Lauran Neergaard, The Associated Press
Published Friday, November 20, 2020 10:02AM EST
Last Updated Friday, November 20, 2020 1:33PM EST
Pfizer said Friday it is asking U.S. regulators to allow emergency use of its COVID-19 vaccine, starting the clock on a process that could bring limited first shots as early as next month and eventually an end to the pandemic — but not until after a long, hard winter.
The action comes days after Pfizer Inc. and its German partner BioNTech announced that its vaccine appears 95% effective at preventing mild to severe COVID-19 disease in a large, ongoing study.
The companies said that protection plus a good safety record means the vaccine should qualify for emergency use authorization, something the Food and Drug Administration can grant before the final testing is fully complete. In addition to Friday’s FDA submission, they have already started “rolling” applications in Europe and the U.K. and intend to submit similar information soon.
“Our work to deliver a safe and effective vaccine has never been more urgent,” Pfizer CEO Albert Bourla said in a statement.
With the coronavirus surging around the U.S. and the world, the pressure is on for regulators to make a speedy decision.
“Help is on the way,” Dr. Anthony Fauci, the top U.S. infectious disease expert said on the eve of Pfizer’s announcement, adding that it’s too early to abandon masks and other protective measures. “We need to actually double down on the public health measures as we’re waiting for that help to come.”
Friday’s filing would set off a chain of events as the FDA and its independent advisers debate if the shots are ready. If so, still another government group will have to decide how the initial limited supplies are rationed out to anxiously awaiting Americans.
How much vaccine is available and when is a moving target, but initial supplies will be scarce and rationed. Globally, Pfizer has estimated it could have 50 million doses available by year’s end.
About 25 million may become available for U.S. use in December, 30 million in January and 35 million more in February and March, according to information presented to the National Academy of Medicine this week. Recipients will need two doses, three weeks apart. The U.S. government has a contract to buy millions of Pfizer-BioNTech doses, as well as other candidates than pan out, and has promised shots will be free.
Not far behind is competitor Moderna Inc.’s COVID-19 vaccine. Its early data suggests the shots are as strong as Pfizer’s, and that company expects to also seek emergency authorization within weeks.
Here’s what happens next:
MAKING THE DATA PUBLIC
The public’s first chance to see how strong the evidence really is will come in early December at a public meeting of the FDA’s scientific advisers.
So far, what’s known is based only on statements from Pfizer and BioNTech. Of 170 infections detected to date, only eight were among people who’d received the actual vaccine and the rest had gotten a dummy shot. On the safety side, the companies cite results from 38,000 study participants who’ve been tracked for two months after their second dose. That’s a milestone FDA set because historically, vaccine side effects don’t crop up later than that.
“We’ll drill down on these data,” said FDA adviser Dr. Paul Offit of the Children’s Hospital of Philadelphia.
Think of it like science on trial. A few days before the meeting, the FDA will release its own internal analysis. That sets the stage for the advisers’ daylong debate about any signs of safety concerns and how the new vaccine technology works before rendering a verdict.
They’ll recommend not just whether FDA should allow broader use of the vaccine generally but if so, for whom. For example, is there enough proof the vaccine works as well for older, sicker adults as for younger, healthier people?
There’s still no guarantee. “We don’t know what that vote’s going to be,” said former FDA vaccine chief Norman Baylor.
EMERGENCY USE ISN’T THE SAME AS FULL APPROVAL
If there’s an emergency green light, “that vaccine is still deemed investigational. It’s not approved yet,” Dr. Marion Gruber, chief of FDA’s vaccine office, told the National Academy of Medicine this week.
That means anyone offered an emergency vaccination must get a “fact sheet” describing potential benefits and risks before going through with the shot, she said.
There will be a lot of unknowns. For example, the 95% protection rate is based on people who developed symptoms and then were tested for the virus. Can the vaccinated get infected but have no symptoms, able to spread the virus? How long does protection last?
That’s why the 44,000-person study needs to keep running — something difficult considering ethically, participants given dummy shots at some point must be offered real vaccine, complicating the search for answers.
“I’m curious,” said Barry Colvin, 52, of White Plains, New York, who is taking part in that study at NYU Langone Health.
But he’s not in a great hurry to find out which group he’s in. “You need to hang in there for a while to understand and answer a lot of the other questions that remain unknown.”
Additionally at least for now, pregnant women won’t qualify because they weren’t studied. Pfizer only recently began testing the vaccine in children as young as 12.
A decision on Pfizer-BioNTech’s vaccine won’t affect other COVID-19 vaccine candidates in the pipeline, which will be judged separately.
Brewing vaccine is more complex than typical drug manufacturing, yet the millionth dose to roll out of Pfizer’s Kalamazoo, Michigan, factory must be the same purity and potency as every dose before and after.
That means the FDA decision isn’t just based on study data, but on its determination that the vaccine is being made correctly.
The Pfizer-BioNTech vaccine — and Moderna’s shots — are made with brand-new technology. They don’t contain the actual coronavirus. Instead, they’re made with a piece of genetic code for the “spike” protein that studs the virus.
That messenger RNA, or mRNA, instructs the body to make some harmless spike protein, training immune cells to recognize it if the real virus eventually comes along.
GETTING INTO PEOPLE’S ARMS
Another government group — advisers to the Centers for Disease Control and Prevention — decides who is first in line for scarce doses. Health and Human Services Secretary Alex Azar said he hopes that decision can be made at the same time as FDA’s.
The Trump administration’s Operation Warp Speed has worked with states to line up how many doses they’d need to cover the populations offered vaccine first.
Pfizer will ship those supplies as ordered by the states — only after FDA gives the OK.
Company projections of how much it will ship each month are just predictions, Baylor warned.
“It’s not like a pizza,” he said. Manufacturing is so complex that “you don’t necessarily end up with what you thought.”
AP video journalist Kathy Young contributed to this report.
Charity tree festooned with Dr. Strang's ties fetches $8K at auction – CBC.ca
As Nova Scotians get ready for Christmas, one anonymous person is celebrating with a tree like none other after winning it at auction for $8,250.
Instead of snowflakes or angels, this tree is adorned with ties from Nova Scotia’s chief medical officer of health, Dr. Robert Strang.
Strang’s eclectic tie collection has been thrown into the spotlight during the province’s regular COVID-19 updates, which are streamed online. It was his wife’s idea to wear a different one every day.
“It became a part of the briefing, me wearing a different tie each time,” said Strang, who started receiving ties as gifts from people as he became a household name among Nova Scotians.
“I don’t think of myself as famous. In some ways, it’s kind of embarrassing. I just happen to be, because of my job, I’m the front face of this.”
‘Light bulb’ idea
A few months ago, Strang was at a book launch and ran into Starr Cunningham, president and CEO of the Mental Health Foundation of Nova Scotia.
Cunningham said she’s always trying to come up with ideas to decorate items for the charity’s big Festival of Trees fundraiser. That encounter led to what she called a “light bulb moment.”
“I thought, ‘Wow, what if we got those ties and got them on a tree?'” she said. “I just reached out to him on a whim and he replied immediately and said, ‘How many do you want?'”
Strang dug through his collection and found 22 ties, each with their own story. One was from Sawyer Burke, an 11-year-old from Hatchet Lake who has become Strang’s penpal.
“He was very excited that what he’s given to me, I was then giving forward to contribute to the fundraiser for broader contributions to mental health,” said Strang.
The tree, trimmed with ties and bottles of hand sanitizer, was placed on the auction block where Cunningham said it received an immediate response.
“We were amazed,” she said. “We were watching the bids all night, because the auction closed at 8:30 and it just kept growing and growing and growing.”
The final price tag was $8,250 — the highest price for any item in the auction.
A timely cause
Strang said the tree was the first direct request he’s received to support a charity, and he was particularly interested in the cause.
“As part of our pandemic response, we need to be paying attention to the mental health impact,” he said. “There’s significant increases around stress, anxiety, depression — particularly in young people.”
Cunningham said the money raised from the tree’s sale will be used to create grants for various programs. This year, the foundation has helped connect people to their families and clinicians during the pandemic through technology.
“Something as simple as a phone in their hand has helped them cope in the pandemic,” said Cunningham.
So far, she is tight-lipped about the tree’s anonymous buyer. But she said people will soon know who spent thousands on Strang’s ties.
“We’re not able to say at this point in time, but it will certainly be shared with the community very soon.”
Pfizer cuts COVID-19 vaccine delivery by half for 2020 due to supply chain issues – Global News
Pfizer has confirmed to Global News that it will be distributing half the amount of COVID-19 vaccines that it had originally proposed for 2020 due to supply chain issues.
In an emailed statement to Global News, the pharmaceutical company confirmed what was first reported by the Wall Street Journal, that it will be delivering up to 50 million doses of the COVID-19 vaccine by the end of 2020 worldwide, down from the 100 million doses previously promised.
“Based on current projections we expect to produce globally up to 50 million vaccine doses in 2020 and up to 1.3 billion doses in 2021,” Pfizer said in a statement.
Pfizer said there are two reasons the number of doses expected has changed.
“For one, scaling up a vaccine at this pace is unprecedented, and we have made significant progress as we have moved forwards in the unknown,” the company said.
“Additionally, scale up of the raw material supply chain took longer than expected.”
Coronavirus: Canadian officials expect Pfizer vaccine ‘likely’ to arrive first
Pfizer also noted that results of its clinical trial were received later than expected.
The company said finished doses are currently being made at a “rapid pace.”
“We are confident in our ability to supply at a pace of approximately 1.3 billion doses by the end of 2021,” Pfizer said.
Pfizer had adjusted its supply outlook in 2020 from 100 million to 50 million in November in publicly available statements, but had promised up to 100 million doses as late as September.
The vaccine has been found to be 95 per cent effective against COVID-19 in recent tests, and the United Kingdom became the first country to approve the vaccine on Wednesday.
Canada is set to receive up to four million doses of Pfizer’s vaccine between January and March 2021, and will finish its review of the vaccine “soon,” according to Health Minister Patty Hajdu.
© 2020 Global News, a division of Corus Entertainment Inc.
11 new COVID cases reported in Nova Scotia Thursday – HalifaxToday.ca
As of today, Dec. 3, Nova Scotia has 119 active cases of COVID-19. Eleven new cases were identified Wednesday, Dec. 2.
Nine of the new cases are in Central Zone. The other two cases are in Northern Zone.
“As we get closer to another weekend under tighter restrictions, I want to remind all Nova Scotians that we need to continue limiting our social contacts and travel so we can contain the virus,” said Premier Stephen McNeil. “We have the ability to slow the spread of COVID-19 in our province if we follow all the public health measures.”
Nova Scotia Health Authority’s labs completed 2,047 Nova Scotia tests on Dec. 2.
Yesterday there were 338 tests administered at the rapid-testing pop-up site in Halifax and 148 tests administered at the rapid-testing pop-up site in Wolfville. There were no positive test results identified at either site.
Since Oct. 1, Nova Scotia has completed 71,631 tests. There have been 254 positive COVID-19 cases and no deaths. No one is currently in hospital. Cases range in age from under 10 to over 70. One hundred and thirty-five cases are now resolved. Cumulative cases may change as data is updated in Panorama.
“It is important to recognize that although our cases numbers are not as high as we expected them to be, we continue to see new cases of COVID-19 every day,” said Dr. Robert Strang, Nova Scotia’s chief medical officer of health. “Now is not the time to let our guard down. Please do your part to slow the spread of this virus by continuing to follow all the public health measures and restrictions.”
Visit https://covid-self-assessment.novascotia.ca/ to do a self-assessment if in the past 48 hours you have had or you are currently experiencing:
— fever (i.e. chills/sweats) or cough (new or worsening)
Two or more of the following symptoms (new or worsening):
— sore throat
— runny nose/nasal congestion
— shortness of breath/difficulty breathing
Call 811 if you cannot access the online self-assessment or wish to speak with a nurse about your symptoms.
When a new case of COVID-19 is confirmed, public health works to identify and test people who may have come in close contact with that person. Those individuals who have been confirmed are being directed to self-isolate at home, away from the public, for 14 days.
Anyone who has travelled outside of Atlantic Canada must self-isolate for 14 days. As always, any Nova Scotian who develops symptoms of acute respiratory illness should limit their contact with others until they feel better.
It remains important for Nova Scotians to strictly adhere to the public health order and directives – practise good hand washing and other hygiene steps, maintain a physical distance when and where required. Wearing a non-medical mask is mandatory in most indoor public places.
Rules concerning interprovincial travel within Nova Scotia, New Brunswick, Prince Edward Island and Newfoundland and Labrador have changed. The premiers of all four Atlantic provinces are cautioning against non-essential travel into neighbouring provinces. Currently, all non-essential travel into Prince Edward Island, New Brunswick and Newfoundland and Labrador requires a 14-day self-isolation. All public health directives of each province must be followed. Under Nova Scotia’s Health Protection Act order, visitors from outside Atlantic Canada must self-isolate for 14 days unless they completed their self-isolation in another Atlantic province.
Nova Scotians can find accurate, up-to-date information, handwashing posters and fact sheets at https://novascotia.ca/coronavirus .
Businesses and other organizations can find information to help them safely reopen at https://novascotia.ca/reopening-nova-scotia .
— testing numbers are updated daily at https://novascotia.ca/coronavirus
— a state of emergency was declared under the Emergency Management Act on March 22 and extended to Dec. 13
— online booking for COVID-19 testing appointments is available for Nova Scotians getting a test at all primary assessment centres or at the IWK Health Centre in Halifax
Government of Canada: https://canada.ca/coronavirus
Government of Canada information line 1-833-784-4397 (toll-free)
The Mental Health Provincial Crisis Line is available 24/7 to anyone experiencing a mental health or addictions crisis, or someone concerned about them, by calling 1-888-429-8167 (toll-free)
Kids Help Phone is available 24/7 by calling 1-800-668-6868 (toll-free)
For help or information about domestic violence 24/7, call 1-855-225-0220 (toll-free)
For more information about COVID-19 testing and online booking, visit https://novascotia.ca/coronavirus/symptoms-and-testing/
The COVID-19 self-assessment is at https://covid-self-assessment.novascotia.ca/
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