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Pfizer to bypass US government system for COVID vaccine distribution – FreightWaves



Pfizer Inc. (NYSE: PFE) will manage distribution of its COVID-19 vaccine on its own rather than through the U.S. government’s designated coordinator, but officials question whether the U.S. has an adequate supply of medical-grade freezers at the point of use for vaccines requiring storage at ultra-cold temperatures.

The Centers for Disease Control and Prevention in August tasked McKesson Corp. to be the central distributor for COVID vaccines and related supplies needed to administer vaccinations. Most pharmaceutical companies will deliver approved vaccines to McKesson distribution centers, which will arrange delivery to hospitals, nursing homes and other administration points.

Pfizer has a different, just-in-time distribution plan. It will ship COVID medicine directly from U.S. manufacturing facilities and warehouses to end users with the help of trusted transportation providers, said Tanya Alcorn, the company’s vice president for biopharma global supply chain, during a Thursday webinar organized by the U.S. Chamber of Commerce.

“We’ve been working from the beginning with the U.S. government to ensure that model is successful,” she said.

The U.S. government has contracted with the New York-based pharmaceutical company to deliver 100 million initial doses once its vaccine is approved, with an option for an additional 500 million doses. Pfizer’s product must be maintained at minus 75 degrees Celsius (-109.3 degrees Fahrenheit) to maintain its effectiveness. Officials this week said they expect to provide safety data from final-stage clinical trials to the Food and Drug Administration by the third week of November and then apply for an emergency use authorization if everything checks out.

Moderna also is also developing a vaccine for the government with similar technology and temperature requirements. It said Thursday it too is on pace to deliver data from a Phase 3 trial of its experimental COVID-19 vaccine in November. The company expects to be able to produce 20 million doses by the end of the year, and between 500 million and 1 billion in 2021.

Pharmaceutical and logistics industry representatives on the Chamber webinar said the U.S. is well positioned to handle ultra-cold vaccines, but federal health regulators last month expressed doubts about whether there is adequate infrastructure nationwide.

The responsibility for determining how many deep-freeze machines exist at health care facilities has fallen on states because there is no central inventory.

“Not all of those [vaccination sites] will have the ultra-cold deep freezers to be able to store vaccines, particularly the Pfizer product,” said Jay Butler, CDC deputy director for infectious diseases, during a mid-October media briefing. “So that is an important part of the state planning effort to determine where that capacity is.” 

That means the nation’s 64 vaccinations jurisdictions are on their own to secure cryogenic freezers, which could lead to shortages as every region competes for a limited resource, much like states fought each other for ventilators early in the pandemic, Roll Call recently reported.

“There’s no historical precedent for us maintaining vaccines on dry ice in the United States. That’s never happened,” testified Paul Offit, an adviser to the FDA on vaccines and director of vaccine education at the Children’s Hospital of Philadelphia, before a House panel Sept. 30. “We’ve always shipped in the United States at most at freezer temperatures. … I do worry about that. I think it’s going to be an enormous challenge.”

Those worries are one reason some believe the Defense Department will deploy roll-on/roll-off cargo aircraft that can quickly transport large amounts of frozen vaccine, possibly in truck trailers, during the initial wave of distribution. 

Experts say vaccines will likely be administered at hospitals and other large sites because typical spots such as pharmacies and doctor’s offices don’t have ultra-cold freezers. Large sites could share some of their shipments with local facilities if they have excess doses, but the vaccines could lose a day or two of freshness for transport, experts told Roll Call.

Nancy Messonnier, the CDC’s director of immunization and respiratory diseases, recommended during an industry conference call in late September against states investing in their own deep freezers, which cost as much as $15,000, because they won’t be needed for very long as less sensitive vaccines that take longer to develop are produced, according to the Roll Call report.

If sites quickly use up the doses ultra-cold storage may be less of a concern.

Medicines at standard frozen and refrigerated temperatures are much easier to distribute, according to industry representatives. Johnson & Johnson’s vaccine can remain stable at minus 20 Celsius.

“Our vaccine candidate is better suited to the world,” especially areas that don’t have the latest cold storage technology, said Remo Colarusso, vice president of supply chain at Johnson & Johnson, during the U.S. Chamber event.  

Pfizer packaging innovation

Direct shipping enables Pfizer to have greater control and real-time insights into the status of the frozen vials.

Uncertainty about the cold-chain capabilities of transportation providers and vaccine administration facilities led the drugmaker to co-create a special thermal cooler with real-time GPS and thermal monitoring that can keep its vaccine in a deep freeze for 10 days if left unopened. The shipping container, about the size of a small suitcase, uses dry ice to maintain recommended storage conditions. Once opened, vials can be stored at normal refrigerated temperatures for five days. Replenishing dry ice can extend the storage time after opening to 15 days.

Alcorn said Pfizer also developed a control tower that will get real-time alerts if the temperature deviates from the required range or a shipment doesn’t reach its destination within a prescribed time frame.

Control towers are centralized hubs with logistics specialists that capture data from all stages of the supply chain to improve processes and manage events.

Data loggers have provided GPS information for pharmaceutical shipments for several years, but Alcorn said having location data integrated with temperature readings from a refrigerated container is new for the industry.

Click here for more FreightWaves/American Shipper stories by Eric Kulisch.


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Ontario reports record-high 1,589 new COVID-19 cases as Toronto, Peel lock down –



Premier Doug Ford is scheduled to hold a news conference beginning at 1 p.m. at Queen’s Park. Ford’s office says he will be joined by several cabinet members, including the minister of health. 

You can watch it live in this story.

Ontario reported 1,589 more cases of COVID-19 on Monday, another single-day record as Toronto and Peel Region move into a second lockdown.

The new cases include 336 in Toronto, 535 in Peel and 205 in York Region. They drive the seven-day average up to 1,423 after six consecutive days of increases.

Other public health units that saw double-digit increases in today’s update were:

  • Waterloo Region: 83
  • Hamilton: 61
  • Windsor: 56
  • Halton Region: 53
  • Durham Region: 41
  • Ottawa: 40
  • Wellington-Dufferin-Guelph: 30
  • Simcoe Muskoka: 25
  • Niagara Region: 24
  • Brant County: 16
  • Thunder Bay: 16
  • Middlesex-London: 13

[Note: All of the figures used in this story are found on the Ministry of Health’s COVID-19 dashboard or in its Daily Epidemiologic Summary, which include data from up until 4 p.m. the previous day. The number of cases for any region may differ from what is reported by the local public health unit, because local units report figures at different times.]

Sixty of the new infections were school-related, including 51 students and nine staff members. A total of 676, or about  14 per cent, of Ontario’s 4,828 publicly-funded schools have reported at least one case of COVID-19. Three schools are remain closed due to the illness.

The additional cases come as Ontario’s labs processed 37,471 test samples for the novel coronavirus, and 18,394 were added to the queue to be completed. The province reported an overall test positivity rate of 4.6 per cent.

There are currently 13,004 confirmed, active cases of COVID-19 in the province, the most at any point since the outbreak began in late January. 

Nineteen more people with COVID-19 have died, the province said, pushing the official death toll to 3,505. The additional deaths include a man in his 20s, the fifth person in their 20s to die with COVID-19 in Ontario. So far this month, 360 people with infections of the novel coronavirus have died provincewide.

Meanwhile, Toronto and Peel Region have entered the most restrictive tier of Ontario’s pandemic protection plan.

It means that for at least the next 28 days, non-essential retailers can only offer curbside pickup, while restaurants are closed to all but takeout and delivery orders.

Personal services have also been forced to close, but schools and child-care centres remain open.

Premier Doug Ford announced the move on Friday, but it didn’t come into effect until 12:01 a.m. today.

That gave residents of Toronto and Peel the chance to stock up over the weekend, and many did — flooding local malls, even as those facilities extended hours in an effort to prevent too many people from coming at once.

While Toronto and Peel face the strictest measures, other areas of the province are also seeing rules tighten.

Durham Region and Waterloo joined York Region in the red classification today. The rules limit restaurants, gyms and food courts to 10 indoor patrons with social distancing, with even tighter restrictions on private gatherings.

The areas around Huron, Perth, Simcoe, Muskoka, and Windsor-Essex have moved to the orange classification, which caps gatherings at staffed businesses to 50 people indoors, or four per table at restaurants.

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Toronto and Peel Region enter lockdown for at least 28 days – CP24 Toronto's Breaking News



Toronto and Peel are officially under the lockdown stage of Ontario’s framework for COVID-19 restrictions, meaning that all non-essential retail stores are limited to curbside pickup only and a wide swath of other businesses are closed entirely.

The hard-hit regions entered the category at 12:01 a.m. and will remain under the added restrictions associated with it for at least the next 28 days.

It means that retail stores, with some exceptions for grocers, hardware stores, discount and big box retailers selling groceries, and corner stores, will be prohibited from allowing customers into their stores. Personal care services, like barbers and salons, have also been forced to close and restaurants are now limited to takeout only.

Meanwhile, new rules have went into effect in Toronto and Peel to limit all indoor gatherings to only those who live in the household. The limit for outdoor gatherings has also been lowered from 25 to 10 people.

What is allowed and what is not under a lockdown

“The main thing people can do now is please stay home,” Mayor John Tory told CP24 on Monday morning. “It matters less in the context of achieving the result which kind of stores are close and not closed. It matters more whether people decide to follow the advice, which is if it is at all possible just stay home.”

The province announced the added restrictions for Toronto and Peel on Friday as new cases of COVID-19 continued to surge in both jurisdictions.

In anticipation of the rules going into effect, several malls extended their hours over the weekend and there were reports of long lineups at stores.

Speaking with CP24, Tory said that the strict new rules are an important, even if there is not a lot of data pointing to widespread transmission in settings like retail stores, for example.

“We don’t really know in every single case exactly where people picked up this virus, we just know it is spreading and was spreading in a fashion last week and the week before and the week before that that was clearly unacceptable in terms of the trend line we were on,” he said. “Look it is a sad day today just to see this kind of thing having to happen but again the choice was to not do these kind of things and have a much longer, much broader, much worse kind of lockdown happen latter when we had completely lost control of this thing as you have seen elsewhere in the world.”

While the lockdown will shutter a number of businesses across Toronto and Peel, schools and childcare centres will remain open as will services deemed essential like dentist offices and physiotherapists.

Industries like film production and construction that were largely shut down in the spring will also continue top operate with restrictions.

That means that several major Hollywood productions currently being shot in the GTA will not be halted, including a movie featuring comedian Kevin Hart.  

“I am a little bit concerned that this shutdown doesn’t focus on the largest area of spread. In Brampton our largest source of transmission is industrial settings. Our largest two sectors are transportation logistics and food processing and neither of those sectors are shut down because they are considered essential,” Brampton Mayor Patrick Brown told CP24 on Monday. “So this isn’t truly a lockdown for Brampton. Small businesses have been shut down but with the largest portion of our workforce being essential workers nothing has really changed.”

In addition to the new rules in Toronto and Peel, Durham Region and Waterloo have also been moved into the red category alongside York Region as of today. The rules for that category limit restaurants, gyms and food courts to 10 indoor patrons at a time.

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U.S. could begin COVID-19 vaccine rollout by mid-December, top health official says –



The head of the U.S. effort to produce a coronavirus vaccine said the first inoculations could happen as soon as 24 hours after the Food and Drug Administration grants approval, which would kick off the largest inoculation campaign in U.S. history starting in mid-December.

“Within 24 hours from the approval, the vaccine will be moving and located in the areas where each state will have told us where they want the vaccine doses,” Dr. Moncef Slaoui, the chief scientific adviser for the government’s “Operation Warp Speed” vaccine program, told NBC’s Meet the Press.

The FDA’s outside advisers will meet on Dec. 10 to discuss whether to authorize the COVID-19 vaccine developed by Pfizer and German partner BioNTech for emergency use. Slaoui told CNN he expects vaccinations would begin on the second day after approval, Dec. 12.

Moderna Inc is expected to seek approval later in December for its COVID-19 vaccine.

The effort to roll out vaccines across the country of 330 million people comes as U.S. President Donald Trump has blocked the normal transition of government before the inauguration of President-elect Joe Biden on Jan. 20. Slaoui said he hoped for a smooth transition and did not expect the vaccination effort to be derailed.

Vaccines will be distributed based on each state’s population, Slaoui said. Each state will decide who gets the vaccine first with the recommendation that priority be given to health care workers, front-line workers and the elderly who face the highest risks of dying from the virus.

About 70 per cent of the country’s population needs to be immunized to achieve herd immunity, a goal the U.S. could reach by May, Slaoui said.

Millions ignoring Thanksgiving warnings

As new COVID-19 cases continue to surge, millions of Americans are ignoring federal and state warnings to stay home for Thanksgiving to prevent overwhelming already strained hospitals. Many people are trying to get tested before the holiday on Thursday, leading to long lines in New York City and elsewhere.

Testing shortages still plague many parts of the country with most pharmacies offering COVID-19 tests in suburban Chicago were fully booked ahead of Thanksgiving and long lines at state drive-through testing facilities.

Dr. Moncef Slaoui, chief adviser to ‘Operation Warp Speed,’ said about 70 per cent of the country’s population needs to be immunized to achieve herd immunity, a goal the U.S. could reach by May. (Evan Vucci/The Associated Press)

“We’re clearly involved now in a very, very difficult surge here throughout the United States and even globally,” Dr. Anthony Fauci, the country’s top infectious disease expert, told NBC.

Last week Biden called the vaccination program a “massive undertaking” and “one of the greatest challenges we will face as a nation.”

The U.S. must distribute tens of millions of vaccines while also combating misinformation about vaccines spread on social media. A recent Gallup poll showed only 58 per cent of Americans would get the vaccine, up from 50 per cent in September.

Incoming White House Chief of Staff Ron Klain said it was crucial to have a seamless flow of information between Trump’s coronavirus experts and Biden’s transition team to avoid delays in distribution after Biden takes office on Jan. 20.

WATCH | Who would get a COVID-19 vaccine first and when?

Dr. Caroline Quach-Thanh, chair of the National Advisory Committee on Immunization, discusses how vulnerable populations will be prioritized when a  COVID-19 vaccine rolls out. 9:01

Biden warned last week that “more people will die if we don’t coordinate.”

The number of U.S. coronavirus cases has surpassed 12 million and rose by more than one million cases in less than a week for the first time.

Deaths have topped 256,000, according to a tally by Johns Hopkins University, with many health experts warning deaths will rise to over 2,000 a day in the coming weeks.

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