An announcement parents of young kids had been anticipating, on Thursday Health Canada announced the authorization of Moderna’s Spikevax mRNA COVID-19 vaccine for children between the ages of six months and five years old.
As the first COVID-19 vaccine to be given the green light for this age group in this country, 1.7 million children in Canada are now eligible to be vaccinated against COVID-19.
“This authorization comes at a critical time in the pandemic as we progress through the seventh wave,” Health Canada’s Chief Medical Adviser Dr. Supriya Sharma said Thursday. “And though children are less likely to experience complications from COVID-19, they can still get very sick.”
From how soon infants, toddlers and preschoolers could be receiving their shots, to what the dosages will be, CTVNews.ca takes a look at what parents need to know.
HOW SOON CAN THIS AGE GROUP BE VACCINATED?
While vaccine rollouts are the responsibility of provinces and territories, Deputy Chief Public Health Officer Dr. Howard Njoo told reporters on Thursday that based on provincial and territorial projections, there will be sufficient supply of the Moderna vaccine for children six months to five years of age with the rollout beginning soon.
“There’s been work behind the scenes and certainly we’re in a good position. My understanding is that there will be enough available vaccine, and they will be distributed to the provinces and territories so they can begin their programs to offer vaccination to young children in this age group very shortly,” Njoo said.
The federal government is suggesting parents check with local health authorities about when the vaccine will be available in their area.
HOW EFFECTIVE IS IT?
According to clinical trial data, the immune response from Moderna’s vaccine for children ages six months to five years old is comparable to the response seen in people between the ages of 18 and 25 years old.
Trials showed that beginning two weeks after the second dose, this vaccine was 37 per cent effective in trial participants ages two to five yeas old, and 51 per cent effective in those ages six to 23 months.
“The clinical trials were conducted when Omicron was the predominant variant circulated in Canada and the United States,” Sharma noted.
WHAT IS THE DOSAGE?
Health Canada has authorized a two-dose primary series of the Moderna vaccine, with each dose being 25 micrograms, delivered intramuscularly.
This is half the size of the dosage authorized for children ages six to 11, and one quarter of the dose authorized for those 12 years of age and older.
While Health Canada has authorized the shots to be given four weeks apart, the National Advisory Committee on Immunization (NACI) is recommending the doses be administered eight weeks apart in most cases.
For children who are six months to five years of age who are moderately or severely immunocompromised, NACI has issued a discretionary recommendation they be offered three doses, using an interval of four to eight weeks between each dose.
NACI also strongly suggests this Moderna vaccine not be given on the same day as other vaccines.
“This precaution will help determine if a side effect that may arise following immunization is due to the COVID-19 vaccine or a non-COVID-19 vaccine,” Njoo said. “There may be circumstances when it is necessary for a dose of this vaccine to be given at the same time as another vaccine, in which case a health-care provider can help with decision making.”
WHAT ARE THE SIDE EFFECTS?
According to Health Canada, there were no safety concerns identified through the clinical trials, though as is the case with other pediatric vaccines, side effects from the shot could be experienced.
The most common reactions are:
- Irritability or crying,
- Pain at the injection site,
- Sleepiness or fatigue, and;
- Loss of appetite
Some less common side effects are mild to moderate fever, swelling at the injection site, nausea, tender lymph nodes under the arm, headaches and muscle aches.
“The reactions were usually mild to moderate, resolving within a few days of vaccination,” Sharma said.
HOW LONG DID CANADA STUDY THIS?
Health Canada received Moderna’s application to expand the authorization of its COVID-19 vaccine to younger children on April 29, 2022.
This new authorization is the latest in a rolling series of expansions of eligibility for this vaccine.
Health Canada initially authorized Moderna’s vaccine for use in people 18 years of age and older in December 2020, subsequently authorized for children 12 to 17 years of age in August 2021, and then gave the green light to give the shorts to children six to 11 years old in March 2022.
CAN I READ MORE ABOUT THE DATA?
Yes. As has been the case with previous COVID-19 vaccine authorizations, Health Canada has published a series of documents related to the decision, including specific information about why the authorization was granted, what the clinical trials entailed and what the potential side effects are.
NACI has also published a full statement about its guidance, including supporting evidence and rationale for its recommendations, such as the impact of and risk factors associated with COVID-19 infections on this age group, as well as the ethics related to vaccinations in pediatric populations.
The authorization also comes with a requirement for Moderna to continue providing Health Canada with information about the safety and efficacy of this vaccine for the younger age group, including any cases of myocarditis and pericarditis.
WHAT ABOUT OTHER COVID-19 VACCINES?
So far, Moderna’s vaccine is the only COVID-19 shot authorized for children under the age of five.
Though, it may not be the only option for long.
On June 23, Pfizer-BioNTech filed a submission with Health Canada seeking authorization of its Comirnaty COVID-19 vaccine for children in this younger cohort.
That application is currently under review.
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