European regulators are set to start an accelerated review of a Covid-19 vaccine front-runner from the University of Oxford and AstraZeneca Plc, according to a person with knowledge of the situation, in a sign the shot could be the first to seek approval in the region.
The European Medicines Agency is expected to announce the “rolling review” as soon as this week, according to the person, who didn’t want to be identified because the decision is still private. Such assessments are used in emergencies to allow regulators to see trial data while the development is ongoing to speed up approvals of drugs and vaccines that are urgently needed.
The move would be a key step forward for the Oxford-AstraZeneca shot after trials were halted earlier this month due to concerns about a participant in the U.K. study who became ill. The partners, along with companies such as Pfizer Inc. and Moderna Inc., are sprinting ahead with experimental shots as governments look for a way out of the global crisis.
The death toll from the disease exceeded 1 million this week, while the infection rate has rapidly picked up again in Europe.
While the British regulator cleared the Oxford-Astra trial to restart less than a week after it was paused and studies in South Africa, Brazil and India have resumed, U.S. authorities have yet to give the go-ahead.
Late Wednesday, Reuters reported that the U.S. Food and Drug Administration had widened its investigation of the incident that led to the trial halt, citing people familiar with the matter.
The EMA’s head of vaccines, Marco Cavaleri, said in July the agency would start rolling reviews of potential candidates after the summer. The approach means that a final approval could be granted a matter of days after the review period ends. Cavaleri said at the time the first approval of a vaccine could come by the end of the year.
In a normal environment, drugmakers submit trial data to the regulator for a review that can take many months. Once that’s complete, an opinion is given on whether the product should be authorized for use, which must be signed off by the European Commission.
In emergencies like a pandemic, a rolling review avoids delays so that an EMA recommendation and approval from the European Commission can be sought as quickly as possible. The agency started such an evaluation of remdesivir to treat Covid-19 in April, while trials were ongoing, and the drug was given conditional approval three months later.
AstraZeneca declined to comment. A spokesperson for the EMA declined to comment on the review.
“EMA has always stated that it will communicate the start of a rolling review for Covid-19 treatments or vaccines,” it said in a statement. “We have not made such an announcement for a vaccine.”
Fraser Health outbreaks push active COVID-19 infections in B.C. to all-time high of 2390 – Alaska Highway News
B.C. has never had more people actively battling COVID-19 infections, as new government data showed a total of 2,390 people suffering with the virus that has spurred a global pandemic.
That’s 46 more people suffering with the illness than was the case yesterday and it comes as 272 people were newly identified as infected in the past 24 hours. With 10,420 tests conducted, the day’s positive-test rate was 2.6%.
The hotspot for new infections remains the 1.8-million-resident Fraser Health region, which includes much of the eastern and southern Lower Mainland, including 20 communities, such as Burnaby, Coquitlam, Surrey, Delta, Langley, Abbotsford and Chilliwack, but not Richmond or Vancouver.
Only about two-thirds of the new cases are from Fraser Health today, however. That’s down from the average in the past week, which had seen about three-quarters of all new cases located in the Fraser Health region.
Here is the breakdown of all 14,381 detected COVID-19 cases in B.C., by health region, with new cases identified overnight in brackets:
• 4,664 in Vancouver Coastal Health (76);
• 8,219 in Fraser Health (183);
• 256 in Island Health (no change);
• 741 in Interior Health (seven);
• 412 in Northern Health (six); and
• 89 people who reside outside Canada (no change).
The number of COVID-19 patients in hospital fell by six to 78, with 25 of those people having infections serious enough to be in intensive care units.
The vast majority of those infected are self-isolating at home. Health officials are keeping tabs on a record 6,003 people because those individuals have come into contact with others who are known to be carrying the virus.
The vast majority of COVID-19 patients recover: 11,670, or more than 81%.
One new death was recorded overnight, pushing the provincial death toll from the disease to 263. That leaves 58 patients unaccounted for, and health officials have told BIV that it is likely that they left the province without alerting authorities.
“There has been one new community outbreak, at Suncor Firebag Oil Sands,” provincial health officer Bonnie Henry, and Health Minister Adrian Dix said in a joint statement. “There continue to be exposure events around the province.”
One hospital in Fraser Health, Surrey Memorial Hospital, has had an outbreak for weeks. That health authority earlier this week declared that the outbreak at Delta Hospital is over.
There are three new outbreaks at seniors’ homes and healthcare facilities:
• Hawthorne Seniors Care Community in Port Coquitlam;
• CareLife Fleetwood in Surrey; and
• Queen’s Park Hospital: Unit 3C NMSK 2.
Three such outbreaks have been declared over:
• Fort Langley Seniors Community in Fort Langley;
• Sunset Manor in Chilliwack;
• The Village in Langley.
Fraser Health yesterday declared that the outbreak at Good Samaritan Victoria Heights, in New Westminster, is over, and the province confirmed that news today.
Other seniors’ long-term care and assisted living facilities in B.C. that have active outbreaks, include:
• Gateway Assisted Living for Seniors in Surrey;
• Mayfair Terrace Retirement Residence in Port Coquitlam;
• Louis Breyer Home and Hospital in Vancouver;
• Revera Lakeview long-term care home in Vancouver;
• Evergreen Baptist Care Society in White Rock;
• Queens Park Care Centre in New Westminster;
• Three Links Care Centre in Vancouver;
• Royal Arch Masonic Home in Vancouver;
• Haro Park Centre long-term care facility in Vancouver;
• Banfield Pavilion 4 West in Vancouver;
• Peace Portal Seniors Village in Surrey;
• Rosemary Heights Seniors Village in Surrey;
• Zion Park Manor in Surrey;
• Laurel Place in Surrey;
• Amenida Seniors Community in Surrey;
• Baillie House in Maple Ridge;
• Fellburn Care Centre long-term care facility in Burnaby;
• St. Michael’s Centre long-term care facilityin Burnaby;
• Fair Haven Homes Burnaby Lodge in Burnaby; and
• Agassiz Seniors Community in Agassiz.
“As we all enjoy Halloween tomorrow, make it about the treats and not the tricks,” Henry and Dix said.
“Respect homes that are choosing not to participate this year and give everyone the space to stay safe, both indoors and outdoors.”
British Columbia reports 272 new cases of COVID-19 – Vancouver Is Awesome
VICTORIA — The B.C. government says it will increase surveillance this weekend as an order limiting the number of people who can visit a home is in effect because of COVID-19.
Provincial health officer Dr. Bonnie Henry announced this week that gatherings are now limited to people in an immediate household, plus their so-called “safe six”‘ guests.
In a joint statement, Henry and Health Minister Adrian Dix are reminding people to make the Halloween weekend safe for everyone by maintaining safe physical distances from one another.
They say this is also not the time for large gatherings in homes as the number of cases of COVID-19 spikes.
The province reported another 272 cases of COVID-19 on Friday and one additional death, bringing the total number of people who have died to 263.
There are 2,390 active cases of COVID-19 in the province, and 6,003 people are under public health monitoring after being exposed to a known case.
This report by The Canadian Press was first published Oct. 30, 2020.
The Canadian Press
Researcher predicts 4,000 daily new COVID-19 cases in Alberta by mid-December if measures not taken – CBC.ca
A researcher is sounding the alarm about Alberta’s significant increase in the number of new and active cases of COVID-19, warning that things could rapidly get worse in the province should additional measures not be taken.
Malgorzata Gasperowicz, a developmental biologist and associate in the school of medicine at the University of Calgary, says that given the province’s current doubling time, the province could be reporting more than 1,000 new cases per day by Nov. 11.
But Gasperowicz also told CBC Calgary News at 6 that without “strong, decisive measures” given the province’s current doubling time, Alberta could see around 2,400 daily new cases of COVID-19 on Dec. 5, and 4,800 on Dec. 23.
WATCH | Malgorzata Gasperowicz discusses the COVID-19 numbers Alberta could be seeing in the coming months:
But even should the province shut everything down today, it’s not as though the numbers will instantly drop.
“They usually take like, what we [saw] in the first wave in [introducing restrictions], it took at least three or four weeks to see the cases drop down,” Gasperowicz said. “So we will still be doubling for three weeks at least.”
That would mean the province would still be seeing around 1,600 or 2,000 daily new cases before dropping down, Gasperowicz said.
Given a situation where the province shut down on Nov. 15, Gasperowicz said, the province would see 3,000 daily new cases before bending the curve.
AB doubling time is 2.5 weeks.<br>It seems to be über-exponential➡️the doubling time shortens with time.<br><br>At this rate we will have:<br>Nov 11, 1000+ daily new cases<br>Nov 28, 2000+ daily new cases<br>Dec 15, 4000+ daily new cases<br>and so on.<br><br>Cases beget hospitalizations and deaths.<br>1/ <a href=”https://t.co/dIa0vqmf9l”>pic.twitter.com/dIa0vqmf9l</a>
Alberta at ‘a tipping point’
On Monday, Alberta introduced new social gathering restrictions, bringing in mandatory limits of 15 people in Edmonton and Calgary.
“You have heard me say many times that we need to achieve a balance between minimizing the risk of COVID-19 and minimizing the risk of harms of restrictions,” Dr. Deena Hinshaw, the province’s chief medical officer of health, said during a news conference.
“This requires us to keep the spread of COVID-19 manageable. We have now crossed a tipping point and are losing the balance we have been seeking.”
WATCH | Dr. Hinshaw says Alberta is at a tipping point for COVID-19
When asked whether the province would consider implementing another shutdown, Tom McMillan, a spokesperson with Alberta Health, pointed to the measures introduced Monday.
“We announced new measures on Monday. We are watching the data in Alberta closely and will consider if adjustments to the public health approach are needed in the days to come,” McMillan said in an email.
Speaking Thursday, Hinshaw reiterated that the province’s focus at this time was to strike “a difficult, but necessary balance when responding to COVID-19.”
“We must follow the evidence, and take the steps needed to prevent cases from rising exponentially and overwhelming our health system,” Hinshaw said.
“At the same time, every element of Albertans’ health is important. We must also limit the harms that our measures can have, as much as possible.”
Implementing ‘strong measures’
Gasperowicz pointed to a “cocktail of measures” that have worked to decrease numbers in other western jurisdictions.
The cocktail of measures that worked (turned exp. growth into exp. decrease) in Western jurisdictions:<br><br>- quarantine of all incoming travellers / travel rstrxns<br>- shut down *with financial support for businesses and people*<br>- support for marginalized/vulnerable groups<br><br>5/
“I’m convinced that if strong measures would be implemented, we would have the decrease,” she said. “But if we won’t implement strong measures and just have little tweaks, I don’t think it will slow the virus down.
“Strong measures worked in Australia, and they have zero cases now, and they’re celebrating.”
Speaking Thursday, Hinshaw said the choice is not between implementing another lockdown or letting COVID-19 run unimpeded.
“Instead, we must make it as easy and safe as possible for Albertans to live with this virus for the foreseeable future,” she said.
One day before Halloween, Alberta reported 622 new cases of the virus, a new daily record. It pushed the number of active cases in the province to a record 5,172.
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