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Pfizer officially requests Health Canada approval for kids' COVID-19 shot – CTV News

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OTTAWA —
Pfizer-BioNTech has asked Health Canada to approve the first COVID-19 vaccine for children aged five to 11 years old.

The vaccine was developed in partnership with Germany’s BioNTech and is now marketed under the brand name Comirnaty. It was authorized for people at least 16 years old last December, and for kids between 12 and 15 in May.

Pfizer already submitted clinical trial data for its child-sized dose to Health Canada at the beginning of the month. The company said the results were comparable to those recorded in the Pfizer-BioNTech study in people aged 16 to 25.

Health Canada said it will prioritize the review of the submission, while maintaining high scientific standards for safety, efficacy and quality, according to a statement from the department.

“Health Canada will only authorize the use of Comirnaty if the independent and thorough scientific review of all the data included in the submission showed that the benefits of the vaccine outweighed the potential risks in this age group,” the statement read.

The doses are about one-third the size given to adults and teens age 12 and up.

As soon as the regulator gives the green light, providers will technically be able to start offering the COVID-19 shot to kids, though new child-sized doses might need to be procured.

Pfizer has delivered more than 46 million doses to Canada to date, and an analysis of the available data on administration from provincial and federal governments suggests there are more than enough Pfizer doses already in Canada to vaccinate kids between five and 11 years old.

But simply pulling smaller doses from the vials Canada already had stockpiled across the country may not be advised, chief public health officer Dr. Theresa Tam said at a media briefing late last week.

“We also understand from Pfizer that this actual formulation has shifted, this is a next generation formulation, so that is something that needs to be examined by the regulator,” Tam said Friday.

Canada signed a new contract with Pfizer for pediatric doses last spring.

The Pfizer-BioNTech vaccine has also been tested on children as young as six months old. Topline data for children under five years old is expected as soon as the end of the year.

Health Canada said it expects to receive more data for review from Pfizer for younger age groups, as well as other manufacturers for various age ranges in the coming months.

The Public Health Agency of Canada has noted rare incidents of myocarditis, an inflammation of the heart muscle, after receiving an mRNA vaccine like Pfizer-BioNTech and Moderna.

As of Oct. 1, Health Canada has documented 859 cases associated with the vaccines, which mainly seem to affect people under 40 year old. On balance, the risk appears to be low, according to Tim Sly, a Ryerson University epidemiologist with expertise in risk management.

“Of course, no one considers any complication in a child to be acceptable, and a tremendous amount of caution is being taken to look for and identify all problems,” said Sly in a recent email exchange with The Canadian Press.

COVID-19 infection also produces a very high risk of other cardiovascular problems, he said.

Aside from protecting kids against more serious symptoms of COVID-19, the vaccine would also reduce the risk of a child passing the virus on to a vulnerable family member and make for a better school environment with less stress about transmission.

Once the vaccine is approved for kids, the National Advisory Committee on Immunization will weigh in on whether the benefits of the shot outweigh potential risks for young children.

This report by The Canadian Press was first published Oct. 18, 2021.

– With files from Mia Rabson

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Canadians, other foreigners will need COVID-19 test a day before flights to U.S. – CBC.ca

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The United States is making it mandatory next week for Canadians and other foreign visitors who arrive by air to get a COVID-19 test within 24 hours of their departure, regardless of their vaccination status, as part of a pandemic battle plan for the winter months.

U.S. President Joe Biden announced his administration’s plan on Thursday during a visit to the National Institutes of Health in Bethesda, Md.

The new travel rule on obtaining a negative COVID-19 test will take effect on Monday at 12:01 a.m. ET, sources briefed on the matter said.

Currently, international air travellers are required to get a test within 72 hours of leaving for the U.S. A senior White House official who spoke on condition of anonymity told CBC News that the new protocol will not apply to those crossing the Canada-U.S. land border.

“We’re pulling out all the stops to get people maximum protection from this pandemic,” White House press secretary Jen Psaki told a briefing on Thursday in advance of Biden’s afternoon announcement.

Passengers arrive at John F. Kennedy International Airport In New York City on Nov. 8. By early next week, Canadians and all other foreign visitors who travel to the U.S. by air will need to get a COVID-19 test no later than 24 hours before their departure. (Eduardo Munoz/Reuters)

“Our view and belief, and the belief of our medical team, is that we have the tools to keep people safe. We’re executing on a robust plan that builds off of all the actions we’ve taken to date — we are not starting from scratch here.”

Fully vaccinated travellers entering the U.S. by land from Canada currently do not need to present a negative COVID-19 test, as long as they show proof of vaccination or attest to their vaccination status upon request by a border agent. That rule has been in place since the land border reopened to non-essential travel on Nov. 8.

In Canada, all those entering the country must provide proof of a negative COVID-19 molecular test result, taken within 72 hours of arrival by land or air.

However, since Nov. 30, the rule has been adjusted for Canadians who depart and re-enter Canada within 72 hours, meaning those taking trips of that duration or shorter no longer need proof of a negative COVID-19 test to return home.

WATCH | Travel Insurance, trip planning and the omicron variant: 

Travel Insurance, trip planning and the omicron variant

Travel insurance consultant Martin Firestone lays out what travellers should know about the latest travel restrictions. 4:48

Under the U.S. plan to combat the spread of COVID-19 over the winter months, the Transportation Security Administration is extending its mask mandates on transit through March 18. Passengers on domestic flights, trains and public transportation will be required to continue wearing face masks.

Other components of the 10-point U.S. strategy include:

  • A plan to expand access to booster shots, with a comprehensive outreach effort to convince nearly 100 million eligible Americans to get one.
  • New family vaccination clinics to provide a one-stop vaccination stop for entire households.
  • Accelerating the effort to safely vaccinate children under the age of five.
  • Expanding the availability of at-home test kits.
  • Rapid response teams to help with widespread omicron outbreaks.
  • Another 200 million COVID-19 vaccine doses donated internationally within the next 100 days.

Biden’s speech outlining the plan comes a day after the U.S. confirmed its first case of the omicron variant of the coronavirus in a traveller who arrived in San Francisco from South Africa on Nov. 22.

The new variant is “cause for concern but not panic,” Biden said.

More omicron cases reported

U.S. health officials confirmed a second case of the variant on Thursday in Minnesota. It involved a vaccinated man who had attended an anime convention just before Thanksgiving in New York City that drew an estimated 50,000 people. That would suggest the variant has begun to spread within the U.S.

In addition to the convention attendee, health officials in New York said tests showed five other people in the city recently infected with COVID-19 had the variant.

New York City Mayor Bill de Blasio said the geographic spread of the positive tests suggested the variant was undergoing “community spread” in the city and wasn’t linked to any one event.

Another U.S. case of the variant was reported Thursday in a Colorado woman who had recently travelled to southern Africa.

COVID-19 cases and deaths in the U.S. have dropped by about half since the delta variant peak in August and September, but at about 86,000 new infections per day, the numbers are still worrisomely high — especially heading into the holidays, when people travel and gather with family.

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U.S. to not reimburse private health insurers for covering at-home COVID test costs

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The U.S. government will not reimburse private health insurance companies for covering the cost of at-home COVID-19 tests, a White House official said on Thursday.

The Families First Coronavirus Response Act and the Coronavirus Aid, Relief, and Economic Security Act require coverage of diagnostic testing for COVID-19 without any cost-sharing requirements during the public health emergency,” the White House official said.

“The Departments of Health and Human Services, Labor and the Treasury will clarify that coverage of over-the-counter COVID-19 tests is generally subject to those provisions”, the official added.

 

(Reporting by Jeff Mason, writing by Kanishka Singh)

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Oil up on OPEC+ plan to meet ahead of schedule if Omicron dents demand

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Oil prices climbed on Friday, extending gains after OPEC+ said it would review supply additions ahead of its next scheduled meeting if the Omicron variant hits demand, but prices were still on course for a sixth week of declines.

U.S. West Texas Intermediate (WTI) crude futures rose 27 cents, or 0.4%, to $66.77 a barrel at 0122 GMT, adding to a 1.4% gain on Thursday.

Brent crude futures rose 12 cents, or 0.2%, to $69.79 a barrel, after climbing 1.2% in the previous session.

The Organization of the Petroleum Exporting Countries, Russia and allies, together called OPEC+, surprised the market on Thursday when it stuck to plans to add 400,000 barrels per day (bpd) supply in January.

However the producers left the door open to changing policy swiftly if demand suffered from measures to contain the spread of the Omicron coronavirus variant. They said they could meet again before their next scheduled meeting on Jan. 4, if needed.

That boosted prices with “traders reluctant to bet against the group eventually pausing its production increases,” ANZ Research analysts said in a note.

Wood Mackenzie analyst Ann-Louise Hittle said it made sense for OPEC+ to stick with their policy for now, given it was still unclear whether Omicron could resist existing vaccines.

“The group’s members are in regular contact and are monitoring the market situation closely,” Hittle said in emailed comments.

“As a result, they can react swiftly when we start to get a better sense of the scale of the impact the Omicron variant of COVID-19 could have on the global economy and demand.”

The market has been roiled all week by the emergence of Omicron and speculation that it could spark new lockdowns, dent fuel demand and spur OPEC+ to put its output increases on hold.

Brent was poised to end the week down about 4%, while WTI was on track for a 2% drop on the week, both down for a sixth straight week.

 

(Reporting by Sonali Paul; editing by Richard Pullin)

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