Swedish Company Creating Powered Vaccine That Doesn’t Need Cold Temps

The Swedish compnay is an alternative to Pfizer’s new vaccine which need to be in freezing temperatures. Zicum created the technology that can convert any vaccine to a powdered version that can survive without refrigeration. Before vaccination you add water turning it into solution.

The company Zicum plans to build a factory which will send vaccines through a nebulizer inside a machine, creating tiny droplets that flow down a column. Dry air flowing outside the column brings the vapor upward so that the non-water portion of the vaccine can be collected in a filter. The resulting powdered vaccine can survive at ambient temperatures more than a month. Pfizer is also working on a powdered version of its COVID-19 vaccine but it still would require some refrigeration.

Moderna

Biotech company Moderna in Cambridge, Massachusetts, reported that its RNA-based vaccine is more than 94% effective at preventing COVID-19, on the basis of an analysis of 95 cases in its ongoing phase III efficacy trial.

Scientists share a few more details than last week’s positive announcements from Pfizer and BioNTech, which are together working on a rival RNA vaccine, and from the Russian developers behind the controversial ‘Sputnik V’ vaccine. Moderna released figures suggesting that its vaccine is likely to prevent severe COVID-19 infections, something that was not clear from the other developers’ announcement.D vaccine resuts mean for the pandemic

Daniel Altmann, an immunologist at Imperial College London, says although they would like to see the peer-reviewed data, but by any standards, this looks like more very good news.

Anthony Fauci, director of the US National Institute of Allergy and Infectious Diseases in Bethesda, Maryland, says“The results of this trial are truly striking, “which is co-developing the vaccine.

Moderna was one of the first developers to announce that it was working on a COVID-19 vaccine and to move testing to clinical trials in humans. Its vaccine comprises RNA instructions for cells to produce a modified form of the coronavirus spike protein, the immune system’s key target against coronaviruses. The company began a phase III trial on 27 July, and has enrolled roughly 30,000 people.

That trial continues. But an analysis conducted on 15 November by an independent data-safety committee found that 95 participants in the trial had developed COVID-19. Of these, 90 were in the group that received a placebo injection and 5 had received the vaccine, which equates to an efficacy of 94.5%. Pfizer and BioNTech reported greater than 90% efficacy on the basis of 94 cases, whereas Sputnik V’s 92% efficacy was measured with only 20 COVID-19 cases recorded

Once the Moderna trial is complete, the final calculation of the vaccine’s efficacy might be lower — although probably not by much, says Stephen Evans, a statistical epidemiologist at the London School of Hygiene & Tropical Medicine. The interim data suggest that the efficacy could be as low as about 86%, because of statistical uncertainty, he says. “What it is saying to me is that both the Pfizer vaccine and the Moderna vaccine have notably more efficacy than most scientists would have expected.”

Moderna also presented some evidence that its vaccine protects against severe cases of COVID-19 — something not mentioned in the Pfizer/BioNTech and Sputnik press releases.

In its guidelines for emergency approval of COVID vaccines, the US Food and Drug Administration has said that efficacy trials should include at least five severe cases in the placebo group if a vaccine is to get the green light.

It is not clear how long the vaccine’s protective effects last; whether it can block people from transmitting the virus; or whether the vaccine works as well in higher-risk groups such as older adults. The company reported that, of the 95 cases, 15 were in people over 65, but it didn’t indicate which arm of the trial these participants were in.

A key question will be how many of the 5 infections among vaccinated individuals occurred in people over 65, says Evans, which could indicate whether the vaccine is less effective in that group than in others. He thinks that’s unlikely, because of data showing that older participants generate a strong immune response to the vaccine. In the press release, Moderna said: “Preliminary analysis suggests a broadly consistent safety and efficacy profile across all evaluated subgroups.”

Researchers were also uplifted by Moderna’s announcement that its vaccine remains stable in conventional refrigerators for a month and ordinary freezers for six months; While Pfizer’s vaccine must be stored at −70 °C before delivery, which means it could be difficult to distribute in parts of the world that do not have the infrastructure to keep it that cold.

The COVID-19 Vaccine

Pfizer and partner BioNTech says that their vaccine against Covid-19 was strongly effective. The companies said an early analysis of the results showed that individuals who received two injections of the vaccine three weeks apart experienced more than 90% fewer cases of symptomatic Covid-19 than those who received a placebo.

Keeping within the guidelines of the FDA, the companies will not file for an emergency use authorization to distribute the vaccine until they reach another milestone: when half of the patients in their study have been observed for any safety issues for at least two months following their second dose. Pfizer expects to cross that threshold in the third week of November.

Pfizer hasn’t released the results in a peer-reviewed medical journal and that it still has to get emergency use approval from the Food and Drug Administration (FDA).

Even if Pfizer’s vaccine gets the FDA’s emergency use approval, the process to develop, test, manufacture, distribute, storage and administer the COVID-19 vaccine isn’t a quick one

The most likely group to get the vaccine first is healthcare workers on the front lines, followed by high-risk individuals and older adults.

Pfizer will have approximately 50 million vaccine doses to start so it’d take several months before the vaccine makes its way to the general population.

Health experts expect to see vaccinations start in December, before expanding to other high-risk groups toward the end of the first quarter of 2021.

Dr. William Schaffner, the medical director of the National Foundation for Infectious Diseases says “This will be an ongoing effort through the many months of 2021. We can’t do this in a week and a half,”.. It is estimated to be around the third week of November, the pharmaceutical company hopes to submit its findings to the FDA for emergency use authorization (EUA).

“FDA will review in under 4 weeks or so and if EUA is granted, could initiate distribution as early as late December,” said Dr. Onyema Ogbuagu, a Yale Medicine infectious disease specialist and associate professor of medicine who is the principal investigator of the Pfizer trial at Yale School of Medicine.

Distributing and storing the Pfizer vaccine is complicated because it needs to be stored at frigid temperatures, around -70°C (-94°F).

The doses will be distributed to predetermined locations (set by the state health departments) in cases packed with dry ice.

Once the vaccine doses reach their final location (a hospital, a nursing home or a retail pharmacy), they may be put on new dry ice or stored in cooling units.

According to Schaffner, some state health departments may invest in mobile units to deliver the immunizations at various sites, such as nursing homes and hospitals.

The vaccine is given in two doses, 21 days apart. This means that only 25 million people will have access to the first batch. It takes two doses to ensure protection.

Pharmacies involved in the distribution include retail chains like Rite Aid and Walgreens, supermarket drug stores like Albertsons and Publix, and big box stores like Costco and Walmart.

CVS and Walgreens are collaborating to deliver vaccines to nursing homes and administer shots.

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The Pfizer Vaccine To Combat COVID 19

The Pfizer vaccine uses technology called messenger RNA, or mRNA, to produce an immune response in people who are vaccinated. It uses genetic material to trick cells into producing bits of protein that look like COVID-19. Then, the immune system attacks those bits and, in theory, would react fast to any actual infection. 

Dr. Anil Keswani is co-chair of the Scripps Health COVID-19 Vaccine Committee, which is tasked with deciding which vaccine they will provide their staff and patients waiting for more data.

Pfizer announced Monday that researchers found the vaccine to be 90% effective during what they called a peek at the data. The Federal Drug Administration was hoping for 50%. 

The timeline is still a ways off but leaders at Pfizer, which has labs in San Diego, say they are confident they will have a vaccine before the end of the year. The committee have narrowed the vaccines down to four: Pfizer, Moderna, Johnson and Johnson and AstraZeneca.

“Both Moderna and Pfizer are using mRNA – a messenger RNA platform. There’s never been a vaccine using messenger RNA that’s been approved, which is what Pfizer is going after,” said Susan Little, principal investigator for UC San Diego for the AstraZeneca and Janssen trials.

China Launches 6G Satellite Into Orbit

China sent “the world’s first 6G experiment satellite into space” local media reported on Friday.

The experimental 6G satellite will “verify the terahertz (THz) communication technology in space, a breakthrough in space communication,” according to state-affiliated daily Global Times.

The 6G satellite was among three Chinese satellites successfully launched into orbit, along with 10 commercial remote sensing satellites developed by Argentinian company Satellogic, the report said.

All of them were launched using a single Long March 6 rocket that took off from the Taiyuan Satellite Launch Center in northern Shanxi province.

This was the 351st rocket of China’s indigenously developed Long March series.

In September, China launched its third maritime satellite into space, and has also sent an observation satellite, Gaofen 11-02, into orbit to help in mapping efforts for its Belt and Road Initiative.

The observatory will begin full operation in January 2021 after passing a “series of technical and performance assessments.”

China’s National Astronomical plans to open its 500-meter Aperture Spherical Radio Telescope, the world’s largest single-dish radio telescope, to global scientists next year for research work, state broadcaster CGTN reported.

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Europe’s Second Wave Of COVID 19

Europe has surpassed the United States in cases per capita; last week, it accounted for half of the more than 3 million cases reported to the World Health Organization (WHO). WHO’s European regional director Hans Kluge says “Europe is at the epicenter of this pandemic once again,” .

Officials differ about the best way to bring the numbers down again, and how low a level they should strive for. And no one knows what comes next. Short of vaccines to save the day, countries may face an exhausting series of lockdowns—a sawtooth pattern, “up and down and up and down,” that could wreck the economy, says Albert Osterhaus, a virologist at the University of Veterinary Medicine, Hanover. “There is no strategy in Europe,” he concludes.

Europe has had a more science-driven pandemic response than the United States, but unlike many Asian countries, it was unable to avert a resurgence. Instead of using the summer to drive cases down to practically zero, Europe celebrated the holiday season. People seemed to lose their fear of the virus, says Michael Meyer-Hermann, a modeler at the Helmholtz Centre for Infection Research who was involved in drawing up Germany’s lockdown plans. They increasingly flouted rules on physical distancing, mask wearing, and avoiding large gatherings.

“The infectious seeds in the community have always remained above a certain threshold, where if you relax the physical distancing, it’s all going to come back,” says University of Hong Kong epidemiologist Gabriel Leung. Numbers crept up and overwhelmed the other pillar of virus control, which some countries never managed well to begin with: testing, isolating cases, and tracing and quarantining their contacts.

The fact that life has largely moved indoors in recent weeks likely aided the resurgence, and cooler air may also favor the virus. “I think winter does make things much harder,” says Adam Kucharski, a modeler at the London School of Hygiene & Tropical Medicine. “Countries have probably been doing control on ‘easy’ setting over the summer.”

Not everyone is convinced lockdowns are the answer. On 28 October, the day Chancellor Angela Merkel announced the new measures, Germany’s National Association of Statutory Health Insurance Physicians presented a strategy paper arguing against a lockdown. “We cannot put the entire country, or even a continent, into an induced coma for weeks or months,” said Andreas Gassen, head of the association. Instead of closing millions of public places and spending billions to keep them afloat, Germany should spend money on communicating the need to better follow the rules, enforcing them strictly, and even creating some opportunities for people to safely enjoy riskier things such as parties, he says.

Artificial Intelligence Tool Can Detect Differences Between Coughs Of Healthy Individuals & Asymptomatic People With COVID-19 Infections.

Method

Researchers developed an AI speech processing framework that leverages acoustic biomarker feature extractors to pre-screen for COVID-19 from cough recordings, and provide a personalized patient saliency map to longitudinally monitor patients in real-time, non-invasively, and at essentially zero variable cost. Cough recordings are transformed with Mel Frequency Cepstral Coefficient and inputted into a Convolutional Neural Network (CNN) based architecture made up of one Poisson biomarker layer and 3 pre-trained ResNet50’s in parallel, outputting a binary pre-screening diagnostic. Our CNN-based models have been trained on 4256 subjects and tested on the remaining 1064 subjects of our dataset. Transfer learning was used to learn biomarker features on larger datasets, previously successfully tested in our Lab on Alzheimer’s, which significantly improves the COVID-19 discrimination accuracy of our architecture. Results: When validated with subjects diagnosed using an official test, the model achieves COVID-19 sensitivity of 98.5% with a specificity of 94.2% (AUC: 0.97). For asymptomatic subjects it achieves sensitivity of 100% with a specificity of 83.2%. Conclusions: AI techniques can produce a free, non-invasive, real-time, any-time, instantly distributable, large-scale COVID-19 asymptomatic screening tool to augment current approaches in containing the spread of COVID-19. Practical use cases could be for daily screening of students, workers, and public as schools, jobs, and transport reopen, or for pool testing to quickly alert of outbreaks in groups.

Published in IEEE Open Journal of Engineering in Medicine and Biology ( Early Access ) September 29,2020