Here’s how the U.S. government plans to distribute the first Covid-19 vaccines.

In the wake of a steady stream of positive results indicating the effectiveness of several coronavirus vaccines, the official in charge of the federal coronavirus vaccine program explained on Sunday news shows how the vaccines might be distributed to Americans as early as next month.

Dr. Moncef Slaoui, head of the administration’s Operation Warp Speed, said that within 24 hours after the Food and Drug Administration approves a vaccine, doses will be shipped to states to be distributed. “Within 48 hours from approval,” the first people would likely receive injections, Dr. Slaoui said on ABC’s “This Week With George Stephanopoulos.”

Two companies, Pfizer and Moderna, announced this month that their vaccines were about 95 percent effective, and Pfizer formally submitted an application to the F.D.A. for emergency approval. Regulators at the agency will spend about three weeks reviewing the application. On Dec. 10, an outside advisory board on vaccines will meet to discuss the application, and the agency is expected to make a decision shortly after that meeting. Moderna is expected to submit its own application soon.

Even if the first vaccine is authorized in mid-December, officials and company representatives have estimated that there will only be enough doses available to treat about 22.5 million Americans by January. Each vaccine requires two doses, separated by several weeks.

Dr. Slaoui said vaccines would be shipped to states, proportioned according to their population, and that states would decide how and where to distribute the doses. He said that likely within a day after a vaccine receives F.D.A. authorization, a committee at the Centers for Disease Control and Prevention would issue recommendations for which groups should be first to receive a vaccine.

High-priority groups are likely to include frontline medical workers and residents of nursing homes. Dr. Scott Gottlieb, a former F.D.A. commissioner, said on the CBS show “Face the Nation” that those groups would likely be followed by other older adults and then expanded to younger adults in the spring. Both he and Dr. Slaoui estimated that tens of millions of adults could be vaccinated by sometime in May.

Immunizations for children would follow. Dr. Slaoui said on the CNN show “State of the Union” that the youngest participants in the clinical trials so far have been 12 to 14 years old and that approval for younger children and toddlers would likely not occur until late in 2021, after clinical trials for those age groups are conducted.

On “Face the Nation,” Larry Merlo, the chief executive of CVS Health, said that pharmacists and other medical staff from CVS plan to immunize residents of more than 25,000 long-term care facilities, beginning about 48 hours after a vaccine is approved. He said that for several years, CVS has been going to nursing homes to administer the seasonal flu vaccine, so “we have the systems, we have the processes, and we have built the logistics directly for the Covid vaccine.”

Mr. Merlo, whose company runs 10,000 pharmacies across the country, also said as the supply

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Belgian COVID cases climb as government mulls lockdown

FILE PHOTO: Medical personnel wearing personal protective equipment (PPE) arrive at the emergency unit of the CHU Dinant-Godinne hospital with a patient on a stretcher, amid the coronavirus disease (COVID-19) outbreak, in Mont-Godinne, Belgium October 28, 2020. REUTERS/Yves Herman

BRUSSELS (Reuters) – Belgium, one of worst affected European countries by the new coronavirus, recorded an average of 15,316 new infections per day in mid-October, health officials said on Friday, hours before the government was due to consider a lockdown.

Home to the headquarters of the European Union and NATO, Belgium has one of the world’s highest fatality figures per capita from the virus and now, in the second wave, has one of the highest per capita rates of COVID-19 infections.

“We see no favourable change for the moment,” health ministry spokesman Yves Van Laethem told a news conference.

The 38% increase in confirmed cases for the Oct. 20-26 period compared to the previous week takes the total number of infections since the beginning of the outbreak to 392,258 in the country of 11 million people, according to data from the Sciensano health institute.

After implementing a night curfew, closing bars, restaurants, gyms and cultural spaces, Belgium’s federal government is set to decide on Friday whether to implement a nationwide lockdown following a similar move by France to try to contain the epidemic.

Hospital admissions in Belgium dipped slightly on Thursday to 673, from 743 patients hospitalised with the virus the day before, but the level is still above the peak of the first wave, Sciensano figures showed.

Reporting by Robin Emmott; Editing by Kirsten Donovan

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Veteran-Owned Healthcare Company Awarded Medical Equipment Government Contract Valued at $450 Million

Alliant Healthcare Products will provide the Department of Defense and other federal agencies with a customer-friendly source for innovative medical products via new PMCE contract

Grand Rapids, Michigan –News Direct– Alliant Healthcare Products

Alliant Enterprises (dba Alliant Healthcare Products) has been awarded a Patient Monitoring & Capital Equipment (PMCE) contract by the Defense Logistics Agency (DLA) valued at $450 million over 10 years. The contract includes medical products from many of Alliant’s high-profile OEM partners, including Olympus America Inc., Philips Healthcare, Skytron, LINET Americas, Belimed Inc., PROCEPT BioRobotics, Veran Medical Technologies, and many others. The PMCE contract is pre-established and pre-vetted by the government as a source for medical equipment and acts as one of the preferred purchasing platforms for the Department of Defense (DoD).

From robotic-assisted surgical devices to hospital beds and endoscopy equipment, this contract will help America’s service members gain access to more than 8,000 best-in-class medical devices and products over the next 10 years. When it comes to new and innovative technology, the lengthy and arduous procurement process has historically limited the ability of the US Department of Veterans Affairs (VA) and DoD to quickly and efficiently purchase critical products. This contract will remove some of the bureaucratic red tape and pave the way to a smoother procurement process for federal government customers, ensuring veterans and active duty military personnel have quicker access to new technologies and life-saving medical equipment.

“This PMCE contract solidifies Alliant’s position as one of the leading providers of medical equipment to the federal government. As a service-disabled veteran-owned small business, we strive to serve those who are actively working to protect our country,” said Eric Albery, President, Alliant Healthcare Products. “As a result of this contract, Alliant is able to provide federal government customers with access to some of the most advanced medical equipment on the market, through an efficient, net-centric ordering, distribution and payment system.”

“Olympus and Alliant have established a high-trust relationship based on mutual respect and alignment of goals to meet the unique equipment needs of the federal government,” said Steve Wendt, Vice President for Government and Distributor Relations, Olympus America Inc. “We are excited to work with Alliant to successfully implement this new agreement administered by the Department of Defense, which will bring additional visibility to Olympus’ innovative technologies and make them more accessible to our nation’s service men and women, and our country’s veterans.”

“There is no community more deserving, and we look forward to working with Alliant to understand how we can better serve the needs of veterans, active duty service men and women, as well as federal health facilities,” said Derek Farias, National Director Government Channel, Philips Healthcare.

The new PMCE contract is effective immediately for government customers, adding to Alliant’s arsenal of pre-established government contracts for medical products. Founded in 2002, Alliant Healthcare has become a trusted and respected staple within the federal government healthcare market, working closely with the DoD, VA, Indian Health Service, National Institute of Health and many

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Federal government to pay for coronavirus vaccine for all Americans

The Centers for Medicare and Medicaid Services said it will pay for any Covid-19 vaccine that is authorized or approved by the US Food and Drug Administration to allow for “broad vaccine access and coverage for all Americans.”



a person wearing a mask: WORCESTER, MA - SEPTEMBER 4: Hilda Ramirez receives an injection from RN Bethany Trainor at the University of Massachusetts Medical School in Worcester, MA on September 04, 2020. Ramirez is taking part in a clinical trial for a COVID-19 vaccine. (Photo by Craig F. Walker/The Boston Globe via Getty Images)


© Craig F. Walker/The Boston Globe/Getty Images
WORCESTER, MA – SEPTEMBER 4: Hilda Ramirez receives an injection from RN Bethany Trainor at the University of Massachusetts Medical School in Worcester, MA on September 04, 2020. Ramirez is taking part in a clinical trial for a COVID-19 vaccine. (Photo by Craig F. Walker/The Boston Globe via Getty Images)

The agency also announced it will help cover a larger portion of the cost of new Covid-19 treatments that may be coming down the pipeline for Medicare recipients.

“There are several vaccines in Phase 3 trials, production and distribution plans are well underway, and CMS is doing its part by laying the essential groundwork for coverage and payment when a vaccine does arise. It’ll be widely available and accessible to seniors and every American,” CMS administrator Seema Verma said during a briefing Wednesday.

She said that while the federal government is paying for the vaccine, insurers including Medicare, Medicaid and private plans must cover the cost of administering it.

For Medicare recipients, any future vaccine would be covered by Medicare Part B as a preventative vaccine at no cost to beneficiaries. Medicare Part B covers doctor visits and outpatient services such as lab tests, diagnostic screenings and medical equipment.

“The rule removes any existing ambiguity surrounding Medicare’s coverage of the Covid-19 vaccine and allows us to focus on the paramount goal of ensuring that all of Medicare’s 62 million beneficiaries, including those enrolled in a Medicare Advantage plan, can receive the vaccine at their provider, their choice, again, at no cost,” said Verma.

She estimated that if “literally every senior got immunized,” it would cost “likely around $2.6 billion — that’s if everybody got vaccinated in the Medicare program.”

The new CMS rule requires most private health insurance plans, including individual health insurance and employer health plans — representing about 200 million Americans, according to Verma — to provide both in-network and out-of-network coverage of the vaccine, at no cost to their members.

The agency said that as a condition of receiving free Covid-19 vaccines from the federal government, providers may not charge people for administration of the vaccine.

“Providers who receive free Covid-19 vaccines from the federal government will be prohibited from charging consumers any additional costs for the administration of the vaccine beyond what their insurance covers. Surprise or balanced billing for vaccine costs is strictly prohibited,” she said.

The 68 million beneficiaries on Medicaid and the Children’s Health Insurance Programs will also be covered for their Covid-19 vaccines during the public health emergency; the Provider Relief Fund will cover the cost for those without insurance coverage.

In addition to covering the cost of a vaccine, the new CMS rule also outlines how Medicare plans to cover the “new generation of Covid-19

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Ontario fitness industry urges members to pressure Ford government to allow gyms to reopen

Goodlife Fitness is urging its members to pressure the Ontario government to allow gyms to reopen in parts of the province where they’ve been forced to close because of rising COVID-19 cases.

In an email sent to members across the province Tuesday, the fitness giant is encouraging its members to write a letter to their local MPP, Premier Doug Ford and Health Minister Christine Elliott among others.

“Between mandated shutdowns, capacity restrictions, and ongoing questions about the safety of fitness facilities, our industry is facing the most difficult time in its history,” the email reads.

Jason Sheridan, senior vice-president of operations at Goodlife, said the email was sent to more than 175,000 members.

The campaign is led by the Fitness Industry Council of Canada. Other businesses who are part of the industry council will also take part.

“Through this campaign . . . we are keen to advance the discussions with the Ontario government and public health and to help co-create any enhanced guidelines for gyms across Ontario,” Sheridan told the Star.

“We are open to navigating this situation together and working to develop solutions that would allow us to continue to invest in the health and wellness of Ontarians.”

The letter, sent with the subject line Stand Up for Fitness, discusses the impact the shutdown has had on the province’s fitness industry, citing the benefits of physical benefits on mental health during the pandemic and reducing the strain on local health-care systems as a result.

As cases spiked in the province, and concerns that group activity in indoor spaces may be adding to the transmission of the virus, Ford ordered the closure of all gyms in Ottawa and parts of the GTA on Oct. 10.

In Quebec, a group of fitness centre owners says its members are no longer planning to open Thursday in defiance of that government’s lockdown orders.

On Monday, a coalition of more than 250 gym owners threatened to open their doors this week, prompting a warning from Premier Francois Legault that they and their clients would be fined.

Gym owners in Ontario have not gone that far, but are still heated over the impact from the temporary closure.

The office of Lisa MacLeod, Ontario minister of heritage, sport and tourism, acknowledges the struggles the fitness industry is going through but says the government will continue to follow public health advice.

“This is a difficult time for so many businesses that are already struggling, which is why we are working hard to make $300 million available as soon as possible to cover fixed costs,” minister spokesperson Dakota Brasier said.

“We will continue to take prudent and progressive action to reopen based on expert public health advice as soon as it’s safe to do so.”

Sweat and Tonic, a Toronto boutique fitness studio is part of an online petition in collaboration with the Ontario Independent Fitness Studios Association and 300 other businesses to advocate for the re-opening of fitness studios.

Morgan Thomas, general manager at Sweat and

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Government Payment Rules Are the Culprit on Infusion

Scientists work with a bioreactor at a Regeneron Pharmaceuticals facility in New York, Oct. 2.



Photo:

/Associated Press

Regarding Drs. Scott Gottlieb and Mark McClellan’s “Where Do I Go to Get My Covid Antibody Cocktail?”(op-ed, Oct. 19): They are right regarding the need for the government to prime the pump to stimulate the development of private infusion clinics for Covid patients. However, they overstate the associated problems.

Infusion clinics are quite simple, requiring only a room, one registered nurse, four patients and IV poles. Infusion pumps are generally not necessary. The big issue is the Centers for Medicare & Medicaid Services’ payment scheme for professional services, which is in the range of $60-$70 per infusion, regardless of how long it takes (many exceed four hours for allergy and neurology services). Hence, the profit in such centers hinges on the split between the cost of the drug and the amount a payor gets reimbursed for it. In such circumstances, volume is the key to financial stability.

If CMS will change its reimbursement methodology to reimburse professional services by the hour infused, and reimburse for drugs with modest profit for the provider, there will be no shortage of clinics.

Robert Chiffelle

Phoenix

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Calls on Ford Government to Implement Them Immediately

TORONTO, Oct. 23, 2020 (GLOBE NEWSWIRE) — The Ford government’s Long-Term Care Commission’s interim recommendations support the need for immediate action on improving care levels by increasing the supply of PSWs and an appropriate staff mix including nurses to meet the complex care needs of residents. They also validate the Coalition’s long-standing call for a minimum average care standard of 4-hours, access to full-time work, and immediate implementation of these measures. In addition, they reinforce the calls for family and caregiver access to residents. These are important, said the Ontario Health Coalition in reaction to the release of the recommendations today.

Also vitally important, reported the Coalition, are the recommendations that hospitals be teamed with long-term care homes and public health units to help stop the spread of COVID-19 in the homes that are at risk, and to get these relationships in place immediately rather than waiting for after outbreaks are out of control. The Commission called for residents to be moved out of long-term care homes to hospitals or other alternative settings to avoid further transmission of the virus and to help them recover, and it called for these plans to be put in place in advance. The Coalition expressed support for this plan, provided it does not include transfers of residents to private for-profit retirement homes which are not health care facilities or coercive measures to move residents home without consent and robust care.

Finally, the Commission has made important recommendations to prioritize testing and results for long-term care homes, create a dedicated infection control lead, and enhance inspections and compliance with a focus on infection control measures. The Coalition, which represents more than half-a-million Ontarians, reported that is in full support of these recommendations.

“Many of these measures are things that we have been advocating for months,” reported Natalie Mehra, executive director of the Ontario Health Coalition which has put out repeated reports and releases through the pandemic calling for an immediate staff recruitment drive by the government, minimum care standards, teams to be set up to go into the homes, residents to be moved out where care and infection control cannot be safely provided in the homes, testing as a priority, improved infection control and management and inspections.

“There can be no excuse for further failure to implement these recommendations immediately. There must be accountability for the failure to have done so in the summer months when case levels had gone down and there was a lull in the pandemic. But what is most important to express today is that not one more day can be lost now. Mr. Ford, it is beyond time to act. Ontarians need you to get these measures in place now,” she said. The Coalition also called on all provincial political parties to support the minimum care standards Private Member’s Bill, Bill 13 the Time to Care Act, that is going to Second Reading in the Ontario Legislature on October 28.

The Coalition is concerned that there is not

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Walmart sues US government in dispute linked to opioid crisis

Retail giant Walmart filed suit Thursday against the US Justice Department over what it said was an unfair attempt to hold it legally responsible for certain sales of opioid drugs.

The lawsuit is the latest legal battle linked to the opioid crisis in the United States, where widespread abuse has led to government efforts to address the problem and hold drugmakers accountable.

In its lawsuit brought before a federal court in Texas, the US retailer says its pharmacists and pharmacies were being put “in an untenable position” by the government.

The suit, which also names the US Drug Enforcement Administration (DEA), says Walmart was acting preemptively to head off a separate civil suit that the Justice Department has been preparing to file against it.

Walmart said the government’s rules were unclear and that pharmacists could not be expected to know when a prescription written by a licensed doctor should not be filled.

“Walmart and its pharmacists should not be held responsible for the government’s failures to address the opioid crisis,” the suit says.

With the help of aggressive marketing from pharmaceutical companies, particularly through doctors, prescriptions for highly addictive opiate painkillers that had previously been reserved for serious cases skyrocketed in the late 1990s.

According to the Centers for Disease Control and Prevention, more than 500,000 Americans have died of opioid overdoses — both prescription and non-prescription — since 1999.

Walmart accuses the DEA of seeking to pass blame for its failures.

It alleges the agency “authorized manufacturers to produce ever-increasing quantities of the drugs, and largely abandoned its most potent enforcement tools against bad actors.”

It also said that “nearly 70 percent of the doctors whose prescriptions” the government intends to challenge “maintain their DEA prescription privileges to this day.”

Walmart alleges the government has spent years and considerable amounts of money on a criminal investigation that has not produced an indictment and was now turning to a civil lawsuit instead.

It is calling on the court to state that the company and its pharmacists are not subject to the legal responsibility with which the government is seeking to brand it.

Other large companies, including drug distributors Cardinal Health and McKesson, have been targeted in lawsuits by local and state authorities that accuse them of turning a blind eye to millions of opioid prescriptions despite knowing their addictiveness.

A settlement was reached between three distributors and two Ohio counties in October 2019, raising the possibility of a larger settlement.

On Wednesday, the Justice Department announced that Purdue Pharma, manufacturer of the drug OxyContin, had agreed to plead guilty as part of a deal worth some $8.3 billion.

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Most People Would Get COVID-19 Vaccine if Offered by Government or Employer: Poll | Top News

LONDON (Reuters) – Most people would get a COVID-19 vaccine if their government or employer recommended it, results of a global poll showed on Tuesday, amid growing concerns about public distrust of the shots being developed at speed to end the pandemic.

Some 71.5% of participants said they would be very or somewhat likely to take a COVID-19 vaccine and 61.4% reported they would accept their employer’s recommendation to do so, according to the survey in June of more than 13,000 people in 19 countries.

The poll was overseen by the Vaccine Confidence Project (VCP), a global surveillance programme on vaccine trust funded by the European Commission and pharmaceutical companies among others, as well as Business Partners to CONVINCE, a U.S./British initiative that is partly government funded.

All respondents, regardless of nationality, said they would be less likely to accept a COVID-19 vaccine if it were mandated by employers.

There were regional differences in responses though, highlighting the polarisation in attitudes on the topic.

Almost 90% of participants in China said they accepted a vaccine, but the rate in Russia was less than 55%. In France, the positive response rate 58.89%, compared with 75.4% in the United States and 71.48% in Britain.

At least 60-70% of the population would need to have immunity to break the chain of transmission, according to the World Health Organization.

Respondents were aged 18 years or older from 19 countries from among the top 35 countries affected by the pandemic in terms of cases per million population.

The results will likely stir the debate about how to overcome public safety concerns, particularly in Western countries, about the frenetic speed of work to develop vaccines, potentially hampering efforts to control the pandemic and revive the global recovery.

There are about 200 COVID-19 vaccine candidates in development globally, including more than 40 in human clinical trials to test for safety and effectiveness. Many are being squeezed into a matter of months for a process that would typically take 10 years or longer.

Scott Ratzan, co-leader of Business Partners to CONVINCE and lecturer at CUNY Graduate School of Public Health and Health Policy, said the data demonstrated diminished public trust.

“It will be tragic if we develop safe and effective vaccines and people refuse to take them,” he said in an email.

“We need to develop a robust and sustained effort to address vaccine hesitancy and rebuild public confidence in the personal, family, and community benefits of immunisations.”

Reporting a willingness to get vaccinated might not be necessarily a good predictor of acceptance, as vaccine decisions can change over time.

Also the poll took place before Russia started the mass inoculation of its population with its Sputnik V shot before full studies had been completed and AstraZeneca

had to pause its late-stage study in September due to a participant’s illness.

Last month, nine leading U.S. and European vaccine developers issued a pledge to uphold scientific standards and testing rigour.

Last week, Facebook Inc

said it would start banning

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UK Needs Three-Week Lockdown for COVID Reset: Government Adviser | World News

LONDON (Reuters) – Britain needs to impose a three-week period of national lockdown restrictions immediately to stop cases of COVID-19 spiralling, government scientific adviser Jeremy Farrar said, adding that current regional measures would not be effective.

“The current tiered restrictions will not bring the transmission rates down sufficiently or prevent the continued spread of the virus,” he said.

“A three-week period of nationally increased restrictions, with the right levels of financial support, will allow us to reset before winter, stop transmission spiralling, protect and prepare health services, give time to get the test-trace-isolate systems fully functional, and save lives,” he said.

Farrar, who is director of the Wellcome Trust and a member of the government’s Scientific Advisory Group for Emergencies, said the response needed to be immediate because putting it off would only worsen and lengthen the crisis.

He told Sky News that the best time to have locked down was two to three weeks ago, but it wasn’t too late now.

Senior minister Michael Gove, however, said a two- or three- week national lockdown – named a “circuit breaker” by some – was not being considered.

“The spread and the nature of the disease does not merit that approach at the moment,” he told Sky News on Sunday.

Gove did concede that there were problems with the level of compliance with the rules already in place for those who tested positive for COVID-19.

He said the level of government support available for those who were required to self-isolate was kept under constant review.

(Reporting by Paul Sandle; Editing by Kirsten Donovan)

Copyright 2020 Thomson Reuters.

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