OTTAWA — Canada’s drug regulator approved Moderna’s COVID-19 vaccine for infants and preschoolers Thursday, making it the first vaccine approved for that age group in the country.
Health Canada now says the Moderna vaccine can be given to young children between the ages of six months and five years old in doses one-quarter the size of that approved for adults.
“After a thorough and independent scientific review of the evidence, the department has determined that the vaccine is safe and effective at preventing COVID-19 in children between 6 months and 5 years of age,” the department said in a statement.
The National Advisory Committee on Immunization gave provinces its assent to offer the vaccine to children in that age group Thursday, by recommending that children “may” be offered the vaccine.
The committee’s executive secretary, Dr. Matthew Tunis, said NACI is acknowledging that this could be an “important protective measure” for parents who want to exercise the option for their kids, and the recommendation could be strengthened as more data becomes available.
While serious illness among children is rare, the committee said the number of children hospitalized for COVID-19 shot up dramatically as the Omicron variant spread rampantly last winter.
“This authorization comes at a critical time in the pandemic as we progress through the seventh wave and though children are less likely to experience complications from COVID-19, they can still get very sick,” said Dr. Supriya Sharma, Health Canada’s chief medical adviser, at a media briefing Thursday.
The average monthly rate of young children hospitalized because of COVID-19 increased from 1.4 per 100,000 children under five in the first two years of the pandemic to 15.9 per 100,000 in the first three months of 2022.
Sharma pointed out that even children with mild illness can go on to develop long-term symptoms and, in rare but serious cases, multisystem inflammatory syndrome, which often requires acute hospital care.
Deputy chief public health officer Dr. Howard Njoo advocated for parents to vaccinate their kids as protection against serious illness, even if they’ve already been sick with COVID-19.
Health Canada said it will continue to keep a close eye on the safety of the vaccine, and has required Moderna to provide updated data on both the safety and effectiveness of the vaccine.
In its decision posted on the Health Canada website, the agency said Phase 3 trial results for the drug show the immune response in children six months to five years old was comparable to Moderna’s vaccine for 18 to 25-year-olds.
The approval expands COVID-19 vaccine eligibility to nearly two million children in Canada, though where and when the vaccine will be given to kids will be determined by provinces.
Njoo said there is a “sufficient supply” of vaccines, which will be shipped to the provinces so they can begin to offer them to children “very shortly.”
So far Canadian parents have been more hesitant to vaccinate their kids against COVID-19 than they were to vaccinate themselves. As of June 19, about 42 per cent of kids between the ages of five and 11 have had two doses of an approved vaccine.
By comparison, about 90 per cent of Canadians 12 and over have had at least two shots.
Njoo said public health doesn’t want to force the vaccine on families and wants them to feel comfortable with their choice. He encouraged parents to speak with their family doctors or pediatricians if they have any questions about whether their child should get the shot.
In Moderna’s trials, two doses of the child-sized vaccine were given about four weeks apart, but NACI recommends waiting eight weeks between shots.
NACI also recommends a third dose for immunocompromised children, if their parents choose to vaccinate them, with a four to eight-week wait between injections.
For now, the committee says the COVID-19 vaccine should not be given to babies, toddlers or preschoolers at the same time as vaccines for other illnesses to help identify any potential reactions.
Health Canada said there were no safety concerns identified in the study. The most common reactions were similar to the ones kids experience for other pediatric vaccines, like pain at the site, sleepiness and loss of appetite.
Less commonly, some kids got a mild to moderate fever, swelling at the injection site, nausea, tender lymph nodes under the arm, headaches and muscle aches.
Health Canada said there are still some uncertainties about the vaccine because it’s new and there’s no long-term data available yet. For example, there’s little data about the risk of very rare reactions like myocarditis, a swelling of heart tissue, though no cases came up in the trials.
There is also more to learn about the safety and effectiveness of the vaccine in young children with other health conditions or who are immunocompromised, the documents said.
The United States approved Moderna and Pfizer’s pediatric COVID-19 vaccines last month, and so far have immunized 267,000 children in that age group as of July 8.
Pfizer’s pediatric COVID-19 vaccine for young children between six months and five years old was submitted to Health Canada last month and is still under review.
This report by The Canadian Press was first published July 14, 2022.
Laura Osman, The Canadian Press
Saskatchewan warns of elevated monkeypox risk through 'anonymous sexual contact' – Niagara Falls Review
REGINA – Saskatchewan’s health-care delivery agency is warning there’s an elevated risk of acquiring monkeypox through anonymous sexual contact, and it’s expanding vaccine eligibility to adults 18 years and older who are close contacts or deemed higher risk for exposure.
The chief medical officer of health told reporters during a news conference Saturday that monkeypox cases in the province remain low — so far only three have been confirmed.
But Dr. Saqib Shahab says if people meet the risk criteria and have concerns, they should call the province’s 811 HealthLine for advice on testing, as well as on obtaining a pre-exposure vaccination.
The Saskatchewan Health Authority issued a news release saying the warning about catching monkeypox through anonymous sexual contact is due to recent known cases.
It adds information reported to public health, related to travel into and out of province, has prompted the alert.
Shahab says Saskatchewan wants to do everything it can to prevent a surge in cases.
“I think with travel interactions throughout Canada in the summer, I think this risk was bound to change for us in Saskatchewan and that’s why we are now really opening up the vaccine, not just for post-exposure prophylaxis, but for pre-exposure as well, for the very targeted group that we’ve identified,” Shahab said at the news conference.
“Obviously we don’t want over-testing happening, but in the right context, I think it’s important to seek testing, exactly for the reason that we don’t want to miss cases.”
So far, he said there have been no cases in Saskatchewan where a history of exposure hasn’t been identified. Additional vaccine doses have been ordered now that the province has expanded eligibility, he noted.
Monkeypox, which comes from the same family of viruses that cause smallpox, has been endemic in parts of central and west Africa for decades and was not known to trigger large outbreaks beyond the continent until May.
It causes fever, headache, swollen lymph nodes and lethargy, followed by the development of a rash over a person’s body. It spreads through close, personal, often skin-to-skin contact, touching bodily fluids or lesions of a person who is sick with the disease or exposure to contaminated objects such as bed linens or clothing.
The Public Health Agency of Canada says the majority of domestic cases are among men who reported intimate sexual contact with other men. Having multiple sexual partners may increase one’s overall risk, but the agency says the risk of exposure is not exclusive to any group or setting.
The number of Canadian monkeypox cases surpassed 1,000 just this week, though there are early signs the virus may now be spreading at a slower rate.
This report by The Canadian Press was first published Aug. 13, 2022.
Sask Health alerts public of elevated risk of acquiring monkeypox – Global News
The Saskatchewan Health Authority is alerting the public of an elevated risk of acquiring monkeypox through anonymous sexual contact.
Recent known cases have been associated with this form of transmission, and information reported to public health related to travel in and out of the province has prompted the alert.
“We’ve have been following the global monkeypox outbreak very closely for the last five months now,” said Dr. Saqib Shahab, the Chief Medical Health Officer for Saskatchewan.
“We think now there is a higher risk that we may see ongoing transmission in Saskatchewan.”
There are three confirmed cases of monkeypox in the province. Shahab said the cases so far have been from people exposed outside of Saskatchewan, however there are now people who have been exposed inside the province.
“We have evidence of exposures happening in Saskatchewan,” Shahab said. “In many cases through anonymous sexual contacts. This is very similar to what has been seen in other provinces in Canada and internationally.”
Monkeypox is a rare viral illness that causes fever, headache, swollen lymph nodes and lethargy, followed by the development of a rash over a person’s body. Monkeypox does not spread easily from person to person. It is spread through:
- Close, personal, often skin-to-skin contact.
- Touching bodily fluids or lesions of a person who is sick with the disease.
- Exposure to contaminated objects such as bed linens or clothing.
Anyone who believes they have been exposed to monkeypox can contact Healthline 811 to determine if they are considered at risk or eligible for a vaccine.
Eligibility for the monkeypox vaccine has been expanded to adults 18 years and older who are close contacts or deemed higher risk for exposure. Referrals are available through 811.
“With travel, with interactions in summer, this risk was bound to change,” Shahab said. “Now we are really opening up the vaccine for not just post-exposure… but for pre-exposure as well with the groups we have identified.”
The province has ordered additional vaccines to help with both pre-exposure and post-exposure, and plan to order even more if the demand increases.
Shahab hopes with the increase in vaccines and awareness of the symptoms, transmission can stay low in the province.
“We are really hopeful both in Saskatchewan and Canada that through all these measures of raising awareness so people are aware of symptoms and the can isolate, seek testing and now seek pre exposure vaccines, we really hope we can control this outbreak,” he said.
If you have recently been in contact with an individual suspected or confirmed with monkeypox and develop fever or other symptoms of illness, you should call HealthLine 811 or consult a health-care provider immediately.
About 50% of monkeypox vaccine supply used, Canada passes 1,000 cases: Tam
© 2022 Global News, a division of Corus Entertainment Inc.
Worse Vascular Outcomes Found in Patients With Asthma – AJMC.com Managed Markets Network
Patients with symptoms of asthma, regardless of physiological confirmation, experienced worse vascular outcomes and greater cardiovascular risk, which may be due to short-acting beta agonist (SABA) use, according to the results of a recent study.
Individuals with a clinical history of asthma had lower endothelial function than healthy controls, regardless of whether participants had physiological confirmation of the disease.
Study results, which were published in Respiratory Medicine, also showed that that participants with asthma who regularly used short-acting beta agonist (SABA) medications had increased arterial stiffness than those who did not use SABA.
Researchers aimed to compare markers of cardiovascular risk, specifically endothelial function, arterial stiffness, and systemic inflammation, among those with confirmed asthma, unconfirmed asthma, and healthy controls. Researchers also aimed to investigate the effect of SABA use on these vascular outcomes.
This cross-sectional study included 26 patients with confirmed asthma, 15 patients with unconfirmed asthma, and 26 healthy controls all recruited from the Edmonton, Canada metropolitan area. All participants in the study were aged between 18 to 45 years and current nonsmokers.
Participants completed a pulmonary function test and evaluation for asthma. Physiological evidence of asthma was defined as a clinical history of symptoms such as recurrent wheezing, cough, and/or chest tightness. Physiological evidence also includes a reversibility in forced expiratory volume in 1 second (FEV1) of ≥12% and 200mL, a ≥20% reduction in FEV1 after a methacholine challenge, or a ≥10% reduction in FEV1 after an exercise challenge.
Participants were labeled with confirmed asthma if they had a clinical history and physiological evidence of asthma. Those labelled with unconfirmed asthma had a clinical history but no physiological evidence of asthma. Healthy controls had no evidence of asthma. Researchers compared endothelial function, arterial stiffness, and systemic inflammation between these three groups of participants.
Researchers assessed participants’ endothelial function as flow-mediated dilation (FMD) after 5 minutes of supra-systolic forearm occlusion distal to the imaging site. A 1% decreased in FMD correlates with a 7% increase in cardiovascular risk.
Participants’ arterial stiffness was assessed using pulse wave velocity (PWV). PWV was measured between the carotid and radial artery. A 1 m/s increased in PWV corresponds to about a 16% increase in cardiovascular risk.
Systematic inflammation was assessed by C-reactive protein (CRP) levels in serum after venous blood was collected from the participants. CRP levels have been linked with cardiovascular risk, even for those without underlying cardiovascular morbidity.
Endothelial function was significantly lower in both confirmed and unconfirmed asthma groups than compared to healthy controls. There was no significant difference in FMD between the confirmed and unconfirmed asthma groups.
There was no significant difference found in arterial stiffness and systemic inflammation among both asthma groups and the controls.
Participants with bot confirmed and unconfirmed asthma were grouped together and then split based on SABA use. SABA was used by 19 participants and not used by 22 participants in the last year. There was no significant difference between in endothelial function and systemic inflammation between these two groups. However, SABA users had a significantly higher arterial stiffness by an average of 1.5 m/s than those not using SABA.
Limitations of this study include the small sample size and the inability to account for seasonal fluctuations in asthma symptoms due to the cross-sectional design. Also, this study did not adjust for other variables that can impact vascular outcomes.
Reduced vascular function was seen in participants with asthma regardless of physiological confirmation of asthma, suggesting that the link between asthma and cardiovascular risk may be due to factors other than asthma pathophysiology and perhaps due to asthma symptomatology, the researchers noted. The researchers also noted that this study highlights the need for proper asthma management to avoid inappropriate SABA use in patients with unconfirmed physiological asthma.
Henry SL, Moore LE, Brotto AR, Rowland S, Fuhr D, Stickland MK. Systemic vascular health is comprised in both confirmed and unconfirmed asthma. Respir Med. 2022;200. doi:10.1016/j.rmed.2022.106932
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