Canada·Coronavirus Brief

The latest on the coronavirus outbreak for Nov. 16

The latest on the coronavirus outbreak for November 16th.
Police officers in Vienna check the vaccination status of shoppers at the entrance of a store oon Tuesday after the Austrian government imposed a lockdown on the roughly two million people who are not fully vaccinated against the coronavirus disease. (Lisi Niesner/Reuters)

Moderna asks Health Canada to approve its COVID-19 vaccine for children 

Moderna has asked Health Canada to approve its COVID-19 vaccine, for children six to 11 years of age, the department announced on Tuesday.

A news release issued by Health Canada on Tuesday didn't give specific information about Moderna's pediatric version of its vaccine, known as Spikevax, but the company's clinical trials for children used two doses, given a month apart, that were each half the size of its adult shots.

In its release, Health Canada said it would "prioritize" its review of Moderna's submission, as it does with all COVID-19 vaccines, "while maintaining its high scientific standards for safety, efficacy and quality."

"Health Canada will only authorize the use of Spikevax in children if its independent and thorough scientific review of the data in the submission shows that the benefits of the vaccine outweigh the risks in this age group," the release said. "The assessment will include a detailed review of clinical trial results, as well as other evolving data and information about the health impacts of COVID-19 and variants of concern on children in Canada."

Moderna has said that in its trial of 4,753 participants, side effects were mostly mild to moderate in severity. The most common side effects were fatigue, headache, fever and injection site pain. The shots were 50 microgram doses, compared to the 10-microgram doses Pfizer-BioNTech recommends be administered at least three weeks apart for children.

Moderna's vaccine for young children has yet to be authorized anywhere in the world. The European Union's health regulators said last week they'd make a decision on it "in approximately two months" unless supplemental information came in, according to a statement from the European Medicines Agency (EMA).

The Massachusetts biotech company has yet to apply for U.S. authorization of its pediatric shot. Its application for use of its adult vaccine in those aged 12 to 17 was filed in the U.S. in June, but the company said last month that they were told regulators needed additional time to evaluate recent international analyses of the risk of heart inflammation in adolescents after vaccination.

That Moderna vaccine was approved in Canada for those 12 and older in September.

The U.S. three weeks ago became the first G7 country to approve a pediatric COVID-19 vaccine, giving the green light to the Pfizer-BioNTech product. Since that time, tracking from the Centers for Disease Control indicates that over 1.6 million American children under 12 have received a vaccine dose.

Pfizer's submitted its application to Health Canada on Oct. 18 for its vaccine for use in kids age five to 11. It would be one-third the size of the dose given to adults and kids 12 and older.

Last week, Health Canada's chief medical adviser said the agency's review of the pediatric Pfizer vaccine should be completed within "one to two weeks."

Several other countries are vaccinating kids under 12, but using China-produced vaccines.

From The National

COVID-19: Could Canadians kids be vaccinated by Christmas?

8 months ago
Duration 7:06
Ian Hanomansing talks to a virologist and pediatric infectious diseases physician about when Canadian children will get COVID-19 vaccines, parents' concerns and the Johnson & Johnson vaccine.

IN BRIEF

Pfizer signs deal to let generic drug companies make its COVID-19 antiviral pill

Pfizer Inc. has signed a deal with a UN-backed group to allow other manufacturers to make its experimental COVID-19 antiviral pill, a move that could make the treatment available to more than half of the world's population.

In a statement issued Tuesday, Pfizer said it would grant a licence for the antiviral pill to the Geneva-based Medicines Patent Pool, which would let generic drug companies produce the pill for use in 95 countries, making up about 53 per cent of the world's population.

"It's quite significant that we will be able to provide access to a drug that appears to be effective and has just been developed, to more than four billion people," Esteban Burrone, head of policy at the Medicines Patent Pool, said. Burrone estimated that other drugmakers would be able to start producing the pill within months.

In a similar deal with the Medicines Patent Pool announced in October, Merck agreed to let other drugmakers make its COVID-19 pill, molnupiravir, available in 105 poorer countries. The decisions by Pfizer and Merck to share stand in contrast to the refusal of Pfizer and other vaccine-makers to release their vaccine recipes for wider production.

Earlier this month, Pfizer said its clinical trial showed the pill cut the risk of hospitalization and death by between 85 and 89 per cent in people with mild to moderate coronavirus infections, if taken within three to five days of symptom onset. Independent experts recommended halting the company's study based on its promising results.

Pfizer said on Tuesday it filed a request or authorization with the U.S. Food and Drug for is pill, though as of this writing the drug was not listed in Health Canada's COVID-19 drug and vaccine applications database.

Since the pandemic erupted last year, researchers worldwide have raced to develop a pill to treat COVID-19 that can be taken at home easily to ease symptoms, speed recovery and keep people out of the hospital. At the moment, most COVID-19 treatments must be delivered intravenously or by injection.

Britain authorized Merck's COVID-19 antiviral pill earlier this month, and it is pending approval elsewhere, including in Canada.

The Pfizer and Merck trials largely involved unvaccinated participants, with British health officials indicating they would be studying its use in vaccinated individuals this week.

Read more on how the two pills compare and what questions remain regarding their use, courtesy of the health news website STAT.

World roundup: Portugal wary of European trend, U.S. far from out of the woods

Portugal has vaccinated 86 per cent of the country against the coronavirus, but its prime minister warned Tuesday that the latest infection surge across Europe compels the government to consider precautionary measures.

"We can't ignore the signs," Prime Minister Antonio Costa said. "The later we act, the greater the risk."

From roughly mid-September through the end of October, Portugal officially reported fewer than 1,000 new infections a day. The daily number of new cases is now climbing toward 2,000.

So far, daily deaths of people with COVID-19 remain in the single digits, and the number of infected patients requiring ICU treatment has been below 100 since mid-September.

Infection rates, deaths and hospitalizations are relatively low in Portugal compared with the rest of the European Union, and Costa said he does not expect a return to lockdowns. New restrictions on gatherings and rules on mask-wearing are possible, however.

Eastern Europe has been hit particularly hard of late (See chart further down this newsletter). Slovakia's hospitals are in a critical situation because of a surge in coronavirus infections and the government will decide on Thursday on tighter restrictions to limit access to services for unvaccinated people, Prime Minister Eduard Heger said.

The country of 5.5 million reported record daily cases of around 6,500 in recent days. The number of people in hospitals with COVID-19 jumped by 225 on Tuesday to 2,862, the Health Ministry said.

Slovakia is one of Europe's least vaccinated countries, with 45 per cent of the total population vaccinated compared to EU average of 64.9 per cent, according to data from the European Centre for Disease Prevention and Control.

While the U.S. overall is not seeing case totals as great as in September, it is still posting a 7-day average of over 1,000 deaths per day, with large portions of the Upper Midwest taking a hit.

The number of COVID-19 patients at a major hospital network in western Michigan is up 40 per cent since Nov. 1 as a fall surge pounds the state, officials there said Tuesday.

Spectrum Health reported 367 COVID-19 patients at its hospitals, a "dramatic" increase in recent weeks," said Dr. Darryl Elmouchi, president of Spectrum Health West Michigan. The seven-day test positivity rate was 22.6 per cent, the highest since the pandemic began in 2020, Elmouchi said.

The state health department on Monday that Michigan hospitalizations had surpassed 3,000 for the first time in over six months.

The state's website indicates that 59 per cent of the entire Michigan population has been fully vaccinated, although the state has several counties in which just 40-to-49 per cent have been vaccinated, with Cass County in southwestern Michigan at less than 39 per cent fully vaccinated.

Minnesota reported 10,913 new confirmed cases of COVID-19 and 51 new deaths on Tuesday. According to the CDC, no state in the past seven days has had a higher per capita rate of new cases.

More than 95 per cent of the state's available hospital beds were occupied as of Tuesday, which has caused backups in emergency departments and delays in getting treatment, according to health care providers. The state's intensive care units remained close to capacity, with only 46 ICU beds free.

The main reason for the grim numbers is that large segments of Minnesota's population remain unvaccinated, with some counties at the 40 per cent level, said Michael Osterholm, director of the Center for Infectious Disease Research and Policy at the University of Minnesota.

"There's still a lot of human wood out there to keep the virus burning," Osterholm said.

Today's graphic

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With files from Reuters, The Canadian Press, The Associated Press

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