COVID-19 'Pandemic'

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U.S. FDA flags risk of heart inflammation after Novavax COVID vaccine
Author of the article:Reuters
Reuters
Manas Mishra and Mrinalika Roy
Publishing date:Jun 03, 2022 • 12 hours ago • 2 minute read • Join the conversation

The U.S. Food and Drug Administration has raised concerns about a possible risk of heart inflammation from Novavax Inc’s COVID-19 vaccine, even as the company’s data showed it could reduce the chances of mild-to-severe disease.


In Novavax’s nearly 30,000 patient trial, conducted between December 2020 and September 2021, there were four cases of a type of heart inflammation called myocarditis detected within 20 days of taking the protein-based shot.

“These events raise the concern for a causal association with this vaccine, similar to the association documented with mRNA COVID-19 vaccines,” FDA staff wrote in briefing documents released on Friday.

Shares of the company fell nearly 14% after the FDA’s analysis of data from the company’s trial.

The agency said it had requested Novavax to flag myocarditis and another kind of heart inflammation called pericarditis as an “important identified risk” in its materials. The company has not yet agreed to do so.


Novavax, in response to the safety concerns flagged by the FDA, said natural background events of myocarditis can be expected in any sufficiently large database.

“Based on our interpretation of all the clinical data supporting NVX-CoV2373 … we believe there is insufficient evidence to establish a causal relationship,” the company said in a statement.

One patient in the trial reported myocarditis after receiving placebo.

Novavax has said the shot, NVX-CoV2373, will play a role in driving vaccination among those who have been hesitant to get immunized and it has started an educational effort on vaccine choices.

“Despite the wide availability of authorized or approved vaccines, the SARS-CoV-2 pandemic is not well controlled in the U.S. … there remains a desire for vaccines that have been developed using well-understood technology platforms,” it said.


The FDA analyzed data from Novavax’s trial before the Omicron and Delta variant became the dominant strains.

“Based on the efficacy estimate in the clinical trial of this vaccine, it is more likely than not that the vaccine will provide some meaningful level of protection against COVID-19 due to Omicron, in particular against more severe disease,” the FDA staff said.

The vaccine showed an efficacy of 90.4% in Novavax’s study, which enrolled adults across the United States and Mexico.

The FDA’s comments came in a briefing note initially prepared ahead of a May 7 meeting of the agency’s outside advisers.

Its staff comments will be used by those advisers to guide their decision on whether or not to recommend authorizing the vaccine on Tuesday. The FDA is not mandated to follow the advise of its outside experts, but usually does.
 

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Tory MP who won't disclose vaccine status asked to leave House of Commons precinct
Author of the article:Canadian Press
Canadian Press
Publishing date:Jun 03, 2022 • 1 day ago • 1 minute read • 16 Comments

OTTAWA — A Conservative MP who refuses to disclose her vaccination status tried to access the House of Commons precinct after a COVID-19 vaccination mandate was imposed last year and was required to leave.


Cathay Wagantall, who represents the Yorkton-Melville riding in Saskatchewan, told a news conference on Parliament Hill that she was informed she would have to leave the House of Commons.

Wagantall says she spoke with the Conservative House leader Friday, who informed her that though she could stay while the House was sitting, she would have to leave by the end of the day.

The House’s board of internal economy set a requirement in November 2021 that anyone on the precinct must show proof of vaccination against COVID-19, though Speaker Anthony Rota later ruled the board overstepped its authority.

The Liberals and NDP then joined to pass a motion to extend hybrid sittings of Parliament, which also specified that anyone entering the precinct must be fully immunized against COVID-19 or have a valid medical exemption.


Wagantall says she left on her own accord, but believes once the House rose, she would have been apprehended and removed.

After she left the building on her own, she was escorted by Parliament’s sergeant-at-arms.

She says she came to Ottawa at the end of April and before then had driven to and from Ottawa three times on her own.

Wagantall says she is not permitted in her office and has not accessed it since November 2021.

She says she is not allowed to fly or take a train, noting that it takes about three and a half days driving by car to travel to Ottawa from her riding in Saskatchewan.

“Ontario is open. My province has been open for a long time. I’m not making light of anyone who has suffered with COVID. But regardless, it’s time for this country to get on.”
 

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U.K. PM Boris Johnson faces confidence vote in wake of 'partygate'
Author of the article:Reuters
Reuters
Elizabeth Piper
Publishing date:Jun 06, 2022 • 33 minutes ago • 3 minute read • Join the conversation

LONDON — Prime Minister Boris Johnson faced a confidence vote on Monday, after a growing number of lawmakers in the governing Conservative Party questioned the British leader’s authority following a “partygate” scandal.


Johnson, who won a sweeping election victory in 2019, has been under growing pressure after he and staff held alcohol-fueled parties at the heart of power when Britain was under strict lockdowns to tackle COVID-19.

He was met with the chorus of jeers and boos, and some muted cheers, at events to celebrate the Platinum Jubilee of Queen Elizabeth in recent days.

On Monday, the once seemingly unassailable Johnson was also attacked by one-time ally Jesse Norman, a former junior minister who said the prime minister staying in power insulted both the electorate and the party.

“You have presided over a culture of casual law-breaking at 10 Downing Street in relation to COVID,” he said, adding the government had “a large majority, but no long-term plan.”


Norman is one of a growing number of Conservative lawmakers to publicly say that Johnson, 57, has lost his authority to govern Britain, which is facing the risk of recession, rising prices and strike-inflicted travel chaos in the capital London.

Jeremy Hunt, a former health minister who ran against Johnson for the leadership in 2019, said the party knew it was letting the country down. “Today’s decision is change or lose,” he said. “I will be voting for change.”

Johnson’s anti-corruption champion John Penrose quit. “I think it’s over. It feels now like a question of when not if,” he told Sky News when asked about Johnson’s future.

DRAWING A LINE?
Graham Brady, chairman of the party’s 1922 Committee that represents rank-and-file Conservative lawmakers, said a vote would be held between 6 p.m. and 8 p.m. (1700-1900 GMT) on Monday.


“The votes will be counted immediately afterwards. An announcement will be made at a time to be advised,” he said.

A spokesperson for Johnson’s Downing Street office said the vote would “allow the government to draw a line and move on, delivering on the people’s priorities.”

“The PM welcomes the opportunity to make his case to MPs (members of parliament) and will remind them that when they’re united and focused on the issues that matter to voters there is no more formidable political force.”


Johnson, the former London mayor, rose to power at Westminster as the face of the Brexit campaign in the 2016 referendum, and took a tough stance once in power, steering Britain out of the single market and customs union.

Jacob Rees-Mogg, Brexit opportunities minister, told Sky News that completing Britain’s departure from the European Union would be “significantly at risk without his drive and energy.”


Johnson has recently locked horns with the EU over Northern Ireland, raising the prospect of more barriers for British trade and alarming political leaders in Ireland, Europe and the United States about risks to the province’s 1998 peace deal.

OUTCOME UNCERTAIN
A majority of Conservative lawmakers – or 180 – would have to vote against Johnson for him to be removed – a level some Conservatives say might be difficult to reach. If passed, there would then be a leadership contest to decide his replacement, which could take several weeks.

Lawmakers said they had received letters from the prime minister, in which he asked for their support in the vote.

Several ministers in his cabinet team were swift to put out messages of support for the prime minister, with finance minister Rishi Sunak, like other possible successors, saying Johnson had shown “strong leadership.”


“I am backing him today and will continue to back him as we focus on growing the economy, tackling the cost of living and clearing the COVID backlogs,” he said on Twitter in what appeared to be a choreographed expression of support.

Bookmaker Ladbrokes put former health minister Hunt as its favorite to replace Johnson if he was ousted, followed by foreign minister Liz Truss, who also tweeted her “100% backing” of the prime minister in Monday’s vote.

Since the release of a damning report into the so-called “partygate” scandal, which listed fights and alcohol-induced vomiting at lockdown-breaking parties in Downing Street, Johnson and his government had urged lawmakers to move on.

But after parliament took a break last week sending many lawmakers back to their constituencies, or voting regions, several were met by a chorus of complaints over Johnson.

The biting criticism from Norman, who served as a junior minister in the finance ministry between 2019 and 2021, was perhaps the biggest sign that criticism of Johnson had spread beyond a vocal group of so-called rebels.
 

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U.K. PM Boris Johnson scrapes win in party confidence vote
Author of the article:Reuters
Reuters
Elizabeth Piper and Andrew Macaskill
Publishing date:Jun 06, 2022 • 15 hours ago • 3 minute read • 16 Comments

LONDON — British Prime Minister Boris Johnson survived a confidence vote on Monday but a large rebellion in his Conservative Party over the so-called “partygate” scandal dealt a blow to his authority and leaves him with a struggle to win back support.


Johnson, who scored a sweeping election victory in 2019, has been under increasing pressure after he and staff held alcohol-fueled parties in his Downing Street office and residence when Britain was under lockdowns to tackle the COVID-19 pandemic.

The vote was a blow to Johnson, with 41% of his lawmakers casting ballots against his leadership after months of scandals and gaffes that has raised questions over his authority to govern Britain and knocked his standing among the public.

But Johnson, a master of political comebacks, instead described the vote as a “decisive result” meaning that “as a government we can move on and focus on the stuff that I think really matters to people.”


“We can focus on what we’re doing to help people with the cost of living, what we’re doing to clear the COVID backlogs, what we’re doing to make streets and communities safer by putting more police out,” said Johnson, who for weeks has tried to move the national conversation away from “partygate.”


It is a change of fortune for Johnson and underlines the depth of anger against him. He was met with a chorus of jeers and boos, and some muted cheers, at events to celebrate the Platinum Jubilee of Queen Elizabeth in recent days.

Several lawmakers said the vote, which saw 211 lawmakers cast ballots in favor of Johnson against 148, was worse than expected for a prime minister, once seemingly unassailable after winning the Conservatives’ largest majority in more than three decades.

“Boris Johnson will be relieved at this vote. But he will also understand that the next priority is to rebuild the cohesion of the party,” David Jones, a former minister, told Reuters. “I am sure he will be equal to the challenge.”

Others were less optimistic, with one Conservative lawmaker saying on condition of anonymity: “It is clearly much worse than most people were expecting. But it is too early to say what will happens now.”


Roger Gale, a long-time critic of Johnson, urged the prime minister “to go back to Downing Street tonight and consider very carefully where he goes from here.”

12-MONTH REPRIEVE

By winning the confidence vote, Johnson has secured a reprieve for 12 months when lawmakers cannot bring another challenge. But his predecessor Theresa May scored better in her 2018 confidence vote only to resign six months later.

Dozens of Conservative lawmakers have voiced concern over whether Johnson, 57, has lost his authority to govern Britain, which is facing the risk of recession, rising fuel and food prices and strike-inflicted travel chaos in the capital London.

But his Cabinet rallied around him and highlighted what they said were the successes of the government: a quick rollout of COVID-19 vaccinations and Britain’s response to Russia’s invasion of Ukraine.


A majority of the Conservatives’ lawmakers – at least 180 – would have had to vote against Johnson for him to be removed.

Earlier, a spokesperson for Johnson’s Downing Street office said the vote would “allow the government to draw a line and move on” and that the prime minister welcomed the opportunity to make his case to lawmakers.

Johnson, a former London mayor, rose to power at Westminster as the face of the Brexit campaign in a 2016 referendum, and won the 2019 election with the slogan to “get Brexit done.”

Jacob Rees-Mogg, Brexit opportunities minister, told Sky News that completing Britain’s departure from the European Union would be “significantly at risk without his drive and energy.”

Johnson has locked horns with Brussels over Northern Ireland, raising the prospect of more barriers for British trade and alarming leaders in Ireland, Europe and the United States about risks to the province’s 1998 peace deal.


But it was the months of stories of what went on in Downing Street, including fights and alcohol-induced vomiting, when many people were prevented from saying goodbye to loved ones at funerals, that did the real damage.

The move led to lawmakers from different wings of the party revealing that they had turned against their leader. One former ally accused the prime minister of insulting both the electorate and the party by staying in power.

“You have presided over a culture of casual law-breaking at 10 Downing Street in relation to COVID,” Jesse Norman, a former junior minister, said before the vote.

Johnson’s anti-corruption chief John Penrose also quit.
 

Tecumsehsbones

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The Novavax shot is a protein-based vaccine from traditional technology used against influenza and shingles. Many experts are eager to add another vaccine to the toolbox, particularly because the Johnson & Johnson shot is now recommended only for people who cannot or will not take messenger RNA vaccines.
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Guess the cowards and morons will have to make up another excuse.
 

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Ontario's top doc planning for new round of COVID-19 boosters in the fall
Dr. Kieran Moore says preparations for a fall strategy are well underway

Author of the article:Canadian Press
Canadian Press
Publishing date:Jun 10, 2022 • 1 day ago • 4 minute read • 96 Comments

Ontario’s COVID-19 indicators are currently heading in the right direction but the province’s top doctor is preparing for the fall, when trends will likely worsen, with plans including a new round of booster doses.


Chief Medical Officer of Health Dr. Kieran Moore said the preparations include scenarios for various stakeholders in the health system to go through, such as an “aggressive” flu season combined with a COVID-19 resurgence.

Ontario will be purchasing more than six million doses of flu vaccine, he said in an interview, and expects to offer further doses against COVID-19.

“So, another booster dose for the most at-risk of members of our community for COVID, and then potentially opening it up to the general public for another booster dose,” he said.

Third doses are currently available to people 12 and older, and fourth doses are available for people who are 60 and older or First Nation, Inuit and Metis adults as well as their adult household members. Immunocompromised people — such as transplant recipients — aged 60 and older and long-term care residents can get a fifth dose.


Moore anticipates that in the fall a new generation of vaccine will be available that targets both the original COVID strain plus a more up-to-date one that is circulating, such as Omicron.

“We’re looking at distribution models through pharmacy, primary care, and your public health partners,” he said.

“That would be something that could start as early as October. We’ll start with the highest risk, so by age or by occupation, so health-care workers or those over 60, to offer it to them, and then based on the availability and demand expand further.”

Dr. Fahad Razak, the scientific director of the province’s COVID-19 advisory group, said more evidence is needed on benefits of fourth doses for a broader population.


“The evidence for that third dose is very clear,” he said in an interview this week.

“The fourth dose is beneficial for high risk groups ⦠but for the general public, an otherwise healthy 20 or 30 year old who has no risk factors, there really isn’t clear evidence yet to say, ‘Go get that fourth dose.’ It’s not clear. You’ll see some jurisdictions are allowing it, some are not, and that reflects the lack of clarity from the evidence right now.”

Razak said while indicators are positive right now, Ontario is still in the sixth wave.

A combination of high vaccination rates and recent infections has given Ontario a strong “wall of immunity,” but the fall will bring waning immunity as well as other respiratory viruses that have for two years been kept at bay due to COVID-19 public health measures, he said.


There is also the potential for a new variant.

“What we’ve seen in prior waves ⦠is essentially a new wave, a new variant develops and kind of comes through the population roughly every six months,” Razak said.

“Nobody knows whether it will continue, but if that pattern continues we hopefully have a good summer, but we head into a fall season with some risk.”

If another wave of COVID-19 threatens the health system and its ability to deal with the surgical backlog, Moore said there is a possibility mask mandates may return “if it’s really, absolutely required.”

“Certainly any further public health measures beyond that, I don’t think will ever be necessary, given the benefits of the vaccine that we’ve seen and given the effectiveness of masking at a population level,” he said.


Provincial mask mandates for public transit and health-care settings will expire this weekend — though hospitals say they will keep requiring masks. The mandates remain in place in long-term care and retirement homes, and Moore recommends keeping those until at least the summer of 2023.

Meanwhile, Ontario announced Friday that it would move from daily to weekly COVID-19 data reporting and stop publishing details on the virus in long-term care and retirement homes as well as schools. As well, Verify Ontario, which was used to scan vaccine certificates, will be removed from the app store.

The province is also in the midst of preparing for the eventual approval of vaccines for children under five. An application from Moderna for a COVID-19 vaccine for children aged six months to five years old has been under review by Health Canada since late April.

It took Health Canada almost three months to authorize the Moderna vaccine for adolescents, and almost four months for children ages six to 11. Moore said the youngest children may not be able to be vaccinated until at least late summer.

“We’ve already had plans of how to distribute it through our primary care partners, as well as our pharmacy partners,” he said.

“So we’re ready. It’s now just ensuring that the vaccine is safe, that it’s effective, and that it will indeed, protect children fully. And I don’t mind taking that extra time to ensure the data is correct.”