The UK has approved the world’s first COVID antiviral pill that can be taken at home, in a landmark move that could significantly reduce deaths and hospitalisations from the disease.
Molnupiravir is produced by US pharmaceutical company Merck and Ridgeback Biotherapeutics and was approved by the Medicines and Healthcare products Regulatory Agency (MHRA) on Wednesday.
Merck has said the drug will remain royalty-free so long as the World Health Organization classifies the pandemic as a “Public Health Emergency of International Concern”.
Here’s what we know about the “game-changing” drug:
What is it?
Molnupiravir has been designed for people who have had a positive COVID test and are at risk from the disease.
It is the first anti-viral pill for COVID-19 that can be taken at home to be approved in the world.
All other drugs for COVID-19 can only be administered in hospitals and most are by injection or infusion.
Watch: Merck’s COVID Pill Approved by UK Health Authority
It prevents the virus from multiplying, keeping levels low in the body and therefore reducing the severity of the disease.
The treatment involves taking two rounds of four pills twice a day for five days.
The aim is to get it prescribed to the at-risk person as soon as possible to prevent them from developing the severe disease and keep them out of hospital.
It will be branded as Lagevrio in the UK.
How effective is it?
Results from a study by Merck showed the drug reduced hospitalisations and deaths in a population of patients at risk of more severe outcomes by around 50% (from 14.1% to 7.3%).
No patient who took the drug died from the virus.
The results from the study haven’t yet been peer-reviewed or published in a scientific journal.
Who can take it?
Anyone over the age of 18 can take it but it is for people who are most. at risk from COVID such as those who suffer from obesity, diabetes, heart disease, or are over the age of 60.
When will it be available?
The Government announced last month that it had secured 480,000 courses of molnupiravir and will be rolled out within days.
Are there any side effects?
The final stage three trial of the drug found no serious side effects from the drug. No deaths were reported among molnupiravir recipients compared to 8 (2.1%) in placebo recipients
The most common minor side effects were headache and diarrhoea.
What has been the reaction?
Health and Social Care Secretary, Sajid Javid, said: “Today is a historic day for our country, as the UK is now the first country in the world to approve an anti-viral that can be taken at home for COVID-19.
“This will be a gamechanger for the most vulnerable and the immunosuppressed, who will soon be able to receive the ground-breaking treatment.
“We are working at pace across the Government and with the NHS to set out plans to deploy molnupiravir to patients through a national study as soon as possible.”
Watch: How the world could be better after COVID
Professor Penny Ward, an independent pharmaceutical physician, welcomed the approval, but said the NHS needed to outline its plans for rollout and cautioned that supplies were likely to be tight given the strong global demand.
“Comments made by Mr Javid today suggest that it may be made available via a clinical trial, presumably to investigate its effectiveness in vaccinated patients with breakthrough infections, as the original study incorporated unvaccinated adults,” she said.
If given to everyone becoming unwell, the nearly half a million courses would not last very long given the more than 40,000 current daily case rate, she said.
What do the experts say?
Dr June Raine, MHRA chief executive, said: “Following a rigorous review of the data by our expert scientists and clinicians, we are satisfied that Lagevrio (molnupiravir) is safe and effective for those at risk of developing severe COVID-19 disease and have granted its approval.
“Lagevrio is another therapeutic to add to our armoury against COVID-19.
“It is also the world’s first approved anti-viral for this disease that can be taken by mouth rather than administered intravenously.
She added: “With no compromises on quality, safety and effectiveness, the public can trust that the MHRA has conducted a robust and thorough assessment of the data.”
Robert Davis, chief executive officer of Merck Sharp & Dohme (MSD), said: “The first global authorisation of molnupiravir is a major achievement in MSD’s singular legacy of bringing forward breakthrough medicines and vaccines to address the world’s greatest health challenges.
“In pursuit of MSD’s unwavering mission to save and improve lives, we will continue to move with both rigor and urgency to bring molnupiravir to patients around the world as quickly as possible.”
What you need to know about COVID-19 in Ottawa on Wednesday, Dec. 8 – CBC.ca
What’s the latest?
Ottawa Public Health (OPH) reported 74 more COVID-19 cases on Wednesday — once again its most cases in a daily report since the end of September — and no deaths.
Pfizer and BioNTech are sharing preliminary findings that a three-shot course of their COVID-19 vaccine was able to neutralize the new omicron variant in a laboratory test, the first official statement from vaccine manufacturers on the likely efficacy of their shot against omicron.
Ontario Premier Doug Ford’s office tells CBC details of its holiday COVID-19 testing blitz are coming next week.
Ottawa Public Health moved vaccine appointments from the Rideauview Community Centre to the Nepean Sportsplex today because of what police say was a suspicious package in the area. The building was quickly reopened and vaccinations will resume there tomorrow.
How many cases are there?
As of Wednesday, Ottawa has had 32,475 confirmed cases of COVID-19.
There are 475 known active cases, while 31,382 cases are considered resolved and 618 people have died from the illness.
Public health officials have reported more than 61,200 COVID-19 cases across eastern Ontario and western Quebec, including more than 58,800 cases now resolved. Elsewhere in eastern Ontario, 235 people with COVID-19 have died. In western Quebec, the death toll is 223.
Akwesasne has had more than 1,150 residents test positive for COVID-19 and has reported 14 deaths between its northern and southern sections.
What are the rules?
The province’s vaccine passport is required for people age 12 and up in many public places. It won’t be required for younger kids. People can prove their vaccine status with a paper document, a PDF file or a QR code.
Private gathering limits are 25 people inside and 100 people outside.
Health officials say people should recommit to the fundamentals of getting vaccinated, testing and staying home when sick and limiting social contacts.
A vaccine passport is in place for most people age 13 and up in many public spaces. It won’t apply to younger kids. People can use an app or show paper proof.
Other groups in the region are also coming out with their own COVID-19 vaccine policies, including for staff and visitors.
What can I do?
This means it is important to take precautions such as staying home while sick — and getting help with costs if needed — keeping hands and surfaces clean and considering distancing from anyone you don’t live with.
Health Canada recommends older adults and people with underlying medical conditions get help with errands and have supplies in case they need to isolate.
Scientists are working to find out how easily the new omicron coronavirus variant spreads, its severity and the performance of vaccines against it.
Travellers more than 12 years and four months old must now be fully vaccinated to board a plane, train or marine vessel in Canada.
The U.S. requires everyone crossing a land, air or water border to be fully vaccinated. People flying there will need proof of a negative COVID test within a day of departure.
Canadian citizens and permanent residents no longer need proof of a test when returning from trips to the U.S. under 72 hours.
The hope is that other countries will accept provincial or territorial proof of vaccination.
People have to be fully vaccinated and pre-approved to enter Canada. Because of the omicron variant, air travellers from every country except the United States have to take a COVID-19 test upon arrival and isolate until they get results.
There are further travel restrictions from a number of African countries because of omicron.
Health Canada has approved Pfizer-BioNTech’s vaccine for children as young as five. Doses for kids age five to 11 will be given at least eight weeks apart in both local provinces.
Worried about the risk of myocarditis or pericarditis for your child? There have been zero reported cases of this after vaccination in those aged 5-11. For older teens and young adults, a COVID infection is much more likely to cause this condition than the vaccine is. <a href=”https://twitter.com/hashtag/VaxFacts?src=hash&ref_src=twsrc%5Etfw”>#VaxFacts</a> <a href=”https://t.co/8foyEC6FId”>pic.twitter.com/8foyEC6FId</a>
There have been more than 3.8 million COVID-19 first, second and third vaccine doses administered in the wider Ottawa-Gatineau region, which has about 2.3 million residents.
Ontario is vaccinating anyone born in 2016 and earlier.
People can look for provincial appointments online or over the phone at 1-833-943-3900.
Local health units have some flexibility, so check their websites for details. Many offer child-only clinics and doses on short notice as campaigns look to fill gaps in vaccine coverage and cover expanded eligibility.
Pharmacies and some family doctors offer vaccines through their own booking systems.
Clinics for children are in schools and kids will need written consent from a parent to be vaccinated there.
Siblings can be booked together in a single time slot and parents can check a box to signal if their child is nervous.
Symptoms and testing
“Long-haul” symptoms can last for months.
If you have severe symptoms, call 911.
In eastern Ontario:
Our <a href=”https://twitter.com/hashtag/COVID19?src=hash&ref_src=twsrc%5Etfw”>#COVID19</a> pop-up testing clinic has been extended to Dec. 10. Same hours 4:30 – 8:30 p.m. Located at Beechgrove Assessment Centre. Online booked appointments only – no phone bookings or walk-ins. <br><br>Book here: <a href=”https://t.co/6qy35nYz3z”>https://t.co/6qy35nYz3z</a> <a href=”https://t.co/o1FMnFvdr7″>pic.twitter.com/o1FMnFvdr7</a>
Rapid and take-home tests are available in some places, including pharmacies and some child-care settings when risk is high. A positive test will trigger a follow-up.
Travellers who need a test have local options to pay for one.
In western Quebec:
Tests are strongly recommended for people with symptoms and their contacts.
People can make an appointment or see if they’re near a walk-in option online. They can also call 1-877-644-4545 with questions during hours the line is running.
Gargle tests are offered in some places instead of a swab.
Rapid COVID-19 tests are available in all Quebec daycares, preschools and elementary schools. The province has asked the federal government for millions more tests and hopes they can eventually be given out for free.
First Nations, Inuit and Métis:
First Nations, Inuit and Métis people, or someone travelling to work in a remote Indigenous community, are eligible for a test in Ontario.
Akwesasne has COVID-19 test and vaccine clinics, with information online or at 613-575-2341.
Anyone in Tyendinaga who’s interested in a test can call 613-967-3603 and should watch the website for dedicated vaccine clinics.
Inuit in Ottawa can call the Akausivik Inuit Family Health Team at 613-740-0999 for service, including testing and vaccines, in Inuktitut or English on weekdays.
Kingston MOH says COVID-19 vaccines keeping region from locking down – Globalnews.ca
As COVID-19 cases continue to rise in the region, KFL&A Public Health’s medical officer of health joined Tuesday night’s city council meeting to give an update to the region.
At this point, he says lockdown measures are not on the horizon for the area.
“Our two main goals of pandemic response in the KFL&A region is to keep schools and workplaces open and maintain health-care capacity,” Dr. Piotr Oglaza told council.
But, with the Kingston region reaching record-high COVID-19 rates, and the news of Kingston hospitals having to offload some patients due to high COVID-19 hospitalizations, many members of the community are wondering if further restrictions to curb the spread of the virus will follow.
Oglaza has long maintained that lockdown measures that worked before just won’t pass muster in the fourth wave. He says the major difference this time around is the region’s high vaccination rate. As of Tuesday, more than 82 per cent of the five and up population have two doses.
“Some of these broad measures that were saving us in the previous waves are not applicable to a situation where vast majority of the population are immunized and are also not going to address the patterns of spread that we see,” he said.
Oglaza maintains that the driving factor for the spread of the virus is household gatherings, which now account for more than half of local transmission of COVID-19.
Community reacts as COVID-19 cases rise in the Kingston region
And while there are vaccinated individuals contracting the virus, Oglaza says, for the most part, those testing positive for COVID-19 are unvaccinated.
What’s keeping the region from lockdown measures is science, Oglaza said, which has proven that vaccines work in protecting people from serious illness. He said those who are fully vaccinated are at far less risk of getting sick and transmitting the virus to others.
“We have not seen a significant burden of infection and transmission coming from places where proof of vaccination is in effect,” he said.
But, despite recent moves from the health unit to limit private gatherings to 10 people and add extra screening at schools, the region is seeing unprecedented numbers.
KFL&A is currently third in the province in active cases per 100,000, behind only the Algoma and Sudbury health unit regions.
Councillors Ryan Boehme and Wayne Hill pressed the doctor on restrictions, asking if more should be done, but Oglaza maintained that widespread community lockdowns will do more harm than good.
“Are there other restrictions coming or are we basically talking about cancelling Christmas this year,” Boehme asked.
Oglaza said implementing a total lockdown like seen before, is not an option.
“Probably one of the most successful ways of of of stopping the chain of transmission is something that I don’t believe that anyone in this community is is is willing to accept. And we’ve seen that before. We’ve seen a stay at home order,” he said.
He said these orders adversely impact the most vulnerable populations in the region, and that many people with good jobs able to do remote work will still be able to work under stay-at-home orders.
“Others who rely on that in-person work cannot be working from home and they’re not going to be able to to really do well under these circumstances. They are disproportionately bearing the consequences of some of these very harsh measures,” he said.
He said any further restrictions would be tailored to target symptomatic people attending gatherings.
COVID-19: Ontario’s top doctor calls modelling projections, ICU admissions ‘disconcerting’
“In the vast majority of all of these circumstances, there is a symptomatic person present in that social setting, that gathering, whether it’s an outbreak setting, workplace, school or household, the spread comes from an infected individual being present,” he said.
He said more information on masking and screening protocols will come in the next couple of days. But for now, the medical officer of health told those who are vaccinated to have faith in the protection associated with the vaccine, and urged those who are not to get their shots.
“Vaccines do work. They do show effectiveness and they do change the situation in this fourth wave compared to everything we’ve experienced so far,” he said.
“It is because of the vaccines that we can keep the workplaces and schools open.“
Oglaza will be holding a press conference at 1:30 p.m. Wednesday to answer further questions.
© 2021 Global News, a division of Corus Entertainment Inc.
Young adults with prior self-harm and eating disorders report mental health issues during the pandemic – News-Medical.Net
Young adults with previous self-harm or eating disorders reported higher levels of depression and anxiety during the pandemic, even when restrictions had eased, according to new research.
The study, led by the University of Bristol and funded by Elizabeth Blackwell Institute, Medical Research Council and Medical Research Foundation, has been published in the Journal of Eating Disorders. It looked at questionnaire information for 2,657 individuals from world-renowned health study Children of the 90s (also known as the Avon Longitudinal Study of Parents and Children) before and during the COVID-19 pandemic.
Researchers analyzed the relationship between previous reports of eating disorder symptoms and self-harm before the pandemic, and mental health problems (symptoms of depression and anxiety) and mental wellbeing during the COVID-19 pandemic. The study also assessed whether lifestyle changes, such as more sleep, relaxation techniques, or visiting green space, could be linked to mental health and wellbeing in young adults with and without previous eating disorder symptoms or self-harm.
Researchers studied questionnaire data from 2017, when the participants were then aged 25 years, as well as data taken during the pandemic in 2020.
At age 25, 32% of the 2,657 young adults reported at least one eating disorder symptom, 9% reported self-harm, and 5.5% reported both an eating disorder symptom and self-harm in the last year.
During the pandemic, those with previously reported eating disorder symptoms and/or self-harm had more symptoms of depression and anxiety, and worse mental wellbeing, compared to individuals without previous symptoms. This remained the case after adjusting for their pre-pandemic levels of depression, anxiety and mental wellbeing.
Lifestyle changes appeared to have little effect on the increased risk for mental health problems in those with prior eating disorder symptoms or self-harm.
Eating disorders and self-harm are common and troubling mental health problems among young adults. In the UK, approximately 1.25 million people are living with an eating disorder and almost 1 in 15 adults report self-harm.
Our research has highlighted individuals with prior self-harm and eating disorder symptoms are key risk groups and further longitudinal research is needed to understand their ongoing mental health as well as risk and protective factors.
Individuals with previous eating disorder symptoms and self-harm should be considered vulnerable to depression and anxiety throughout the pandemic and beyond. Funding for rapid and responsive service provision is essential to reduce the impact of the pandemic on those with mental health problems.”
Dr Naomi Warne, Lead Author, Senior Research Associate, Centre for Academic Mental Health, University of Bristol
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