators sought information about some neurologic complaints reported in Britain; ultimately, there was no evidence the vaccine was to blame.

Last week, more than a dozen countries, mostly in Europe, temporarily suspended their use of the AstraZeneca shot after reports it was linked to rare blood clots — even as international health agencies insisted the benefits of the vaccine outweighed the risks. On Thursday, the European Medicines Agency concluded after an investigation that the vaccine did not raise the overall risk of blood clots, but could not rule out that it was connected to two very rare types of clots. It recommended adding a warning about these cases to the vaccine’s leaflet.

It’s not unheard of for such rare problems to crop up as vaccines are rolled out since trials typically look at tens of thousands of people, and some issues are only seen once the shot is used in millions of people.

France, Germany, Italy and other countries subsequently resumed their use of the shot on Friday, with senior politicians rolling up their sleeves to show the vaccine was safe.

AstraZeneca said it would continue to analyze the U.S. data before submitting it to the FDA in the coming weeks. It said the data would also soon be published in a peer-reviewed journal.

The AstraZeneca shot is what scientists call a “viral vector” vaccine. The shots are made with a harmless virus, a cold virus that normally infects chimpanzees. It acts like a Trojan horse to carry the coronavirus’s spike protein’s genetic material into the body that in turn produces some harmless protein. That primes the immune system to fight if the real virus comes along.

Two other companies, Johnson & Johnson and China’s CanSino Biologics, make COVID-19 vaccines using the same technology but using different cold viruses.


LONDON (AP) — By MARIA CHENG and LAURAN NEERGAARD

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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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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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AUB starts U.S.-based company for research on cardiovascular disease

Inside Telecom Staff

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cardiovascular disease

In a MedTech first for the Mediterranean country of Lebanon, a team from the American University of Beirut (AUB) has established a biotech corporation in the U.S. devoted research on biomarkers for cardiovascular disease.

The school told Inside Telecom that team physicians and scientists from AUB have founded the first US-based biotech S-Corporation, Teucer Biotech Inc., centered on an AUB-generated original invention.

Teucer Biotech Inc. is founded around U.S. Patent 10,801,066 issued for the “Determination of risk for development of cardiovascular disease by measuring urinary levels of podocin and nephrin messenger RNA,” with patent positions also issued in Canada, Europe, and Australia.

“We believe we have uncovered a novel clinical biomarker which predicts the development of adverse cardiovascular outcomes (hypertension, acute coronary syndrome, stroke, dementia, peripheral vascular disease, and others) much earlier and with substantially greater prediction power than the earlier currently employed risk predictor, namely “moderate albuminuria (increase albumin in urine),” said Dr. Kamal Badr, AUB professor of internal medicine.

An S-Corporation is akin to a limited liability company or partnership. In general, the corporation itself does not pay any income tax but rather any gain or losses are divided among the partners or shareholders who are then responsible for payment as an individual income tax.

Along with AUB, the company is owned by co-founders Kamal Badr; Assaad Eid, associate professor of anatomy and molecular medicine; Robert Habib, former AUB faculty member and current director of the Society of Thoracic Surgeons Research Center, Chicago, IL, USA; and Joao Lima, professor of cardiology, radiology, and epidemiology, Johns Hopkins University.

Additionally, Dr. Yousif Asfour, chief innovation and transformation officer, represents AUB on Teucer’s Board of Directors, which is chaired by Professor Badr.

“We contend that our findings, once validated across large populations and disease states, will significantly reduce the global burden of cardiovascular disease, the leading cause of death in the world, by providing a more robust and reliable indicator for pre-clinical systemic vascular injury many years prior to overt cardiovascular events, thereby triggering much earlier behavioral and pharmacological interventions,” added Dr. Badr.

On March 31, 2021, Drs. Kamal Badr, Assaad Eid, and Yousif Asfour presented AUB President Fadlo Khuri with the stock certificate representing AUB’s part ownership of Teucer Biotech Inc.

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