Pfizer and BioNTech seeking emergency use authorization from FDA for Covid-19 vaccine for children younger than 5

Pfizer and BioNTech explained they have initiated a rolling submission of knowledge to the US Foodstuff and Drug Administration immediately after a ask for from the agency. They expect to complete the EUA submission in the coming days and say they will also post medical trial information to the European Medications Agency and other businesses about the world.

Safety and usefulness are essential, explained Dr. Paul Offit, a member of the committee and director of the Vaccine Instruction Centre at Children’s Clinic of Philadelphia.

“The self-assurance of the American general public is dependent on that, that you you might be recommending a little something that you would give to your own little ones,” Offit instructed CNN. “It all relies upon on the knowledge. The facts will tell us just how very good these are. There should be a strong basic safety profile and a sturdy efficacy profile and immunogenicity profile. And if that is genuine, velocity doesn’t really issue, as prolonged as they have those people data.”

The Pfizer/BioNTech vaccine is now authorized for use in men and women as youthful as 5 and would be the initially Covid-19 vaccine offered for the youngest young children.

The go arrives “in response to the urgent general public wellness want in this populace,” the organizations claimed in a news launch.

Since the start out of the pandemic, at the very least 11.4 million little ones have tested constructive for Covid-19, the American Academy of Pediatrics described Monday, with in excess of 3.5 million situations reported in January alone. Small children made up 22.8{cfdf3f5372635aeb15fd3e2aecc7cb5d7150695e02bd72e0a44f1581164ad809} of the whole documented weekly circumstances for the week ending January 27.

“Pediatricians have viewed firsthand the concern, strain and hardship that so many family members of young youngsters have endured as they await a vaccine,” Dr. Moira Szilagyi, president of the American Academy of Pediatrics, claimed in a assertion. “We urge a clear and facts-driven method to consider this vaccine for this age group and look ahead to offering its protection to our youngest little ones.”

The corporations are continuing to take a look at a 3-dose edition of the vaccine in the youngest children.

In December, Pfizer prolonged its vaccine trial in young kids just after two child-sized doses of the vaccine did not generate the expected immunity in 2- to 5-yr-olds, even though it did so for the infants up to age 2.

The organizations explained details on a third dose given at minimum eight months following the second dose is anticipated in the coming months, which will also be submitted to the Fda.

Pfizer's child-sized vaccine fails to produce expected immunity in younger kids; company adds third dose to trials

“As hospitalizations of small children underneath 5 due to COVID-19 have soared, our mutual purpose with the Fda is to get ready for long run variant surges and supply moms and dads with an possibility to aid defend their small children from this virus,” Pfizer Chairman and CEO Albert Bourla mentioned. “Ultimately, we consider that 3 doses of the vaccine will be required for small children 6 months by 4 several years of age to reach high concentrations of security from recent and opportunity upcoming variants.

“If two doses are authorized, mother and father will have the prospect to get started a COVID-19 vaccination sequence for their little ones when awaiting likely authorization of a third dose.”

For people today 12 and more mature, the Pfizer/BioNTech vaccine dose is 30 micrograms of vaccine, and for little ones ages 5 to 11, it was stepped down to 10 micrograms. The dose for the youngest small children is even lessen: 3 micrograms.

CNN reported previously Tuesday that Pfizer was inspired to seek authorization for the two-dose vaccine by federal regulators, who hope the EUA can be granted by late February. Waiting around on data for a few doses could extend the hold out until March.

“If the intention of the vaccine is to get baseline immunity in the young ones — to reduce seriously undesirable results and you are seriously not using the vaccine as a resource to avert an infection in the 1st position — two doses could do that,” Dr. Scott Gottlieb, a previous Food and drug administration commissioner and existing Pfizer board member, stated on CBS on Sunday. “I feel that may possibly be why federal overall health officials are rethinking this.”

CNN’s Katherine Dillinger, John Bonifield, Jen Christensen and Brenda Goodman contributed to this report.

COVID-19 vaccines have no effect on fertility

A pregnant person receiving a COVID-19 vaccine in in Lipetsk, RussiaShare on Pinterest
A pregnant individual receiving a COVID-19 vaccine in Lipetsk, Russia. Alexander RyuminTASS through Getty Pictures
  • Some reproductive-aged men and women are worried about the prospective adverse effects of COVID-19 vaccination on their means to conceive.
  • Some previously study has concluded that COVID-19 vaccinations do not look to cut down fertility.
  • A new study provides to this proof, getting that the vaccines do not have an impact on fertility in males or women.
  • On the other hand, SARS-CoV-2 infection in males does seem to have shorter-time period effects on fertility.

Although scientists have demonstrated that COVID-19 vaccines are harmless and effective, vaccine hesitancy persists. A huge selection of myths and misconceptions perform a portion in this hesitancy, a person of which is a worry that the vaccines lessen fertility.

Scientists from the Boston College School of Community Health and fitness a short while ago set out to investigate this issue. They concluded that vaccination — in both males and girls — does not appear to have an impact on fertility.

The analyze, which seems in the American Journal of Epidemiology, also examines the results of SARS-CoV-2 infection on fertility.

Safety is an vital variable in choosing irrespective of whether to acquire a COVID-19 vaccination. A person of the most frequent good reasons for deciding upon to stay unvaccinated is problem concerning possible facet effects. This is especially real for those people wishing to grow to be expecting.

As the authors of the new analyze reveal, minimal details are obtainable on the affiliation amongst COVID-19 vaccination and fertility in females. Even a lot less evidence exists on the doable consequences of vaccination on male fertility.

To enable fill this gap, the researchers took facts from an net-centered preconception cohort analyze known as Pregnancy Research On the net, or PRESTO.

The review recruited 2,126 persons from December 2020 until eventually November 2021. Suitable participants resided in the United States and Canada and self-determined as women concerning 21 and 45 many years of age who had been trying to conceive devoid of the use of fertility solutions.

The researchers gave the contributors the alternative of inviting their male companions to take part in the research. All individuals completed a baseline questionnaire that involved data about sociodemographics, life style, and reproductive and clinical histories. The females stuffed out adhere to-up questionnaires each 8 months for up to 12 months.

The information from PRESTO showed that the fertility rates between female individuals who experienced been given at least one particular dose of a COVID-19 vaccine had been virtually equivalent to those people of unvaccinated woman participants. The final results were related for their male partners.

“Our results that COVID-19 vaccination was not related to fertility are steady with other studies from partners undergoing fertility treatment method,” Amelia Wesselink, lead author of the analyze and a analysis assistant professor of epidemiology at Boston University, stated in an interview with MNT. She continued:

“The evidence on this challenge is expanding, and almost everything so much implies that the COVID-19 vaccine is not leading to infertility.”

William Schaffner, a professor of infectious illnesses at Vanderbilt College Medical Middle in Nashville, TN, spoke with MNT about the Boston University analyze.

“This review clearly confirms the concept and the other info out there stating that the vaccines do not predispose to any issues with fertility,” claimed Prof. Schaffner.

The analyze also investigated male fertility in relation to the vaccine and SARS-CoV-2 infection. Despite the fact that the staff found no associations with the vaccine, the info did display a quick-time period drop in male fertility following SARS-CoV-2 infection.

The authors be aware that previous research has demonstrated fever to affect sperm concentration and motility soon after any infection. As fever is a popular symptom of COVID-19, this could clarify the decrease in male fertility just after a recent SARS-CoV-2 an infection.

“Regardless, we did not observe any association involving SARS-CoV-2 an infection and fecundability that persisted past 60 days,” reported the researchers.

The authors note a number of strengths to their review, including a substantial selection of participants from geographically and socioeconomically assorted populations.

The study’s restrictions contain a reliance on self-reporting of an infection and vaccination position. Also, as the authors be aware, “for partners in which the male partner did not finish his questionnaire, we relied on woman report of male vaccination standing.”

When MNT questioned Prof. Schaffner what even more investigate is necessary, he described: “As we go forward and build other new vaccines — current COVID-19 vaccines and any many others that involve reproductive-age grown ups — fertility is an issue that demands to be addressed. It will appear up yet again with other vaccines.”

Wesselink agreed and included: “We definitely require to know extra about the results of COVID-19 itself on reproductive health. In our review, for occasion, we didn’t have info on symptoms or severity of an infection, so research investigating how these components correlate with reproductive perform is warranted.”

For dwell updates on the most up-to-date developments relating to COVID-19, click listed here.

Today’s coronavirus news: Ontario reporting 2,983 people hospitalized with COVID-19, 583 in ICU; Boris Johnson says sorry after ‘partygate’ report released

The latest coronavirus news from Canada and around the world Monday. This file will be updated throughout the day. Web links to longer stories if available.

6:15 p.m.: The Star’s Rosie Dimanno has touched down in Beijing for the upcoming 2022 Summer Olympics. But as the columnist writes, “never before … have I ever felt so alien and menacing a presence, not to mention barely tolerated.”

Read the full column here.

6:02 p.m.: U.S. Defense Secretary Lloyd Austin, in letters to seven governors, is reaffirming the need for members of their states’ Army and Air National Guards to get the mandatory COVID-19 vaccine or lose their Guard status.

In nearly identical letters signed late last week, Austin tells the governors that the virus “takes our service members out of the fight, temporarily or permanently, and jeopardizes our ability to meet mission requirements,” according to copies obtained Monday by The Associated Press.

The letters, which have not been publicly released, come as the military services begin to ramp up the number of active-duty troops being discharged for refusing the vaccine. Nearly 600 Marines, airmen and sailors have been thrown out of the military or dismissed from entry-level training at boot camps as of last week.

Two of the letters — to Alaska and Texas state leaders — note that they have an ongoing lawsuit over the vaccine and that, Austin said, limited his abililty to comment further on their concerns.

Texas, Oklahoma and Alaska filed lawsuits challenging the military’s vaccine mandate, but a federal judge has already rejected the Oklahoma challenge. The Alaska governor was one of five Republican state leaders who sent a letter to Austin asking him not to enforce the mandate on National Guard troops. The other four were governors from Wyoming, Mississippi, Iowa and Nebraska.

The latest letters were to those five governors along with Idaho and Texas.

According to the Centers for Disease Control and Prevention, nearly 87 per cent of the U.S. population age 18 or older has gotten at least one shot.

5:30 p.m.: Joe Rogan has apologized after being critized for hosting two guests in recent weeks on his popular podcast who espoused dangerous COVID misinformation.

In his apology episode, Rogan also thanked his listeners who have enjoyed his podcast and said he would “try harder to get people with differing opinions on right afterward” and “do my best to make sure I have researched these topics, the controversial ones in particular, and have all the pertinent facts at hand before I discuss them.”

Read the full story by the Star’s Alessia Passifiume here.

5:22 p.m.: Saskatchewan Premier Scott Moe says Saskatchewan’s proof of vaccination against COVID-19 has run its course, but he won’t commit to removing the requirement before the public health order expires at the end of the month.

He says the government doesn’t make decisions overnight, but discusses them with health officials who provide input.

On the weekend, Moe said in a letter in which he supported a truck convoy against mandatory vaccines that Saskatchewan would remove the public health order in the “not-too-distant” future.

Since then, the premier has said proof of vaccination or a negative test no longer help with preventing transmission of COVID-19.

5:00 p.m.: With leaders such as Ontario Premier Doug Ford and Toronto chief medical officer of health Dr. Eileen de Villa calling for Canadians to learn to “live with” COVID-19, what does that exactly mean?

The Star’s Jenna Moon spoke with several doctors to try to map out a way forward past the pandemic.

4:47 p.m. Prime Minister Justin Trudeau says he will neither meet with nor be intimidated by the convoy of Canadians he says spent the last few days harassing local businesses, waving Nazi flags and stealing food from the homeless.

Speaking to Canadians from isolation after testing positive for COVID-19 Monday, Trudeau said “freedom of expression, assembly and association are cornerstones of democracy.”

“But Nazi symbolism, racist imagery, and desecration of war memorials are not,” he said. “It is an insult to memory and truth. Hate can never be the answer.”

Trudeau and his family were moved to an undisclosed location Saturday as thousands of people converged all over Ottawa, including some near his official residence on the grounds of Rideau Hall.

3:40 p.m. For nearly two years, Canadians have faced rolling restrictions on public life due to the ongoing threat of COVID-19. As the Omicron wave begins to wane in the province, politicians and doctors alike are beginning to envision a world where we move beyond emergency measures and live alongside the virus.

Ontario Premier Doug Ford said Friday that the province needs to learn to “live with” COVID-19. That thought was echoed the same day by Toronto’s medical officer of health Dr. Eileen de Villa, who said a mix of vaccinations, masking, distancing and ventilation will help lessen the risk of severe flare-ups of the virus as Toronto moves away from a “COVID-zero” approach to handling the pandemic. As of Monday, some restrictions placed on indoor dining, gyms and movie theatres have been lifted, though they will only be able to operate at 50 per cent of their regular capacity.

Meanwhile, a study released Monday has shown just how far the virus spread in Canada as a result of the highly-contagious Omicron variant: One in every five households has seen at least one case of COVID since the beginning of December. The same study found that more than half of respondents support an end to restrictions.

But what does “living with” COVID-19 look like? As Dr. Nelson Lee, interim director of the Dalla Lana Institute for Pandemics, told the Star, it’s not so much about living with the virus as it is about overcoming it.

Read the full story from the Star’s Jenna Moon.

3:32 p.m. The Quebec government loosened more COVID-19 restrictions Monday, permitting small private indoor gatherings and reopening restaurant dining rooms at half capacity, after it imposed an abrupt lockdown over the holidays.

After lifting the provincial curfew and allowing in-person classes to resume on Jan. 17, the government is permitting restaurants to host no more than four people at one table, or two households, and forcing them to close at midnight.

3:12 p.m. The prime minister says the government will introduce legislation today to continue providing as many rapid tests as possible to the provinces and territories.

Justin Trudeau made the announcement today during a news conference that addressed the Parliament Hill protest against government-imposed COVID-19 measures.

The bill was added to the order paper on Saturday, ahead of MPs returning to Parliament Monday.

Liberal House leader Mark Holland said at a news conference today that Bill C-10 would accelerate the funding and provision of rapid tests because there is “great” need for them.

2:30 p.m. A truck blockade snarling border traffic between Montana and Alberta is causing political and police tensions to ratchet up.

It began over the weekend alongside the “Freedom Convoy” that made its way into Ottawa, bringing thousands of protesters upset with public health measures and the federal government.

The blockade of trucks in southern Alberta near the village of Coutts is made up of a line of vehicles that backed up traffic for about two kilometres on Sunday, according to local reports.

The Star’s Kieran Leavitt has the latest.

1:55 p.m. The Duke and Duchess of Sussex have “concerns” about how Spotify has allowed and promoted the spread of COVID-19 misinformation on its platform.

Prince Harry and Meghan, who inked an exclusive multiyear partnership with the service in December 2020, said Sunday that they are pressing Spotify to take more care about the rhetoric spread on its airwaves.

“Since the inception of Archewell, we have worked to address the real-time global misinformation crisis. Hundreds of millions of people are affected by the serious harms of rampant mis- and disinformation every day,” a representative for their foundation said in a statement Sunday.

1:45 p.m. As promised by the province, a number of COVID-19 restrictions in Ontario were lifted on Monday.

As of 12:01 a.m., several limits on social gatherings, and indoor and outdoor capacities were eased, as part of a “cautious” three-stage reopening plan released earlier this month. The plan consists of three consecutive phases of public health measures being eased, with 21 days between each phase.

This comes just after Premier Doug Ford said Ontarians need to learn to live with COVID-19 in an interview Friday.

A change in social gathering limits, a return to indoor dining and gyms reopening are all part of the loosened restrictions that are now in place.

Read the full story from the Star’s Akrit Michael

1:30 p.m. It was back to class Monday for students in New Brunswick and Prince Edward Island as a result of eased COVID-19 restrictions.

Both provinces have installed portable HEPA filters in classrooms without mechanical ventilation systems.

Heather Mullen, president of the P.E.I. Home and School Federation, says it’s important for students to be back in school and benefit from social interaction with their classmates.

She says while some parents were nervous about sending their children back today, she believes it’s safe because all students and school staff on the Island needed two negative rapid tests from the weekend, and all are wearing new high-quality masks.

High school students in New Brunswick head back to class Wednesday, while P.E.I. high school students return Thursday.

Last week, New Brunswick Education Minister Dominic Cardy thanked teachers and parents for their efforts during the extended period of online learning that resulted from the Omicron wave of the pandemic.

1:15 p.m. The mayor of a village in southern Alberta says there will be no mail and some students have not gone to school because of a truck convoy that has blockaded a highway at a busy U.S. border crossing as part of a protest against vaccine mandates.

Mayor Jim Willett says he’s angry and frustrated because about 100 trucks lined up on Highway 4 are preventing a mail truck and a school bus from entering Coutts, Alta.

The convoy is one of many in Canadian towns and cities on the weekend that coincided with truckers and their supporters meeting on Parliament Hill in Ottawa to protesting the federal government’s COVID-19 measures.

Willett says he understands freedom to protest, but he adds the Alberta government needs to act to allow the movement of goods and services near the border, where only foot traffic has been able to get through.

1 p.m. Ontario is reporting 583 people in ICU due to COVID-19 and 2,983 in hospital overall testing positive for COVID-19, according to its latest report released Monday morning.

This marks the fifth straight day hospitalization numbers due to COVID have shown a downward trend. It is important to note that all hospitals don’t report COVID numbers on the weekend.

Around 22.6 per cent of the province’s 2,343 adult ICU beds remain available for new patients.

Read the full story from the Star’s Akrit Michael

12:37 p.m. Quebec is taking its first steps on Monday toward reopening the province after partially shutting down over the holidays due to record-high hospitalizations.

Premier François Legault announced plans last week to gradually loosen public health restrictions as the COVID-19 situation began to improve.

Beginning Monday, restaurant dining rooms can open at half capacity, with no more than four people or two different households at a table, and they must close by midnight.

The changes come as Quebec is today reporting 33 additional deaths attributed to COVID-19.

The Health Department says 2,888 people are hospitalized, a drop of seven patients from the previous day, and 223 people are in intensive care, a decline of 10.

Quebec is reporting 2,423 new COVID-19 cases, but authorities have warned that number is not reflective of the actual situation because PCR testing has been limited to certain higher-risk groups.

12:12 p.m. (updated) In a Monday presser, Prime Minister Justin Trudeau, who tested postive for COVID-19, thanks the truckers who are doing hard jobs and are on the road right now. He says they have continued to step up to put food on the shelves and support Canadians with necessary medication.

He says almost 90 per cent are doing the right thing. “We thank you deeply.”

Trudeau says the behaviour in Ottawa this weekend does not represent hard-working truckers.

“This is not the story of our pandemic, of our people,” Trudeau says. “…there is no place in our country to threats and hatred.”

Trudeau says this has to stop.

12:10 p.m. Premier Doug Ford on truckers’ protest: “I was extremely disturbed …to see some individuals desecrate our most sacred monuments and wave swastikas and other symbols of hate and intolerance this weekend. That has no place in Ontario or Canada. Not now. Not ever.”

Ford also said: “Today, Ontario is beginning to ease some public health measures, the first step in returning to normal. All Ontarians are united in their desire to put this pandemic behind us and return to the life we knew before COVID-19.”

11:35 a.m. Moderna announced Monday that U.S. health regulators granted full approval to its COVID-19 vaccine, a shot that’s been given to tens of millions of Americans since its emergency authorization over a year ago.

The action by the Food and Drug Administration means the agency has completed the same rigorous, time-consuming review of Moderna’s shot as dozens of other long-established vaccines.

The decision was bolstered by real-world evidence from the more than 200 million doses administered in the U.S. since the FDA cleared the shot in December 2020. The FDA granted full approval of Pfizer’s vaccine last August.

11:17 a.m. British Prime Minister Boris Johnson apologized Monday for lockdown-flouting parties in Downing Street — but insisted that he and his government can be trusted.

Johnson told lawmakers in the House of Commons that he would make changes to the way the government is run in the wake of the “partygate” scandal.

“I get it and I will fix it,” he said.

He spoke after senior civil servant Sue Gray found that gatherings by the prime minister and his staff when Britain was under coronavirus restrictions represent a “serious failure” to observe the standards expected of government.

10:16 a.m. Ontario is reporting 2,983 people hospitalized with COVID-19 and 583 in the ICU. The province is reporting at least 3,043 new cases.

Note that not all hospitals report on weekends. In Ontario, 30,649,731 vaccine doses have been administered; 91.9 per cent of Ontarians 12+ have one dose and 89.2 per cent have two doses, according to tweets from Health Minister Christine Elliott.

10:12 a.m. Prime Minister Justin Trudeau says he has tested positive for COVID-19.

Trudeau posted on Twitter that he got the positive test result Monday morning. He has been in isolation since last Wednesday when he said that he’d had a positive contact.

CP reported that the contact was one of his children, but the PMO had not identified which of his children had contracted the virus.

“I’m feeling fine — and I’ll continue to work remotely this week while following public health guidelines. Everyone, please get vaccinated and get boosted,” Trudeau tweeted.

Read the full story from the Star’s Tonda MacCharles

9:51 a.m. Prime Minister Justin Trudeau says he’s tested positive for COVID-19.

In a statement on Twitter, Trudeau says: “I’m feeling fine – and I’ll continue to work remotely this week while following public health guidelines. Everyone, please get vaccinated and get boosted.”

9:47 a.m. An investigation says lockdown-breaching parties by Prime Minister Boris Johnson and his staff represent a “serious failure” to observe the standards expected of government.

Senior civil servant Sue Gray concluded that “there were failures of leadership and judgment” in the government and “some of the events should not have been allowed to take place.

The findings are part of what Gray’s office calls an “update” on her investigation, rather than a full report. Major parts of her findings have been withheld at the request of the police, who have launched a criminal investigation into the most serious alleged breaches of coronavirus rules.

The cuts have led opponents to accuse Johnson of a whitewash.

Johnson is due to make a statement on the findings in the House of Commons later Monday.

9:15 a.m. Los Angeles County’s nursing homes have observed an extraordinary increase in coronavirus case rates during the Omicron surge — reaching levels exceeding even last winter’s wave — but that unprecedented torrent of infections hasn’t been matched by a record-high number of daily COVID-19 deaths, county health data show.

The county has instead observed a relatively small increase in daily COVID-19 deaths at nursing homes during the omicron surge, officials said. And new daily coronavirus cases have already started to drop.

As of mid-January, L.A. County was tallying a daily COVID-19 death rate of 20 fatalities for every 100,000 nursing home residents. That’s about one-fifth of the peak of last winter’s surge, and roughly one-fourth the rate of the pandemic‘s early days in spring 2020, according to figures presented by L.A. County Public Health Director Barbara Ferrer.

8:55 a.m. Hamilton school boards say they are struggling to put teachers in classrooms as systems report average staff absences of more than 1,000 a day.

Schools reopened to in-person learning Jan. 19 for the first time since before the winter break amid a rapidly spreading Omicron wave of COVID.

“It has been challenging,” said Hamilton-Wentworth Catholic District School Board chair Pat Daly. “The absenteeism rates have been higher than pre-pandemic. It was a challenge before the pandemic, so it’s been exacerbated now.”

The Catholic board reported average daily vacancy rates of about 504 — or 12 per cent — among staff, which includes educators, as well as administrative and custodial staff, and 212 among teachers in the first three days back to school.

8:30 a.m. Grocery prices are skyrocketing. Inflation is at a 30-year high. Interest rate hikes are on the horizon. And the housing market shows no signs of cooling.

And yet your salary hasn’t changed — maybe even in years.

Canadians are noticing their dollar isn’t stretching as far these days, and wondering when their pay will catch up.

At the same time, a tight labour market means companies are doing more, such as raising wages on new job postings, to try to attract and retain talent.

Read the full story from the Star’s Rosa Saba

8:12 a.m. One of Peel’s highly visited COVID-19 vaccination clinics is back to allow those with busy daytime schedules to receive the first, second or booster dose.

The Doses After Dark clinic is set to run at Brampton’s Save Max Sports Centre on Feb. 5 and at Mississauga’s Rockwood Mall on Feb. 12, both from 1 p.m. till midnight.

Appointments are now live and can be booked online through the provincial website or on Peel Region’s COVID-19 website.

“Our previous Doses after Dark events were very well received so, please book as this special event and these late evening appointments will go quickly,” said the region’s medical officer of health, Dr. Lawrence Loh.

7:10 a.m. Prime Minister Boris Johnson has received a long-awaited report from an investigation into lockdown-breaching government parties, the government said Monday.

The Cabinet Office said senior civil servant Sue Gray “has provided an update on her investigations to the Prime Minister.”

Johnson’s office has promised the report will be published “swiftly,” and that the prime minister will address Parliament about its findings.

But Monday’s “update” is unlikely to tell the full story. Some of Gray’s findings are being withheld because of a separate police investigation into whether some of the gatherings broke COVID-19 laws.

Allegations that the prime minister and his staff flouted restrictions imposed on the country to curb the spread of the coronavirus have caused public anger and led some Conservative lawmakers to call for Johnson’s resignation.

6:20 a.m.: Gyms, movie theatres and museums in Ontario will also be able to reopen Monday, after having been shut down for the last several weeks.

Perhaps more than anything, business owners are hoping this is the last time they’re forced to close, after having gone through waves of lockdowns and reopenings, then back into lockdown, since the COVID-19 pandemic began in March 2020.

They’re also left to wonder: Will the customers come back?

Read the full story from the Star’s Josh Rubin.

6:20 a.m.: A senior Hong Kong government official has resigned after attending a large birthday party that fueled complaints of double standards by authorities enforcing strict Covid-control measures.

Home Affairs Secretary Caspar Tsui handed his resignation to Hong Kong Chief Executive Carrie Lam on Monday and will leave the post immediately, he said in a statement. Lam is set to hold a briefing at 3 p.m., at which more details are expected.

“As one of the principal officials taking the lead in the anti-epidemic fight, I have not set the best example during the recent outbreak,” he said in the statement. Tsui added that he had “behaved in an inappropriate manner when all efforts should have been devoted to controlling the spread of the virus.”

His resignation marks the first time a government official has left a post after flouting pandemic guidance, and comes as the city’s strict zero-tolerance approach to Covid is strained by an omicron variant-fueled surge.

Lam launched a disciplinary probe after Tsui and some 30 officials were found to be among about 250 attendees at a party for the local representative of a mainland Chinese economic development agency on Jan. 3. Days earlier, the government had urged the public to avoid large gatherings due to the global spread of omicron.

6:20 a.m.: New Zealand Prime Minister Jacinda Ardern said Monday she has tested negative for the coronavirus after coming into close contact with an infected person on a commercial flight.

Ardern had been isolating since late Saturday after the Jan. 22 exposure first came to light. She intends to continuing isolating through Tuesday to complete a 10-day health requirement. She has had no symptoms.

The exposure occurred on a flight from the town of Kerikeri to New Zealand’s largest city, Auckland. Health officials listed a dozen flights as exposure events late Saturday, possibly indicating infections among flight crews.

Ardern and Gov.-General Cindy Kiro, who is also isolating while awaiting a second test, were in the Northland region to do some filming ahead of New Zealand’s national day, Waitangi Day, on Feb. 6.

New Zealand has managed to stamp out or contain the virus for much of the pandemic, and has reported just 52 virus deaths among its population of 5 million. But an outbreak of the omicron variant is starting to take hold and is expected to rapidly grow over the coming weeks.

About 77{cfdf3f5372635aeb15fd3e2aecc7cb5d7150695e02bd72e0a44f1581164ad809} of New Zealanders are fully vaccinated, according to Our World in Data. That figure rises to 93{cfdf3f5372635aeb15fd3e2aecc7cb5d7150695e02bd72e0a44f1581164ad809} of those aged 12 and over, according to New Zealand officials.

6:19 a.m.: Tokyo has launched a mass inoculation drive for COVID-19 booster shots at a temporary center operated by the military as Japan tries to speed up delayed third jabs to counter surging infections.

Japan began administering booster shots to medical workers in December, but has only provided such inoculations to 2.7 per cent of the population after delaying a decision to cut the interval between the first two coronavirus shots and a booster to six months from the initial eight.

Demand for the shots is intense: Online reservations that started on Friday resulted in all slots for about 4,300 doses to be given at the center this week being filled within 9 minutes. The center is providing the vaccine made by Moderna, Inc.

On a smaller scale, people 65 and older can get booster shots elsewhere.

The center run by the Self-Defense Force in downtown Tokyo reopened Monday after closing down in late November. It will be vaccinating about 720 people aged 18 or older per day this week, ramping up to more than 2,000 a day next month. Another military-run center will begin booster shots next week in Osaka.

6:18 a.m.: People across Asia prepared Monday for muted Lunar New Year celebrations amid concerns over the coronavirus and virulent Omicron variant, even as increasing vaccination rates raised hopes that the Year of the Tiger might bring life back closer to normal.

The Lunar New Year is the most important annual holiday in China and falls on Tuesday, Feb. 1. Each year is named after one of twelve signs of the Chinese zodiac in a repeating cycle. The Year of the Tiger follows the Year of the Ox.

This will be the third new year in a row celebrated in the shadow of the pandemic. It was two days before the holiday in 2020 that China locked down Wuhan — a city of 11 million people — following the detection of the coronavirus there.

Some 85{cfdf3f5372635aeb15fd3e2aecc7cb5d7150695e02bd72e0a44f1581164ad809} of Chinese are now fully vaccinated, according to Our World in Data, and more Chinese have been travelling domestically this year, despite government warnings. Many people prepare to celebrate by buying red lanterns and other decorations for their homes, and food to mark the beginning of a new year.

6:18 a.m.: Legislators plan to return to the House of Commons on Monday morning as a Parliament Hill protest against government-imposed COVID-19 measures enters its third full day.

Many of the horn-honking demonstrators who brought Ottawa to a near standstill on the weekend showed no signs of budging as parliamentarians, businesses and school administrators were left wondering when the usual rhythm of the frazzled national capital would resume.

Alexandra Maheux, a spokeswoman for government House leader Mark Holland, said the ongoing protest is not interfering with parliamentary business.

“We have important work to accomplish for Canadians in Parliament, and we’re looking forward to getting this done and delivering results,” Maheux said late Sunday.

She noted that MPs have the flexibility to work in a hybrid House in this sitting, which remains in effect until June, to help curb the spread of COVID-19.

“Some MPs will be in the chamber on Monday and beyond, and others will participate virtually,” Maheux said.

A memo circulated Sunday by Patrick McDonell, the House sergeant-at-arms, said security plans were being developed to ensure personal safety.

Holland has scheduled a morning news conference in Parliament’s West Block to discuss the sitting.

He is likely to face questions about the roaming crowds and ear-splitting truck horns outside on Wellington Street, and just how long the protest will be allowed to continue.

6:17 a.m.: A study published Monday in the Canadian Medical Association Journal found that adult COVID-19 patients with disabilities had 36 per cent longer hospital stays and a 77 per cent increased risk of readmission within 30 days.

Advocate Sandi Bell, who has a mobility disability and vision impairment, said it’s important to see studies highlighting the challenges that COVID-19 has caused for many people with disabilities.

“There is a definite demand for data, because a lot of people just don’t know about the daily barriers,” said Bell, a member of the Board of Directors of ARCH Disability Law Centre.

“COVID has been the most isolating situation that one could imagine for people with disabilities.”

Researchers at the University of Toronto and Unity Health Toronto looked at 1,279 patients — 22.3 per cent of whom had a recorded disability — who were hospitalized for COVID-19 at seven nearby hospitals from January through November 2020.

They found that patients with traumatic brain injury, intellectual or developmental disabilities, and multiple disabilities had the highest risks for poor COVID-19 outcomes.

The longer hospital stays and increased rates of readmission for people with disabilities persisted even after accounting for age and other factors that might explain differences.

6:16 a.m.: On the East Coast, schools were set to reopen to in-person learning in New Brunswick and Prince Edward Island Monday, with added safety measures in place.

6:16 a.m.: Quebec is taking its first steps today to reopen the province after partially shutting down over the holidays due to record-high hospitalizations.

Premier François Legault announced plans last week to gradually loosen public health restrictions as the COVID-19 situation has improved somewhat.

Restaurant dining rooms can open at half capacity today, with no more than four people or two different households at a table. Closing time is set for midnight, with last call at 11 p.m.

Private indoor gatherings of up to four people, or two family bubbles, are also permitted.

Extracurricular sports can resume in elementary and high schools, CEGEPs and universities, with the mandatory vaccine passport for students 13 and over.

The second phase of Quebec’s plan to ease restrictions is set for a week from now, with places of worship, entertainment and sports venues allowed to reopen at limited capacity on Feb. 7.

6:15 a.m.: Ontario’s restaurants, gyms and theatres will welcome patrons back today for the first time in nearly a month.

It’s the first step in the province’s plan to gradually ease public health restrictions meant to curb the spread of COVID-19.

Restaurant dining rooms, gyms and cinemas will reopen at half capacity today after being shuttered on Jan. 5 due to the rapid spread of the Omicron variant of the coronavirus.

Larger venues will also reopen with capacity limited to 50 per cent or 500 people — whichever is fewer.

Limits on indoor gatherings will increase from five people to 10, while the cap on outdoor gatherings will go from 10 to 25.

The province plans to ease COVID-19 measures further on Feb. 21.

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Doctors in Canada sought more mental health support during COVID-19

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Humber River Hospital’s Intensive Care Unit, in Toronto, Canada, on April 28, 2020. COLE BURSTON/Getty Images
  • An observational study examined data from around 34,000 physicians in Ottawa, Canada.
  • Researchers found physicians participated in nearly 26{cfdf3f5372635aeb15fd3e2aecc7cb5d7150695e02bd72e0a44f1581164ad809} more mental health and substance use visits during the first year of the COVID-19 pandemic compared to the year prior.
  • The study team believes the increase is attributable to both increased stressors during the pandemic and additional access to mental health services through virtual outpatient options.

There is no denying the fact the COVID-19 pandemic has had an impact on the mental health of people worldwide. A recent study found the pandemic increased cases of major depressive disorder by 53 million and anxiety disorders by 76 million globally.

But for those working on the front lines of the pandemic — such as healthcare workers — how has the situation affected their mental health?

A team of researchers from the University of Ottawa Department of Family Medicine and The Ottawa Hospital in Canada is helping answer that question. Their new study has found a link between the pandemic and the number of outpatient healthcare visits physicians participated in for mental health and substance use concerns.

Researchers believe their study results will help shed light on the need for increased mental health services for the medical community.

The results from this population-based cohort study appear in JAMA Open Network.

Before the COVID-19 pandemic, studies showed an elevated rate of mental health issues among healthcare workers. One such study in 2015 found resident physicians were at high risk for depression. Another study in 2018 examined burnout among United States healthcare professionals, finding over one-half of physicians and one-third of nurses had symptoms affecting their mental health.

Interestingly, other studies have linked higher levels of substance misuse issues to healthcare professionals. According to American Addiction Centers, approximately 4.4{cfdf3f5372635aeb15fd3e2aecc7cb5d7150695e02bd72e0a44f1581164ad809} of medical workers have a problem with heavy alcohol consumption. And about 5.5{cfdf3f5372635aeb15fd3e2aecc7cb5d7150695e02bd72e0a44f1581164ad809} of healthcare personnel experience illicit drug use.

Dr. Daniel Myran, a family physician, public health and preventive medicine specialist, and postdoctoral fellow at the University of Ottawa Department of Family Medicine and The Ottawa Hospital, is the lead author of this current study.

According to him, multiple surveys have found high levels of mental distress in healthcare workers, including physicians, during the COVID-19 pandemic.

“However, because these surveys generally look at one or two points in time, it limits our understanding of whether these concerning rates of mental distress reflect a worsening during COVID-19 or reflect pre-pandemic baselines,” Dr. Myran told Medical News Today. “In addition, most surveys have low response rates, which raises concerns that their results may not represent the overall mental health of physicians.”

The team addressed this by taking an alternative approach, looking at changes in mental health care-related visits that physicians made during the pandemic. “Because we were able to follow mental health visits before and during the pandemic, we were able to quantify how visits changed over time,” Dr. Myran explained.

Dr. Myran and his team conducted a population-based cohort study of 34,055 physicians, fellows, and residents registered with the College of Physicians and Surgeons of Ontario between 1990 and 2018. All study participants were eligible for the Ontario Health Insurance Plan. The researchers collected the data from the Ontario Health Insurance Plan from March 2017 to March 2021.

During the study, researchers examined all in-person and virtual outpatient visits via telemedicine to either a psychiatrist or primary care physician. Researchers considered all psychiatry visits mental health or substance use-related medical visits. In their study, the team also included any visits to a primary care physician that included a diagnostic or fee code related to mental health or substance use.

The research team also investigated specific demographic characteristics, including:

  • age
  • sex
  • residence, whether urban or rural
  • previous mental health history

According to the study, data on race and ethnicity was not available. And the researchers also looked at the data by physician specialty to see if a specific area of the healthcare industry was more prone to mental health concerns.

According to the study results, physicians participated in 29,460 mental health visits during the first year of the COVID-19 pandemic.

This is almost a 26{cfdf3f5372635aeb15fd3e2aecc7cb5d7150695e02bd72e0a44f1581164ad809} increase compared to the 23,574 mental health care visits physicians made the year prior.

When looking at mental health visits, researchers found anxiety was a frequent cause in both the first year of COVID-19 and the year before. Indeed, anxiety visit frequency increased during the first year of COVID-19 from 66.5{cfdf3f5372635aeb15fd3e2aecc7cb5d7150695e02bd72e0a44f1581164ad809} to 69.1{cfdf3f5372635aeb15fd3e2aecc7cb5d7150695e02bd72e0a44f1581164ad809}.

Researchers found that drug and alcohol-related visits saw a slight decline to 5.8{cfdf3f5372635aeb15fd3e2aecc7cb5d7150695e02bd72e0a44f1581164ad809} during the first year of COVID-19 from 7.4{cfdf3f5372635aeb15fd3e2aecc7cb5d7150695e02bd72e0a44f1581164ad809} the year before.

When looking at demographic information, researchers reported female medical professionals and healthcare workers in urban areas had a larger percentage of mental health and substance use visits. And among physician specialties, psychiatrists had the highest number of mental health care visits during the first year of COVID-19, while surgeons had the lowest.

The research team also reported that physicians without a history of mental health issues or substance misuse had the largest increase in the rate of visits compared to physicians with such a history. “This finding may reflect how the pandemic created new and highly stressful challenges for physicians,” Dr. Myran explained.

“These challenges may have caused a deterioration in the mental health of doctors who otherwise never would have needed care.”

“Another possibility is that changes in how health services were offered during COVID-19 — offering virtual mental health care — decreased important barriers to access for some physicians who used this opportunity to seek care for preexisting mental health concerns that they had never sought treatment for before,” Dr. Myran added.

In general, Dr. Myran believes the increased access to virtual options through telemedicine may partially explain the overall increase in mental health visits during the COVID-19 pandemic. “Physicians with mental health concerns that pre-dated COVID-19 may have used these services during the pandemic, as they were more accessible and less visible, reducing concerns over stigma,” he said.

Dr. Myran feels this research helps support the continuation of virtual mental health and substance use medical care for healthcare workers.

“While we suspect that much of the increase in visits during the pandemic is related to increased stressors and challenges, some of this increase may be related to better mental health access and reduced stigma.”

– Dr. Myran

“Ongoing access to virtual care services may be an important component of a post-pandemic mental health strategy aimed at improving the mental health of physicians and health care workers.”

Dr. Ken Duckworth, chief medical officer of the National Alliance on Mental Illness (NAMI), agrees. “It doesn’t surprise me that doctors are taking advantage of (teletherapy) — there’s probably no time in the middle of a busy day to see a mental health practitioner,” he told MNT.

“The pandemic represented this tremendous switch being flipped towards the understanding that teletherapy is a safe way to deliver effective care. Teletherapy is the silver lining to this really dark cloud we’re dealing with.”

Dr. Duckworth views this study’s findings as positive, as they show a change in the “old school” mentality that doctors would ever need or require help. “The idea of physicians accepting help, discussing their vulnerabilities, taking care of themselves under stress, so they can take good care of other people is to me, a very positive development,” he said.

“The stressors of the pandemic are clear — they impact anybody who’s in a frontline role. I would be very distressed if the finding was that physicians in the context of the pandemic were not seeking mental health and addiction support.”

As for the next steps, Dr. Myran plans to look at the time after the start of the COVID-19 pandemic. “Our study only looked at the first year of the pandemic, but the situation now is very different than it was a year ago,” he said.

“We plan on continuing to understand the longer-term changes in mental health visits in physicians during the pandemic. We are also interested in understanding predictors of mental health care use by physicians so that services and interventions can be better targeted to meet physician needs.”

Dr. Duckworth added he would like to see a study of this type conducted for United States physicians. And for frontline workers seeking mental health resources, he suggests visiting the Frontline Wellness section of NAMI’s website for free, confidential resources for all frontline workers, including healthcare professionals.

Alzheimer’s and severe COVID-19: Comparing brain damage markers

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Healthcare worker Demetra Ransom comforts a person with COVID-19 at United Memorial Medical Center in Houston, Texas, on December 4, 2020. MARK FELIX/Getty Images
  • A study demonstrated that participants hospitalized with COVID-19 experiencing neurological complications had higher levels of blood proteins or biomarkers associated with neurological damage than people with Alzheimer’s.
  • Increased biomarker levels correlated with COVID-19 severity, mortality risk, and the presence of neurological disorder.
  • Long-term follow-up is necessary to determine if biomarker elevation is associated with an increased risk of developing subsequent neurodegenerative disorders.

COVID-19, the disease that a SARS-CoV-2 infection causes, often brings on mild upper respiratory symptoms. However, some individuals may experience severe illness requiring hospitalization. This can occur due to pneumonia and lung damage causing respiratory failure.

In addition, neurological manifestations commonly occur in people hospitalized with COVID-19. Neurological disorders may include encephalopathy, seizures, stroke, encephalitis, Guillain-Barré syndrome, and acute demyelinating encephalomyelitis.

Researchers at NYU Grossman School of Medicine conducted a study that investigated whether people with COVID-19 experiencing new-onset neurological complications during hospitalization had elevated blood markers indicating neurological damage.

The investigators published study results in the journal Alzheimer’s and Dementia.

Dr. Thomas Wisniewski, M.D., a co-author of the study, professor of neurology, pathology, and psychiatry, and director of both the NYU Alzheimer’s Disease Research Center and the Center for Cognitive Neurology, spoke about the study in an MNT interview.

He explained: “It’s clear that the [SARS-CoV-2] virus has a propensity for inducing vascular damage, targeting in the endothelial cells, and causing disruption of the blood-brain barrier, as well as inducing generalized neuroinflammation. Cytokines like interleukin 6 and interleukin 1 are much elevated in [individuals with COVID-19], and these are cytokines that drive neurodegeneration and Alzheimer’s disease.”

Cytokines are proteins that help the body’s cells to communicate.

Dr. Wisniewski added, “In our study, we became interested in looking at these types of biomarkers, [since these biomarkers] are what we follow in our Alzheimer’s disease research center for looking at the progression of Alzheimer’s-related pathology and other neurodegenerative disorders.”

In an interview with MNT, Jennifer Bramen, Ph.D., a senior research scientist at the Pacific Neuroscience Institute at Providence Saint John’s Health Center in Santa Monica, CA, who was not involved in the study, described the seven biomarkers the study measured:

  • Total tau and pTau181 are indicators of neuron damage. Their levels increase as AD progresses. In AD, abnormal proteins form tangles, blocking the communication between brain cells, she explained.
  • Ubiquitin C-terminal hydrolase L1 (UCHL1) is an enzyme that breaks down unnecessary proteins in brain cells. Brain injury or neurodegenerative diseases such as AD cause levels of UCHL1 to increase.
  • Increased glial fibrillary acidic protein (GFAP) levels indicate damage to the glial cells. Glial cells help maintain the health of brain cells and the blood-brain barrier, which filters toxic substances.
  • Neurofilament light chain (NfL) measures damage to axons of myelinated neurons. The axon is the part of the neuron that conducts electricity, and myelin is the insulation surrounding the neuron.
  • Amyloid-β (Aβ) 40 and 42 are proteins that build up and cause the formation of amyloid plaques in AD, which disrupt brain cell function and communication.
  • Lastly, a person’s pTau181 to Aβ42 ratio may identify early stages of AD.

Investigators also attempted to determine the association of increased biomarkers with rates of discharge to home and in-hospital death rates.

To assess the level of injury, the researchers compared serum biomarker levels of a control group of participants who had “normal” cognition, mild cognitive impairment (MCI), and AD with the biomarkers of people during hospitalization with COVID-19 and new neurological findings.

Researchers conducted a retrospective analysis of participants enrolled in the Study of Neurologic and Psychiatric Events in Acute COVID-19 (SNaP Acute COVID study), which examined serum samples people gave during their hospitalization for COVID-19.

Dr. Wisniewski explained, “We specifically excluded patients who have a preexisting cognitive disorder, any sort of dementia, or mild cognitive impairment, [to prevent clouding of the results].”

The SNaP Acute COVID study was a prospective study of 4,491 participants conducted in four New York hospitals between March 10 and May 20 of 2020, which evaluated the development of new neurological events during acute COVID-19 hospitalization.

The non-COVID control group comprised blood samples from the NYU Alzheimer’s Disease Research Center clinical core cohort banked before January 1, 2020. This was the date of the first reported COVID-19 cases in New York City. The researchers used validated testing tools — version three of the Uniform Data Set and the Clinical Dementia Rating — to stratify the control participants into three subgroups: normal cognitive functioning, MCI, and AD.

The study measured blood markers using an ultrasensitive testing methodology called single-molecule array technology.

The COVID-19 group consisted of 251 participants with a median age of 71. This group was 63{cfdf3f5372635aeb15fd3e2aecc7cb5d7150695e02bd72e0a44f1581164ad809} male. There were 161 participants in the control group with a median age of 71. Participants in the control group were 35{cfdf3f5372635aeb15fd3e2aecc7cb5d7150695e02bd72e0a44f1581164ad809} male.

The most common neurological complications included toxic metabolic encephalopathy (TME) in 63{cfdf3f5372635aeb15fd3e2aecc7cb5d7150695e02bd72e0a44f1581164ad809} of participants and brain injury due to reduced oxygen or blood flow in 46{cfdf3f5372635aeb15fd3e2aecc7cb5d7150695e02bd72e0a44f1581164ad809}.

The severity of COVID-19 correlated most strongly with total tau, pTau181, and NfL levels.

Higher GFAP and pTau181/Aβ-42 levels were associated with a significantly increased risk of death during hospitalization. Results showed that elevated levels of total tau, NfL, and GFAP corresponded to decreased discharge-to-home rates.

Those participants with COVID-19 who experienced new neurological events during hospitalization had significantly higher total tau, pTau181, NfL, and UCHL1, with the highest levels occurring in those with TME. The participants with COVID-19 had a 179{cfdf3f5372635aeb15fd3e2aecc7cb5d7150695e02bd72e0a44f1581164ad809} percent higher NfL, 73{cfdf3f5372635aeb15fd3e2aecc7cb5d7150695e02bd72e0a44f1581164ad809} higher GFAP, and 13{cfdf3f5372635aeb15fd3e2aecc7cb5d7150695e02bd72e0a44f1581164ad809} higher UCHL1 level than the AD group.

Dr. Wisniewski commented:

“In the study, we found very marked elevations of these seven biomarkers, indicating [the] significant presence of neurodegeneration, neuronal death, and gliosis. With marked neurodegeneration, neuroinflammation, and — at least at one time point — elevation of Alzheimer’s disease biomarkers, each […] correlated with the presence of neurological disease and the severity of infection as well as the outcome.”

Dr. Braman stated: “One limitation is that [the study] is only looking at hospitalized patients, so it’s still not clear if these biomarkers might be present in patients with less severe COVID-19 symptoms. Future research would be [needed] to understand how long lasting these effects are and how much they link up with actual cognitive deficits.”

Dr. Wisniewski agreed:

“We have been following these patients for 6 months and one year […] and there was the persistence of cognitive dysfunction [in up to 50{cfdf3f5372635aeb15fd3e2aecc7cb5d7150695e02bd72e0a44f1581164ad809} of these folks]. Hence, it’s important to follow this up. [P]erhaps biomarker findings speak of an increased risk of subsequent neurodegenerative disorders in this population.”

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