AstraZeneca to seek FDA authorization for vaccine based on foreign trial data

The company also said it would work with the agency to adjust the design of its late-stage U.S. trial to test the half-dose regimen, rather than the higher dose that proved less effective in the U.S and Brazil studies. That U.S. trial has enrolled about 10,000 of a planned 40,000 participants, but the company has not released any data from that study.

The U.K. and Brazil studies have enrolled about 24,000 participants — fewer than the 30,000 participants that the FDA is requiring for late-stage coronavirus vaccine trials.

The initial findings were based on 131 infections among trial participants. The company did not break down how many cases were reported among those who got a placebo versus those who got the vaccine, and within that vaccine group, how cases split among the two doses tested.

AstraZeneca also said that none of the infected people had severe Covid-19 or were hospitalized, but offered no further safety information.

Promising logistics: The AstraZeneca vaccine is cheaper and easier to distribute than the other two shots that have proven effective. It can be transported and stored under refrigerated conditions for at least six months, and the company says it can make up to 3 billion doses next year.

Vaccines from Pfizer and Moderna, which have each proven about 95 percent effective, must be frozen during distribution and kept at very cold temperatures.

“AstraZeneca and Oxford have developed an affordable, scalable vaccine that crucially can be stored and shipped in a regular refrigerator,” said Richard Hatchett, CEO of the Coalition for Epidemic Preparedness Innovations, said in a statement. “This makes it appropriate for use and easy to deliver almost anywhere in the world, including in low-resource settings.”

But questions remain: Others doubt whether the FDA will authorize the vaccine.

“We believe that this product will never be licensed in the US,” investment bank SVB Leerink analyst Geoffrey Porges said in a note on Monday. “This belief is based on the design of the company’s pivotal trials (which does not appear to match the FDA’s requirements for representation of minorities, severe cases, previously infected individuals and elderly and other increase risk populations), and based on the occurrence of severe safety events (why take the risk) that resulted in the extended clinical hold on enrollment into the trials in the US.”

The company halted its U.S. trial in early September over safety concerns, after a trial participant reported neurological problems. The study resumed earlier this month after FDA concluded that no evidence linked the volunteer’s symptoms to the shot.

Background: The AstraZeneca vaccine was developed by scientists at Oxford University, and uses a different technology than the Moderna and Pfizer vaccines. It uses a weakened version of the common cold that contains some genetic material from the coronavirus.

U.S. vaccine and therapeutics accelerator Operation Warp Speed paid for some of the clinical development of the AstraZeneca vaccine and purchased 300 million doses for $1.2 billion.

Other clinical trials are ongoing in Japan, Russia, South Africa, Kenya

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Coronavirus cases in Texas surpass 900,000, state data shows

Coronavirus cases in Texas surpassed 900,000 over the weekend, according to state estimates.

As of Sunday, some 904,855 cases of the novel virus were reported in the Lone Star State, with more than 4,000 new cases reported on Sunday alone. Overall, more than 18,000 lives have been lost to COVID-19 in Texas, including the 53 new fatalities reported on Sunday. 

As of Sunday, some 904,855 cases of the novel virus were reported in the Lone Star State. (iStock)

As of Sunday, some 904,855 cases of the novel virus were reported in the Lone Star State. (iStock)

Additionally, more than 5,600 people are currently hospitalized with COVID-19 in the state. 

Texas is No. 2 in the nation for the most cases of the deadly virus reported in the past seven days, according to data from the Centers for Disease Control and Prevention (CDC). Illinois has reported the most in the past week, with 44,570 cases. Texas, meanwhile, has reported 42,480 cases in the past seven days, per the CDC. 

WAYS TO REDUCE ELECTION DAY STRESS, ANXIETY

The news comes as some states are encouraging, but not requiring, face masks at the polls ahead of Election Day on Tuesday. While officials in some states have said they will require voters who refuse to wear a mask to cast their vote either curbside or at an isolated location, a federal appeals court in Texas halted an order that would’ve required voters to wear a face mask while at the polls.

ARE POLL WORKERS AT AN INCREASED RISK FOR CORONAVIRUS?

As of Monday, the U.S. had tallied over 9.2 million cases of coronavirus and more than 231,000 deaths. A number of regions are seeing a surge in cases, as health officials have urged the public to refrain from letting so-called “coronavirus fatigue” set in, especially as the U.S. heads into flu season.

Fox News’ Alexandria Hein contributed to this report. 

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Fitness tracker and smartwatch data used to predict COVID-19 cases

A preliminary study, from a large and ongoing research project, is suggesting measurements from fitness tracker wearables and smartwatches, alongside self-reported symptom data, can effectively detect cases of COVID-19. The goal of the project is to develop a real-time tracking system that can help identify and contain viral outbreaks at their earliest point.

“One of the greatest challenges in stopping COVID-19 from spreading is the ability to quickly identify, trace and isolate infected individuals,” explains Giorgio Quer, first author on the new study. “Early identification of those who are pre-symptomatic or even asymptomatic would be especially valuable, as people may potentially be even more infectious during this period. That’s the ultimate goal.”

Researchers from Scripps Research Translational Institute have previously demonstrated how influenza outbreaks can be tracked using wearable fitness devices such as a Fitbit. Early in 2020 the researchers launched a new study called DETECT (Digital Engagement and Tracking for Early Control & Treatment), which called for the general public to sign up to a research app that collects fitness tracker data and logs self-reported symptoms. By June over 30,000 subjects had signed on to the project.

A newly published study in the journal Nature Medicine is reporting the first results from DETECT, revealing fitness wearable data, along with self-reporting of symptoms, can detect cases of COVID-19 with around 80-percent accuracy. This predictive rate is significantly higher than models based on self-reported symptoms alone.

“This is really an exciting result,” says Eric Topol, Director of Scripps Research. “It shows that passive, continuous monitoring, with devices like Fitbit and the Apple Watch might turn out to be an important public health surveillance tool for COVID-19. Especially in a time when we don’t have enough tests or at enough frequency with enough turnaround of results, this might be a way to identify and isolate the individuals who are infected.”

Heart rate, sleep, and activity data were the key wearable measurements that proved most helpful in detecting COVID-19 cases. While everyone’s individual baseline measurements were slightly different, by evaluating deviations from normal measurements over time the researchers were able to effectively detect cases of COVID-19.

The predictive model being developed through the DETECT study still needs more work before it can be deployed in the real-world so Jennifer Radin, a Scripps epidemiologist leading the study, is calling for citizen scientists to download the free app and anonymously offer their wearable data to help accelerate the research project.

“We’re just getting started with DETECT,” says Radin. “We have so much more research to do and that’s going to require many more participants. I’d love for us to have 100,000 or more people. That would give us the data we need to take this to the next level.”

If you are interested in helping out with the project, more information can be found at Detect Heath Study.

The new study was published in the journal Nature Medicine.

Source: Scripps Research

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New data shed more light on source of coronavirus clusters around Mass.

Of the 28 COVID-19 clusters linked to child care from Sept. 27 through Oct. 24, just 70 confirmed infections were identified, along with 253 close contacts that required additional tracing and testing.

Similarly, just 70 confirmed cases were identified from 19 clusters in restaurants and food courts, the data show.

In posting the new data, Massachusetts joins a handful of other states that are sharing such information.

Health departments in some states, including Louisiana, post reports from their contact-tracing programs that specify the businesses, schools, or other facilities where outbreaks are occurring. Others, such as Vermont and Colorado, post the occupations, industries, or settings — such as bars, casinos, or food processing plants — with the highest number or percentages of infections in their states.

Massachusetts’ new data show 2,707 clusters involving 6,830 new cases linked to households. That accounts for about a third of all the new infections in the past month.

“A large amount of transmission is occurring in households, a place where people let their guard down and feel safe,” said Tory Mazzola, a spokesman for the state’s coronavirus command center. ”It’s critical that residents are aware of this and — especially those living in multi-generational homes or with family members who have underlying conditions — take precautions even in their home, such as wearing a mask, washing hands and not sharing utensils, as a few examples.”

Carlene Pavlos, executive director of the Massachusetts Public Health Association, said the household data leaves too many unanswered questions.

“What we really want to understand is how is the spread getting into the community,” she said. “Residents living in the same household, we know they are likely to spread it to each other.”

Earlier this week, Governor Charlie Baker said workplace infections are not driving the state’s surge in cases, but the new data suggests that’s an open question.

The data do not identify whether the cases and clusters identified in nursing homes, hospitals, and other health care settings are among workers or patients. But it does show that about 16 percent of the confirmed cases linked to clusters in the past month are from various sites, including health care, restaurants, retail stores, and other settings.

As the holidays approach, Baker has urged residents to be cautious about social gatherings, but the new data suggest those gatherings are not necessarily fueling the latest surge in coronavirus infections.

The new numbers show 11 new clusters traced to social gatherings in the last month. Yet those clusters accounted for just 67 new confirmed cases, along with 50 other people considered close contacts who may have been infected.

“Clearly that is not what is driving this latest spike of over 1,000 new cases a day,” Pavlos said.


Kay Lazar can be reached at [email protected] Follow her on Twitter @GlobeKayLazar.

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Pritzker Defends Coronavirus Data Used To Ban Indoor Dining

CHICAGO — Gov. J.B. Pritzker defended the metrics used to guide his regional COVID-19 resurgence mitigation plan, which have triggered restrictions on indoor service at restaurants and bars across most of the state.

Coronavirus positivity rates in all but one region of Illinois are above the 8 percent fail-safe threshold that leads to increased restrictions under the governor’s Restore Illinois plan and executive orders.

“Let’s be clear,” Pritzker said. “Well-meaning and reasonable people can have fair disagreements about how and where to draw lines and connect dots, but when every single metric in every single corner of our state is trending poorly, we have to take meaningful action to keep our people safe”

In addition to a positivity rate that has risen by 3.4 percentage points since Oct. 1, the number of hospitalized patients with COVID-19 rose by 73 percent, while the number of coronavirus patients in the state’s intensive care units is up by 61 percent this month, according to Illinois Department of Public Health data Pritzker shared at a briefing Thursday in Chicago.

Of the two regions where restrictions have yet to be imposed: Region 6, the Champaign EMS region, is on track to see restrictions announced Friday, having already averaged two days above the 8 percent mark. And Region 2, the Peoria EMS region, saw its positivity rate rise to 7.9 percent on the most recent day for which data was available.

The restrictions can also be triggered by a period of seven out of 10 days with both increasing positivity rates and an increasing rounded rolling average number of new daily hospitalizations of people with coronavirus symptoms. That led to the first tier of mitigations in suburban Cook County and Chicago before the regions also triggered restrictions by spending three days above the 8-percent mark.

“Bars and restaurants are spreading locations,” Pritzker said. “We need to clamp down because we need to bring the numbers down. They’re headed in the wrong direction, and unfortunately bars and restaurants are the location — no fault of the people who own them or operate them or even people who visit them — but it is true that those are places where there is a higher transmission likelihood than other locations.”

Tiered mitigations restricting indoor dining and limiting the size of gatherings have been imposed on nine of the state’s 11 regions. Region 3, the Springfield emergency medical services region, Thursday became the latest to trigger the additional measures. One region — Region 1 in Northwest Illinois — has advanced to the second tier of mitigations. “Tier 2” includes a 10-person gathering size limit and a six-person limit at outdoor tables.

Pritzker was asked whether the first two tiers of limitations that be enough to curb the spread.

“I don’t know. I really would like to know the answer to that. This virus is unknowable, seemingly,” he said. “We didn’t know when we put the stay-at-home order back in March, we didn’t know if that was enough. We

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Meet The US-Based Fitness Brand Using Data To Design The Perfect Workouts

US-based fitness brand P.volve has designed its workout programmes so they can be done anywhere. And behind all of the training is a simple idea: workouts should translate to real-life movements. Why should we go to the gym and move our bodies in a way we never do in our daily life? Despite a hugely varied repertoire of classes and streaming workouts, don’t expect to see any burpees or old-fashioned crunches. The goal is to work with your body not against it. It’s all about toning, lengthening and developing long and lean muscles. And many of the workouts are designed for busy schedules, with no shortage of high-intensity classes lasting 10, 20 or 30 minutes. But what really makes P.volve different is its well-targeted equipment range, much of which tucks neatly into a suitcase or weekend bag.

Tell me about the new LA studio and what you were looking to achieve? What about the Chicago studio?

Rachel Katzman, CEO and co-founder of P.Volve: Because we’ve built this global streaming community since day one, we have been able to connect with our members around the world and understand exactly what they want. Immediately after opening our New York studio, we knew Chicago would be the next market for us, given our streamer base there. Because of the pandemic, opening in Chicago last month in the West Loop neighborhood was all about providing a support system and wellness community for Chicago citizens, with safety, of course, at the forefront. Hosting both limited-capacity indoor classes, as well as classes on the sidewalk outside our studio really has been amazing.

In today’s world, we know that people want a hybrid approach to fitness—workout in-studio with their close friends and accountability partners, stream from home for a quick 15-minute burn when their schedule is tight, and have the option to train privately. And that’s what we strive to do at P.volve.

How has the virus changed the way P.volve runs its business and classes? Do you think these will be permanent changes? We had to follow all of the guidelines and shut down our NYC studio and production studio in March—but we knew that we couldn’t stop producing fresh content, especially given how many people were now stuck at home and facing challenges on finding ways to move.

We sent all of our trainers tripods and lighting equipment, so they could easily produce videos from their homes. We produced content for our 0n-demand platform but then also released free content on our Instagram channel daily, so that anyone had access to ways to workout from home—even if they weren’t already a member with us. We also quickly launched a seven-day reset program, which included nutritional tips.

We’ve always been a data-obsessed company, but now more than ever, we are really listening and watching what specific content people want. We spend countless hours a week watching our members and our trial participants,

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Coronavirus In Riverside County: Updated Data

RIVERSIDE COUNTY, CA — Riverside County’s coronavirus positivity rate has climbed to 5.6 percent amid a significant increase in the volume of people being tested countywide, health officials told the Board of Supervisors this week.

According to Department of Public Health Director Kim Saruwatari, the county’s testing rate has reached 221.6 tests per 100,000 population, compared to 195.5 tests per 100,000 a week ago. The state’s testing threshold for large counties is 239.1 per 100,000.

“There’s been a tremendous amount of effort to increase testing in the county,” Saruwatari told the board on Tuesday.

With the increase in screening, there has been a proportional rise in positive results. The 5.6 percent positivity rate compares to an overall rate of 5.2 percent last week.

Additionally, the daily COVID-19 case rate in Riverside County is now 10.1 infections per 100,000 population, according to state data. The previous rate calculated by the state on Oct. 20 was 9.1 per 100,000.

The high case rate and below-threshold testing make the county ineligible for movement back into the “red tier” under the California Department of Public Health’s parameters. On Oct. 20, the CDPH reclassified the county in the “purple tier,” the most restrictive under the state’s color-coded coronavirus regulatory framework, meaning some businesses that had reopened in recent weeks were required to close again or move outdoors, though the compliance level was unknown. The designation impacts gyms, restaurants, movie theaters and places of worship, which can still operate outdoors only.

The total number of COVID-19 infections recorded since the public health documentation period began in early March increased Wednesday by 306 to 67,299, compared to 66,993 on Tuesday, according to the Riverside University Health System. The number of verified patient recoveries is 59,909.

The RUHS reported two additional deaths tied to COVID-19, bringing the county’s death toll from the virus to 1,305.

The number of COVID-positive hospitalizations is now 143 compared to 166 on Tuesday. The figure includes 32 intensive care unit patients, a decrease of 26 since Tuesday.

All COVID-19 hospitalization counts are currently at or below levels reported in April, and Emergency Management Director Bruce Barton told the board Tuesday that “hospitals have resumed normal operations.”

He additionally said that temporary overflow COVID-19 emergency treatment facilities at the Indio Fairgrounds and the shuttered Sears building on Arlington Avenue in Riverside had been “broken down” and the equipment stored in a warehouse for lack of need.

—City News Service contributed to this report.

This article originally appeared on the Temecula Patch

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Data for Lilly’s bamlanivimab (LY-CoV555) in COVID-19 outpatients published in New England Journal of Medicine

INDIANAPOLIS, Oct. 28, 2020 /PRNewswire/ — The New England Journal of Medicine has published data from the monotherapy arms of BLAZE-1, a Phase 2 study assessing the efficacy and safety of Eli Lilly and Company’s (NYSE: LLY) bamlanivimab (LY-CoV555) – a neutralizing antibody – in the COVID-19 outpatient setting. This study focused on ambulatory COVID-19 patients being treated in the outpatient setting, whose symptoms did not require hospitalization at the time of enrollment. The publication, which can be found here, follows Lilly’s proof-of-concept data announcement for bamlanivimab as monotherapy in September 2020.

“The publication of these data in a peer-reviewed journal adds to the growing body of evidence for the potential utility for neutralizing antibodies as therapeutics for people recently diagnosed with mild to moderate COVID-19, particularly high-risk patients,” said Ajay Nirula, M.D., Ph.D., vice president of immunology at Lilly and co-first author of the study. “These data show bamlanivimab may be effective in treating COVID-19 by reducing viral load, symptoms and the risk of hospitalization in outpatients.”

“It is important to treat people with COVID-19 as soon as possible after diagnosis in order to forestall development of more severe disease,” said Peter Chen, M.D., director of Pulmonary and Critical Care Medicine at Cedars-Sinai and co-first author of the study. “Our findings indicate that neutralizing antibodies may have the potential to be useful in this early-stage intervention.”

These data were submitted as part of Lilly’s request for an emergency use authorization from the U.S. Food and Drug Administration for bamlanivimab in higher-risk patients who have been recently diagnosed with mild to moderate COVID-19.

About BLAZE-1

BLAZE-1 ( NCT04427501 ) is a randomized, double-blind, placebo-controlled Phase 2 study designed to assess the efficacy and safety of bamlanivimab alone or in combination with a second antibody for the treatment of symptomatic COVID-19 in the outpatient setting. To be eligible, patients were required to have mild or moderate symptoms of COVID-19 as well as a positive SARS-CoV-2 test based on a sample collected no more than three days prior to drug infusion.

The monotherapy arms of the trial enrolled mild to moderate recently diagnosed COVID-19 patients, studying three doses of bamlanivimab (700 mg, 2800 mg, and 7000 mg) versus placebo.

The primary outcome measure for the completed arms of the BLAZE-1 trial was change from baseline to day 11 in SARS-CoV-2 viral load. Additional endpoints include the percentage of participants who experience COVID-related hospitalization, ER visit or death from baseline through day 29, as well as safety.

The study is ongoing with additional treatment arms. Across all treatment arms, the trial will enroll over 800 participants.

Data from the BLAZE-1 study show bamlanivimab may be effective in treating COVID-19 by reducing viral load, symptoms and the risk of hospitalization in patients recently diagnosed with mild to moderate COVID-19. In the BLAZE-1 trial, rates and types of adverse events were similar between bamlanivimab and placebo, with the majority being mild to moderate in severity and with no drug-related serious adverse events reported thus

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Louisiana coronavirus: 503 more cases, 10 more deaths reported Wednesday; see latest data | Coronavirus

The Louisiana Department of Health reported 503 more coronavirus cases and 10 more deaths in its noon update Wednesday.

The number of hospitalizations increased by 13, and the number of patients in need of ventilators decreased by 11.

These are another few key statewide statistics as of Wednesday:

— Total cases: 181,443

— Total deaths: 5,676

— Currently hospitalized: 613

— Currently on ventilators: 80

— Presumed recovered: 168,634 as of Oct. 26 (updated weekly)

— Probable cases: 4,379 as of Oct. 28 (updated weekly)

Note: The Advocate and The Times-Picayune staff calculates daily case count increases based on the difference between today’s total and yesterday’s total of confirmed coronavirus cases. The Louisiana Department of Health releases a daily case count on Twitter based on the deletion of duplicate cases. That case count can be different than the one listed here.

You can view more graphs and charts breaking down the data by clicking here.

Louisiana began reopening for Phase 1 on May 15-16 then moved to Phase 2 on June 5. Louisiana Gov. John Bel Edwards extended Louisiana’s Phase 2 restrictions twice in August before moving the state to Phase 3 on Sept. 11.

This is a developing story. More details and analysis to come.

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Highly anticipated COVID-19 vaccine data from Pfizer unlikely to come before Election Day: CEO

ABC News Corona Virus Health and Science

“This will not be a Democratic vaccine or Republican vaccine.”

Pfizer executives said in a third-quarter investor presentation on Tuesday they have not seen the first interim efficacy data yet. The Data Monitoring Committee, an independent group of experts monitoring the clinical studies and the data collection, “has not conducted any interim efficacy analyses to date,” according to Pfizer.

The slight delay from an earlier prediction of data by the end of October means results will likely not be known by Election Day, despite claims by President Donald Trump for months that a vaccine is “weeks away.”

The Data Monitoring Committee has thresholds for review that are triggered when a certain number of trial volunteers become sick with COVID-19. The first interim analysis is scheduled to happen when 32 people develop COVID-19, according to Pfizer’s extensive clinical trial protocol.

Bourla said, however, the company is still on track for a November application for authorization, if the vaccine shows to be effective and, just as importantly, safe.

Pfizer CEO Albert Bourla had previously said the company “may know whether or not our vaccine is effective by the end of October.”

Once there are 32 volunteers infected with COVID-19, Pfizer will analyze how many of them received the vaccine and how many received a placebo. If more than 76.9% of the grouping is in the placebo group, Pfizer will consider the vaccine efficacious.

Once an independent review board releases information on the trials, the company will need a week to review it internally, Bourla said.

Pfizer plans to release the interim data if it is negative (worse than 11.8%) or positive (better than 76.9%) for efficacy. If the data is somewhere in between, Pfizer will wait for more conclusive results, Bourla said.

“In case of a conclusive readout, positive or negative, we will inform the public as soon as we complete the necessary administrative work, which we estimate to be completed within one week from the time we know,” he explained to investors, adding that the company “reached the last mile here and we expect these things will start coming soon, so let’s all have patience.”

He said he is “cautiously optimistic” the vaccine will work based on earlier studies.

PHOTO: Medical syringes stand in front of the Pfizer company logo, Oct. 12, 2020.

Medical syringes stand in front of the Pfizer company logo, Oct. 12, 2020.

Pfizer said it expects efficacy and safety data will be available in November, and if it is, it will apply for emergency use authorization.

Pfizer’s vaccine candidate was also developed with the German biotech firm BioNTech. There are 150 clinical trial sites around the world.

More than 42,000 participants have been enrolled and nearly 36,000 have received a second dose of the vaccine. Expanding the number of participants has allowed trials to include additional populations, among them children between 12 and 18 and people with preexisting conditions.

When

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