BioNTech and InstaDeep are creating a joint AI innovation lab in Europe to develop novel immunotherapies. “We see a significant opportunity at the intersection of AI and immunology by computational design of new precision immunotherapies,” says BioNTech. One of the key research areas will be the development of next generation vaccines and biopharmaceuticals – including for COVID-19 – as well as for the treatment of cancer and prevention and therapy of infectious diseases. The partnership between Mainz-headquarted BioNTech (which is collaborating with Pfizer on one of the leading mRNA-based COVID-19 vaccine candidates) and London-based InstaDeep will create a joint AI innovation lab between the two cities. The lab will advance a portfolio of initiatives across drug discovery and design, protein engineering, manufacturing and supply chain optimization. Founded in 2014, InstaDeep has already developed collaborations in the global AI ecosystem: such as Google DeepMind, Nvidia and Intel. It was nominated by CB ...
A COMPARISON OF NEUTRALIZATION TITERS AND PROTECTION DATA ACROSS CANDIDATES AND AGE GROUPS BY SELINA KOCH, EXECUTIVE EDITOR NOV 20, 2020 | 10:34 AM CST UPDATED ON NOV 20, 2020 AT 11:03 AM CST A pressing question about COVID-19 vaccines is how well they will perform in the elderly, who are at higher risk for severe disease. Wednesday’s report of strong efficacy in subjects over 65 given Pfizer and BioNTech’s mRNA vaccine could portend good news for several of the next candidates. In early-stage clinical trials, at least four other vaccines produced neutralizing antibody levels in non-elderly adults that were in line with those of BNT162b2 from Pfizer Inc. (NYSE:PFE) and BioNTech SE (NASDAQ:BNTX), and for the most part, the vaccines’ titers fell less with age than BNT162b2. Only Ad5-nCoV from CanSino Biologics Inc. (HKEX:6185; Shanghai:688185) produced somewhat lower neutralization titers that fell farther with age than BNT162b2 in a live virus assay. Moderna Inc. ...
How prepared is the existing global cold chain, and especially refrigerated transport, to cope with the full temperature ranges required for the multiple COVID-19 vaccine candidates? A cold chain expert responds. “Overall, securing an end-to-end unbroken cold chain – from vaccine manufacturer to the site of injection, is an extremely hard thing to do. It requires constant monitoring and remedial action. “Why? The constituent parts of the cold chain are vastly distinct. They are separately operated but uniformly coordinated systems within an overall vaccine supply chain,” said Raja Rao, director, cold chain strategy and markets, B Medical Systems. Storage Vaccine distribution is complexity at its finest, he said. “It is almost always the case that the cold chain is relatively strongest between the site of manufacture and arrival at the port of entry, from Belgium to Nairobi, for example. This is because vaccines are air-shipped in modern, cold storage containers, ...
The companies announced the conclusion of the vaccine’s Phase 3 trial earlier this week: reporting 95% efficacy. They also announced that they had gathered the two months of safety data required by the US’ Food and Drug Administration (FDA) for a Emergency Use Authorization (EUA) submission. Dr. Albert Bourla, Pfizer Chairman and CEO, said: “Filing in the US represents a critical milestone in our journey to deliver a COVID-19 vaccine to the world and we now have a more complete picture of both the efficacy and safety profile of our vaccine, giving us confidence in its potential. “We look forward to the upcoming Vaccines and Related Biological Products Advisory Committee discussion and continue to work closely with the FDA and regulatory authorities worldwide to secure authorization of our vaccine candidate as quickly as possible.” Other regulatory submissions will follow ‘immediately’ Pfizer and BioNTech have already started rolling reviews of the ...
The European Commission has granted a marketing authorization for Sanofi’s Supemtek, a quadrivalent (four-strain) recombinant influenza vaccine: representing the first and only recombinant influenza vaccine approved in the European Union. The European Commission has granted a marketing authorization for Sanofi’s Supemtek, a quadrivalent (four-strain) recombinant influenza vaccine: representing the first and only recombinant influenza vaccine approved in the European Union. The vaccine is already approved in the US under the tradename Flublok Quadrivalent (where it is also the only recombinant influenza vaccine). The first European launches could become available for the 2021-2022 influenza season in certain countries; with the main launch set for the 2022-2023 season. The flu vaccine’s new recombinant technology is also being used in Sanofi’s lead COVID-19 vaccine candidate with GSK: which is expecting to launch a pivotal Phase 3 study before the year is out. This could be followed by a request for regulatory approval in ...
A man works in a laboratory of Sinovac Biotech in Beijing on Sept. 24. The Chinese company is developing an experimental coronavirus vaccine. (Thomas Peter/Reuters) By Eva Dou November 18, 2020 at 5:09 p.m. GMT+8 Sinovac Biotech, one of China’s coronavirus vaccine front-runners, published mixed findings from its two first clinical trials Tuesday, raising the stakes in Indonesia, which has already declared plans to roll out Sinovac’s vaccine. While the vaccine appeared to be safe in these early clinical trials, the company reported that it generated lower levels of protective antibodies in the bloodstream compared with those arising in recovered coronavirus patients. In comparison, Moderna and Pfizer, which have separate experimental vaccines, had reported antibody levels on par with or higher than those produced in recovered coronavirus patients. These early results put Sinovac on the back foot to prove its vaccine is effective in ongoing Phase 3 trials. “That is a concern,” ...
By Elizabeth Cohen and Lauren Mascarenhas, CNN Updated 0510 GMT (1310 HKT) November 12, 2020 Fauci says vaccine could be available to all by April 02:52 (CNN)Moderna has finished accumulating data for a first analysis of its Covid-19 vaccine and expects to have an announcement on the vaccine’s efficacy by the end of the month, the company said in a statement Wednesday. Pfizer announced Monday that its coronavirus vaccine is more than 90% effective. Moderna is conducting a clinical trial of 30,000 participants, with half receiving the vaccine and half receiving a placebo, which is a shot of saline that does nothing. In order for Moderna’s vaccine to be considered for authorization by the US Food and Drug Administration, at least 53 study participants needed to become ill with Covid-19. The trial hit that 53 mark Wednesday, but Moderna doesn’t know if the participants who became ill received the vaccine or the ...
Monday, November 09, 2020 – 06:45am Vaccine candidate was found to be more than 90% effective in preventing COVID-19 in participants without evidence of prior SARS-CoV-2 infection in the first interim efficacy analysis Analysis evaluated 94 confirmed cases of COVID-19 in trial participants Study enrolled 43,538 participants, with 42% having diverse backgrounds, and no serious safety concerns have been observed; Safety and additional efficacy data continue to be collected Submission for Emergency Use Authorization (EUA) to the U.S. Food and Drug Administration (FDA) planned for soon after the required safety milestone is achieved, which is currently expected to occur in the third week of November Clinical trial to continue through to final analysis at 164 confirmed cases in order to collect further data and characterize the vaccine candidate’s performance against other study endpoints This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201109005539/en/ NEW YORK & MAINZ, GERMANY–(BUSINESS WIRE)– Pfizer Inc. (NYSE: ...
President Fernández reveals in interview with Russian news agency that government will receive initial 10 million doses of Sputnik V vaccine by as early as December, should it clear clinical trials. resident Alberto Fernández said Monday that Argentina has accepted a proposal from Russia to buy an initial 10 million doses of its experimental Covid-19 vaccine, with delivery expected before the end of the year. The vaccine, which is given in two parts, could even arrive as early as next month provided clinical trials are successful, the president said in an interview with a Russian news agency. If successful, another 15 million doses could arrive in January, he added. The news comes just days after Perfil journalist Rosario Ayerdi revealed that Health Access Secretary Carla Vizzotti had travelled to Russia on October 17 on a fact-finding mission to learn more about the Russian vaccine, known as Sputnik V. Fernández confirmed Vizzotti’s ...
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