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Efficacy analysis demonstrates Covaxin to be 77.8 per cent effective against symptomatic COVID-19, through evaluation of 130 confirmed cases, with 24 observed in the vaccine group versus 106 in the placebo group.Bharat Biotech has concluded the final analysis for Covaxin efficacy from Phase 3 clinical trials.
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Efficacy analysis demonstrates Covaxin to be 93.4 per cent effective against severe symptomatic COVID-19. Safety analysis demonstrates adverse events reported were similar to placebo, with 12 per cent of subjects experiencing commonly known side effects and less than 0.5 per cent of subjects feeling serious adverse events.
The data demonstrates 63.6 per cent protection against asymptomatic COVID-19 and efficacy data demonstrates 65.2 per cent protection against the SARS-CoV-2, B.1.617.2 Delta variant.
Bharat Biotech on Saturday announced safety and efficacy analysis data from Phase III clinical trials of Covaxin, a whole virion inactivated vaccine against SARS-CoV2, which was developed in partnership with ICMR and NIV Pune.
Phase 3 clinical trials of COVAXIN was an event-driven analysis of 130 symptomatic COVID-19 cases, reported at least two weeks after the 2nd dose, conducted at 25 sites across India. Covaxin is formulated with a novel Algel+IMDG adjuvant. IMDG is a TLR7/8 agonist known to induce memory T cell responses along with strong neutralizing antibodies.
The activation of cell-mediated immune responses is especially valuable in a multi-epitope vaccine such as Covaxin where immune protection can be achieved from S, RBD and N proteins alike. IMDG was developed under a partnership between Virovax and NIAID, National Institutes of Health, USA.
Covaxin was well tolerated and the Data Safety Monitoring Board has not reported any safety concerns related to the vaccine. The overall rate of adverse events observed in COVAXIN was lower than that seen in other Covid-19 vaccines.
The safety profile of Covaxin is now well established based on inactivated vaccines technology, and in large part due to the extensive 20-year safety track record of Bharat Biotech's Vero cell manufacturing platform. Furthermore, Bharat Biotech has so far not sought indemnity for Covaxin from the Governments.
No licensed SARS-CoV-2 vaccine has reported efficacy against asymptomatic infection in a randomised controlled trial, based on qPCR testing. Covaxin is the first to report promising efficacy against asymptomatic infections based on qPCR testing that will help in reducing disease transmission.
Krishna Ella, Chairman & Managing Director, Bharat Biotech, said, "The successful safety and efficacy readouts of Covaxin as a result of conducting the largest ever COVID Vaccines trials in India establishes the ability of India and developing world countries to focus towards innovation and novel product development. We are proud to state that Innovation from India will now be available to protect global populations."
Covaxin has been specifically designed to meet the needs of global distribution chains, the requirements for which are more critical in low- and middle-income countries. It has been formulated to enable shipping and long-term storage at 2-8. It is also formulated to adhere to a multi-dose vial policy, thereby reducing open vial wastage, saving money to procurement agencies and governments alike.
Balram Bhargava, Secretary Department of Health Research & Director General Indian Council of Medical Research, said, "I am delighted to note that Covaxin, developed by ICMR and BBIL under an effective public-private partnership, has demonstrated an overall efficacy of 77.8 per cent in India's largest COVID phase 3 clinical trial thus far. Our scientists at ICMR and BBIL have worked tirelessly to deliver a truly effective vaccine of the highest international standards. Covaxin will not only benefit the Indian citizens but would also immensely contribute to protecting the global community against the deadly SARS-CoV-2 virus. I am also pleased to see that Covaxin works well against all variant strains of SARS-CoV-2. The successful development of Covaxin has consolidated the position of Indian academia and industry in the global arena."
Bharat Biotech is a company driven by science and validated by empirical evidence. Its commitment to data transparency has been proven again with 10 publications on COVAXIN, covering all aspects of product development, all within 12 months.
Bharat Biotech's commitment to continuous improvement of COVAXIN is well underway with additional clinical trials to establish safety and efficacy in children between 2-18 years of age. A clinical trial to determine the safety and immunogenicity of a booster dose is also in process. Several research activities are being carried out to study variants of concern and to assess their suitability for follow up booster doses.
Suchitra Ella, Joint Managing Director, Bharat Biotech, said, "It is a momentous day for everyone, at Bharat Biotech, as we announce the Final Phase-3 Results of COVAXIN and its efficacy of 77.8 per cent. We sincerely thank all our employees for enduring work pressures through the pandemic & lockdowns, with 24x7 commitment amidst an unprecedented number of physical challenges, stress and continuous operations. We especially thank our medical affairs team for leading the project, the technical and marketing teams who have relentlessly worked to complete the clinical trials and coordination of 25 sites across the country since May 2020."
Covaxin has been evaluated through neutralizing antibody responses against several variants of concern, namely B.1.617.2 (Delta), B.1.617.1 (Kappa), B.1.1.7 (Alpha), B.1.351 (Beta), P2- B.1.1.28 (Gamma). The data from these studies have been extensively published in peer-reviewed journals and available for review in the public domain.
Priya Abraham, Director National Institute of Virology ICMR said, "The overall efficacy of 77.8 per cent following the phase III clinical trial of Covaxin is wonderful news. ICMR-NIV and BBIL have had very fruitful interactions during this exhilarating journey. Sera from Covaxin recipients have also been evaluated against viral variants detected in India i.e., the Alpha, Beta, Zeta, Kappa and Delta. The making of this vaccine entirely on Indian soil is a matter of great pride to every Indian."
Covaxin has now received emergency use authorizations in 16 countries including, Brazil, India, Philippines, Iran, Mexico, etc with EUA's in process in 50 countries worldwide. The company is in discussions with WHO to obtain emergency Use Listing for Covaxin.
ALSO READ Vaccine isn't sufficientThe product has been exported to several countries with additional requests for supplies being received.Bharat Biotech has established COVAXIN manufacturing at 4 facilities within India, further expansions are in process to reach an annualized capacity of 1 billion doses by the end of 2021. Technology transfer activities are in progress to companies in the United States and other countries. (IANS/AD)
As robots evolve to do more work around us, the UK-based humanoid robot manufacturer Engineered Arts has infused more human-like facial expressions into one of its robots, which may leave you with an eerie feeling.
In a video posted on YouTube, the robot called 'Ameca' displays various human expressions, like appearing to "wake up" from sleep, as its face shows confusion and frustration when it opens its eyes.
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Once awake, 'Ameca' starts looking at its hands and arms, opens its mouth and raises its eyebrows, just like a human does.
At the end of the video, Ameca smiles and holds a welcoming hand out towards the viewer.
According to Engineered Arts, the humanoid bot is currently unable to walk and it is working towards giving it the ability in the near future.
"Designed specifically as a platform for development into future robotics technologies, 'Ameca' is the perfect humanoid robot platform for human-robot interaction," says the company.
The 'Ameca' hardware is a development based on its own research into humanoid robotics and built on its advanced 'Mesmer' technology.
Ameca' on display at the CES 2022 conference in Las Vegas in the US in January.Unsplash
Also read: NASA humanoid robot dances to technology
Engineered Arts is slated to put 'Ameca' on display at the CES 2022 conference in Las Vegas in the US in January.
"Human-like Artificial Intelligence needs a human-like artificial body. Artificial Intelligence and Machine Learning systems can be tested and developed on Ameca alongside our powerful 'Tritium' robot operating system," the company posted on its website. (IANS/PR)
(Keywords: Humanoid Robot, Ameca, Technology)
Microsoft has disrupted the activities of a China-based hacking group, gaining control of the malicious websites the group used to attack organisations in the US and 28 other countries around the world.
The Microsoft Digital Crimes Unit (DCU) said in a statement that a federal court in Virginia granted its request to seize websites of the hacking group called 'Nickel', enabling the company to cut off Nickel's access to its victims and prevent the websites from being used to execute attacks.
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"We believe these attacks were largely being used for intelligence gathering from government agencies, think tanks and human rights organisations," said Tom Burt, Corporate Vice President, Customer Security and Trust at Microsoft.
Obtaining control of the malicious websites and redirecting traffic from those sites to Microsoft's secure servers will help the company protect existing and future victims while learning more about Nickel's activities.
Also Read : Fortnite : A Gold Mine for Hackers
"Our disruption will not prevent Nickel from continuing other hacking activities, but we do believe we have removed a key piece of the infrastructure the group has been relying on for this latest wave of attacks," Burt said late on Monday.
To date, in 24 lawsuits - five against nation-state actors -- Microsoft has taken down more than 10,000 malicious websites used by cybercriminals and nearly 600 sites used by nation-state actors.
"We have also successfully blocked the registration of 600,000 sites to get ahead of criminal actors that planned to use them maliciously in the future," the tech giant informed.
"We believe these attacks were largely being used for intelligence gathering from government agencies, think tanks and human rights organisations."Unsplash
In some observed activity, Nickel malware used exploits targeting unpatched on-premises Exchange Server and SharePoint systems.
"However, we have not observed any new vulnerabilities in Microsoft products as part of these attacks. Microsoft has created unique signatures to detect and protect from known Nickel activity through our security products, like Microsoft 365 Defender," the company noted.
Nickel has targeted organisations in both the private and public sectors, including diplomatic organisations and ministries of foreign affairs in North America, Central America, South America, the Caribbean, Europe and Africa. (IANS/SP)
(Keywords : hacking, China, Microsoft, website, victim, intelligence, attack, malicious, traffic, server, company, disruption, lawsuits, cybercriminals, vulnerability.)
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Chip manufacturer MediaTek on Monday announced that it is focused on making 2022 a year aimed at rapid growth, business success, substantial expansion in Research and Development capabilities.
MediaTek's plans to boost technology democratisation and enable access to disruptive connectivity with its range of mainstream to flagship 5G chips.
"We at MediaTek are focused on making 2022 a year aimed at rapid growth, business success, and substantial expansion in our R&D capabilities. For 2022, we are focused on further strengthening our presence in India, offering incredible experiences to customers, and supporting the country's technology initiatives with our expertise and collaboration with leading OEMs," Anku Jain, Managing Director, MediaTek India said in a statement.
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In the flagship segment, MediaTek recently announced the Dimensity 9000 chip, which is a milestone of innovation and a rise to the incredible, built-to-power flagship 5G smartphones in the world, the company claims.
MediaTek Dimensity 9000 features a single Cortex-X2 performance core clocked at 3.05GHz, three Cortex-A710 cores at 2.85GHz and four Cortex-A510 efficiency cores at 1.8GHz.
It packs a 10-core Arm Mali-G710 that takes care of graphics processing, the report said.
The chipset also comes packed with MediaTek's fifth-generation APU with six total cores for AI processing.Unsplash
Also read: Realme Unveils First 5G Smartphone
The chipset also comes packed with MediaTek's fifth-generation APU with six total cores for AI processing.
The chipset can handle screens with up to a 180Hz refresh rate at Full HD+ resolutions. It is also the first chipset to have an 18-bit image signal processor, offering the ability to capture 4K HDR video using up to three cameras at the same time, or still photos using up to a massive 320MP sensor. (IANS/PR)
(Keywords: 5G, smartphones, Mediatek)