Alberta is expanding access for the cystic fibrosis drug Trikafta to children between six and 11 years old.
Since last September, the province has provided coverage for the drug to Albertans who are 12 and older.
At a Monday news conference, Alberta Health Minister Jason Copping said access to the drug for young children with cystic fibrosis (CF) will improve their quality of life.
“This change means younger children can now benefit from treatment from this highly effective prescription drug and achieve the same improved health outcomes that others are experiencing,” said Copping.
Health Canada approved the use of Trikafta to treat children between six and 11 on April 19. On July 6, the Canadian Agency for Drugs and Technologies in Health recommended the drug for listing.
CF is a genetic disease that causes mucus to build up in the lungs, digestive tract and other parts of the body.
Other provinces such as Ontario have also made the move to expand coverage of Trikafta for the six to 11 age group.
‘Truly life-changing’ medication
Sharon Stepaniuk, an advocate for people living with CF and mother to two children with the disease, said she’s grateful for the government’s decision to expand access.
“This announcement today that allows children to start treatment earlier than ever before will open up a world of possibility for them,” Stepaniuk said at Monday’s news conference.
Stepaniuk said starting the drug treatment early in life will prevent substantial, permanent damage to the lungs and allow young people with CF to live “longer, healthier and fuller lives.”
Amanda Bartels, a CF patient and advocate, said she’s been using Trikafta for just over two years.
Before Trikafta, Bartels was admitted to the hospital with lung infections about three to four times a year. She was given compassionate access to the drug in June 2020 as she was one of the sickest CF patients in the country, Bartels said at the news conference.
“I am so grateful that I was given this life-saving medication and that I was able to help show our government how truly life-changing this medication is,” she said.
Bartels was on the road to getting a double lung transplant, but plans for that surgery have been halted indefinitely since Bartels started using Trikafta.
“I’m blessed to be turning 40 with my original lungs, healthier than I have been in years, which has brought both joy and relief to my family.”
Delivering new services ‘complicated,’ Freeland says of planned dental care program
OTTAWA — The government is working hard to meet its end-of-year deadline to deliver dental-care coverage to kids, the deputy prime minister said Tuesday, but added providing new services is “complicated.”
The Liberals agreed to offer dental coverage to low- and middle-income children by the end of the year as part of their confidence and supply deal with the New Democrats to keep the minority government from toppling before 2025.
Several groups have raised concerns about the very tight deadline, and four sources close to the program say the government is working on a temporary solution to give money directly to qualifying families while it comes up with a permanent program.
“As we experienced, for example, in rolling out child-care agreements across the country, delivering new services to Canadians is complicated,” Freeland said when asked about the stopgap plan at a news conference in Toronto.
“I think Canadians understand that.”
Freeland did not confirm or deny the government’s immediate plans but said the Liberals are committed to the dental-care program, and it’s a commitment she’s “happy to make.”
The government could pursue dental-care deals that resemble the ones it made with provinces to lower the cost of child care, in which it offered provincial governments money to administer their programs under a prescribed set of criteria. However, that route is looking increasingly unlikely.
Federal officials have also canvassed dental-health experts about other approaches. The government could contract out a national program to a private insurance firm or have federal public servants take on the work.
“Kids should not have their teeth get rotten just because their parents don’t have enough money to pay for them to go see a dentist, I think it’s as simple as that,” Freeland said.
The Liberals set aside $5.3 billion over five years to fully implement the program. They hope to start with children under the age of 12 with an annual household income of less than $90,000.
Last week NDP Leader Jagmeet Singh said he was confident the dental-care program would come together by the end of the year, as outlined in the agreement with the Liberals.
Freeland said the government is working “very, very hard” to make good on the promise to the NDP. The Liberals risk the NDP walking away from the supply and confidence agreement entirely if they don’t.
This report by The Canadian Press was first published Aug. 9, 2022.
Laura Osman, The Canadian Press
Top commander defends military’s vaccine requirement, says ‘tweak’ in the works
OTTAWA — Canada’s top military commander said he will “tweak” the vaccine mandate for the Armed Forces in the next few weeks but defended vaccine requirements as necessary to keep the military ready to respond to any emergency.
“This is an institution that’s unlike any other because we do have to be operationally ready, we are the nation’s insurance policy,” chief of the defence staff Gen. Wayne Eyre told The Canadian Press in an interview.
“We have to go into dangerous locations and close confined quarters, we have to deploy overseas, where there’s potentially an increased threat with the pandemic. We also don’t know the trajectory of this pandemic, where it’s going to go into the future.”
When Eyre ordered all troops vaccinated against COVID-19 last October, he said it was to both protect the force and “demonstrate leadership” as the Liberal government adopted vaccine mandates across the federal public service.
The public service vaccine mandate was suspended in June but the military one persists, a fact that has heightened criticism of the military’s policy.
The Department of National Defence said more than 98 per cent of Canadian troops complied with the order. Defence Minister Anita Anand was briefed in June that 1,137 remained unvaccinated.
Those who refuse vaccination face the risk of forced removal from the military. The department says 241 unvaccinated troops have been ousted with disciplinary measures initiated against hundreds more.
Eyre said he is trying to find the “sweet spot” between the military’s medical, legal, operational and ethical requirements.
“We need to maintain our operational viability going forward,” he said. “So over the course of the next number of weeks, we will tweak the policy, we’ll put out something amended. But we also need to realize that this is a dynamic environment, and things can change, the trajectory of the pandemic can change. So we’ve got to maintain that flexibility as well.”
He added that not only has the military been called upon to assist in communities across Canada that have been hit by the pandemic, but that vaccine requirements still exist in many allied and foreign nations and militaries.
The U.S. military still requires all troops to be vaccinated as do some NATO facilities and bases.
“There are going to be operational requirements where to operate with allies, (vaccination) is going to be essential,” he said. “But as we go forward, the options are being developed looking at those four factors that I talked about and finding the right balance.”
Eyre’s comments appear to contradict a draft copy of a revised vaccine policy obtained by the Ottawa Citizen last month, which suggested vaccine requirements for military personnel would be lifted.
The draft document, which officials say has not been approved by Eyre, said military personnel as well as new recruits would no longer have to attest to their vaccination status.
The document also noted potential legal difficulties ahead to deal with people who were kicked out of the military because of the vaccine mandate, suggesting they could be forced to apply for re-enrolment.
By contrast, other unvaccinated federal public servants were put on leave without pay but allowed to return to their jobs when the mandate was suspended.
The military mandate was unsuccessfully challenged several times in Federal Court, most recently last month.
Phillip Millar, the London, Ont.-based lawyer who appeared before the court to seek an injunction on behalf of unvaccinated service members, said the court ultimately decided it couldn’t rule on the issue until the new policy was released.
Millar, who is also representing James Topp, an army reservist charged with publicly speaking out against federal vaccine mandates while wearing his uniform, said he was disappointed with the decision given the lack of timeline for the new policy.
“The military is deliberately dragging its feet on this new direction because it just wants to kick people out,” Millar alleged, adding: “It’s obviously a political policy, not an operational policy.”
Eyre would not say whether Armed Forces members are still being kicked out, or whether such releases have been suspended pending the results of his review.
The Defence Department says there have been more than 9,500 cases of COVID-19 among military personnel, including 113 active cases as of Aug. 1. It did not say whether there have been any deaths associated with the illness.
This report by The Canadian Press was first published Aug. 9, 2022.
Lee Berthiaume, The Canadian Press
Double mRNA COVID-19 vaccination found to increase SARS-CoV-2 variant recognition – News-Medical.Net
In a recent study posted to the bioRxiv* preprint server, researchers evaluated the impact of double BNT162b2 messenger ribonucleic acid (mRNA) vaccination in recognition of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variants of concern (VoCs).
Studies have reported that double coronavirus disease 2019 (COVID-19) vaccinations generate high titers of SARS-CoV-2 S-targeted antibodies (Ab), Bmem and T lymphocytes; however, VoCs with SARS-CoV-2 S receptor-binding domain (RBD) mutations can evade humoral immune responses.
Booster doses have been reported to enhance VoC recognition by Abs; however, it is not clear whether VoC recognition is enhanced due to higher Ab titers or due to the increased capacity of Ab binding to S RBDs.
About the study
In the present study, researchers evaluated the benefit of double BNT162b2 vaccinations on SARS-CoV-2 VoC recognition.
Healthy and SARS-CoV-2- naïve persons (n=30) without immunological or hematological diseases were enrolled in the study to assess their peripheral blood B-lymphocyte subsets between February and June 2021. Samples were obtained before the BNT162b2 vaccination, after three weeks of the first vaccination, and four weeks following the second vaccination.
Serum memory B lymphocytes (Bmem) counts and Ab titers were assessed using recombinant SARS-CoV-2 spike (S) protein RBDs of the Wuhan, Gamma, and Delta strains. Neutralizing Ab (NAb) titers were evaluated using 293T-ACE2 cells and SARS-CoV-2 pseudotyped viral assays. Further, the nature of RBD-targeted Bmem was examined based on the expression of cluster of differentiation (CD) 21, 27, and 71.
Enzyme-linked immunosorbent assays (ELISA) were performed to evaluate variant-specific S RBD antibody titers and the serum dilution needed for preventing 50% SARS-CoV-2 entry (ID50) values were ascertained. Flow cytometry (FC) was performed to evaluate Bmem counts. Immunoglobulin G (IgG) titers against SARS-CoV-2 nucleocapsid (N) protein RBD and S RBD were evaluated before and post the first and second BNT162b2 vaccination.
In total, 28, 30, and 30 samples were obtained pre-vaccination, after three weeks of the first dose and after four weeks of the second dose, respectively. All the participants remained SARS-CoV-2-naïve throughout the study without anti-SARS-CoV-2 N antibodies. Most participants (n=22) induced NAbs after the first vaccination, and the NAb titers after the second vaccination had IC50 values >100.
Double BNT162b2 vaccination generated robust NAb responses among all study participants. Immunoglobulin G+ (IgG+) and IgM+ RBD-targeted Bmem were generated after the first vaccination, and IgG1+ Bmem counts increased after the second vaccination. Most RBD-targeted Bmem showed binding with Delta and/or Gamma VoCs, which increased significantly after the second vaccination.
The RBD-targeted Bmem compartment comprised mainly IgG1+ or IgM+ cells, and contrastingly, the total Bmem compartment comprised more IgG2+ cells and fewer IgG1+ cells compared to the RBD-targeted Bmem compartment.
After the second vaccination dose, RBD-targeted IgG1, 2 and 3-expressing Bmem populations expanded significantly, although the total Bmem lymphocyte compartment was unaltered.
The number of RBD-targeted IgG+ Bmem correlated positively with RBD-targeted serum IgG post first and second vaccinations. While two subsets of IgM+ Bmem lymphocytes (CD27+ IgM+ and CD27+ IgM+ IgD+) proportionally decreased after the second vaccination dose, the absolute cell counts were identical to those observed post the first vaccine dose. Taken together, BNT162b2 vaccinations particularly affected the antigen-targeted Bmem lymphocyte counts, and the production of IgG1-expressing Bmem lymphocytes was boosted after the second BNT162b2 vaccination.
CD27 was expressed by 95% of anti-RBD and IgG-expressing Bmem lymphocytes, the proportion of which did not differ between the initial and subsequent BNT162b2 vaccination. After the first vaccine dose, 15% of anti-RBD Bmem lymphocytes were CD21lo, the proportion of which was marginally but significantly lower (reduced to 10%) after four weeks of the second vaccination.
CD71 was expressed by 10% of anti-RBD Bmem lymphocytes after the first and second vaccination. In the total population of Bmem lymphocytes, the results after the first and second vaccination did not differ significantly, denoting the Bmem compartment stability. After four weeks of vaccination, anti-RBD Bmem lymphocytes exhibited a nature and resting Bmem lymphocyte immunophenotype.
Anti-Wuhan S RBD- IgG titers exhibited partial recognition of the Beta, Gamma and Delta VoCs with more prominent reductions for Gamma and Beta VoCs than for the Delta VoC. The second vaccine BNT162b2 dose significantly enhanced anti-Wuhan RBD antibody binding to Gamma and Beta VoCs; however, the neutralization potency of vaccine-induced NAbs against Gamma and Beta was lesser than for Delta.
Delta RBD and Gamma RBD were recognized by 50% and 70% of RBD-targeted Bmem lymphocytes after the first and second vaccinations, respectively, and the increase in VoC-recognizing Bmem counts was largely due to elevated IgG1+ Bmem counts.
Overall, the study findings showed that the second BNT162b2 vaccination elevated NAb titers and SARS-CoV-2 RBD-targeted Bmem counts and that double BNT162b2 vaccination was especially needed for Delta and Gamma VoC recognition. The findings indicated that the second vaccine dose improved S RBD-targeted Bmem counts and the Bmem affinity to overcome VoC mutations.
bioRxiv publishes preliminary scientific reports that are not peer-reviewed and, therefore, should not be regarded as conclusive, guide clinical practice/health-related behavior, or treated as established information.
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