Britain’s National Health Service (NHS) announced an agreement with pharmaceutical giant Novartis (NYSE: NVS) to help accelerate the review process for its heart drug inclisiran. The agreement would see inclisiran provided to patients who are at high risk of cardiovascular incidents (heart attacks and strokes) once a separate U.K.-based clinical trial yields its results.
The drug has already been submitted for approval from U.S. regulators back in 2019 and is currently pending approval. Inclisiran goes after a specific protein called PCSK9, which plays a role in producing LDL cholesterol (also known as the “bad” cholesterol) and is intended to be used alongside conventional cholesterol-lowering medications such as statins.
Image source: Getty Images.
Heart disease is the leading cause of death in the U.K., causing twice as many deaths in comparison to the second biggest killer, lung cancer. However, the overall number of deaths in the U.K. has fallen by almost 50% over the past decade, although national healthcare agencies are far from satisfied with leaving it at that.
What this means for Novartis
Novartis is expecting that future sales for its drug will shoot up significantly thanks to this deal. The company ended up buying the rights for inclisiran for $9.7 billion back in 2019 and expects the drug to be a major blockbuster in the years to come.
If inclisiran ends up winning approval from U.K. health regulators, the deal also stipulates that the NHS will subsidize the price of the drug and offer it as an add-on therapy for patients that don’t respond well to statins. While an official price wasn’t agreed upon, inclisiran is intended to be competitively priced alongside competitor drugs such as Sanofi’s Praluent and Amgen’s Repatha.
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Toronto police officers who ignore COVID-19 vaccinate mandate policy will be put on unpaid leave – CBC.ca
Toronto police officers who aren’t fully vaccinated or haven’t disclosed their COVID-19 vaccination status by Nov. 30 will be put on indefinite unpaid leave, the service says.
Any such member, uniformed or not, will not be allowed to enter buildings until they comply with the mandatory vaccine and disclosure policy.
Those members will also not be eligible for promotions to supervisory or management positions, the service said in a news release Thursday.
“Vaccination against COVID-19 protects the health and safety of each of our members, our workplaces and the public we serve,” said Chief James Ramer.
Consistent communication needed for kids COVID-19 vaccine rollout: experts – Delta-Optimist
Kelly Grindrod remembers the confusion pharmacists felt last spring as Canada’s COVID-19 vaccine policy changed rapidly throughout the rollout, sometimes with little warning.
Shifting eligibility requirements differed across the country, booking sites were harder to navigate in some regions, and one vaccine product came to be seen as inferior to the rest, infuriating the public and vaccinators alike.
Grindrod, an associate professor at the University of Waterloo and the pharmacy lead for Waterloo Region’s vaccine rollout, hopes provinces learned lessons from Canada’s first vaccination campaign for adults.
And if a COVID-19 vaccine is soon approved for children, she said a kid’s rollout needs consistent and clear messaging.
“Communication was a real challenge,” Grindrod recalled. “(Policy) would be announced nationally and everybody on the ground had to scramble because we were all hearing it at the same time.
“Immediately the phones would go crazy in pharmacies because people were trying to make sense of it…. We need a bit more lead-in, a bit more clarity, so (vaccinators) have answers before people start calling.”
Pfizer-BioNTech asked Health Canada to authorize its COVID-19 vaccine for kids aged five-to-11 this week. The regulator is reviewing data before making a decision.
Prime Minister Justin Trudeau said Thursday that Pfizer is ready to ship millions of child doses in the event of authorization, while Public Services and Procurement Minister Anita Anand added that Canada has already procured syringes and other supplies needed to speed up the rollout.
In the United States,an advisory group with the Food and Drug Administration, which received an approval request from Pfizer earlier this month, is scheduled to meet next week. The Centers for Disease Control and Prevention is then set to discuss authorization in early November.
Grindrod said U.S. regulators, which sometimes stream meetings online, have shown “more transparency around the (decision-making) process.”
Health Canada and the National Advisory Committee on Immunization supply “fairly comprehensive” documents after they’ve made decisions, she said, but vaccinators could use a heads up “to facilitate planning.”
Logistics of the kids rollout — where children get a vaccine, how they book appointments and whether certain kids will be prioritized — are still to be determined. Ontario said Tuesday it was open to running mass vaccine clinics at schools after school hours.
Omar Khan, an immunology and infectious disease expert with the University of Toronto, said school clinics are a great way to reach more kids. Pharmacies and family doctors can also help, but proper scheduling — which includes flexibility around parents’ work hours — is needed to ensure half-empty vaccine vials aren’t tossed at the end of the day.
“Anything that reduces accessibility barriers will help distribute (vaccines) to the queue of people waiting to get vaccinated across multiple sites,” he said.
Most logistics can be ironed out once supply is determined, Grindrod said.
Pfizer’s pediatric vaccine involves a different formulation, but Grindrod said some pharmacists have asked whether they must wait for kid-specific shipments or if a diluted adult dose could serve if supply was scarce. She urged clear information as soon as possible.
Messaging around the kids vaccine in general has to be handled with more care, she said,starting with whatever NACI and Health Canada recommend after reviewing its safety and efficacy.
“We need very careful communication … because we haven’t seen the data,” she said. “There are questions that need to be answered very clearly — what is the risk of COVID to kids at the point at which vaccines become available? What are the known side effects we expect to see based on data from trials?
“And then separately, what are the unknowns?”
Science communicator Samantha Yammine noted the difficulty in maintaining consistent vaccine advice when the science on COVID-19 evolved quickly throughout the pandemic.
Policies introduced midway through the adult rollout, such as NACI’s recommendation against using AstraZeneca for second doses, seemed to contradict earlier advice. But public health messaging constantly adapts to new data, she said.
While communication was confusing at times, the country still vaccinated nearly 82 per cent of its eligible population to date.
Since parents are likely more concerned about vaccinating children than getting the jab themselves, fears should be addressed honestly and parents made to feel part of the plan, Yammine said.
That includes equipping parents with child-friendly information they may need to field youngsters’ questions about the vaccine, she added.
And kids’ comprehension level shouldn’t be underestimated.
“I’m advising people to acknowledge how great a job kids have done,” Yammine said. “Wearing masks, understanding why they have to play with friends outside, it’s been really hard on kids.
“But they’ve shown us they can be involved and they can understand complex things.”
This report by The Canadian Press was first published Oct. 21, 2021.
Melissa Couto Zuber, The Canadian Press
Get the flu shot: Public Health – Quinte News
Local public health officials says getting the flu shot this year is especially important to reduce the risk of illness during the COVID-19 pandemic.
Since many people are vulnerable to serious risks related to the flu, officials say everyone can help reduce the spread by getting vaccinated.
In a release, Hastings Prince Edward Public Health points out that it’s safe to get the flu vaccine at the same time as, or any time before or after the COVID-19 vaccine.
They point out influenza can be a serious disease and can lead to pneumonia or organ failure.
Statement from Hastings Prince Edward Public Health:
Getting the flu vaccine is especially important this year, to reduce your risk of illness during the COVID-19 pandemic. As many people are vulnerable to serious risks related to the flu, everyone can help reduce the spread by getting vaccinated. Your choice to get vaccinated will also help ensure critical health care resources are available to those who need them most. It’s safe to get the flu vaccine at the same time as, or any time before or after the COVID-19 vaccine, so do not delay – protect yourself with these important vaccines today!
Influenza is not caused by the viruses that cause COVID-19 or a cold. It can be a serious disease that causes some individuals to be in bed for a week or longer. It can also lead to complications such as pneumonia or organ failure. Vaccinated individuals are less likely to have severe complications and end up in the hospital – which will help ensure health care resources are available to those who need them most.
This year, residents are encouraged to seek their flu vaccination as soon as possible through their health care provider or a pharmacy. As public health resources continue to be redeployed to the COVID-19 pandemic, HPEPH is not able to offer community flu clinics to the general public this year. However, flu vaccination remains the best way to protect yourself and those you love from serious illness and complications. Getting your flu vaccine early is the best way to protect yourself from the flu, as it can take up to two weeks to build immunity. The vaccine is available to individuals over 2 years of age at local pharmacies, and everyone over 6 months of age can receive the flu vaccination from their health care provider. HPEPH is considering the feasibility of offering small flu vaccination clinics to populations who are unable to receive the vaccine through these avenues, but any such clinics are dependant on the rollout of COVID-19 vaccination and local case rates, as resources continue to be required for COVID-19 case and contact management.
“You got your COVID-19 vaccine – now it’s time to protect yourself, and those you love, from the flu,” says Dr. Ethan Toumishey, Acting Medical Officer of Health at HPEPH. “The COVID-19 vaccine has shown us how important and effective vaccines can be at reducing the severity of illness. While the COVID-19 vaccine reduces your risk of complications from COVID-19, it won’t protect you from the flu.”
To reduce the spread of illness in the community, all residents should continue public health precautions. The same measures that are helping control the spread of COVID-19 will help reduce the spread of seasonal influenza. If you have symptoms of the flu, stay home and follow testing guidance for COVID-19. Even if you are vaccinated against both the flu and COVID-19, you can still get a mild case of these illnesses and spread them to others. The same public health precautions that prevent the spread of COVID-19, will prevent the spread of the flu.
- Stay home when you are sick
- Get tested for COVID-19 (if advised by screening)
- Wash your hands often
- Cover your cough and sneeze
- Clean frequently touched surfaces often
- Get vaccinated.
For more information, visit https://www.ontario.ca/page/flu-facts
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