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What you need to know before the J&J vaccines are distributed in Canada – ABC17NEWS – ABC17News.com

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    TORONTO, Ontario (CTV Network) — Canada welcomed the newest vaccine to its supply chain earlier this week with the arrival of the single-dose Johnson & Johnson vaccines, but quality concerns have halted its distribution across the country for now.

The only single-dose vaccine approved for use in Canada has been hailed by experts as a key to getting people in remote locations vaccinated, and as an important tool in turning the tide of the third wave of COVID-19 across the country.

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The vaccines were set to be distributed to provinces next week.
However, on Friday, Health Canada said it was holding the 300,000 doses as it reviews the quality of the vaccines.

In a statement, Health Canada stated it “learned that a drug substance produced at the Emergent site (in Baltimore) was used in the manufacturing of the initial Janssen vaccines” slated for use in Canada.

An inspection of the facility by the U.S. Food and Drug Administration found multiple areas of concern, including peeling paint and sanitary issues.

The substance is the “active ingredient” that undergoes further processing before becoming the final product – in this case, the vaccine, the statement continues.

The final Janssen vaccines were manufactured at a different site located outside of the U.S.

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It’s unclear how long this review will take.

Clinical researcher and Toronto physician Dr. Iris Gorfinkel said Health Canada is in a position where it has to be transparent with its review but not feed into vaccine hesitancy.

“Basically Health Canada has said we are going to look carefully to make sure that these doses are safe, and because they were made in this facility, that does raise a question or two,” Gorfinkel said in a telephone interview with CTVNews.ca Saturday. “They want to make sure that what’s in it is what’s promised and that they are meeting a high enough standard.”

Before Health Canada and the National Advisory Committee on Immunization release their review and recommendations on the use of the Johnson & Johnson vaccine, here is what you need to know:

HOW EFFECTIVE IS THE J&J VACCINE?

In its Phase 3 clinical trial at the end of January, Johnson & Johnson’s vaccine data suggested their vaccine reduced severe COVID-19 disease by 85 per cent and prevented 100 per cent of COVID-19-related hospitalization or death.

The vaccine had a 72 per cent efficacy rate in preventing COVID-19 infections after 28 days in the U.S. trials.

“The numbers we now have are based on the first trial called Ensemble One, where they have 40,000 volunteers, and it is still ongoing to look for safety issues,” Gorfinkel said. “Basically what they found in that trial is that it is 100 per cent reduction in hospitalization, so from a public health perspective, that’s what matters.”

Pfizer and Moderna showed 95 per cent efficacy in their trials, but those trials did not test against variants of concern like the B1.1.7 variant, which have become the drivers behind the majority of cases in Canada.

Gorfinkel said an issue with people jumping to compare vaccine efficacy rates is that many do not understand that the trials are not comparable.

“You can’t compare when it was in different countries, with different types of volunteers, in different seasons with different amounts of variables present,” she said. “So they’re not actually comparable and people kind of lose sight of that and I think that’s a critical thing from a public health perspective.”

IT’S SAFE

The U.S. Centers for Disease Control (CDC) released their new review of the Johnson & Johnson COVID-19 vaccine safety monitoring data Friday, and found that only three per cent of reported reactions after receiving the shot are classified as “serious.”

The report analyzed the latest safety data on the vaccine, which included 13,725 incidents reported through the health agency’s Vaccine Adverse Events Reporting System (VAERS). Their data showed that 97 per cent of the incidents reported were non-serious.

‘EXTREMELY RARE’ BLOOD CLOTS

The CDC found there were a total of 17 incidents of blood clots out of more than nearly 8 million inoculations from people also experiencing low blood platelet levels.

“A rare but serious adverse event occurring primarily in women, blood clots in large vessels accompanied by a low platelet count, was rapidly detected by the U.S. vaccine safety monitoring system,” the report states. “Monitoring for common and rare adverse events after receipt of all COVID-19 vaccines, including the Janssen COVID-19 vaccine, is continuing.”

Out of the 17 blood clot events, 14 were in the brain’s venous sinuses and three were elsewhere in the body among women who were younger than 60.

The data included 88 deaths reported after vaccination, three of which occurred in patients with “cerebral venous sinus thrombosis.” The report noted that after preliminary review of the three deaths, “no other deaths appear to have an association with vaccination.”

Health Canada updated the Johnson & Johnson COVID-19 vaccine product label to include the “very rare” risk of blood clots on Monday.

‘ANXIETY-RELATED EVENTS’

The CDC report also noted an increase in what they call “anxiety-related events” in the waiting period after getting the vaccine. Symptoms of incidents reported to VAERS included things like fainting, rapid heart rates, and rapid breathing.

Gorfinkel broke down the phenomenon into placebo and nocebo effects.

“If I give you a sugar pill and say ‘you’re going to take this and you will feel so good,’ people will feel better. If I can be compelling enough, I can change how you feel,” she said. “On the flip side, there is something called the nocebo effect. In other words, you read about the problem and in fact become more likely to get it.”

Gorfinkel used the example of the common COVID-19 vaccine side-effect of soreness at the injection site.

“By reading: ‘You will experience soreness at the injection site,’ just by reading that, you will experience it and more often than not it’ll feel worse,” she said. “If I talk to you and ask about your dog and give you the vaccine, chances are you will barely notice – but if I say, ‘This will hurt a bit,’ guess what? It will hurt and you will probably feel worse.”

Gorfinkel said a lot of people confuse nocebo with being transparent or being honest, but that it helps to keep perspective if Canadians are feeling anxious about being vaccinated.

“You can’t devote too much energy to those things that you cannot change,” she said. “There is risk in taking the vaccine. There is risk in not taking the vaccine and the risk of not taking the vaccine is far greater, not just a little greater, far greater.”

WHAT ARE THE ADVANTAGES TO THE J&J VACCINE?

The J&J COVID-19 vaccine is currently the only vaccine approved for use in Canada that is a single dose, and can also be stored in a regular refrigerator – making it substantially easier to distribute and makes them good candidates for mobile or pop-up clinics.

The Pfizer vaccine initially needed ultra-cold storage temperatures between -60 C and -80 C, although Health Canada amended its guidance to say that it could be stored in a regular freezer for up to 14 days. Moderna’s vaccine can be stored at freezer temperatures and AstraZeneca’s vaccines can be stored in the fridge.

“J&J has approval in Canada as a one-shot deal and when you think about it, they are huge in COVAX and have basically created 500 million doses and committed those to COVAX on a world scale,” Gorfinkel said. “They’ve also said we’re going to do this in a way which is not going to make a lot of money, and understand that when companies say they’re going to do something like that, that translates into tremendous benefit for the world, because this is a world problem.”

COVAX is the global vaccine-sharing initiative which is co-ordinated by the World Health Organization, the Coalition for Epidemic Preparedness Innovations, Gavi and the Vaccine Alliance.

HOW DOES IT WORK?

The Johnson & Johnson vaccine does not use mRNA technology the way Pfizer and Moderna does to deliver the vaccine, instead using a de-activated cold virus to carry genetic materials to the cells, which then prompts them to create the “spike protein” found on the surface of COVID-19. This helps build the antibodies needed to create an immune response against the virus that causes COVID-19, known as SARS-C0V-2.

“They’re both genetic packages to instruct our cells to make the spike proteins, they just go about it in a different way,” Gorfinkel said. “One does it by using messenger RNA, which instructs our cells to make spike protein. The other takes adenovirus, which is an inactivated, unable to divide cold virus, and they put a slice of DNA onto it.”

“They both cause the cells to produce spike protein, and when the body sees the spike protein, it produces an immune response,” she continued, adding that other immune cells are produced against the protein, not just antibodies.

Gorfinkel said it might be helpful to think of the COVID-19 spike protein entering the cell like a “skeleton key” that can go into any lock, but once the immune response is built after vaccination – the lock changes and the key can no longer enter.

Please note: This content carries a strict local market embargo. If you share the same market as the contributor of this article, you may not use it on any platform.

ctvnews.caproducers@bellmedia.ca

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Measles case reported locally turns out to be negative: health unit

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NEWS RELEASE
SIMCOE MUSKOKA DISTRICT HEALTH UNIT
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On March 26, the Simcoe Muskoka District Health Unit (SMDHU) was notified by Public Health Ontario’s (PHO) laboratory that due to laboratory error, the case of measles that had been lab-confirmed positive on March 12, based on symptoms and a positive urine measles laboratory result by PHO’s laboratory, is in fact negative for the measles virus.

“With this new information of the negative lab result, we believe that that individual was not infected with measles and that there has not been any public exposure to measles resulting from this individual’s illness,” said Dr. Charles Gardner, medical officer of health. “We recognize that notifying the public of what we believed to be a positive measles case in our area created worry, anxiety and disruption for some, and we regret this.

“We do know that, despite best efforts, on rare occasions laboratory errors can occur. We are working closely with the PHO’s laboratory to do all that we can to ensure that such an incident does not occur again.”

Measles is a highly contagious viral infection that spreads very easily through airborne transmission. The measles virus can live in the air or on surfaces for up to two hours.

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Symptoms of measles begin seven to 21 days after exposure and include fever, runny nose, cough, drowsiness, and red eyes. Small white spots appear on the inside of the mouth and throat but are not always present. Three to seven days after symptoms begin, a red, blotchy rash appears on the face and then progresses down the body.

The risk of transmission to those vaccinated with two doses is low, and when it does occur tends to show a reduction in the severity of these symptoms.

“Although we are relieved for the individual involved, and for all Simcoe-Muskoka residents, that this case has now been confirmed as negative, we know that measles is still active in Ontario at this time and the potential remains for new cases to arise, especially given the increase in Ontarians travelling to areas in the world that have higher numbers of measles cases,” said Dr. Gardner. “This is why we continue to advise individuals to keep up to date with their routine immunizations, including measles, mumps and rubella (MMR) vaccination.”

The risk of measles is low for people who have been fully immunized with two doses of measles vaccine or those born before 1970; however, many children have been delayed in receiving their routine childhood immunizations and people who have not had two doses of measles vaccine are at higher risk of contracting the disease.

People who do get sick usually recover without treatment, but measles can be more severe for infants, pregnant women, and those with compromised immune systems. Possible complications include middle-ear infections, pneumonia, diarrhea, or encephalitis (swelling of the brain) and occasionally death in the very young. Even individuals who are up to date with the measles vaccine should watch for symptoms of measles for 21 days after exposure.

For more information about measles, please visit smdhu.org or call Health Connection at 705-721-7520 or 1-877-721-7520, Monday to Friday between 8:30 a.m. and 4:30 p.m. to speak with a public health professional.

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Kate Middleton Not Alone. Cancer On Rise For People Under 50, Say Experts

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Kate Middleton revealed on Friday that her cancer was discovered after she received abdominal surgery

London:

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When Catherine, Princess of Wales, revealed she was being treated for cancer last week, part of the shock was that an otherwise healthy 42-year-old has a disease that mostly plagues older people.

However, researchers have been increasingly sounding the alarm that more and more people under 50 are getting cancer — and no one knows why.

Across the world, the rate of under-50s diagnosed with 29 common cancers surged by nearly 80 percent between 1990 and 2019, a large study in BMJ Oncology found last year.

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The researchers predicted the number of new cancer cases among younger adults will rise another 30 percent by the end of this decade, with wealthy countries particularly affected.

The increase in cases — and soaring global population — means that the number of deaths among under 50s from cancer has risen by nearly 28 percent over the last 30 years.

This occurred even as the odds of people of all ages surviving cancer have roughly doubled over the last half century.

Shivan Sivakumar, a cancer researcher at the UK’s University of Birmingham, called it an “epidemic” of young adult cancer.

Since Kate Middleton revealed on Friday that her cancer was discovered after she received abdominal surgery earlier this year, Sivakumar and other doctors have spoken out about the uptick in younger cancer patients they have been seeing at their clinics.

While breast cancer remains the most common for people under 50, the researchers expressed particular concern about the rise of gastrointestinal cancers — such as of the colon, pancreas, liver and oesophagus — in younger adults.

Colon cancer is now the leading cause of cancer deaths in men under 50 in the United States, according to the American Cancer Society. For women, it is number two — behind only breast cancer.

One high profile case of colorectal cancer was “Black Panther” actor Chadwick Boseman, who died at the age of 43 in 2020.

Why is this happening?

“We just don’t have the evidence yet” to say exactly what is causing this rise, Sivakumar told AFP, adding it was likely a combination of factors.

Helen Coleman, a cancer epidemiology professor at Queen’s University Belfast who has studied early onset cancer in Northern Ireland, told AFP there were two potential explanations.

One is that people in their 40s were exposed to factors known to cause cancer — such tobacco smoke, alcohol or being obese — at an earlier age than previous generations.

She pointed out that the “obesity epidemic” did not start until the 1980s.

Sivakumar felt that at least part of the puzzle could be explained by obesity.

However, there is “another wave” of under-50 patients who are neither obese nor genetically predisposed still getting cancer, he emphasised, adding that this could not be put down to “statistical chance”.

The other theory, Coleman said, is that “something different” has been going on with her generation.

Fingers have been pointed out a range of possible culprits — including chemicals, new drugs and microplastics — but none have been proven.

Some have suggested that so-called ultra-processed foods could be to blame. “But there’s very little data to back any of that up,” Coleman said.

Another theory is that the food we eat could be changing our gut microbiome.

While there is nothing conclusive yet, Coleman said her own research suggested that cancer causes changes to the microbiome, not the other way around.

Anti-vaxx conspiracy theorists have even tried to blame Covid-19 vaccines.

This is easily disproven, because the rise in young adult cancer has taken place over decades, but the vaccines have only been around for a few years.

What can be done?

To address the rise in younger colorectal cancer, in 2021 the US lowered the recommended age for screening to 45. Other countries have yet to follow suit.

But the researchers hoped that Catherine’s experience would remind people at home that they should consult their doctor if they sense anything is wrong.

“People know their bodies really well,” Sivakumar said.

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“If you really feel that something isn’t right, don’t delay — just get yourself checked out.”

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Almost 3,000 students suspended in Waterloo Region over immunization issues

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Close to 3,000 children attending elementary school across Waterloo Region were suspended from school on Wednesday morning for not having up-to-date immunization records.

The region says Waterloo Public Health suspended 2,969 students under the Immunization of School Pupils Act (ISPA).

For several months, the region has been campaigning for people to get their children’s vaccinations up to date, including sending letters home to parents on a couple of occasions, warning that students’ records needed to be up to date or they would be suspended.

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It announced in January that 32,000 students did not have up-to-date records: 22,000 elementary students and 10,000 high school students.


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“We have made remarkable progress from the original 27,567 immunization notices we sent to parents in November and December 2023,” Dr. Hsiu-Li Wang, medical officer of health, stated.

“Since that time, we have resolved more than 24,500 outdated vaccination records, providing students with valuable protection against these serious and preventable diseases.”

The high school students still have a few weeks to get their records up to date or else face suspension.

The ISPA requires students to have proof-of-vaccination records for diphtheria, polio, tetanus, pertussis, measles, mumps, rubella, varicella (chickenpox) and meningitis, which must be on file with public health.

Public health says caregivers whose children are suspended will need to book an appointment at regionofwaterloo.ca/vaccines for clinics, which will be held in Cambridge and Waterloo on weekdays.

“Given the high number of suspensions, it may take several days before you can be seen at an appointment and return your child to school,” a release from the region warns.

“Record submission and questions must be done in person to ensure immediate resolution.”

The last time suspensions over immunizations were issued was in 2019, when 1,032 students were suspended.

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