fbpx
Connect with us

MedTech

J&J single-dose COVID-19 vaccine 85% effective

Inside Telecom Staff

Published

 on

J&J single-dose COVID-19 vaccine 85% effective

Johnson & Johnson (J&J) announced late last week its single-dose COVID-19 vaccine that proved to be 85 percent effective in preventing severe disease across all regions studied, 28 days after vaccination in all adults 18 years and older.

The J&J single-dose COVID-19 vaccine – which was developed by its Janssen Pharmaceutical Companies – underwent phase 3 of trial testing, with data based on 43,783 participants accruing 468 symptomatic cases of COVID-19.

The phase 3 trial is being conducted at the height of the COVID-19 pandemic in eight countries and three regions, at a time when disease spread has accelerated throughout the world resulting in people having increased exposure to the virus.

“J&J embarked on the global effort to combat the COVID-19 pandemic a year ago, and has brought the full force of our capabilities, as well as tremendous public-private partnerships, to enable the development of a single-shot vaccine. Our goal all along has been to create a simple, effective solution for the largest number of people possible, and to have maximum impact to help end the pandemic,” Alex Gorsky, Chairman, Board of Directors and Chief Executive Officer, Johnson & Johnson, said in a statement.

The phase 3 study is designed to evaluate the efficacy and safety of the J&J single-dose COVID-19 vaccine candidate in protecting moderate to severe cases, with co-primary endpoints of 14 days and 28 days following vaccination, the company statement highlighted.  

Among all participants from different geographies and including those infected with an emerging viral variant, J&J single-dose COVID-19 vaccine candidate was 66 percent effective overall in preventing moderate to severe cases, 28 days after vaccination.

The onset of protection was observed as early as day 14. The level of protection against moderate to severe infection was 72 percent in the United States, 66 percent in Latin America and 57 percent in South Africa, 28 days post-vaccination.

Forty-one percent of participants in the study had comorbidities associated with an increased risk for progression to severe COVID-19 (overall 41 percent), obesity (28.5 percent), type 2 diabetes (7.3 percent), hypertension (10.3 percent), HIV (2.8 percent); also, other immunocompromised participants were in the study.

Protection was generally consistent across race, age groups, including adults over 60 years of age (N= 13,610), and across all variants and regions studied, including South Africa where nearly all cases (95 percent) were due to infection with a SARS-CoV-2 variant from the B.1.351 lineage.

The company intends to file for U.S. Emergency Use Authorization (EUA) in early February and expects to have product available to ship immediately following authorization. It expects to share more information on specifics of deployment as authorizations are secured and contracts are finalized.

J&J’s anticipated manufacturing timeline will enable it to meet its 2021 supply commitments, including those signed with governments and global organizations.

“A one-shot vaccine is considered by the World Health Organization to be the best option in pandemic settings, enhancing access, distribution and compliance. Eighty-five percent efficacy in preventing severe COVID-19 disease and prevention of COVID-19-related medical interventions will potentially protect hundreds of millions of people from serious and fatal outcomes of COVID-19, Paul Stoffels, M.D., Vice Chairman of the Executive Committee and Chief Scientific Officer at J&J, said in the statement.

We’re a diverse group of industry professionals from all corners of the world. Our desire is to provide a high-quality telecoms publication that caters to an international market, offering the latest and most relevant telecoms information to businesses, entrepreneurs and enthusiasts.

Continue Reading
Advertisement

MedTech

Sleep therapy device raises over $315.38 in crowdfunding

Karim Husami

Published

 on

A UK-designed sleep therapy solution with global ambitions raised over $314.21 in the first week of a Crowdcube crowdfunding campaign.

SleepCogni, a portable device with data support for people suffering from insomnia, has so far attracted funds from 157 different investors in this latest fundraiser that combines venture capital investments and crowdfunding.

The firm’s latest lenders include Chasnay ​​Capital Investments, a new private investment fund founded by three former senior executives from General Electric (GE) Healthcare.

Co-founded by Sheffield-based entrepreneur Richard Mills, who has personally suffered from sleeping disorders, and Dutch chronobiologist and sleep expert, Dr Maan van de Werken, said the device allows users to self-manage their insomnia, a condition which affects one in three people across the world.

“Our successful crowdfund campaign builds on the momentum of last month’s FDA registration and the completion of clinical trials where SleepCogni achieved extraordinary results reducing clinical insomnia in just seven days.”

Reinaldo Garcia from Chasnay Capital Investments added: “We’re excited by our investment into SleepCogni for many reasons: its patented technology and clinically validated solution addresses an unmet need in the global sleep aid market, and the company is backed by an excellent team. As experienced global senior leaders with a proven track record, we can add value in this next exciting stage of the business and help SleepCogni scale on a global level.”

Continue Reading

MedTech

Pfizer vaccine efficacy falls to 84% after 6 months

Hala Turk

Published

 on

Pfizer and BioNTech published on Wednesday new data indicating their COVID-19 vaccine efficacy decline from 96 percent to 84 percent over six months.

These numbers are regarded as a big motivator to the drug makers currently developing a third “booster shot” to target the Indian Delta variant. 

The released data shows that the antibody levels are much higher against the Alpha coronavirus variant and the South African Beta variant, after a third dose.

Based on the figures, the efficacy “declined gradually” as it dropped from 96 percent during the first week to around two months after receiving a second jab. The dose’s effectiveness then plummeted to 83.7 percent four to six months later with an average drop of 6 percent over the last two months.

The findings may be considered by U.S. health authorities in deciding when the pair’s booster shot might be needed.

The data, which involved tests of 23 people, was published by Pfizer and has not been peer reviewed by the scientific community.

The announcement of the data and was released on the day of the company’s earnings call.

During the call, Mikael Dolsten chief scientific officers described the new data on a third dose of vaccine “encouraging.”

“Receiving a third dose more than six months after vaccination, when protection may be beginning to wane, was estimated to potentially boost the neutralizing antibody titers in participants in this study to up to 100 times higher post-dose three compared to pre-dose three,” Dolsten said in a statement.

Despite Pfizer and its German partner BioNTech’s booster shot plans, both Centers for Disease Control and Prevention (CDC) as well as Food and Drug Administration (FDA) released a joint statement highlighting that Americans who have been fully vaccinated do not need a booster shot at this moment in time.

The statement noted that FDA, CDC, and National Institutes of Health (NIH) are engaged in a science-based process to consider whether or when a booster might be necessary.

Continue Reading

MedTech

Google delays return to office, mandates vaccines

Associated Press

Published

 on

Google delays return to office, mandates vaccines

Google is postponing a return to the office for most workers until mid-October and rolling out a policy that will eventually require everyone to be vaccinated once its sprawling campuses are fully reopened.

The more highly contagious delta variant of the coronavirus is driving a dramatic spike in COVID-19 cases and hospitalizations. Google’s Wednesday announcement was shortly followed by Facebook, which also said it will make vaccines mandatory for U.S. employees who work in offices. Exceptions will be made for medical and other reasons.

In an email sent to Google’s more than 130,000 employees worldwide, CEO Sundar Pichai said the company is now aiming to have most of its workforce back to its offices beginning Oct. 18 instead of its previous target date of Sept. 1.

The decision also affects tens of thousands of contractors who Google intends to continue to pay while access to its campuses remains limited.

“This extension will allow us time to ramp back into work while providing flexibility for those who need it,” Pichai wrote.

And Pichai disclosed that once offices are fully reopened, everyone working there will have to be vaccinated. The requirement will be first imposed at Google’s Mountain View, California, headquarters and other U.S. offices, before being extended to the more than 40 other countries where Google operates.

“This is the stuff that needs to be done, because otherwise we are endangering workers and their families,” said Dr. Leana Wen, a public health professor at George Washington University and a former health commissioner for the city of Baltimore. “It is not fair to parents to be expected to come back to work and sit shoulder-to-shoulder with unvaccinated people who could be carrying a potentially deadly virus.”

Because children under the age of 12 aren’t currently eligible to be vaccinated, parents can bring the virus home to them from the office if they are around unvaccinated colleagues, Wen said.

Various government agencies already have announced demands for all their employees to be vaccinated, but the corporate world so far has been taking a more measured approach, even though most lawyers believe the mandates are legal.

Delta and United airlines are requiring new employees to show proof of vaccination. Goldman Sachs and Morgan Stanley are requiring their employees to disclose their vaccination status, but are not requiring staffers to be vaccinated.

Less than 10% of employers have said they intend to require all employees to be vaccinated, based on periodic surveys by the research firm Gartner.

While other major technology companies may follow suit now that Google and Facebook have taken stands on vaccines, employers in other industries still may be reluctant, predicted Brian Kropp, chief of research for Gartner’s human resources practice.

“Google is seen as being such a different kind of company that I think it’s going to take one or two more big employers to do something similar in terms of becoming a game changer,” Kropp said.

Google’s vaccine mandate will be adjusted to adhere to the laws and regulations of each location, Pichai wrote, and exceptions will be made for medical and other “protected” reasons.

“Getting vaccinated is one of the most important ways to keep ourselves and our communities healthy in the months ahead,” Pichai explained.

Google’s decision to require employees working in the office to be vaccinated comes on the heels of similar moves affecting hundreds of thousands government workers in California and New York as part of stepped-up measures to fight the delta variant. President Joe Biden also is considering mandating all federal government workers be vaccinated.

The rapid rise in cases during the past month has prompted more public health officials to urge stricter measures to help overcome vaccine skepticism and misinformation.

The vaccine requirement rolling out in California next month covers more than 240,000 government employees. The city and county of San Francisco is also requiring its roughly 35,000 workers to be vaccinated or risk disciplinary action after the Food and Drug Administration approves one of the vaccines now being distributed under an emergency order.

It’s unclear how many of Google’s workers still haven’t been vaccinated. In his email, Pichai described the vaccination rate at the company as high.

Google’s decision to extend its remote-work follows a similar move by another technology powerhouse, Apple, which recently moved its return-to-office plans from September to October, too.

The delays by Apple and Google could influence other major employers to take similar precautions, given that the technology industry has been at the forefront of the shift to remote work triggered by the spread of the novel coronavirus.

Even before the World Health Organization declared a pandemic in March 2020, Google, Apple and many other prominent tech firms had been telling their employees to work from home. This marks the third time Google has pushed back the date for fully reopening its offices.

Google’s vaccine requirement also could embolden other employers to issue similar mandates to guard against outbreaks and minimize the need to wear masks in the office.

While most companies are planning to bring back their workers at least a few days a week, others in the tech industry have decided to let employees do their jobs from remote locations permanently.


SAN RAMON, Calif. (AP)

Continue Reading

Trending