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J&J single dose COVID-19 vaccine receives FDA emergency use authorization

Inside Telecom Staff

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single dose COVID-19 vaccine

Johnson & Johnson’s single dose COVID-19 vaccine has received its Emergency Use Authorization (EUA) by the U.S. Food and Drug Administration (FDA) to prevent COVID-19 in individuals 18 years of age and older.   

The vaccine was developed by the Janssen Pharmaceutical Companies of Johnson & Johnson, and received authorization based on the totality of scientific evidence, including data from the Phase 3 ENSEMBLE study that demonstrated the vaccine was 85 percent effective in preventing severe disease across all regions studied, and showed protection against COVID-19 related hospitalization and death, beginning 28 days after vaccination.

The terms of the EUA allow use of the vaccine while more data are gathered. The Company plans to file for a Biologics License Application (BLA) with the FDA later in 2021.

“This milestone follows a year of incredible work by our dedicated teams and unprecedented collaboration with health leaders around the world – all of whom shared a goal of bringing a single-shot vaccine to the public,” said Alex Gorsky, Chairman and Chief Executive Officer at Johnson & Johnson. “We will do everything we can to help bring this pandemic to an end, in the United States and throughout the world.”

According to a company statement, J&J will look to make its COVID-19 vaccine available on a not-for-profit basis for emergency pandemic use. The company has begun shipping its COVID-19 vaccines to the U.S. government and expects to deliver enough single-shot vaccines by the end of March to enable the full vaccination of more than 20 million people in the U.S.

“We believe the Johnson & Johnson single-shot COVID-19 vaccine is a critical tool for fighting this global pandemic, particularly as it shows protection across countries with different variants,” said Paul Stoffels, M.D., Vice Chairman of the Executive Committee and Chief Scientific Officer, Johnson & Johnson. “A vaccine that protects against COVID-19, especially against the severe outcomes of hospitalization and death, will help ease the burden on people and the strain on health systems worldwide.”

The company plans to deliver 100 million single-shot vaccines to the U.S. during the first half of 2021. “The U.S. government will manage allocation and distribution of the vaccine in the U.S. This will be prioritized according to the populations identified by the CDC’s Advisory Committee on Immunization Practices (ACIP) guidelines,” the statement read.

In parallel, J&J recently announced its submission of a European Conditional Marketing Authorization Application to the European Medicines Agency as well as its filing for an Emergency Use Listing (EUL) with the World Health Organization for its COVID-19 vaccine candidate.

“We are thankful for the efforts of all those who have volunteered to participate in our clinical trials, our scientists, collaborators, clinical trial sites and investigators. Through the combined commitment of everyone involved, we have been able to discover, develop and manufacture a single dose COVID-19 vaccine to protect people around the world,” said Mathai Mammen, M.D., Ph.D., Global Head, Janssen Research & Development, Johnson & Johnson. 

According to the company, the vaccine is estimated to remain stable for two years at -4°F (-20°C), and a maximum of three months at routine refrigeration at temperatures of 36-46°F (2 to 8°C).

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MedTech

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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MedTech

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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MedTech

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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