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BioNTech to seek global approval to use its COVID-19 vaccine in 5-11 year olds: report

From link.

COVID-19 vaccine approval could be requested in children as young as 5 in next few weeks, reports say​


BioNTech is set to request approval across the globe to use its COVID-19 vaccine in children as young as five over the next few weeks and preparations for a launch are on track, the biotech firm's two top executives told Der Spiegel.

"Already over the next few weeks we will file the results of our trial in five to 11 year olds with regulators across the world and will request approval of the vaccine in this age group, also here in Europe," Chief Medical Officer Oezlem Tuereci told the German news weekly.

The confident statements underscore the lead that BioNTech, which collaborates with Pfizer, holds in the race to win broad approval to vaccinate children below the age of 12 in Western countries.
BioNTech has said it expected to file its regulatory dossier on the five to 11 year olds in September. It has also laid out plans to seek approval in children aged six months to two years later this year.

Tuereci also told Spiegel that final production steps were being adjusted to bottle a lower-dose pediatric version of its established Comirnaty vaccine. It is currently approved for adults and youngsters at least 12 years of age.

The raw trial data was now being prepared for a regulatory filing and "things are looking good, everything is going according to plan", Chief Executive Ugur Sahin told Der Spiegel.
Runner-up Moderna said on Thursday a trial testing its shot in children between six and 11 years was now fully enrolled and that it was working on the best dosage in another study involving infants as young as six months.

China has been ahead in lowering the age limit of its immunization campaign. The country's health authorities in June approved emergency use of Sinovac's vaccine in children as young as three years.
Chile, which has relied heavily on Sinovac's shot, this month approved use of the vaccine in children over 6 years of age.

Israel's health ministry said in July that children as young as five can get the Pfizer-BioNTech shot if they suffer from conditions that make them particularly vulnerable to COVID-19.

FDA says robust safety data needed before approval in kids​


The U.S. Food and Drug Administration said on Friday clinical trials testing COVID-19 vaccines for children are expected to include a monitoring period of at least two months after half the participants get the shots to ensure safety.

The comments come as vaccine makers race to submit clinical data seeking regulatory approval for the use of their vaccines in children below 12, as schools around the country begin to reopen for in-person learning.
"Children are not small adults — and issues that may be addressed in pediatric vaccine trials can include whether there is a need for different doses or different strength formulations of vaccines already used for adults," FDA Acting Commissioner Janet Woodcock said in a joint statement with the director of Center for Biologics Evaluation and Research.
 
A rather effective poster from Australia, thanks to Guardian.

covid.jpg
 
A rather effective poster from Australia, thanks to Guardian.
Though Australia seems to have gone off the rails in some ways. They are doing things like locking down all residents of entire apartment buildings where people have COVID, regardless of any tests for COVID, it's simply "you live in this building, you are locked down."

On top of that, you have situations like the police searching all bags from incoming deliveries, and confiscating items.


Can you imagine if Toronto Public Health locked down a TCHC building for COVID--that alone seems bizarre for Canada--but then also stationed police outside to enforce things like daily alcohol consumption limits on the residents?
 
Though Australia seems to have gone off the rails in some ways. They are doing things like locking down all residents of entire apartment buildings where people have COVID, regardless of any tests for COVID, it's simply "you live in this building, you are locked down."

On top of that, you have situations like the police searching all bags from incoming deliveries, and confiscating items.


Can you imagine if Toronto Public Health locked down a TCHC building for COVID--that alone seems bizarre for Canada--but then also stationed police outside to enforce things like daily alcohol consumption limits on the residents?

One thing I've learned about Australia is that they are alot like the US in terms of security, immigration and politics.
 
OOPS! Corrected figures!

784 cases reported today based on 23,625 tests. Another 11,733 got vaccine # 1 and a further 23,625 got # 2.
 
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What about those over 12 with achondroplastic? Since people with dwarfism can be smaller in body mass than some children under 12. What is the amount of any of the vaccines they get?
 

Will vaccine mandates make health-care workers and teachers quit? That might be the wrong question

From link.
In less than two weeks, the unvaccinated workers who care for 95-year-old Wanda Oko in her Toronto nursing home won’t be allowed to dine in a restaurant or go to the movies. But their jobs with vulnerable residents will continue uninterrupted, an alarming contradiction for families who watched COVID-19 rampage through the home once before.

Only 64 per cent of staff at Oko’s home are fully immunized against COVID-19, despite an education campaign and an outbreak last year in which 22 residents died. Though Oko and 98 per cent of Ontario long-term-care residents are vaccinated, recent outbreaks have shown the risk of breakthrough infections for seniors and people with underlying medical conditions.

“It feels like we’re a ticking time bomb,” said Mary Oko, Wanda’s daughter.

The provincial government is facing growing criticism for its decision to impose mandates on non-essential spaces but not health-care facilities and schools, a move critics say represents a failure to protect vulnerable people. As of Sept. 22, unvaccinated individuals won’t be allowed in casinos and bingo halls, but they can still work in emergency departments or cancer treatment centres. They can’t enter strip clubs or concert halls, but they can teach a classroom full of elementary schoolchildren who are ineligible for vaccination.

The Ontario government has repeatedly cited concerns about workplace mandates triggering labour shortages, especially in the health-care sector, but many believe the issue is political, and that potential staff losses are a secondary concern to the damage that could be caused by further outbreaks and the burden of a prolonged pandemic.

The policy stands in contrast to provinces like Quebec, which is requiring all health-care staff get vaccinated by October, and B.C., which has mandated vaccines for long-term-care staff and signalled that a broader health-care mandate coming. And it puts the onus on employers to mandate their own policies, a challenge for smaller operations that fear legal action or being targeted by protesters.

On Friday, Copernicus Lodge, the not-for-profit nursing home where Wanda Oko has lived through three waves of COVID-19, took the extraordinary step of announcing its own vaccination mandate requiring all workers to receive a first dose by Oct. 4 and be fully immunized by Nov. 4, or face a temporary unpaid leave of absence or suspension of privileges — a move that few smaller long-term-care homes have been willing or able to make.

“I commend them for doing this to best protect their residents and staff, but I think it’s highly unfortunate that individual LTC homes are needing to assume risk of legal action,” said Dr. Nathan Stall, a Toronto geriatrician. “Many smaller homes may not be able to afford to do this. The government needs to lead here.”

In a statement, Copernicus said the mandate was a necessary and reasonable move: “It is our duty to care for and protect our residents and tenants who are at greater risk of health complications, hospitalizations and death due to COVID-19.”

With 36 per cent of the home’s staff currently unvaccinated, the possibility of losing workers was a consideration, but Copernicus runs the risk of staff losses with or without an immunization requirement, the statement said. “A vaccine mandate means staff may leave. However, if they become ill, that would make us vulnerable to staff loss.”
 
Mary Oko was grateful to hear the news about her mother’s home, but remains frightened for the fall. “We won’t achieve full vaccination until November, and we’re in wave four. There’s no guarantee we’re going to come out of this without more needless deaths,” she said.

“Copernicus shouldn’t have had to make this move on their own. It should not be a patchwork of different policies. The government needs to show true leadership.”

Colleen Flood, research chair in law and health policy at the University of Ottawa, said that at this point in the pandemic, “there’s really no excuse not to have a vaccine requirement,” to protect vulnerable people.

“Normally, what we would want to do is educate, cajole, do whatever we can to get people there without having to have a mandate,” Flood said. “But we’re starting a fourth wave and it’s a very dangerous time.”

In February, Flood and colleagues delivered advice on vaccine mandates in a policy analysis published in the Canadian Medical Association Journal: “Provincial and territorial governments should set clear rules for vaccination of healthcare workers across public and private settings and not leave this task to individual employers.”

Flood said a provincewide vaccination mandate would reduce the overall burden of COVID-19 on the health system, protect individual employers from legal challenges and ensure rules are consistent with the best public health evidence.

Almost 78 per cent of eligible Ontarians have now received two doses of the vaccine, but health officials say that level won’t be enough to slow rising case counts in a fourth wave largely driven by the unvaccinated. Dr. Kieran Moore, Ontario’s chief medical officer of health, has said we must aim to surpass 90 per cent.

Instead of a vaccine mandate, Premier Doug Ford’s government in August imposed a policy requiring health-care and education workers who choose not to be vaccinated to complete an education module and agree to regular testing.

Moore described that policy as the “bare minimum” that must be done to protect vulnerable people in high-risk settings, and said he supported individual hospitals and workplaces that had gone further.

The provincial government and some organizations opposed to vaccine mandates have cited concerns about potential labour shortages sparked by workers choosing to quit rather than get vaccinated.

Stall, the Toronto geriatrician, said concerns about staff attrition are worth considering, but should come secondary to protecting the health and wellbeing of older people, immunocompromised individuals and schoolchildren too young to be vaccinated.

“I really believe that we have a moral obligation to be using the strongest available tools to protect this population,” said Stall, who is running as a Liberal candidate for Toronto-St. Paul’s in the June provincial election. “We shouldn’t be imposing policies that are the bare minimum.”

Research on the impact of vaccine mandates is limited, but two studies suggest fears of mass staff losses may be unfounded.

A 2014 systematic review published in the American Journal of Preventive Medicine examined 12 studies on influenza vaccine mandates in the U.S. and concluded that making immunization a condition of employment led to vaccine rates above 94 per cent with very rare occurrence of termination or voluntary resignations.

An August 2021 study examining the impact of a mandatory COVID-19 vaccination policy in one U.S. nursing home found that it resulted in “high staff vaccination rates and minimal staff turnover.” Ninety per cent of workers complied, while seven per cent — 18 staff members — chose to resign.

A spokesperson for the Ministry of Health did not respond directly to questions about what research the government has considered regarding the labour shortage concern. Instead, the spokesperson pointed the Star to comments made by Michael Hurley, president of CUPE’s Ontario Council of Hospital Unions, in an Ottawa Citizen story. Hurley praised the government’s plan and noted that a hospital in Texas lost almost five per cent of its staff over a vaccine requirement.

A growing number of hospitals across Ontario have imposed mandates that require vaccination as a condition of employment, with penalties ranging from unpaid leaves to termination: the University Health Network, which includes Toronto General, Toronto Western and Princess Margaret hospitals; the Hospital for Sick Children; the Centre for Addiction and Mental Health; Unity Health; Holland Bloorview Kids Rehabilitation Hospital; the Children’s Hospital of Eastern Ontario; and more. Deadlines at most hospitals are in October.

“To date, we have not seen any increased attrition related to our COVID-19 vaccination policy,” said Sick Kids spokesperson Sarah Warr. “We will continue to work with staff to ensure they receive the answers and support they need to make their decision.”

“We have not seen any indication that the policy will impact staffing levels at Holland Bloorview,” said Julia Hanigsberg, the hospital’s president and CEO, in a statement. The policy “was not our first choice, nor was it an easy one to make,” she said.

Sick Kids and Bloorview noted that 70 and 71 per cent, respectively, of the patients they serve are under 12 and not yet eligible for vaccination.

Gillian Howard, a spokesperson for UHN, said it’s too early to tell what impact their policy may have on staffing, “beyond saying that it is the right thing to do for patients and our staff and that we are currently at 95 per cent vaccinated,” with a goal of reaching 100 per cent.

“A provincial mandate would help,” Howard added, “but there is much progress being made without that mandate.”

Flood said Ontario may lose more health-care workers to burnout than vaccination mandates. “Health-care professionals are exhausted and tired. If we don’t control this fourth wave, I think we face a much higher risk of our health-care professionals as a whole getting burnt out, vaccinated or not.”

Dr. Michael Warner, medical director of critical care at Michael Garron Hospital, said he doesn’t expect vaccine mandates to lead to staff shortages, “especially if all health-care organizations have the same policy.” He believes the risk of losing staff to COVID-19 infections is a bigger concern.

“The more unvaccinated health-care workers you have, the more likely it is that they will get infected. There’s already a shortage of health-care workers. The system cannot tolerate large groups of health-care workers being off work for 14 days or longer as they quarantine (and) recover from illness.”

In late August, five major for-profit long-term-care home operators, including Chartwell, Extendicare and Revera, together announced their intention to require that staff be fully vaccinated by October or face an unpaid leave of absence. But many smaller homes cannot afford to take on potential legal action that may ensue without legislation. AdvantAge Ontario, which represents not-for-profit and municipal homes in Ontario, has called on the provincial government to mandate vaccinations across the health-care sector to “level the playing field” and avoid staffing instability.

Summer outbreaks in nursing homes with low staff vaccination rates have been triggering for long-term-care residents and their family members, who remain traumatized from the fear, uncertainty and isolation they have experienced during the pandemic.

Two residents died in an August COVID-19 outbreak at Labdara Lithuanian Nursing Home in Etobicoke, leaving some families fuming about the home’s low staff vaccination rate: only 51 per cent of Labdara workers had received a single dose by Aug. 19, the home acknowledged in a letter to families, far below the provincial average of 91 per cent with two doses.

The home’s board of directors blamed the government. “Labdara cannot force staff to get vaccinated,” the board wrote in a letter posted on the home’s website, noting that management had done everything it could to increase vaccination rates. “You are encouraged to write and direct any anger or frustration towards government officials who have failed to protect the residents of long-term care homes by not mandating COVID-19 vaccination for healthcare workers.”

Last week, two residents died in a COVID-19 outbreak at an Oshawa long-term-care home, Hillsdale Estates, where 95 per cent of residents and 83 per cent of employees were fully vaccinated.

That outbreak worries Mary Oko because Hillsdale’s staff vaccination rate, while below the provincial average of 91 per cent, is much higher than the current rate at her mother’s home.

Oko’s mother, who loves to sing Polish folk songs and rode a bicycle well into her 70s, has been fortunate not to contract the virus, but Oko fears the impact of the fourth wave, both on her mom and on her own mental health.

For Oko, who works as an accountant, leads the Copernicus family council, advocates for long-term-care residents and staff, and visits her mother several times a week, it has been a long 18 months.

“If we have another outbreak, I know, probably, that I’m going to lose it mentally.”
 
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857 cases reported today based on 26,268 tests. Another 16,532 got vaccine # 1 and a further 23,688 got # 2.
Isn't that yesterday's data? Today's was 784 cases reported today with 6 deaths and 23,625 tests processed.

 
Health minister Christine Elliott is making an announcement on COVID-19 vaccine certificates Tuesday afternoon, as the province prepares to roll out the program next week.
This is the first I've heard it's next week, though I don't really follow local news that closely.
 

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