By Emerald Bensadoun
Health Canada’s chief medical adviser said Wednesday it was “within the realm of possibility” that Moderna’s novel coronavirus vaccine could be approved for children by 2021.
Dr. Supriya Sharma’s announcement came shortly after the federal government authorized the Moderna vaccine for use among Canadians aged 18 and older.
“It’s not unusual that first trials for any vaccines, or any medications for that matter, are actually done in adults,” she said.
According to Sharma, recruitment for trials for children aged 12 to 17 are already underway. “The plan is to recruit approximately 3,000 participants in that clinical trial, and that’s already started,” she said.
Pfizer-BioNtech is also planning to study the effects of its vaccine on children as young as five years old, which Sharma said will likely begin in the spring.
“Because we already have some data in adults, we don’t have to redo the huge Phase III trials with tens of thousands of individuals in those trials — we can use some of the data that we already have,” she explained.
“But it’s really, really important that we do have information for use in children before we would have any authorization or recommendations that may be used in the younger population.”
By the end of December, Canada will have access to up to 168,000 doses of Moderna’s coronavirus vaccine.
Colin Furness, an epidemiologist teaching at the University of Toronto, said testing a vaccine out on adults first is common procedure. “You don’t test on children right away, and this is true for a lot of medications,” he said.
“I wouldn’t expect any of the new vaccines to … have been tested on kids.”
Children are considered a vulnerable population, and Furness said it’s important to ensure the safety of a vaccine before subjecting kids to it.
Testing on children was more time-consuming and therefore more expensive, he explained, adding that ethics review boards are also “very cautious about enrolling vulnerable populations into these sorts of trials.”
Next, Furness said vaccine developers will be monitoring the reaction to their vaccines closely as doses roll out around the world, engaging in a so-called phase four.
“Once you’ve established safety in phase four, then you can circle back and say, ‘OK, now it’s time to start on kids,’” he said.
Moderna vaccine approved:
What we know about side effects, ingredients and doses
Canada has approved Moderna’s novel coronavirus vaccine.
Dr. Supriya Sharma, Health Canada’s chief medical adviser, says the country will receive up to 168,000 doses of the Moderna vaccine before the end of December, providing hope that the country will be able to begin transitioning back to some semblance of normal after a pandemic that has killed more than 1.7 million worldwide people so far.
Here’s what we know about the vaccine’s doses, side effects and ingredients.
How to administer the doses?
The Moderna COVID-19 vaccine is a two-dose series given approximately one month apart through a muscle injection. The doses inject a molecule called mRNA, which includes instructions for the body on how to produce antibodies to fight COVID-19, into a person’s upper arm.
Speaking to reporters on Wednesday, Sharma said the first dose of Moderna’s vaccine is expected to achieve around 80 per cent immunity to the virus, followed by a second dose 28 days later.
She said the immunity is expected to last for a “significant period of time” after both shots have been given, however, she added that “we wouldn’t recommend that there be a significant delay in that second dose.”
“We haven’t seen anything in the evidence that would show that there would be a significant decrease in immunity if that is delayed for a few weeks,” she said.
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“But again, we really don’t have the data to be able to say that, or to confirm that one way or the other.”
Moderna’s vaccine is more widely accessible than its competitor, Pfizer and BioNtech’s, she noted. It can be stored in regular freezers, as opposed to the -70 C refrigerators needed to safely store the Pfizer vaccine.
The vaccine has been authorized for use for Canadians aged 18 and older, but the Sharma said the federal government is currently conducting additional studies in children from 12 years of age and older.
Side effects
All vaccines can cause side effects, although Health Canada says most from Moderna’s vaccine are expected to be mild and shouldn’t last very long.
These include pain or swelling where the vaccine was injected, tiredness, headaches, muscle aches and stiffness, chills, fever, nausea or vomiting, and enlarged lymph nodes.
Signs of an allergic reaction will include hives, difficulty breathing and a swollen tongue, face or throat. Health Canada has advised anyone who believes they may be experiencing an allergic reaction to get medical attention “immediately.”
Canada to receive up to 168,000 doses of Moderna’s COVID-19 vaccine before year’s end’
Coronavirus: Canada to receive up to 168,000 doses of Moderna’s COVID-19 vaccine before year’s end
Coronavirus: Canada to receive up to 168,000 doses of Moderna’s COVID-19 vaccine before year’s end – Dec 23, 2020
What’s in the vaccine?
A full list of the vaccine’s ingredients:
Messenger ribonucleic acid (mRNA)
1,2-distearoyl-sn-glycero-3-phosphocholine (DSPC)
Acetic acid (also known as ethanoic acid)
Cholesterol
PEG2000 DMG (1,2-dimyristoyl-rac-glycerol,methoxy-polyethyleneglycol)
Lipid SM-102
Sodium acetate (a type of organic sodium salt)
Sucrose (a common sugar)
Tromethamine
Tromethamine hydrochloride
Water for injection
The federal government is advising anyone allergic to the “active substance” or any of the vaccine’s ingredients to take a pass on these doses and opt for the Pfizer vaccine instead.
Any Canadians who may have an allergy or are unsure of whether they fall into a risk group is encouraged to consult with a doctor on their vaccine options.
“If you have an allergy, a serious allergy, if you’ve had a serious allergy to a vaccine in the past or obviously if you have an allergy to this vaccine or… to any of the components of this vaccine, then you should not get it,” said Sharma.
Source: globalnews.ca
