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Moderna Covid-19 vaccine stability eases distribution challenges

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Moderna Inc’s experimental COVID-19 vaccine is more stable than expected at temperatures that ordinary refrigerators can provide and can be distributed using existing cold-chain shipping and storage infrastructure.

That opens the door for its early use in hard to reach places that might not be appropriate for Pfizer Inc’s vaccine which needs ultra-cold storage.

Moderna’s vaccine is stable for up to six months at a temperature of minus 20 degrees Celsius (-4 F), about home freezer levels, when shipped and stored.

The company said it expects the vaccine to be stable when kept at standard refrigerator temperatures of 2 to 8 degrees Celsius for 30 days, up from an initial projection of 7 days. The vaccine will be distributed in 10-dose vials and can be kept at room temperature for up to 12 hours after thawing.

By comparison, Pfizer’s vaccine can be transported and stored for up to 6 months at minus 70 degrees Celsius (-94 F). It can be stored at standard refrigerator temperatures for up to five days.

Moderna’s vaccine will be distributed by the U.S. government’s Operation Warp Speed program. U.S. health officials have said that at first they are most likely to distribute vaccines to healthcare workers, people who are in nursing homes, first responders and those with health conditions who are high-risk.

Most Americans will be inoculated in May or June, according to Dr. Anthony Fauci, the nation’s top infectious disease expert.

Under Operation Warp Speed’s distribution plan, the first group of shots will likely be distributed to and administered in closed settings, like hospitals and nursing homes.

https://indianexpress.com/article/explained/explained-moderna-covid-19-vaccine-stability-eases-distribution-challenges-7053670/HELP US SPREAD GOOD NEWS!

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India to Get 100 Million Astra Vaccine Shots by Next Month

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The world’s largest vaccine maker is ramping up production of AstraZeneca Plc’s Covid-19 shot, aiming to have 100 million doses ready by December for an inoculation drive that could begin across India that same month.

If final-stage trial data show AstraZeneca’s candidate gives effective protection from the virus, the Serum Institute of India Ltd. — which is partnered to produce at least one billion doses — may get emergency authorization from New Delhi by December, said Adar Poonawalla, chief executive officer of the family-owned firm based in the western city of Pune.

That initial amount will go to India, Poonawalla said in an interview on Thursday. Full approval early next year will allow distribution on a 50-50 basis with the South Asian nation and Covax, the World Health Organization-backed body that’s purchasing shots for poor nations. Serum, which has tied up with five developers, has so far made 40 million doses of AstraZeneca’s vaccine in the past two months and aims to start manufacturing Novavax Inc.’s contender soon.

Serum Institute Of India Ltd. Chief Executive Officer Adar Poonawalla Interview

Adar PoonawallaPhotographer: Dhiraj Singh/Bloomberg

“We were a bit concerned it was a big risk,” said 39-year-old Poonawalla. But both AstraZeneca and Novavax’s shots “are looking pretty good.”

https://www.bloomberg.com/news/articles/2020-11-13/india-to-get-100-million-astra-shots-next-month-says-serum-headHELP US SPREAD GOOD NEWS!

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36,370 Fresh Covid Cases In India, Lowest 1-Day Tally In Over 3 Months

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With a jump of 36,370 fresh COVID-19 cases in a day India reported the lowest number of new coronavirus infections in the country since mid-July, taking its tally to 79.46 lakh, government data shows. July 18 was the last time India reported less than 36,000 cases. Continuing with the downward trend in cases, India recorded an average of 55,000 daily Covid cases last week, against the weekly average of 90,000 during the peak in September, data shows. The weekly average of one-day tally has since dropped consistently and sharply, from about 80,000 in early October to 45,000 now.

https://www.ndtv.com/india-news/coronavirus-36-370-fresh-covid-19-cases-in-india-total-cases-at-79-46-lakh-488-deaths-in-24-hours-1-19-502-total-deaths-2316202HELP US SPREAD GOOD NEWS!

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14-year-old girl won a $25K prize for a discovery that could help lead to a cure for Covid-19

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As scientists around the world race to find a treatment for the coronavirus, a young girl among them stands out.

Anika Chebrolu, a 14-year-old from Frisco, Texas, has just won the 2020 3M Young Scientist Challenge — and a $25,000 prize — for a discovery that could provide a potential therapy to Covid-19.

Anika’s winning invention uses in-silico methodology to discover a lead molecule that can selectively bind to the spike protein of the SARS-CoV-2 virus.

“The last two days, I saw that there is a lot of media hype about my project since it involves the SARS-CoV-2 virus and it reflects our collective hopes to end this pandemic as I, like everyone else, wish that we go back to our normal lives soon,” Anika told CNN.

Anika, who is Indian American, submitted her project when she was in 8th grade — but it wasn’t always going to be focused on finding a cure for Covid-19.

Initially, her goal was to use in-silico methods to identify a lead compound that could bind to a protein of the influenza virus.

“After spending so much time researching about pandemics, viruses and drug discovery, it was crazy to think that I was actually living through something like this,” Anika said.

“Because of the immense severity of the Covid-19 pandemic and the drastic impact it had made on the world in such a short time, I, with the help of my mentor, changed directions to target the SARS-CoV-2 virus.”

“Anika has an inquisitive mind and used her curiosity to ask questions about a vaccine for Covid-19,” Dr. Cindy Moss, a judge for the 3M Young Scientist Challenge, told CNN.

“Her work was comprehensive and examined numerous databases. She also developed an understanding of the innovation process and is a masterful communicator. Her willingness to use her time and talent to help make the world a better place gives us all hope.”

“My effort to find a lead compound to bind to the spike protein of the SARS-CoV-2 virus this summer may appear to be a drop in the ocean, but still adds to all these efforts,” she said. “How I develop this molecule further with the help of virologists and drug development specialists will determine the success of these efforts.”

https://edition.cnn.com/2020/10/18/us/anika-chebrolu-covid-treatment-award-scn-trnd/index.htmlHELP US SPREAD GOOD NEWS!

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India begins selecting people for priority coronavirus vaccines

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India’s coronavirus infections rose by another 62,212 cases over the previous day and a local media report said on Saturday that the government had begun identifying about 300 million people who would be given the vaccine first when it is ready.

The Times of India said that frontline health and sanitation workers, police officials and elderly people with co-morbidities will get the vaccine on priority.

The plan, which is still in the draft stage, aims to cover 23% of the population in the first phase. The final plan is likely to be ready by end October-November, the report said.

The selected individuals will be given an estimated 600 million doses.

https://www.reuters.com/article/us-health-coronavirus-india-cases/india-begins-selecting-people-for-priority-coronavirus-vaccines-idUSKBN272084HELP US SPREAD GOOD NEWS!

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Dozens of COVID-19 vaccines are in development. Here are the ones to follow

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More than 150 coronavirus vaccines are in development across the world—and hopes are high to bring one to market in record time to ease the global crisis. Several efforts are underway to help make that possible, including the U.S. government’s Operation Warp Speed initiative, which has pledged $10 billion and aims to develop and deliver 300 million doses of a safe, effective coronavirus vaccine by January 2021. The World Health Organization is also coordinating global efforts to develop a vaccine, with an eye toward delivering two billion doses by the end of 2021.

Vaccine prospects

The COVID-19 candidates, like all vaccines, essentially aim to instruct the immune system to mount a defense, which is sometimes stronger than what would be provided through natural infection and comes with fewer health consequences.

To do so, some vaccines use the whole coronavirus, but in a killed or weakened state. Others use only part of the virus—whether a protein or a fragment. Some transfer the coronavirus proteins into a different virus that is unlikely to cause disease or even incapable of it. Finally, some vaccines under development rely on deploying pieces of the coronavirus’s genetic material, so our cells can temporarily make the coronavirus proteins needed to stimulate our immune systems. 

Novavax

Name: NVX-CoV2373

What: Novavax has bioengineered the coronavirus’s spike proteins, the parts that help the virus invade cells but cannot replicate or cause COVID-19. Its vaccine candidate combines those proteins into a knucklebone-shaped nanoparticle. This can be injected along with its proprietary Matrix-M adjuvant—a compound that stimulates immune cells—to elicit an immune response. The vaccine is administered in two doses, 21 days apart. On September 2, a study of the company’s phase one trial published in the New England Journal of Medicine found that the vaccine was safe and produced coronavirus antibodies at a higher level than is seen among those who have recovered from COVID-19. It also stimulated T cells, another arm of the human immune response.

Status: On September 24, Novavax announced the launch of its phase three trial in the United Kingdom, which will evaluate the vaccine in up to 10,000 people, both with and without underlying conditions. Up to 400 participants will also be vaccinated against the seasonal flu as part of a sub-study that will help determine whether it is safe to give patients both vaccines at the same time.

Johnson & Johnson

Name: JNJ-78436735

What: Johnson & Johnson is developing an adenovector vaccine, which introduces a piece of DNA from SARS-CoV-2 into the common cold-causing adenovirus that has been genetically changed so that it can’t replicate in the body. This vaccine builds on the technology Johnson & Johnson used to develop an Ebola vaccine as well as vaccine candidates for Zika and HIV. In July, a study published in Nature showed that the vaccine elicited neutralizing antibodies in monkeys and provided “complete or near-complete” protection with just one dose.

Status: On September 23, Johnson & Johnson announced the launch of a phase three ENSEMBLE trial that will evaluate the safety of the vaccine—and how well it works—among up to 60,000 adults from a variety of countries. The trial will include “significant representation” from older populations and will include those with underlying conditions that make them more susceptible to COVID-19.

Moderna Therapeutics

Name: mRNA-1273

What: This vaccine candidate relies on injecting snippets of a virus’s genetic material, in this case mRNA, into human cells. They create viral proteins that mimic the coronavirus, training the immune system to recognize its presence. This technology has never been licensed for any disease. If successful, it would be the first mRNA vaccine approved for human use. This vaccine requires two doses, four weeks apart.

Status: On July 27, Moderna announced it had started the third phase of its clinical trials, even as it continues to monitor phase two results. Preliminary findings from phase one have shown that healthy subjects—including elderly patients—produced coronavirus antibodies and a reaction from T cells. Phase three will test the vaccine in 30,000 U.S. participants; Moderna says it is on track to deliver at least 500 million doses per year beginning in 2021, thanks in part to the deal it has struck with Swiss manufacturer Lonza that will allow it to manufacture up to one billion doses a year. In September, however, Moderna’s chief executive Stéphane Bancel told the New York Times that it was unlikely the vaccine would be widely available in the first half of 2021.

Pfizer

Name: BNT162b2

What: Pfizer and BioNTech are also developing an mRNA vaccine based on the German company’s earlier efforts to use the technology in experimental cancer vaccines. Pfizer has signed a nearly $2 billion contract with the U.S. government to provide 100 million doses by December 2020—an agreement that goes into effect when and if the drug is approved and delivered.

Status: On July 27, Pfizer and BioNTech launched a trial that combines phase two and three by enrolling a diverse population in areas with significant SARS-CoV-2 transmission. It has expanded the trial to include 44,000 people across multiple countries. The project is aiming to seek regulatory review before the end of the year—and hopes to supply 1.3 billion doses by the end of 2021. Preliminary results of phase one/two data show the vaccine produces antibodies and T-cell responses specific to the SARS-CoV-2 protein.

University of Oxford

Name: ChAdOx1 nCoV-19

What: Oxford’s candidate is what’s known as a viral vector vaccine, essentially a “Trojan horse” presented to the immune system. Oxford’s research team has transferred the SARS-CoV-2 spike protein—which helps the coronavirus invade cells—into a weakened version of an adenovirus, which typically causes the common cold. When this adenovirus is injected into humans, the hope is that the spike protein will trigger an immune response. AstraZeneca and Oxford plan to produce a billion doses of vaccine that they’ve agreed to sell at cost.

Status: Preliminary results from this candidate’s first two clinical trial phases revealed that the vaccine had triggered a strong immune response—including increased antibodies and responses from T-cells—with only minor side effects such as fatigue and headache. It is in phase three of clinical trials, aiming to recruit up to 50,000 volunteers in Brazil, the United Kingdom, the United States, and South Africa. On September 8, AstraZeneca paused the trials for a safety review due to an adverse reaction in one participant in the U.K. The details remain unclear, though the company has described the pause as a “routine action.” After an investigation by independent regulators, the trials resumed in the U.K., Brazil, South Africa, and India but remained on hold in the U.S. as of September 23.

Sinovac

Name: CoronaVac

What: CoronaVac is an inactivated vaccine, meaning it uses a non-infectious version of the coronavirus. While inactivated pathogens can no longer produce disease, they can still provoke an immune response, such as with the annual influenza vaccine.

Status: On July 3, Brazil’s regulatory agency granted this vaccine candidate approval to move ahead to phase three, as it continues to monitor the results of the phase two clinical trials. Preliminary results in macaque monkeys, published in Science, revealed that the vaccine produced antibodies that neutralized 10 strains of SARS-CoV-2. Sinovac has also released preprint results of its phase two human trial that likewise showed the vaccine produced antibodies with no severe adverse reactions. Phase three will recruit nearly 9,000 healthcare professionals in Brazil. Sinovac will also conduct phase three trials in Indonesia and Bangladesh.

Sinopharm

What: Sinopharm is also using an inactivated SARS-CoV-2 vaccine that it hopes will reach the public by the end of 2020. Preliminary findings from two randomized trials, published in JAMA, have shown the vaccine can trigger an antibody response with no serious adverse effects. The study did not measure T cell-mediated immune responses. These results are significant, though, as they are the first published data from human clinical trials for a COVID-19 vaccine that uses a whole, inactivated virus.

Status: On September 29, the New Yorker reported that Sinoparm is filing its application to China’s regulatory commission for approval of the vaccine, which could arrive sometime in October. The story also notes that hundreds of thousands of Chinese civilians have already been vaccinated under the government’s emergency-use approval. China began to innoculate medical workers and other high-risk groups with the Sinopharm trial vaccines in July, making it the first experimental vaccine available to civilians beyond clinical volunteers. Also in July, Sinopharm launched its first phase three trial among 15,000 volunteers—aged 18 to 60, with no serious underlying conditions—in the United Arab Emirates. The company selected the UAE because it has a diverse population made up of approximately 200 nationalities, making it an ideal testing ground. Sinopharm will also undertake phase three trials in locations such as Peru and Bahrain.

Murdoch Children’s Research Institute

Name: Bacillus Calmette-Guerin BRACE trial

What: For nearly a hundred years, the Bacillus Calmette-Guerin (BCG) vaccine has been used to prevent tuberculosis by exposing patients to a small dose of live bacteria. Evidence has emerged over the years that this vaccine may boost the immune system and help the body fight off other diseases as well. Researchers are investigating whether these benefits may also extend to SARS-CoV-2, and this trial has reached phase three in Australia. Though as of April 12, the World Health Organization says there is no evidence that the BCG vaccine protects people against infection with the coronavirus.

Status: In April, researchers from the Murdoch Children’s Research Institute began a series of randomized controlled trials that will test whether BCG might work on the coronavirus as well. They aim to recruit 10,000 healthcare workers in the study.

CanSino Biologics

Name: Ad5-nCoV

What: CanSino has also developed a viral vector vaccine, using a weakened version of the adenovirus as a vehicle for introducing the SARS-CoV-2 spike protein to the body. Preliminary results from phase two trials, published in The Lancet, have shown that the vaccine produces “significant immune responses in the majority of recipients after a single immunisation.” There were no serious adverse reactions documented.

Status: Though the company was still technically in phase two of its trial, on June 25, CanSino became the first company to receive limited approval to use its vaccine in people. The Chinese government has approved the vaccine for military use only, for a period of one year. On August 15, Russian biopharmaceutical company Petrovax announced it had launched the first phase three clinical trial of Ad5-nCoV.

The Gamaleya National Center of Epidemiology and Microbiology

Name: Sputnik V

What: Gamaleya has developed a viral vector vaccine that also uses a weakened version of the common cold-causing adenovirus to introduce the SARS-CoV-2 spike protein to the body. This vaccine uses two strains of adenovirus, and it requires a second injection after 21 days to boost the immune response. Russia has not published any data from its clinical trials, but officials with the institute state that they have completed phases one and two. The researchers also claim the vaccine produced strong antibody and cellular immune responses.

Status: Despite the lack of published evidence, Russia has cleared the Sputnik V vaccine for widespread use and claimed it as the first registered COVID-19 vaccine on the market. Russia reports that it will start phase three clinical trials on August 12; the World Health Organization, however, lists the Sputnik V vaccine as being in phase one of clinical trials.

Eli Lilly Asks FDA to Authorize Covid-19 Antibody Drug

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Eli Lilly & Co. said it has requested U.S. authorization of the emergency use of an experimental antibody-based treatment for people with recently diagnosed, mild-to-moderate Covid-19, following positive results from clinical testing.

The Indianapolis-based company said it is seeking the authorization for its drug, code named LY-CoV555, which was derived from a blood sample of one of the earliest U.S. survivors of Covid-19.

If cleared, it could be the first to treat less severe cases of Covid-19. The few other therapies authorized for Covid-19 treatment, including remdesivir from Gilead Sciences Inc., target hospitalized patients with more serious cases.

Lilly’s antibody drug could also be the first in a new class of Covid-19 agents that could not only provide treatment but also potentially give temporary protection against the virus to people at risk of infection. That would fill a gap until vaccines are authorized.

The leading experimental antibody drugs have shown enough promise in testing so far that President Trump was given one developed by Regeneron Pharmaceuticals Inc.

Lilly said last month its drug reduced the rate of hospitalization compared with a placebo in a study.

The Indianapolis company is manufacturing doses and could have 100,000 doses this month and as many as one million by the end of the year.

https://www.marketscreener.com/quote/stock/ELI-LILLY-AND-COMPANY-13401/news/Eli-Lilly-Asks-FDA-to-Authorize-Covid-19-Antibody-Drug-Update-31498716/HELP US SPREAD GOOD NEWS!

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India reports lowest number of fresh daily Covid-19 cases in a month

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The country reported the lowest number of new coronavirus disease (Covid-19) cases in at least a month, as 59,980 new infections were reported on Monday.

India has reported 6,681,937 Covid-19 cases to date, according to the data collated by HT’s dashboard.

On Monday, 903 fresh Covid-19 deaths were reported, as the overall toll rose to 1,03,622.

India had reported the first death due to the viral infection on March 12.

Union Ministry of Health and Family Welfare’s (MoH&FW) data showed that the country’s Covid-19 caseload has remained under one million.

https://www.hindustantimes.com/india-news/india-reports-lowest-number-of-fresh-daily-covid-19-cases-in-a-month/story-4mfqv4mJkxsFx2GESTTaEI.htmlHELP US SPREAD GOOD NEWS!

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India’s new paper Covid-19 test could be a ‘game changer’

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A team of scientists in India has developed an inexpensive paper-based test for coronavirus that could give fast results similar to a pregnancy test. The BBC’s Soutik Biswas and Krutika Pathi unpack how it works.

The test, named after a famous Indian fictional detective, is based on a gene-editing technology called Crispr. Scientists estimate that the kit – called Feluda – would return results in under an hour and cost 500 rupees (about $6.75; £5.25).

Feluda will be made by a leading Indian conglomerate, Tata, and could be the world’s first paper-based Covid-19 test available in the market.

“This is a simple, precise, reliable, scalable and frugal test,” Professor K Vijay Raghavan, principal scientific adviser to the Indian government, told the BBC.

Researchers at the Delhi-based CSIR-Institute of Genomics and Integrative Biology (IGIB), where Feluda was developed, as well as private labs, tried out the test on samples from about 2,000 patients, including ones who had already tested positive for the coronavirus.

They found that the new test had 96% sensitivity and 98% specificity. The accuracy of a test is based on these two proportions. A test that’s highly sensitive will detect almost everyone who has the disease; and a test that has high-specificity will correctly rule out almost everyone who doesn’t have the disease.

The first ensures not too many false negative results; and the second not too many false positives. India’s drug regulator has cleared the test for commercial use.

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Over 15,000 children’s homes surprised with free Wi-Fi amid COVID-19 pandemic

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Over 15,000 student households in five school districts were gifted with free internet connectivity this morning, as many children struggle with online learning due to unreliable Wi-Fi amid the novel coronavirus pandemic.

“Good Morning America,” revealed the surprise today to students attending five public school districts located in Allegheny Valley, Pennsylvania, Jackson, Mississippi, Baltimore, Maryland, Santa Fe, New Mexico and South Bend, Indiana. They will now have five years of free internet connection in their homes, thanks to T-Mobile’s Project 10Million–a program that aims to eventually get free Wi-Fi to 10 million students’ households in the US.

“It means a lot to the community–to narrow the gap, for students to have the opportunity to have internet access at home. It’s amazing,” said Shawn Henderson, principal of Riley High School in South Bend. “We’re blessed, thank you.”

Of the 50 million children learning remotely, between 15 and 16 million lack adequate internet connectivity, according to the Center for Democracy and Technology. As a result, many students have turned to fast food restaurants or school parking lots to access online classes.

https://abcnews.go.com/GMA/Living/15000-childrens-homes-surprised-free-wi-fi-amid/story?id=73331800

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