Delays

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Novavax delays U.S. trial of COVID-19 vaccine to November

FILE PHOTO: A woman holds a small bottle labeled with a “Vaccine COVID-19” sticker and a medical syringe in this illustration taken April 10, 2020. REUTERS/Dado Ruvic

(Reuters) – Novavax Inc on Tuesday delayed the start of a late-stage U.S. trial of its experimental coronavirus vaccine by roughly a month to the end of November, citing delays in scaling up the manufacturing process.

The U.S.-based drug developer said data from a separate Phase III trial being conducted in Britain was expected by the first quarter of 2021 and could be the basis for global regulatory approvals although it did not elaborate. Shares of the company rose nearly 3%.

It is not immediately clear whether that could apply in the United States. Novavax did not respond to a request for clarification.

“I think the FDA has generally been loathe to approve vaccines for Americans that haven’t been tested in Americans, historically,” Dr. Paul Offit, an infectious disease expert at the University of Pennsylvania and a member of the U.S. Food and Drug Administration’s vaccine advisory panel, said on in an interview with the editor of JAMA medical journal on Tuesday.

Data from an early-to-mid stage trial of the vaccine is expected on Friday, the company said. Earlier data had showed the vaccine produced high levels of antibodies against the novel coronavirus.

A handful of companies, including larger rivals Pfizer Inc and AstraZeneca Plc, are conducting late-stage trials of their experimental COVID-19 vaccines, though none have reported pivotal data that would be used to seek emergency authorization or approval.

The companies, including Novavax, have already made distribution deals with several countries for the vaccines, once approved.

Novavax in August said it will supply 60 million doses of its coronavirus vaccine to the UK from as early as the first quarter of 2021.

The company is also preparing to deliver 100 million doses to the United States by January after it was awarded $1.6 billion for its potential vaccine, and has also signed supply agreements with Canada and Japan.

Reporting by Manas Mishra in Bengaluru and Julie Steenhuysen in Chicago; Editing by Arun Koyyur and Bill Berkrot

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Novavax Delays U.S. Trial of COVID-19 Vaccine Candidate to November | Top News

(Reuters) – Novavax Inc on Tuesday delayed the start of a late-stage U.S. trial of its experimental coronavirus vaccine by roughly a month to the end of November, citing delays in scaling up the manufacturing process.

The U.S.-based drug developer said data from a separate phase 3 trial being conducted in Britain was expected by the first quarter of 2021 and could be the basis for regulatory approval, sending its shares up 3.4% in early trading.

Data from an early-to-mid stage or phase 2 trial of the vaccine is now expected on Friday, the company said. Early-stage data had showed the vaccine produced high levels of antibodies against the novel coronavirus.

A handful of companies, including larger rivals Pfizer Inc and AstraZeneca Plc, have begun testing their vaccines in late-stage trials, though none of them is yet to win regulatory approvals.

Novavax in August said it will supply 60 million doses of its coronavirus vaccine candidate to the UK from as early as the first quarter of 2021.

The company is also preparing to deliver 100 million doses to the United States by January after it was awarded $1.6 billion for its potential vaccine and has also signed supply agreements with Canada and Japan.

(Reporting by Manas Mishra in Bengaluru; Editing by Bernard Orr and Arun Koyyur)

Copyright 2020 Thomson Reuters.

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New outbreak delays easing of rules in Melbourne

MELBOURNE, Australia — A COVID-19 outbreak in the north of Melbourne has led health authorities in Australia’s Victoria state to hold off on any further easing of restrictions in the beleaguered city.

Victoria Premier Daniel Andrews withheld any announcement on an easing on Sunday as the state awaits results on 3,000 people who were tested in the city’s north in the past 24 hours.

He described it as a “cautious pause” – not a setback – to rule out there wasn’t widespread community transmission linked to the cluster.

Among the current restrictions are mandatory wearing of masks and no traveling beyond 25 kilometers (15 miles) from home. At the start of the second wave of cases two months ago, Andrews instituted an overnight curfew and shut down most businesses.

“I know it is frustrating,” Andrews said. “I know people are keen to have a long and detailed list of changes to the rules. It is not appropriate for us to do that now.”″

Victoria reported seven new coronavirus cases on Sunday, with six linked to the latest outbreak, which involves 39 people across 11 households.

No additional deaths kept the state toll at 817 and the national toll at 905.

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HERE’S WHAT YOU NEED TO KNOW ABOUT THE VIRUS OUTBREAK:

— Surging coronavirus colors White House race in closing days

— Europe, US watch case totals grow, debate new restrictions

— Colombia reaches 1 million confirmed coronavirus cases

— Iran’s supreme leader has urged authorities to prioritize public health above any economic or security concerns, amid the Mideast’s worst outbreak of the coronavirus. Iran’s death toll from the global pandemic topped 32,000 this week.

— Pope Francis met with the Spanish prime minister Saturday at the Vatican, which has had a rash of COVID-19 infections confirmed in recent days, but neither man used a face a mask during the public part of their meeting.

— Poland’s President Andrzej Duda has tested positive for the coronavirus; apologizes to those in quarantine because of contact, including Poland’s recent French Open winner.

— Police force in England says it will try to stop people from leaving Wales, which has started a 17-day lockdown to slow a surging rate of coronavirus infections.

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Follow all of AP’s coronavirus pandemic coverage at http://apnews.com/VirusOutbreak and https://apnews.com/UnderstandingtheOutbreak

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HERE’S WHAT ELSE IS HAPPENING:

COLOMBO, Sri Lanka — Sri Lankan authorities have terminated a number of passenger trains and widened the curfew as COVID-19 cases related to a new cluster at a garment factory continue to surge.

The Railway Department canceled at least 16 trains — mostly ran through busy office hours — after the number of commuters declined due to the curfew imposed in many parts of the country.

More than a dozen villages are isolated in densely populated Western province, which includes capital Colombo.

Authorities last week closed the island’s main fish market on Colombo’s outskirts after 49 traders tested positive for the coronavirus. By Sunday, the number of cases from the fish

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health

Disneyland Reopening Schedule, Delays Threaten Nearby Businesses

ANAHEIM, CA — It may be “A Small World After All,” as the song goes, but Disneyland is too big to reopen at present, according to the governor’s office. On Tuesday, the state’s newly released reopening guidelines showed that while some small amusement parks may reopen, large-scale theme parks will be at the back of the line.

The much-awaited reopening guidelines, shared Tuesday by California Health and Human Services Secretary Dr. Mark Ghaly, show that Disneyland Resort and California’s large-scale theme parks may not reopen until the county reaches the Yellow (minimal) Tier, likely not in 2020.

The reopening has been a concern not just for Walt Disney Co. but also for the city of Anaheim, which has suffered the loss of multiple businesses and livelihoods in the wake of the park closure.

Many Anaheim businesses depend on the Disneyland Resort for their survival, from restaurants to transportation and hotels.

The Castle Inn, one such business, sits directly across the street from the Disneyland main gates. With its royal theme and walkable distance to the resort, the 50-year-old hotel is a favorite among guests.

Today, the lobby sits empty. The hotel has no guests and no revenue, though there are many expenses that go with maintaining the property, according to owner Bharat Patel.

Bharat Patel discusses his empty hotel, crushing bills, and the sadness of letting longtime employees go. Interview photo.
Bharat Patel discusses his empty hotel, crushing bills, and the sadness of letting longtime employees go. Interview photo.

Seven months into the coronavirus pandemic, his hotel is devoid of guests. There are no little princesses running through the grounds or parents chasing after them. Still, to Patel, that isn’t the hardest part.

The most difficult thing he’s experienced thus far in the coronavirus pandemic is being forced to let a significant number of his staff go, he says.

“I still think about them every day,” he said, voice full of emotion. “How do you tell someone that put their blood sweat and tears into your dream that you don’t have the work for them?”

Patel doesn’t know when he can reopen, and that uncertainty keeps him up at night.

“I don’t think we can hold on much longer,” he says. “We need help.”

To Patel, Anaheim is a family, and that family is hurting.

Read also: Anaheim Will Survive, Officials Concerned With Closure Fallout

Orange County currently sits at the second, or Red (Substantial), tier of Gov. Gavin Newsom’s Blueprint For A Safer Economy. For weeks, the county has teetered on the verge of the Orange tier; however, the case counts for daily positive cases remain stubbornly at the Substantial tier rankings.

As of Tuesday, Orange County is experiencing 4.6 new daily cases per 100,000 people, still in the Red tier. Meanwhile, the testing positivity percentage remains in the middle of the Orange tier rankings, at 3.2 positive tests per 100,000 people tested.

Disneyland will not be allowed to reopen until those two positivity percentages are solidly under 2 percent, according to the governor’s current plan.

According to the state, management can set to work

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Coronavirus Testing Delays Still Prevent Effective Disease Control, Survey Finds : Shots

People wait in the shade while in line to get Covid-19 tests in Revere, MA.

David L. Ryan/Boston Globe via Getty Images


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David L. Ryan/Boston Globe via Getty Images

People wait in the shade while in line to get Covid-19 tests in Revere, MA.

David L. Ryan/Boston Globe via Getty Images

People are getting the results of coronavirus tests in the U.S. faster than they were in the spring, but testing still takes far too long to help effective disease control measures such as contact tracing and quarantining, according to the results of a large national survey.

The survey, which is conducted monthly by a consortium of researchers from Northeastern, Northwestern, Harvard and Rutgers universities, also finds that Hispanics and African-Americans are waiting about a day longer than whites on average, underscoring yet another way the pandemic is hitting minorities harder.

The researchers also found that a disturbingly high proportion of those testing positive — almost half — are never contacted by a health worker to determine who they may have infected, a crucial step for preventing outbreaks.

“That is how you limit the spread of the disease and limit the number of people who have to socially isolate and avoid lockdowns,” says Dr. David Lazer of Northeastern University, who led the team conducting the survey. “The good news is there has been some improvement. The bad news is everything is still taking far too long.”

The researchers surveyed 52,329 people in all 50 states and the District of Columbia in July, August and September as part of a series of ongoing surveys the team has been conducting since April.

Of those surveyed, 12,911 got a coronavirus test, including 8,843 whose sample was collected with a nasal swab.

Among that group, the average wait time for results was 2.7 days in September, down from four days in April, the researchers found. In addition, the proportion of people getting their results back within 24 hours increased from 23% to 37%.

While that’s an improvement, the turnaround time is still “too slow in most cases to support a successful strategy of contact tracing,” and most people are still waiting far too long, the researchers wrote.

“Despite decreased average wait times, a substantial proportion of Americans still endure long waits,” they added.

They noted that in September, 42% of those tested had to wait at least three days before getting their results.

The average black respondent waited 4.4 days to receive results and the average Hispanic respondent waited 4.1 days. In comparison, white and Asian American respondents respectively waited an average of 3.5 and 3.6 days, the researchers found.

“We know that African-Americans and Hispanics are underserved medically,” Lazer says. “This is reflective of that larger reality. It’s terrible.”

To keep outbreaks from occurring, people who are infected need to be contacted quickly, ideally within 24-36 hours to make sure they don’t infect other people and find out who they may have come into contact with so those people

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