Organization: Public Health Agency of Canada
Cat.: HP5-139/2-2022E-PDF
ISBN: 978-0-660-44455-0
Pub.: 220313
Published: 2022-07-14
Publication date: July 14, 2022
On this page
- Overview
- What you need to know
- Quotes
Overview
- On July 14, 2022, the Public Health Agency of Canada (PHAC) released recommendations from the National Advisory Committee on Immunization (NACI) regarding the use of Moderna Spikevax COVID-19 vaccine in children 6 months to 5 years of age. This guidance is based on current evidence and NACI's expert opinion.
- On July 14, 2022, Health Canada authorized Moderna Spikevax (25 mcg) mRNA COVID-19 vaccine for use as a two dose primary series in children 6 months to 5 years of age. This is the first COVID-19 vaccine authorized in Canada for use in children under the age of 5.
- NACI reviewed clinical trial data on the safety, efficacy and immune response generated by Moderna Spikevax (25 mcg) COVID-19 vaccine in children 6 months to 5 years of age, as well as the spread and severity of COVID-19 in children under 5.
- For children 6 months to 5 years of age, NACI recommends that:
- A primary series of two doses of Moderna Spikevax (25 mcg) COVID-19 vaccine may be offered to children 6 months to 5 years of age who do not have contraindications to the vaccine, with a dosing interval of at least 8 weeks between the first and second dose. (Discretionary NACI recommendation)
- A primary series of three doses of Moderna Spikevax (25 mcg) COVID-19 vaccine may be offered to children 6 months to 5 years of age who are moderately to severelyimmunocompromised, with an interval of 4 to 8 weeks between each dose. (DiscretionaryNACI recommendation)
- At this time, Moderna Spikevax (25 mcg) COVID-19 vaccine should not routinely be given concurrently (i.e., same day) with other vaccines. (Strong NACI recommendation)
- As this is a newly authorized COVID-19 vaccine in this age group, NACI recommends that Moderna Spikevax (25 mcg) COVID-19 vaccine should be given 14 days before or after a different vaccine. This will help to determine if a potential side effect is due to Moderna Spikevax (25 mcg) COVID-19 vaccine or a different vaccine. A shorter interval between the administration of Moderna Spikevax (25 mcg) vaccine and a different vaccine may be warranted in some circumstances at the discretion of a health care provider.
For the full statement, including supporting evidence and rationale, please see NACI Statement: Recommendations on the use of Moderna Spikevax COVID-19 vaccine in children 6 months to 5 years of age.
For more information on NACI's recommendations on the use of COVID-19 vaccines, please refer to the COVID-19 vaccine chapter in the Canadian Immunization Guide (CIG), as well as additional statements on the NACI web page.
What you need to know
- On July 14, 2022, Health Canada authorized Moderna Spikevax (25 mcg) COVID-19 vaccine as a two dose primary series for children 6 months to 5 years of age. The dose for this age group (25 mcg) is half the dosage of Moderna Spikevax (50 mcg) COVID-19 vaccine offered to children 6 to 11 years of age. This is the first COVID-19 vaccine authorized in Canada for use in children under the age of 5.
- When developing these recommendations, NACI reviewed clinical trial data on the safety, efficacy and immune response generated by Moderna Spikevax (25 mcg) COVID-19 vaccine in children 6 months to 5 years of age, as well as the spread and severity of COVID-19 in children under the age of 5.
- Most children who get COVID-19 have mild or asymptomatic disease; however, some children experience severe disease and require hospitalization.
- Children who have had COVID-19 are at risk of experiencing multisystem inflammatory syndrome in children (MIS-C), a rare but serious complication from COVID-19 that usually requires hospitalization.
- Children who have an underlying medical condition are at higher risk of severe outcomes from COVID-19, but severe disease and MIS-C can occur in any child, even those without an underlying condition.
- Studies from British Columbia and Quebec suggest that many children under the age of 5 have had COVID-19, with the majority of infections having occurred since Omicron became the dominant variant. It is not clear if these studies are generalizable to other parts of Canada.
- Previous SARS-CoV-2 infection provides some protection but studies in adults show that vaccination following infection provides stronger and longer-lasting protection.
- The clinical trial evaluating Moderna Spikevax (25 mcg) COVID-19 vaccine in children 6 months to 5 years of age took place in Canada and the United States when Omicron was the dominant variant.
- Clinical trial findings show that a Moderna Spikevax 25 mcg dose primary series produces an immune response in children under 5 years of age equivalent to the immune response seen in young adults 18 to 25 years of age who receive the 100 mcg dose primary series.
- Preliminary efficacy of the vaccine in preventing symptomatic COVID-19 when Omicron is the dominant variant is estimated at 50.6% in children 6 to 23 months of age and 36.8% in children 2 to 5 years of age starting 14 days after the second dose.
- There were no deaths or cases of severe COVID-19 or MIS-C among trial participants that received Moderna Spikevax (25 mcg) COVID-19 vaccine. As such, it was not possible to evaluate efficacy against severe COVID-19 or MIS-C.
- Real world evidence shows that in older age groups, mRNA COVID-19 vaccines are highly effective at preventing severe COVID-19 outcomes. Efficacy estimates of Moderna Spikevax (25 mcg) vaccine against symptomatic disease during the Omicron wave in children aged 6 months to 5 years are consistent with efficacy of Pfizer-BioNTech Comirnaty (10 mcg) vaccine among children 5 to 11 years of age during the Omicron wave. mRNA vaccines are also highly effective at preventing hospitalization due to MIS-C in adolescents.
- Clinical trial data show that Moderna Spikevax (25 mcg) COVID-19 vaccine was well tolerated in children 6 months to 5 years of age. No safety signals were reported in the trial. It is important to note that due to the size of the trial, it is unlikely that adverse events that occur at a frequency less often than 6 in 10,000 people would be detected. NACI, Health Canada and PHAC will continue to closely monitor real world data from the use of this vaccine for potential rare and very rare side effects.
- For children who have already had COVID-19, NACI suggests waiting 8 weeks after the start of COVID-19 symptoms or a positive COVID-19 test before beginning or continuing the primary series. This interval may be shortened to 4 weeks for children who are moderately to severely immunocompromised.
- Both Moderna Spikevax (25 mcg) COVID-19 vaccine and Pfizer-BioNTech Comirnaty COVID-19 vaccine (10 mcg) are authorized for children who are 5 years of age. Please see the full statement and the COVID-19 vaccine chapter in the Canadian Immunization Guide for guidance on vaccines that are recommended for children who are 5 years of age and for children who turn 6 after the first dose of their primary series.
- NACI will continue to monitor the safety and effectiveness of Moderna Spikevax (25 mcg) COVID-19 vaccine in children 6 months to 5 years of age and will update guidance as needed.
For the full statement, including supporting evidence and rationale, please see NACI Statement: Recommendations on the use of Moderna Spikevax COVID-19 vaccine in children 6 months to 5 years of age.
For more information on NACI's recommendations on the use of COVID-19 vaccines, please refer to the COVID-19 vaccine chapter in the Canadian Immunization Guide (CIG), as well as additional statements on the NACI web page.
Quotes
"NACI is further expanding COVID-19 vaccine recommendations to include children six months to 5 years of age. While most children in this age group have relatively mild disease, some do experience severe illness, especially those with underlying medical conditions. NACI has carefully reviewed the available evidence, and recommends that vaccine may be offered to these young children using a similar approach as older age groups in terms of interval between doses, or interval between infection and doses. We expect that these recommendations will come as a relief to many parents who have been waiting for these vaccines to become available to protect their youngest children."
(Video) Feb 4, 2022 ACIP Meeting - VSD & Updates to Clinical Considerations- Dr. Shelley Deeks, NACI Chair
"I welcome this advice from NACI on the use of the Moderna Spikevax COVID-19 vaccine for children aged 6 months to 5 years. Most children who are infected with the SARS-CoV-2 virus that causes COVID-19 have mild or no symptoms of the illness. However, some children experience severe COVID-19 disease and require hospitalization. Children who get COVID-19 can also develop a rare but serious condition called multisystem inflammatory syndrome in children (MIS-C) and while evidence in this age group is limited, may be at risk of post-COVID-19 condition (also known as long COVID). The availability of the Moderna Spikevax COVID-19 vaccine for children aged 6 months to 5 years provides families with a vaccine option to help protect their young children from COVID-19. It is very important that all children and their caregivers are supported during the decision-making process and that their decisions related to COVID-19 vaccination are respected. Health Canada, the Public Health Agency of Canada and the National Advisory Committee on Immunization will closely monitor the domestic and international rollout of the vaccine in young children."
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FAQs
How serious is COVID-19 usually for most children? ›
For most children and young people, these illnesses will not be serious, and they will soon recover following rest and plenty of fluids.
Is AstraZeneca COVID-19 vaccine recommended for children? ›COVID-19 Vaccine AstraZeneca is not recommended for children aged below 18 years. No data are currently available on the use of COVID-19 Vaccine AstraZeneca in children and adolescents younger than 18 years of age.
Who are at higher risk of developing serious illness from COVID-19? ›Older people, and those with underlying medical problems like cardiovascular disease, diabetes, chronic respiratory disease, and cancer are more likely to develop serious illness.
How many doses of the COVID-19 vaccine do 16 year olds need? ›The NHS is offering COVID-19 vaccine to some children and young people. This includes those aged 12 to 17 years who need 2 doses of the vaccine 12 weeks apart or 8 weeks apart if at increased risk. All young people aged 16 and 17 years and at risk children aged 12 to 15 will be offered a booster dose 12 weeks after the second dose.
Has Canada dropped all COVID-19 restrictions? ›Canada announced on Monday that it would remove all remaining coronavirus entry restrictions, including testing and quarantine requirements, effective Oct. 1, ending some of the worlds longest and most stringent rules.
Is there a COVID-19 vaccine for the 17 year old in the UK? ›At this time, the Pfizer-BioNTech BNT162b2 vaccine is the only vaccine authorised for persons aged 12 to 17 years in the UK. The Conditional Marketing Authorisation for Pfizer-BioNTech BNT162b2 came into effect on 9 July 2021, with approval previously being provided under Regulation 174.
How can I book a COVID-19 vaccine appointment? ›Please use the NHS website first. If you cannot use the NHS website, you can phone 119 free of charge. You can ask someone else to do this for you if you prefer.
Can I get COVID-19 from my pet? ›COVID-19 in the UK is spread between humans. There is limited evidence that some animals, including pets, can become infected with SARS-CoV-2 (the virus that causes COVID-19) following close contact with infected humans.
Can you take ibuprofen if you have the coronavirus disease? ›Patients can take paracetamol or ibuprofen when self-medicating for symptoms of COVID-19, such as fever and headache, and should follow NHS advice if they have any questions or if symptoms get worse.
Are respiratory symptoms of a COVID-19 or any other infection common in children during the winter months? ›Respiratory infections are common in children and young people, particularly during the winter months. Symptoms can be caused by several respiratory infections including the common cold, COVID-19 and RSV.
How does the AstraZeneca COVID-19 vaccine work? ›
COVID-19 Vaccine AstraZeneca stimulates the body's natural defences (immune system). It causes the body to produce its own protection (antibodies) against the virus. This will help to protect you against COVID-19 in the future. None of the ingredients in this vaccine can cause COVID-19.
Can excess weight increase risk of serious illness from COVID-19? ›Excess fat can affect the respiratory system and is likely to affect inflammatory and immune function. This can impact people’s response to infection and increase vulnerability to severe symptoms of COVID-19. Obese people may be less likely to access healthcare and support, and it is also thought that COVID-19 affects other diseases associated with obesity.
Are smokers at risk to the coronavirus disease? ›A small but highly impactful survey from China finds that smokers with COVID-19 are 14 times more likely to develop severe disease. In addition, the repetitive hand to mouth movement provides an easy route of entry for the virus, putting smokers at greater risk of contracting COVID-19.
Does obesity increase the risk of getting the COVID-19? ›The current evidence does not suggest that having excess weight increases people’s chances of contracting COVID-19. However, the data does show that obese people are significantly more likely to become seriously ill and be admitted to intensive care with COVID-19 compared to those with a healthy BMI.
How long after COVID-19 can you get booster? ›You will still need the booster but you should wait at least 4 weeks from your COVID-19 infection.
Is Pfizer COVID-19 booster safe? ›Yes, booster shots are proven to be safe. Pfizer released a study of 10,000 participants in which half of them received a booster dose and half a placebo. In terms of safety, they found no new adverse events, meaning it was consistent with what has been seen in previous studies.
Could COVID-19 vaccine affect menstrual cycle? ›The findings of this study suggest that COVID-19 vaccination can lengthen the menstrual cycle and that this effect may be mediated by ovarian hormones. However, importantly, it found that the menstrual cycle returns to its pre-vaccination length in unvaccinated cycles.
Does the NHS COVID-19 app identify me? ›The app does not identify you or your location to other app users.
Is COVID-19 still a pandemic? ›With over 1 million deaths this year alone, the pandemic remains an emergency globally and within most countries. "The COVID-19 summer wave, driven by Omicron BA.4 and BA.5, showed that the pandemic is not yet over as the virus continues to circulate in Europe and beyond," a European Commission spokesperson said.
Can I go abroad if I don't have the COVID-19 vaccine? ›If you have not been fully vaccinated, you should continue to follow the entry requirements of the country you are travelling to, such as proof of a negative COVID-19 test on arrival. You should carefully research the requirements of your destination country before travelling.
Can I develop immunity to COVID-19 after testing positive for PCR? ›
If you have previously tested positive for COVID-19, you will probably have developed some immunity to the disease. However, it cannot be guaranteed that everyone will develop immunity, or how long it will last. It is possible for PCR tests to remain positive for some time after COVID-19 infection.
How many doses of the COVID-19 vaccine do 16 year olds need? ›The NHS is offering COVID-19 vaccine to some children and young people. This includes those aged 12 to 17 years who need 2 doses of the vaccine 12 weeks apart or 8 weeks apart if at increased risk. All young people aged 16 and 17 years and at risk children aged 12 to 15 will be offered a booster dose 12 weeks after the second dose.
How serious is COVID-19 usually for most children? ›For most children and young people, these illnesses will not be serious, and they will soon recover following rest and plenty of fluids.
Is AstraZeneca COVID-19 vaccine recommended for children? ›COVID-19 Vaccine AstraZeneca is not recommended for children aged below 18 years. No data are currently available on the use of COVID-19 Vaccine AstraZeneca in children and adolescents younger than 18 years of age.
What is the Yellow Card scheme for the COVID-19 vaccine? ›The Yellow Card scheme is a mechanism by which anybody can voluntarily report any suspected adverse reactions or side effects to the vaccine. It is very important to note that a Yellow Card report does not necessarily mean the vaccine caused that reaction or event.
Who might be at higher risk of becoming ill with COVID-19? ›People who are at higher risk from COVID-19 and other respiratory infections include: Older people. Those who are pregnant. Those who are unvaccinated. People of any age whose immune system means they are at higher risk of serious illness. People of any age with certain long-term conditions.
Is AstraZeneca COVID-19 vaccine recommended for children? ›COVID-19 Vaccine AstraZeneca is not recommended for children aged below 18 years. No data are currently available on the use of COVID-19 Vaccine AstraZeneca in children and adolescents younger than 18 years of age.
Is Pfizer COVID-19 booster safe? ›Yes, booster shots are proven to be safe. Pfizer released a study of 10,000 participants in which half of them received a booster dose and half a placebo. In terms of safety, they found no new adverse events, meaning it was consistent with what has been seen in previous studies.
How many doses of the COVID-19 vaccine do 16 year olds need? ›The NHS is offering COVID-19 vaccine to some children and young people. This includes those aged 12 to 17 years who need 2 doses of the vaccine 12 weeks apart or 8 weeks apart if at increased risk. All young people aged 16 and 17 years and at risk children aged 12 to 15 will be offered a booster dose 12 weeks after the second dose.
Is there a COVID-19 vaccine for the 17 year old in the UK? ›At this time, the Pfizer-BioNTech BNT162b2 vaccine is the only vaccine authorised for persons aged 12 to 17 years in the UK. The Conditional Marketing Authorisation for Pfizer-BioNTech BNT162b2 came into effect on 9 July 2021, with approval previously being provided under Regulation 174.
Do smokers suffer from worse COVID-19 symptoms? ›
Early research indicates that, compared to non-smokers, having a history of smoking may substantially increase the chance of adverse health outcomes for COVID-19 patients, including being admitted to intensive care, requiring mechanical ventilation and suffering severe health consequences.
Could COVID-19 vaccine affect menstrual cycle? ›The findings of this study suggest that COVID-19 vaccination can lengthen the menstrual cycle and that this effect may be mediated by ovarian hormones. However, importantly, it found that the menstrual cycle returns to its pre-vaccination length in unvaccinated cycles.
How long do COVID-19 booster side effects last? ›Like all medicines, the COVID-19 vaccines can cause side effects, but not everyone gets them. Most side effects are mild and should not last longer than a week, such as: a sore arm from the injection.
Does the NHS COVID-19 app identify me? ›The app does not identify you or your location to other app users.
Has Canada dropped all COVID-19 restrictions? ›Canada announced on Monday that it would remove all remaining coronavirus entry restrictions, including testing and quarantine requirements, effective Oct. 1, ending some of the worlds longest and most stringent rules.
What is the Ronapreve? ›Ronapreve is the first neutralising antibody medicine specifically designed to treat COVID-19 to be authorised by the Medicines and Healthcare products Regulatory Agency (MHRA) for use in the UK.