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The Latest: FDA will allow short studies of virus variants – OrilliaMatters

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WASHINGTON __ President Joe Biden says the number of lives lost to COVID-19 in the U.S. tops the combined death toll from World War I, World War II and the Vietnam War.

The number of U.S. deaths blamed on the coronavirus crossed the 500,000 threshold Monday.

Biden says it’s a “truly grim, heartbreaking milestone.”

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Biden is urging Americans to resist becoming “numb to the sorrow” and “viewing each life as a statistic.” He says the people lost were “extraordinary.”

Biden also touched on the personal tragedy he’s experienced in losing his first wife and baby daughter in a car collision, and later losing an adult son to brain cancer.

Biden tells the nation’s he knows it’s hard but that “to heal, we must remember.”

He spoke before holding a moment of silence in the White House and inviting the public to join.

___

THE VIRUS OUTBREAK:

— Researchers in Scotland say its COVID-19 vaccination program has caused hospitalizations to plummet

— British Prime Minister Boris Johnson to lay out plan to ease coronavirus restrictions but pubs, gyms and hairdressers to stay closed for weeks

— Russia’s vaccine rollout picks up speed but experts say the campaign is still moving slowly

— Elementary schools and kindergartens reopen in over half of Germany’s 16 states

— Every Democratic vote is needed on $1.9 trillion COVID-19 relief bill, but minimum wage and other issues will force choices

— Follow all of AP’s pandemic coverage at https://apnews.com/hub/coronavirus-pandemic, https://apnews.com/hub/coronavirus-vaccine and https://apnews.com/UnderstandingtheOutbreak

___

HERE’S WHAT ELSE IS HAPPENING:

HOUSTON — Authorities in Houston are opening a giant vaccination centre that will serve an estimated 126,000 people over the next three weeks.

The federally funded site will fully open Wednesday at Houston’s NRG Park, near the home stadium of the NFL’s Houston Texans. Staff will distribute first doses seven days a week for three weeks, then transition to second doses.

Harris County Judge Lina Hidalgo, the county’s chief elected official, says authorities will prioritize people who live in areas hardest hit by the coronavirus. Hidalgo and Houston Mayor Sylvester Turner say their staffs have identified ZIP codes where people have been most affected and lack the same access as other places to medical care.

The site opens as Texans recover from a devastating winter storm that killed at least 35 people and left millions without power and water. While Houston and other cities have lifted boil orders on drinking water, many people are still affected by broken pipes and shutoffs of systems.

Says Hidalgo, “It’s been trauma after trauma, and people deserve some good news, some hope.”

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WASHINGTON– Drugmaker Johnson & Johnson says it will be able to provide 20 million U.S. doses of its single-shot COVID-19 vaccine by the end of March, assuming it gets the greenlight from federal regulators.

J&J disclosed the figure in written testimony ahead of a Congressional hearing on Tuesday looking at the country’s vaccine supply. White House officials cautioned last week that initial supplies of J&J’s vaccine would be limited.

The company reiterated that it will have capacity to provide 100 million vaccine doses to the U.S. by the end of June. That supply will help government officials reach the goal of having enough injections to vaccinate most adult Americans later this year. On a global scale the company aims to produce 1 billion doses this year.

U.S. health regulators are still reviewing the safety and effectiveness of the shot and a decision to allow its emergency use is expected later this week. J&J’s vaccine would be the first in the U.S. that requires only a single shot.

Currently available vaccines from Pfizer and Moderna require two doses spaced several weeks apart. Executives from both companies and two other vaccine makers will also testify at Tuesday’s hearing.

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WASHINGTON — The Food and Drug Administration said Monday that it won’t require huge, months-long studies if COVID-19 vaccines eventually need tweaking to better match a mutating virus — small, short studies will suffice.

The vaccines now being rolled out do still protect against different variants of the virus, the FDA stressed. But viruses mutate constantly, and some new versions are starting to raise concerns. So FDA issued new guidelines for vaccines — as well as for virus tests and treatments — on steps that companies can start taking to get ready.

“We’re trying to be prepared in advance,” said Dr. Peter Marks, the FDA’s vaccines chief.

Already major manufacturers have started updating their vaccine recipes if regulators eventually decide that’s necessary.

Marks said the needed tests would include a few hundred people rather than thousands, and could take just two or three months. Volunteers would receive experimental doses of the tweaked vaccine and then have their blood checked to see if it revved up the immune system about as well as the original vaccines do.

Marks said the hope is that if vaccines have to be updated, they would work broadly enough to cover both the original virus and a new mutant version — rather than requiring a combination shot like flu vaccines. Having to make multiple kinds of vaccine and then combine them would put a greater strain on already stretched production capabilities.

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WASHINGTON — The White House now says it expects to catch up by mid-week on deliveries of coronavirus vaccine doses that were delayed by severe weather.

Officials had said on Friday that they anticipated catching up by the end of this week. Some 6 million doses were delayed by snow and icy conditions.

But White House coronavirus response co-ordinator Andy Slavitt is attributing the improved timeline to an “all-out, round-the-clock” effort.

Slavitt says pharmaceutical distributor McKesson ran extended shifts over the weekend to pack vaccines with employees volunteering to work in the middle of the night to prepare shipments. UPS also participated.

Slavitt says 7 million doses — a combination of those delayed by weather and the regular distribution — were being delivered Monday as a result of those and other efforts.

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BISMARCK, N.D. — North Dakota’s Republican-led House endorsed a measure Monday that would prohibit state or local governments from mandating face coverings.

Representatives approved the measure 50-44. The bill also prohibits “making use of a face mask, shield, or covering a condition for entry for education, employment, or services.”

The bill now goes to the Senate.

Bill sponsor GOP Rep. Jeff Hoverson and others argued there was no proof that masks work to slow the spread of the coronavirus and they questioned the government’s role in mandating them.

The state health officer, backed by Gov. Doug Burgum, imposed a mask mandate in November after months of refraining from such an order, hoping to stem a coronavirus surge that had been among the worst in the U.S. and threatened to overwhelm the state’s hospitals.

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HARTFORD, Conn. – A major change to Connecticut’s vaccination schedule was announced Monday, with the state continuing with a mostly age-based system to make the rollout less complicated after seeing the challenges other states have faced in vaccinating essential workers and people with underlying health conditions.

“The lesson learned here from all these other states is, complexity is the enemy of equity and speed, which makes it the enemy of public health,” Max Reiss, spokesman for Gov. Ned Lamont, told The Associated Press.

Beginning March 1, anyone aged 55 to 64 will be allowed to get a COVID-19 vaccine. That group will be followed by people 45-54 on March 22; 35-44 years on April 12; and everyone else 34 years and younger on May 3.

Lamont previously said he would release details this week about which essential workers and people with underlying medical conditions could soon begin signing up for vaccinations.

Currently, only people ages 65 and older and medical workers are eligible. The previous group eligible for the vaccine included people 75 years and older.

Lamont said Friday he would release a list on Monday of the particular medical conditions that would make people eligible.

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OKLAHOMA CITY — Oklahoma opened its second phase of coronavirus vaccinations on Monday, providing inoculations to public school teachers and staff and to adults of any age with illnesses that make them susceptible to the virus.

“Our goal is to make sure that every Oklahoma teacher and staff member who wants the COVID-19 vaccine can get it by spring break” in mid-March, said health commissioner Dr. Lance Frye at a vaccination clinic in Norman.

More than 681,000 Oklahomans had been vaccinated as of Friday, according to the state health department, and an estimated 60,000 more vaccinations were administered during the weekend, said deputy health commissioner Keith Reed.

State schools superintendent Joy Hofmeister said she expects a high percentage of public school staff to accept the vaccine.

“Teachers have been clamouring for the prioritization of having the vaccine,” Hofmeister said.

There have been 419,853 coronavirus cases and 4,203 deaths due to COVID-19 in Oklahoma since the pandemic began, the state health department reported.

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LONG BEACH, Calif. — More than 7.3 million Californians have received at least one dose of COVID-19 vaccine but supplies are well below the amount that the state has the capacity to administer, Gov. Gavin Newsom said Monday.

“There’s not enough vaccines to accommodate the need and demand,” Newsom said during a stop in Long Beach on a tour of vaccination efforts around the state. “Sites all across the state of California are toggling back based up on limited supply. That’s a manufacturing issue.”

California anticipates receiving 1.4 million doses this week and 1.5 million next week, he said.

“It’s simply not what we’re capable of administering, we could do exponentially more, but nonetheless we are seeing modest improvement week to week,” he said.

Overall, there is a “bright light” at the end of the tunnel, the governor said.

The state’s seven-day test positivity rate was 3% as of Monday compared to 8.9% a month earlier, he said. Daily deaths totalled 233, well below the high of 764 a month earlier. Hospitalization and ICU counts were also significantly improved.

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WASHINGTON — President Joe Biden plans to order all U.S. flags lowered at federal buildings for the next five days in order to memorialize the deaths from the coronavirus.

White House press secretary Jen Psaki says the president will also make remarks later Monday to commemorate the grim milestone of roughly 500,000 people dying from COVID-19.

Psaki says Biden will be speaking from the White House and will ask all Americans to observe a moment of silence during a candlelight service at sundown.

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MADRID — Coronavirus infections, hospitalizations and deaths continue receding in Spain, but the top official guiding the country’s response to the pandemic is warning against relaxation of restrictions.

“We continue to have a high incidence that doesn’t allow us to relax measures of control,” says Fernando Simón, head of Spain’s health emergency co-ordinationcentre.

Despite the warning, some regional governments on Monday joined others that have already reopened bars and restaurants, reduced the nighttime curfew or allow small gatherings of people who are not living together.

The two-week rate of infection continued dropping to 252 cases per 100,000 on Monday from a high of nearly 900 cases at the end of January.

The Health Ministry recorded 20,849 new infections and 535 deaths since Friday, bringing the pandemic’s confirmed totals to 3.1 million infections and 67,636 fatalities.

Spain has administered over 3 million vaccine doses, with nearly 1.2 million fully vaccinated, mostly residents in nursing homes, their caretakers and health workers.

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JUNEAU, Alaska — Alaska Gov. Mike Dunleavy is in quarantine at his home near Wasilla after learning he was in close contact with someone later found to be positive for COVID-19, his office said Monday.

Dunleavy learned of the close contact Sunday and went into quarantine after receiving a COVID-19 test, which came back negative on Monday, his office said.

Dunleavy shows no symptoms and will teleworking from home and receive additional tests “until it is certain he is free of the virus,” his office said. He will follow health guidelines and remain at home for at least seven days, the release states.

The U.S. Centers for Disease Control and Prevention says it endorses 14-day quarantines but says local public health authorities make the final decision for how long quarantine should last and lists as options possibly ending quarantine after the seventh day after a negative test result from a test taken on the fifth day or later.

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BATON ROUGE, La. — Louisiana’s health department said Monday that the delayed Pfizer vaccine doses were received Friday and the state will continue to get the final doses from last week’s shipments by Tuesday.

The state’s Moderna doses from last week were expected to arrive Monday through Wednesday.

Louisiana’s network of hospitals, clinics, community vaccine sites and pharmacies will be getting double allocations of doses in some instances this week.

And those delayed doses come right as Gov. John Bel Edwards has expanded access to the shots for teachers, daycare workers, pregnant women and people age 55 to 64 who have certain preexisting conditions.

Kanter said he expects it could take the state a week or two to catch up on distributing its vaccine doses, after the disruptions caused by the icy weather last week.

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SALT LAKE CITY — The Southwest Utah Public Health Department has announced plans to reschedule appointments for coronavirus vaccinations delayed by a winter storm last week.

The severe weather impacted shipments of vaccine to area clinics from outside the state.

The state health department says its Feb. 18 appointments have been rescheduled for Feb. 22, 25 and 27. The Weber-Morgan Health Department also rescheduled Feb. 18 appointments for Feb. 22.

Utah residents age 65 and older are now eligible to receive vaccines and should check with local health departments for appointment availability. Utah so far has distributed more than 607,000 vaccines.

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ATLANTIC CITY — Fans will be allowed to attend sports and entertainment events at New Jersey’s largest facilities in limited numbers starting next week, Gov. Phil Murphy said Monday.

New Jersey venues with an indoor seating capacity of 5,000 or more will be allowed to have 10% of those seats occupied by fans starting on March 1, the Democratic governor said on the WFAN sports radio station.

For outdoor venues over 5,000 seats, the number will be 15% of capacity.

Murphy said he decided to allow the limited in-person attendance after reviewing a vast array of coronavirus-related statistics including hospitalizations, the number of hospital admissions versus discharges, overall positivity rate for COVID-19, and the rate of transmission, and determining that small crowds can be permitted safely.

He said face coverings and social distancing will be required at these venues.

___

NEW YORK — New York City officials expect to catch up on their vaccination efforts after being forced to put off scheduling tens of thousands of appointments last week, Mayor Bill de Blasio said Monday.

“The supply that we expected last week is arriving today,” de Blasio said. “That means we’ve basically lost a full week in our vaccination efforts. But it will not stop us from reaching our goal of 5 million New Yorkers vaccinated by June because we still have the ability and the capacity to do it.”

___

ATLANTA — A new study finds that teachers may be more important drivers of COVID-19 transmission in schools than students.

The paper released Monday by the U.S. Centers for Disease Control and Prevention studies nine COVID-19 transmission clusters in elementary schools in the Atlanta suburb of Marietta in December and January.

In only one cluster was a student clearly the first documented case. The CDC again advises that schools need to pursue “multifacted” strategies to prevent the spread of the virus, including cutting down on teacher-to-teacher meetings, making sure masks are worn correctly, and increasing physical distancing.

In addition, the CDC says it might be desirable to vaccinate teachers although the CDC restates teacher vaccination isn’t required to reopen.

The Associated Press


















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New technology to advance women’s cancer care at Southlake

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NEWS RELEASE
SOUTHLAKE REGIONAL HEALTH CENTRE
**************************
This Cancer Awareness Month, Southlake is adding advanced technologies to detect and treat breast cancer and other women’s cancers thanks to generous community donor support, most recently through the HERE is Where Cancer Meets its Match campaign. New cancer care technology, including new mammography machines, the MyoSure System and the MOLLI 2® System will make a measurable impact in diagnosing and treating women’s cancers in the communities Southlake serves.

Southlake is installing three new mammography machines to expand its breast cancer screening program to 1,500 more women each year. Two of these machines have new biopsy capabilities that will reduce the number of cancelled exams due to equipment failure, ensuring timely care for women. Women ages 40 to 49 years old will be able to self-refer for publicly funded mammograms through the Ontario Breast Screening Program starting this fall.

“Early detection is critical when treating breast cancer and other women’s cancers,” said Lorrie Reynolds, Director, Regional Cancer Program at Southlake. “We treat more than 1,700 breast cancer patients at Southlake every year. By adding advanced technology, like the new mammography machines, we’re ensuring women have the best experience at Southlake.”

Southlake is also introducing the MyoSure System, an innovative technology that can help detect female reproductive cancers. Damaged tissue in a woman’s uterus such as fibroids and polyps can now be removed in a precise, minimally invasive procedure that leaves the rest of the uterus intact. This will improve the overall patient experience by supporting faster recovery, reducing the risk of infection and giving more women the option to have children. An estimated 200 women per year will benefit from the MyoSure System.

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The new mammography machines and the MyoSure System build on Southlake’s recent investment in the MOLLI 2® System, a made-in-Canada wire-free breast localization technology.  This technology is considerably less invasive and more accurate when compared to wire-guided localization, resulting in a better patient experience and improved cosmetic outcomes.  More than 200 women each year will benefit from this innovative medical device as they are treated for breast cancer at Southlake.

“As a clinician caring for women with cancer in our community, I’m incredibly proud of the work Southlake is doing to advance women’s health and improve patient experiences,” said Sara Temple, MD, Surgical Oncologist and Chief of Surgery at Southlake. “Women who visit Southlake can be confident that they are receiving leading edge care, close to home when they need it most.”

The World Health Organization anticipates a 77 per cent increase in cancer diagnoses by 2050.  Southlake serves some of the fastest growing communities in Canada and anticipates that the number of patients requiring cancer care will grow. By investing in new technology, Southlake is ensuring that women in the communities it serves have access to leading edge cancer care. All of these investments were funded with support from community donors who generously gave to Southlake to support investments into women’s health at the hospital.

“The generosity of our donor community and the impact they have made for women receiving cancer diagnosis and treatment at Southlake is something we can all take great pride in,” said Jennifer Ritter, President and CEO of Southlake Foundation. “From our Women’s Health Initiative donors supporting new mammography machines, to the Ladies in Philanthropy for Southlake funding the MOLLI 2 System, to our long-standing partners The Edge Benefits and Pheasant Run Golf Club enabling the introduction of MyoSure System through their joint annual charity golf tournament, we are incredibly lucky to share a vision of access to exceptional care for everyone who depends on Southlake when they need us most. Thank you, to every donor who contributed to these important upgrades to care for women.”

Southlake Foundation’s HERE is Where Cancer Meets its Match campaign supports the Stronach Regional Cancer Centre at Southlake. For more information or to make a donation, visit: southlake.ca/HERE.

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Pasteurized milk includes remnants of H5N1 bird flu, U.S. officials say

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The U.S. Food and Drug Administration says that samples of pasteurized milk have tested positive for remnants of the bird flu virus that has infected dairy cows.

The agency stressed that the material is inactivated and that the findings “do not represent actual virus that may be a risk to consumers.” Officials added that they’re continuing to study the issue.

“To date, we have seen nothing that would change our assessment that the commercial milk supply is safe,” the FDA said in a statement on Tuesday.

The announcement comes nearly a month after an avian influenza virus that has sickened millions of wild and commercial birds in recent years was detected in dairy cows in at least eight states. The Agriculture Department (USDA) says 33 herds have been affected to date.

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FDA officials didn’t indicate how many samples they tested or where they were obtained. The agency has been evaluating milk during processing and from grocery stores, officials said. Results of additional tests are expected in “the next few days to weeks.”

WATCH | Bird flu spread in U.S. cows:

 

Bird flu is spreading in cows. Are humans at risk? | About That

15 days ago

Duration 8:54

For the first time ever, avian influenza, or H5N1 bird flu, was detected in roughly a dozen dairy cow herds across the U.S. About That producer Lauren Bird explores why scientists and public health officials are concerned about the cross-species transmission and whether humans are now at higher risk.

The polymerase chain reaction (PCR) lab test the FDA used would have detected viral genetic material even after live virus was killed by pasteurization, or heat treatment, said Lee-Ann Jaykus, an emeritus food microbiologist and virologist at North Carolina State University

“There is no evidence to date that this is infectious virus, and the FDA is following up on that,” Jaykus said.

Officials with the FDA and the USDA had previously said milk from affected cattle did not enter the commercial supply. Milk from sick animals is supposed to be diverted and destroyed. Federal regulations require milk that enters interstate commerce to be pasteurized.

Tests for viable virus underway, agency says

Because the detection of the bird flu virus known as Type A H5N1 in dairy cattle is new and the situation is evolving, no studies on the effects of pasteurization on the virus have been completed, FDA officials said. But past research shows that pasteurization is “very likely” to inactivate heat-sensitive viruses like H5N1, the agency added.

The agency said it has been evaluating milk from affected animals, in the processing system and on the shelves. It said it is completing a large, representative national sample to understand the extent of the findings.

The FDA said it is further assessing any positive findings through egg inoculation tests, which it described as a gold standard for determining viable virus.

Matt Herrick, a spokesperson for the International Dairy Foods Association, said that time and temperature regulations for pasteurization ensure that the commercial U.S. milk supply is safe. Remnants of the virus “have zero impact on human health,” he wrote in an email.

Scientists confirmed the H5N1 virus in dairy cows in March after weeks of reports that cows in Texas were suffering from a mysterious malady. The cows were lethargic and saw a dramatic reduction in milk production. Although the H5N1 virus is lethal to commercial poultry, most infected cattle seem to recover within two weeks, experts said.

To date, two people in the U.S. have been infected with bird flu. A Texas dairy worker who was in close contact with an infected cow recently developed a mild eye infection and has recovered. In 2022, a prison inmate in a work program caught it while killing infected birds at a Colorado poultry farm. His only symptom was fatigue, and he recovered.


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Remnants of bird flu virus found in pasteurized milk, FDA says – Hamilton Spectator

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The U.S. Food and Drug Administration said Tuesday that samples of pasteurized milk had tested positive for remnants of the bird flu virus that has infected dairy cows.

The agency stressed that the material is inactivated and that the findings “do not represent actual virus that may be a risk to consumers.” Officials added that they’re continuing to study the issue.

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