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The need for speed: How Canada approved five vaccines for COVID-19 in under a year – NewmarketToday.ca

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OTTAWA — In the last four years, Health Canada has approved more than 1,500 new or updated pharmaceuticals.

Ten of them are vaccines.

Five of those are for COVID-19.

Dr. Supriya Sharma, the chief medical adviser at Health Canada helping oversee the review process, has never seen anything like the speed with which the COVID-19 vaccines got approved.

“I mean, unprecedented is the one word that we’ve been overusing, but there’s nothing even close to comparable to this,” she said in an interview.

The five non-COVID vaccines approved, four for influenza and one for shingles, took an average of 397 days from the day the company applied for approval in Canada, until that approval was granted.

The average time for COVID-19 vaccines? 82 days.

That includes 61 days for Pfizer-BioNTech, 72 days for Moderna, 95 days for Johnson & Johnson, 148 days for Oxford-AstraZeneca and 34 days for Covishield, the AstraZeneca vaccine produced by the Serum Institute of India. 

Covishield is a slight outlier because Health Canada mostly just needed to review the manufacturing process, as the vaccine is the same formula as the AstraZeneca doses made elsewhere. Sharma likens it to the same recipe made in a different kitchen, but the kitchen still needs to be up to snuff.

A sixth vaccine from Novavax is still under review, with the results from its big clinical trial not expected until next month. It has been under review by Health Canada for 58 days at this point.

The speed has raised fears among Canadians that everything moved too quickly. Many medical experts worry it is contributing to hesitancy to get the vaccines.

But Sharma says speed did not come at the expense of safety.

“That’s the only priority, the only thought, is what’s best for Canadians,” she said. “There’s no other motivation anywhere.”

Lack of research funds can slow down new drug development, but in this case, as lockdowns shuttered economies worldwide and death tolls mounted, countries poured billions of dollars into getting a vaccine to get us out of the pandemic.

Most of the successful vaccines for COVID-19 so far use  existing vaccine technology that was adjusted for the SARS-CoV-2 virus that causes COVID-19.

They start with lab studies to check for safety on animals and see how the vaccine works in a lab setting on blood samples and on samples of the virus.

Then it is tested on a very small number of humans to look for any glaring safety concerns. Then they test it on a slightly larger number of people — usually fewer than 100 — to look for safety and the development of antibodies.

If that goes well, the trial is expanded to thousands of volunteers, some of whom get the vaccine and some of whom don’t. Then they wait to see how many in each group get infected.

Phase 3 trials usually take between one and four years. For the vaccines approved in Canada so far, phase three trials took about three months.

Sharma said the time a trial takes depends on finding enough patients to participate, and then having enough of their trial participants get sick to know how well the vaccine is or isn’t working.

Fortunately and unfortunately, COVID-19 was spreading so rampantly in so many places, getting enough people exposed did not take very long.

Canada has seen very few vaccines tested here so far, mainly because our infection rates weren’t high enough. 

While the drug makers were busy getting the trials going, Health Canada was getting ready for their submissions. Sharma said discussions about COVID-19 vaccines began in earnest with international bodies in mid-January 2020, before Canada had even had a single confirmed case.

“I think we knew that … we had a virus that was going to be transmissible, that could be causing significant respiratory disease, and that there would be an interest in therapies and vaccines definitely, very early on,” said Sharma.

It was determined quickly that this virus was so new there was no existing vaccine that could be adjusted quickly, as had  happened with the H1N1 pandemic in 2009.

By March, Health Canada had started putting teams in place to review new therapies and vaccines for COVID-19 as soon as they were ready.

Each team was made up of 12 to 15 people, with varying specialties. There was some overlap between the teams but not a lot because many vaccines were being reviewed at the same time.

The experts on the file included infectious disease specialists, pharmacologists, biostatisticians, and epidemiologists.

Separate from that were teams of people looking at manufacturing facilities. Approving a vaccine isn’t just about making sure the clinical data shows it to be safe and effective, but also about making sure the place it is to be made follows the required safety standards.

They needed an emergency order from Health Minister Patty Hajdu to do a rolling review. Normally drug makers can’t apply until they have every piece of data ready but with a rolling review Health Canada scientists can start reviewing the data as it becomes available.

Hajdu granted that on Sept. 16.

Then the vaccine submissions began pouring in — AstraZeneca applied Oct. 1, Pfizer Oct. 9, Moderna on Oct. 12, and J&J on Nov. 30. The Covishield application came Jan. 23 and Novavax submitted on Jan. 29.

Sharma says the teams were working 15 to 18 hours a day, seven days a week, reviewing data, asking the companies questions, requesting more information or new analyses.

Sometimes they were doing it in the middle of the night. Collaborations with international partners in very different time zones, meant 2 a.m. or 4 a.m. video conference calls were not unusual.

When Pfizer and Moderna were reviewed, it was entirely based on clinical trail and pre-market data because the vaccines hadn’t been approved anywhere else. Canada was the third in the world to authorize Pfizer on Dec. 14th, and second to approve Moderna Dec. 23.

By the time Health Canada authorized AstraZeneca — a review process complicated by some mistakes during the clinical trial in dosing and the number of seniors among its volunteer patients — it was also able to pull data from real-world use of the vaccine in the United Kingdom.

The regulatory work doesn’t end when the authorization is announced. The post-market surveillance data is still non-stop. The recent blood clot concern with the AstraZeneca vaccine took a lot of time, but just monitoring the data submitted by the vaccine makers on adverse events overall is still critical.

To date, the adverse event reports in Canada have not been different than what was seen in clinical trials. 

Companies also adjust their submissions requiring further review. Pfizer has so far asked for two changes, one to the number of doses per vial and another for the temperature at which the vaccine has to be kept.

If anything changes on safety, or if the efficacy seen in a clinical trial doesn’t play out in the real world, Sharma says Canada will not hesitate to make adjustments. But those decisions will be made by Canadian experts, said Sharma, the same ones who have been on the files all along.

“It’s important that if anything comes up, we have people that have reviewed it, have gone through every piece of paper, the 2,000 hours, the hundreds of thousands of pages, and that if anything comes up, it’s like they’ve got a really strong science base, and they can put that stuff in context and we can make decisions really quickly.”

This report by The Canadian Press was first published March 28, 2021.

Mia Rabson, The Canadian Press

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Canada finance minister: Pandemic an opportunity to bring in national childcare

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OTTAWA (Reuters) – The COVID-19 pandemic and its damaging impact on women has underlined the need for a national childcare plan, which would also help the economic recovery, Finance Minister Chrystia Freeland said on Thursday.

Since taking up her job in August, Freeland has repeatedly spoken about a “feminist agenda,” and has said childcare will be part of a stimulus package worth up to C$100 billion ($79.6 billion) over three years. She will unveil details in her April 19 budget.

“I really believe COVID-19 has created a window of political opportunity and maybe an epiphany … on the importance of early learning and childcare,” Freeland told a online convention of Canada‘s ruling Liberal Party.

The budget is set to be a springboard for an election that Liberal insiders say is likely in the second half of the year.

Canadian governments of various stripes have mused about a national childcare program for decades but never acted, thanks in part to the cost and also the need to negotiate with the 10 provinces, which deliver many social programs.

Freeland said a childcare program would help counter “an incredibly dangerous drop” in female employment since the start of the pandemic.

“It is a surefire way to drive jobs and economic growth … you have higher participation of women in the labor force,” Freeland said. “My hope … is that being able to make that economic argument as well is going be to one of the ways that we get this done.”

Freeland, who is taking part this week in meetings of the Group of Seven leading industrialized nations and the International Monetary Fund, said U.S. Vice President Kamala Harris and Treasury Secretary Janet Yellen had told her they saw early learning and child care as a driver for economic recovery.

($1=1.2560 Canadian dollars)

 

(Reporting by David Ljunggren; Editing by Leslie Adler)

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COVID-19 in Ottawa: Fast Facts for April 10, 2021

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OTTAWA —
Good morning. Here is the latest news on COVID-19 and its impact on Ottawa.

Fast Facts:

  • Ottawa’s top doctor warns schools could remain closed after the April break next week
  • Ottawa sets new record for COVID-19 cases and hospitalizations on Friday
  • The city of Ottawa admits it doesn’t have enough supply to vaccinate residents 50 and older in high-priority neighbourhoods
  • Kingston closes popular waterfront park to prevent COVID-19 spread

COVID-19 by the numbers in Ottawa (Ottawa Public Health data):

  • New COVID-19 cases: 242 new cases on Friday
  • Total COVID-19 cases: 19,030
  • COVID-19 cases per 100,000 (previous seven days): 146.0
  • Positivity rate in Ottawa: 9.2 per cent (April 2 to April 8)
  • Reproduction Number: 1.05 (seven day average)

Testing:

Who should get a test?

Ottawa Public Health says you can get a COVID-19 test at an assessment centre, care clinic, or community testing site if any of the following apply to you:

  • You are showing COVID-19 symptoms;
  • You have been exposed to a confirmed case of the virus, as informed by Ottawa Public Health or exposure notification through the COVID Alert app;
  • You are a resident or work in a setting that has a COVID-19 outbreak, as identified and informed by Ottawa Public Health;
  • You are a resident, a worker or a visitor to long-term care, retirement homes, homeless shelters or other congregate settings (for example: group homes, community supported living, disability-specific communities or congregate settings, short-term rehab, hospices and other shelters);
  • You are a person who identifies as First Nations, Inuit or Métis;
  • You are a person travelling to work in a remote First Nations, Inuit or Métis community;
  • You received a preliminary positive result through rapid testing;
  • You require testing 72 hours before a scheduled (non-urgent or emergent) surgery (as recommended by your health care provider);
  • You are a patient and/or their 1 accompanying escort tra­velling out of country for medical treatment;
  • You are an international student that has passed their 14-day quarantine period;
  • You are a farm worker;
  • You are an educator who cannot access pharmacy-testing; or
  • You are in a targeted testing group as outlined in guidance from the Chief Medical Officer of Health.

Where to get tested for COVID-19 in Ottawa:

There are several sites for COVID-19 testing in Ottawa. To book an appointment, visit https://www.ottawapublichealth.ca/en/shared-content/assessment-centres.aspx

  • The Brewer Ottawa Hospital/CHEO Assessment Centre: Open Monday to Sunday, 8:30 a.m. to 7:30 p.m.
  • The Moodie Care and Testing Centre: Open Monday to Friday from 8 a.m. to 3:30 p.m. Open Saturday and Sunday, 8 a.m. to 11:30 a.m. (testing only)
  • The Heron Care and Testing Centre: Open Monday to Friday from 8 a.m. to 4 p.m.
  • The Ray Friel Care and Testing Centre: Open Monday to Friday from 8 a.m. to 4 p.m.  Saturday and Sunday, 8 a.m. to 4 p.m. (testing only)
  • COVID-19 Assessment Centre at Howard Darwin Centennial Arena: Open daily 8:30 a.m. – 3:30 p.m.
  • Centretown Community Health Centre: Open Monday, Tuesday, Wednesday, Friday from 9 a.m. to 4 p.m.
  • Sandy Hill Community Health Centre: Open Monday to Friday from 9 a.m. to 3 pm.
  • Somerset West Community Health Centre: Open from 9 a.m. to 4 p.m. Monday to Wednesday.
  • COVID-19 Drive-Thru Assessment Centre at 300 Coventry Road: Open seven days a week from 10 a.m. to 6 p.m.

Vaccine eligibility screening tool:

To check and see if you are eligible to receive a COVID-19 vaccine in Ottawa, click here.

COVID-19 screening tool:

The COVID-19 screening tool for students heading back to in-person classes can be found here.

Symptoms:

Classic Symptoms: fever, new or worsening cough, shortness of breath

Other symptoms: sore throat, difficulty swallowing, new loss of taste or smell, nausea, vomiting, diarrhea, abdominal pain, pneumonia, new or unexplained runny nose or nasal congestion

Less common symptoms: unexplained fatigue, muscle aches, headache, delirium, chills, red/inflamed eyes, croup

Ottawa’s top doctor warns it’s “more likely than not” that all elementary and secondary schools in Ottawa will be closed for in-person learning after the April break.

“I am now thinking the probability that schools will close to in-person learning after the spring break is higher than the probability the COVID-19 situation will improve in time to keep schools open,” said Dr. Vera Etches, Ottawa’s medical officer of health.

“My heart is heavy because I know how important schools are to the health of our community.”

Etches says Ottawa Public Health will make a decision by next Wednesday on whether schools will reopen or close after the April Break.

Ottawa Public Health reported 242 new cases of COVID-19 in Ottawa on Friday, the highest one-day case count in the capital during the COVID-19 pandemic.

The surging numbers prompted the city’s medical officer of health to issue a rallying cry to Ottawa residents, saying the city has reached a key point in the COVID-19 “marathon.”

“We are tired. We’re fatigued. We want this to be over. And this is the point in our COVID marathon where we’re hitting the wall,” Dr. Vera Etches told reporters Friday. “This is our defining moment. It’s a moment where we’ve got to break through that wall.”

Ottawa’s positivity rate increased to 9.2 per cent for the period of April 2 to 8 from 8.8 per cent. Ottawa’s weekly incidence rate is now 146 cases per 100,000 people.

Residents aged 50 and over in three hot spot postal code areas in Ottawa can now book an appointment to receive a COVID-19 vaccine, but the city warns it doesn’t have enough vaccine supply to vaccinate everyone.

On Friday, Ontario opened vaccine appointments at community clinics to residents born in 1971 or earlier who live in certain “hot spots.” In Ottawa, the hot spots have been identified as postal codes K1T, K1V, K2V.

A memo from Dr. Vera Etches and Ottawa’s general manager of emergency and protective services Anthony Di Monte said residents 50 years of age and older living in the provincially identified “hot spots” of K1T, K1V and K2V are eligible for vaccine appointments at community clinics.

Residents living in the high-priority neighbourhoods of Emerald Woods – Sawmill Creek and Greenboro East and Ledbury – Heron Gate and Ridgemont will have the option to book at either a community clinic or at a pop-up clinic.

COVID-19 vaccine Ottawa immunization clinic

One day after a COVID-19 outbreak was declared in Kingston’s University District, the city is closing the popular Breakwater Park until the end of the university school year to prevent large gatherings.

Mayor Bryan Paterson has issued an emergency order to close Breakwater Park for the next 10 days.

“This timeline coincides with students move-out, but can be extended if needed. As one of our most popular community parks, closing it is a last resort,” said Paterson in a statement

“Yesterday, however, we saw troubling instances of overcrowding, which is especially concerning given the current outbreak in the nearby University District.”

Pictures on social media showed dozens of people in the popular park along the waterfront on Thursday.  During the provincewide shutdown, outdoor gatherings are limited to a maximum of five people.

Kingston's Breakwater Park

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Average age of Quebec COVID-19 patients has dropped by 10 to 15 years, doctors say

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MONTREAL — Over the past two to three weeks, Dr. Francois Marquis, head of intensive care at Montreal’s Maisonneuve-Rosemont hospital, says he started noticing the average age of COVID-19 patients dropping.People arriving at the hospital are on average, about 10 to 15 years younger than earlier patients in need of medical care after contracting COVID-19, he said in an interview Wednesday.

“We are starting to see what was very unlikely during the first wave: 30 or 40-year-olds without any previous medical history, people in good health,” Marquis said.

“They’re not seeing a doctor, they’re not taking any kind of medication, they don’t have diabetes, they don’t have high blood pressure — they just get sick.”

Marquis’s observations echo a warning earlier this week from Dr. Theresa Tam, Canada’s chief public health officer, who said health officials across the country are reporting rising numbers of younger patients in hospitals who soon need intensive care.

“Many of them deteriorate quite quickly and have to be admitted to the ICU,” she said.

Dr. Gaston De Serres, an epidemiologist with Quebec’s public health institute, said the proportion of Quebecers over 80 in hospital with COVID-19 has been declining since mid-March — largely due to vaccination.

He said it’s not just the proportion of hospital patients who are younger that’s increasing, the overall number of younger patients is rising as well. De Serres said there were 40 people between 50 and 59 years old who were hospitalized the week of March 7. During the week of March 28, there were 54.But hospitalizations are still not rising significantly among people under 30. “It’s younger,” he said of the average age of patients. “It’s not young.”

Ten people between 20 and 29 years old were hospitalized with COVID-19 in Quebec the week of March 28, up from five two weeks earlier, De Serres said.

“If you have more cases, you will clearly have more hospitalizations, but the proportion of all hospitalized cases will remain small because these younger age groups are very low risk of being hospitalized.”

De Serres said he thinks more younger people are getting sick because the coronavirus variants of concern are more transmissible and they lead to more severe illness more frequently.

Mike Benigeri, director of the data bureau at the Institut national d’excellence en sante et services sociaux, a Quebec government health-care research institute, said that over the past two weeks, there has been a 40 per cent increase in the number of people aged 40 to 69 who have been infected with COVID-19. He said the percentage is even higher among people aged 18 to 30.

Marquis said older people and those with other medical conditions may notice a COVID-19 infection sooner. People who are healthier may not seek medical attention until they’re very ill, he added.

“They will push the limits of endurance up to the point when they say, OK, it’s enough, I really need to go to the hospital,” he said.

Despite the odds of dying being low among younger people, that doesn’t mean the consequences among the small group who do get severely ill are any smaller, he said.

“If you’re that unlucky guy, well, you’re going to die — and you’re not going die 1.5 per cent, you’re going be fully dead.”

Quebec Premier Francois Legault has repeatedly said that with vaccination protecting older people, the province will be able to tolerate more COVID-19 cases.

Dr. Quoc Nguyen, a gerontologist at the Universite de Montreal hospital centre, said while that may be true when it comes to deaths, it may not be the case for ICU capacity.

“When we look at one case in December versus one case in March, it seems that for a single case we have more intensive care than we used to before, but we don’t necessarily have more hospitalization,” he said.

It’s ICU capacity that worries Marquis. His ICU is supposed to have 24 beds, but because staff members have left the health-care system — particularly nurses — it now has a capacity of 14: seven beds dedicated to COVID-19 patients and seven for everyone else.

“I am really afraid that in two weeks we’re going to be in the same place as Ontario is right now and I don’t think that we can deal with that many patients,” he said.

Ontario Premier Doug Ford has imposed a four-week stay-at-home order after a third wave of COVID-19 started to overwhelm the health system.

“They’re going to saturate the ICU availability very, very quickly for a very long time,” Marquis said.

This report by The Canadian Press was first published April 8, 2021.

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