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ACIP Backs Moderna's COVID Shot for Kids 6-17 Years – Medpage Today

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The CDC’s Advisory Committee on Immunization Practices (ACIP) voted unanimously on Thursday to recommend that children ages 6-17 years receive Moderna’s COVID-19 vaccine.

With a 15-0 vote, ACIP endorsed a two-dose primary series of the mRNA vaccine for kids ages 6-11 years (50 mcg per dose) and adolescents ages 12-17 (100 mcg per dose). The recommendation now awaits approval from CDC Director Rochelle Walensky, MD, MPH.

The recommendation was largely expected, and followed FDA’s emergency use authorization last week. Until then, only Pfizer/BioNTech’s mRNA vaccine had been authorized and recommended for these age groups.

At Thursday’s meeting, ACIP members considered safety and efficacy data on Moderna’s vaccine, which was primarily studied during periods where the ancestral SARS-CoV-2 and Delta strains were predominant, in teens and the younger kids, respectively. In both groups, the vaccine was effective against severe disease and hospitalization.

“We know that the benefits outweigh the risks for mRNA COVID-19 vaccine in all ages,” said Sara Oliver, MD, of the CDC’s National Center for Immunization and Respiratory Diseases, during the meeting. “Receipt of this primary series continues to be the safest way to prevent serious COVID-19.”

Oliver emphasized that serious outcomes with COVID-19 do not spare kids. The Omicron wave was accompanied by a surge in hospitalizations among children, and she pointed to 189 COVID-related deaths in kids 5-11 years and 443 in kids 12-17 throughout the course of the pandemic.

Several ACIP members raised questions about the intervals between the first and second dose of the Moderna vaccine, as such an approach may reduce the risk of myocarditis associated with the vaccine. Some evidence suggests the Moderna vaccine carries a higher risk of myocarditis or pericarditis than Pfizer’s vaccine, though CDC experts cautioned that these findings are not consistent in all U.S. monitoring systems.

Among close to 55 million doses of Pfizer’s vaccine administered to individuals ages 5-17 years, the rare adverse event has been observed in at least 635 children, according to the CDC. Risk is typically higher among children ages 12-17, in boys, and after the second dose. Among kids age 5-11, there were no signals detected.

In a presentation on clinical considerations, Elisha Hall, PhD, of the CDC’s National Center for Immunization and Respiratory Diseases, said that although the current recommendation is for a 4-week gap between the first and second doses, the CDC will likely be recommending an 8-week interval for adolescent males. (The CDC also recommends shorter dose intervals for children who are immunocompromised.)

Some of the ACIP members expressed confusion about the product labels on Moderna’s vaccines in each age group. The product authorized for kids 6-11 will have the same color cap as the vaccine for children ages 6 months to 5 years, but a different color border to distinguish the higher concentration. For the product authorized for kids ages 12-17, it will have the same label as the adult vaccine, as it is the same dose.

“I am … concerned about vaccine administration errors,” said Matthew Daley, MD, chair of ACIP’s working group. Others echoed concerns about administration blunders, encouraging more resources for providers and further clarification on labeling from the manufacturer.

Safety and efficacy data for Moderna’s vaccine in this younger population came from two ongoing phase II/III clinical trials (study mRNA-1273-P203 for adolescents ages 12-17 and study mRNA-1273-P204 for kids ages 6-11 years). The studies included nearly 8,000 kids in total.

Among participants ages 12-17, vaccine efficacy was 93.3% (95% CI 47.9-99.9) during a time when the ancestral and Alpha strains were predominant. Among the younger group, vaccine efficacy was 76.8% (95% CI -37.3 to 96.6) during a period when Delta was most prevalent.

The committee agreed on the data that COVID-19 vaccines protect children against severe disease. Many children in this age group, however, remain unvaccinated. Approximately 30% of teens and 65% of younger kids have yet to receive a vaccine, according to Oliver.

“We can predict with future COVID-19 surges, the unvaccinated will continue to bear the burden of disease,” she said.

  • Amanda D’Ambrosio is a reporter on MedPage Today’s enterprise & investigative team. She covers obstetrics-gynecology and other clinical news, and writes features about the U.S. healthcare system. Follow

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Quebec rejects plea to send army to northern region facing health worker shortage

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MONTREAL — Quebec’s Health Department has rejected a request from officials in the northern region of Nunavik to have Armed Forces members brought in to help ease a shortage of health-care workers.

Kathleen Poulin, a spokeswoman for Nunavik Regional Board of Health, said Wednesday that labour shortages in the health sector are hitting Nunavik particularly hard due to the region’s “remoteness and its specific characteristics.”

“In some of the smaller villages that have only two to four nurses, the briefest absence can require a complete reorganization of activities in order to maintain services,” Poulin said in a statement.

“Considering the sizes of the communities, a handful of (additional) health-care workers can make a big difference in the level of services offered to the population.”

The health board, Poulin said, has been asking Quebec in recent weeks to supply medical workers. That included a request that Ottawa send Armed Forces members who can provide health care after some of Nunavik’s 14 Indigenous communities were forced over the summer to limit their services to emergencies only.

Health Minister Christian Dubé told reporters on Wednesday he would “soon” travel to the region to assess the situation, adding that Quebec has a “contingency plan” to handle the crisis.

“We have five or six paramedics already on their way, and doctors from other provinces that offered to help,” Dubé said.

The department, however, opted to seek the Canadian Red Cross’s help in Nunavik rather than the army, Dubé said, as the organization “helped a lot during the pandemic.” The department said the request for Armed Forces support was received Aug. 2.

“It’s a question of who’s the best and most appropriate group to complete our staff,” Dubé said. “The situation is already better than what it was.”

But Charlie Lapointe-Robert, a nurse who works in Inukjuak at the Inuulitsivik Health Centre, said Dubé’s statement is misleading. She said rather than being able to offer proper care to the community, health-care workers are forced to tell residents to “be careful.”

“We’re the ones who are supposed to take care of them,” Lapointe-Robert said in an interview on Wednesday, adding that her health centre still doesn’t know when to expect help from the government.

“We are accumulating delays, blood tests that need to be done, children’s vaccinations, followups, cancer prevention that isn’t done .… The situation is not better than it was. We are heading toward a greater crisis.”

The labour shortage in Nunavik’s health sector is not new — and neither are the requests for government action, Lapointe-Robert said.

The nurse, who’s currently on vacation in Montreal, said she doesn’t understand why it took so long to create a contingency plan as it is now a matter of days before the community could be left with no nurses on duty.

“We are on a tightrope, there is a risk of error and incredible tragedy,” she said, adding that normally up to six nurses are working in Inukjuak.

Poulin said a labour shortage affecting the entire province has left nursing agencies unable to meet the demand.

“Summer means vacation for many. It is necessary for the workers to take some time off, mostly after two years of COVID-19. Again, just a few people more or less make a big difference.”

The union representing nurses in the northern region, the Syndicat nordique des infirmières et infirmiers de la Baie d’Hudson, said it has been warning the government about the situation since last year.

“We are in a G7 country and I believe that the Inuit communities of Hudson Bay have a right to quality health care,” union president Cyril Gabreau said on social media. “Actions could have been taken yesterday to avoid tomorrow’s catastrophe.”

This report by The Canadian Press was first published on Aug. 10, 2022.

This story was produced with the financial assistance of the Meta and Canadian Press News Fellowship.

 

Virginie Ann, The Canadian Press

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Montreal public health investigating after man dies from legionnaires’ disease

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Montreal public health officials say they are investigating a deadly case of legionnaires’ disease in the city’s east end to see if it is linked to two other cases detected in the area.

The city’s public health department said today that the investigation will target water cooling towers in the area.

The victim was only identified as a man.

Last year, two people died after an outbreak of legionnaires’ disease in an adjacent area.

The public health department says 27 cases of legionnaires’ disease, which is caused by bacteria, have been detected in the city so far this year, and that 52 cases were detected last year.

The disease can cause fever, cough, shortness of breath and aches and pains, and it can be fatal in roughly 10 to 15 per cent of cases.

This report by The Canadian Press was first published Aug. 10, 2022.

 

The Canadian Press

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Quebec public health wants smelter’s arsenic emissions cut to 5 times provincial norm

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MONTREAL — Quebec’s public health director is recommending that arsenic levels in the air of a western Quebec city be reduced significantly, but even then they would remain five times higher than the provincial standard.

Dr. Luc Boileau told reporters in Rouyn-Noranda Wednesday that average emissions of 15 nanograms of arsenic per cubic metre of air would be a safe level for people in the city until air quality is “eventually” improved to the provincial standard of three nanograms of arsenic per cubic metre.

“We have to obtain, eventually, the level that is required by the Quebec norms,” he said.

However, in the meantime, he said the 15-nanogram level would allow for “strong protection for the health of unborn babies and young children” and would reduce the risk of lung cancer for the entire population.

The city, more than 600 kilometres northwest of Montreal, is home to the Horne copper smelter, which is currently allowed to emit 100 nanograms of arsenic per cubic metre of air — 33 times the provincial standard. That agreement, which must be renewed every five years, is currently under review by the province.

Boileau said the 15-nanogram cap is his formal recommendation to the provincial government on the smelter’s emissions. He said the new cap should be reached “as soon as possible,” but he did not provide a deadline for when he hopes it will be reached — or when the smelter’s emissions will reach the provincial norm.

The changes required are complex, he said, and “it might take a long time, so maybe a couple of years.”

Quebec Environment Minister Benoit Charette said he will consider Boileau’s recommendations and the emissions cap he plans to place on the smelter will be “much more stringent” than the current level.

“We don’t want to compromise the health of the public, so if public health is talking to us about 15 nanograms, we can’t not consider that advice,” he said.

Glencore, the multinational mining company that owns the smelter, said in a statement after Boileau’s news conference that it was aware of the recommendations.

“We will be unveiling our comprehensive action plan in the coming days, which we hope will address the concerns raised to date, while contributing to the sustainable development of our community,” said Alexis Segal, a spokesman for Glencore Canada.

Studies by Quebec’s public health institute have shown that residents of the city have higher lung cancer rates than people in the rest of the province and predicted that if the concentration of arsenic in the foundry’s emissions isn’t reduced, between one and 14 additional residents will develop lung cancer by 2040.

The new recommendation would result in a fourfold reduction in the risk of lung cancer among people living in the area around the smelter, “a level considered acceptable in similar North American settings,” the institute said Wednesday.

Dr. Frédéric Bonin, a physician who practises in Rouyn-Noranda, said the new recommended level is “a step in the right direction, but it is very insufficient.” He wants the provincial government to apply the three-nanogram standard.

“We have made bad decisions over the last 40 years, the population of Rouyn-Noranda has paid the price and it should not continue to pay the price for bad political decisions,” he said in an interview.

The smelter, which has been in operation since 1927, employs around 650 people.

This report by The Canadian Press was first published Aug. 10, 2022.

 

Stéphane Blais, The Canadian Press

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