The following questions and answers have been developed by the National Immunisation Office.
What is the latest recommendation from the National Immunisation Advisory Committee (NIAC) for COVID-19 vaccine Comirnaty® Omicron XBB.1.5 mRNA vaccine?
NIAC recommend that COVID-19 vaccine Comirnaty® Omicron XBB.1.5 is the preferred COVID-19 vaccine for Primary and booster Immunisation against SARS-CoV-2 infection.
Comirnaty® Omicron XBB.1.5 30 micrograms is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2, in individuals 12 years of age and older.
Comirnaty® Omicron XBB.1.5 10 micrograms is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2, in individuals 5 to 11 years of age inclusive.
Comirnaty® Omicron XBB.1.5 3 micrograms is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2, in individuals 6 months to 4 years of age inclusive.
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What Primary immunisation schedule does NIAC now recommend for ALL COVID-19 vaccines for all those aged 5 and above for vaccination against SARS-CoV-2 infection?
For those aged 5 years and above the recommended primary schedule now consists of a single dose of age-appropriate COVID-19 mRNA vaccine.
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What COVID-19 Primary immunisation schedule does NIAC now recommend for all those aged 6 months to 4 years?
For those aged 6 months to 4 years the recommended primary schedule now consists of: a. two doses of age-appropriate COVID-19 mRNA vaccine for those with no prior history of SARS-CoV-2 infection. b. a single dose of age-appropriate COVID-19 mRNA vaccine for those with a prior history* of SARS-CoV-2 infection.
*Prior history of COVID-19 can be confirmed by any of; positive PCR test, antigen test or clinical diagnosis. For example, a single dose primary series could be considered in a child who had symptoms consistent with COVID-19 at a time when household contacts tested positive.
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What Primary immunisation schedule of COVID-19 vaccine does NIAC now recommend for all those with immunocompromise?
For those with immunocompromising conditions aged 6 months and older, the recommended primary series consists of two doses of an age-appropriate COVID-19 vaccine with an interval of 4 weeks between doses*.
A third dose may be administered following instruction from a relevant specialist physician. **The interval recommended is an eight weeks interval between doses two and three, if three doses are required.
*A minimal interval of three weeks between dose 1 and dose 2 dose may be used if there is urgency to achieve protection.
**A minimal interval of 4 weeks between dose 2 and dose 3 may be used if there is urgency to achieve protection.
This minimum interval applies to the Comirnaty mRNA vaccines only.
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What are NIAC recommendations for booster COVID-19 vaccines?
NIAC recommend a Spring 2024 booster dose in specific at-risk groups
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Who is recommended a Spring 2024 COVID-19 vaccine booster?
- All those aged 80 years and older
- For those aged 70 to 79 years – they should have access to a spring COVID-19 vaccine following discussion with a health care provider (e.g., GP, pharmacist or vaccination centre) requesting vaccination
- those living in long term care facilities for older adults
- For those aged 5 years and above – all those with immunocompromise associated with a suboptimal response to vaccination
- The recommended interval for the Spring Booster is 6 months from a previous COVD-19 vaccine or infection as per the NIAC guidance; however, those eligible may be offered the spring booster at a 3 months interval after their last COVID-19 vaccine or infection to ensure they get their spring booster before the end of May.
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What are NIAC recommendations for Nuvaxovid® XBB.1.5 vaccine Protein Sub unit vaccine?
Nuvaxovid® XBB.1.5 vaccine is licensed for active immunisation to prevent COVID-19 in individuals 12 years of age and older. Nuvaxovid® XBB.1.5 vaccine is the only alternative COVID-19 vaccine (to mRNA Covid-19 vaccines) available. NIAC advise Nuvaxovid® XBB.1.5 vaccine can be offered for primary series in adults and children aged 12 years and above with a contraindication to a mRNA vaccine, or in those who choose not to receive a mRNA vaccine.
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What Primary series COVID-19 vaccine does NIAC now recommend for Nuvaxovid® XBB.1.5 vaccine?
- For immunocompetent adults and children aged 12 years and above, a single dose of Nuvaxovid® XBB.1.5vaccine is recommended.
- For those with immunocompromising conditions, 2 doses of Nuvaxovid® XBB.1.5vaccine should be administered with a four-week interval between dose one and dose two. If a third dose is required, following a recommendation by a specialist, there should be an interval of eight weeks between dose two and three.
The minimum interval cannot be used for Nuvaxovid® vaccine.
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Can Nuvaxovid® XBB.1.5 vaccine be administered if someone had pericarditis or myocarditis after an mRNA vaccine?
Myocarditis and pericarditis are very rare side effects of both mRNA vaccines and Nuvaxovid®, occurring predominantly after the second dose and in males under 30 years of age. Therefore, if a vaccinee has a history of myocarditis or pericarditis after an mRNA COVID-19 vaccine their Cardiologist should be consulted before offering another COVID-19 vaccine if required, including Nuvaxovid® XBB.1.5.
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Is Nuvaxovid® XBB.1.5 vaccine recommended in pregnancy?
As there is more limited experience of Nuvaxovid® XBB.1.5 in those who are pregnant, the vaccine should only be considered when the potential benefits outweigh the potential risks and when mRNA vaccines are contraindicated or declined.
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How is Nuvaxovid® XBB.1.5 vaccine presented?
Nuvaxovid® XBB.1.5 vaccine(manufacturer Novavax) is presented as a multidose vial which contain 5 doses of 0.5 mL per vial. Dilution is not required.
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What are the contraindications to Nuvaxovid® XBB.1.5 vaccine?
Anaphylaxis following a previous dose of the vaccine or any of its constituents including polysorbate 80.
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What are the precautions to Nuvaxovid® XBB.1.5 vaccine?
- Acute severe illness; defer until recovery.
- Previous history of myocarditis or pericarditis after any COVID-19 vaccine; seek specialist advice.
- Allow a four-week interval between mpox vaccine and subsequent Nuvaxovid® XBB.1.5. No interval is required between Nuvaxovid® XBB.1.5 and subsequent mpox vaccines.
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Can GPs or Pharmacists order Nuvaxovid® XBB.1.5 vaccine?
No, the Nuvaxovid® XBB.1.5 vaccineis only available from HSE clinics.
People need to have an appointment arranged by contacting HSELIVE at 1800700700.
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What are the latest recommendations regarding primary COVID-19 vaccination and booster COVID-19 vaccination in pregnancy?
Continuing evidence regarding mRNA COVID-19 vaccination during pregnancy has demonstrated it to be safe and effective. During pregnancy mRNA COVID-19 vaccination recommendation is all year and is not seasonal.
The primary schedule, now one dose may be given at any stage in pregnancy
For pregnant adolescents and adults, a COVID-19 booster vaccine once in pregnancy is recommended if it is more than six months since their previous COVID-19 vaccine or infection.
- COVID-19 vaccine can be given at any stage in pregnancy
- the COVID-19 vaccine booster is ideally given between 20-34 weeks’ gestation
- If it is more than 12 months since their previous COVID-19 vaccine or infection administration earlier in pregnancy should be considered.
For those who are pregnant and are immunocompromised, a second COVID-19 vaccine booster dose within the same pregnancy may be considered if six months has elapsed since their last booster dose or COVID-19 infection.
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Should unvaccinated people who have had COVID‐19 infection be offered COVID‐19 vaccine?
Yes. People who have had COVID‐19 infection should be offered COVID‐19 vaccines.
The primary vaccination course should be deferred until clinical recovery from COVID‐19 and at least four weeks after diagnosis or onset of symptoms, or four weeks from the first PCR positive specimen in those who are asymptomatic. Those with persisting symptoms post COVID-19 may be vaccinated unless there is evidence of recent clinical deterioration.
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What if somebody with immunocompromise is diagnosed with COVID‐19 infection after a first dose of vaccine of the primary vaccination series?
Those who are immunocompromised have had COVID-19 infection after their first dose of COVID-19 vaccine should be given the subsequent dose at least four weeks after diagnosis or onset of symptoms.
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What is the advice if someone has received a COVID-19 vaccine outside Ireland?
- Those who have documentary evidence of a complete COVID-19 vaccination course with a COVID-19 vaccine authorised by the FDA, MHRA or recommended by WHO should be considered fully vaccinated. For immunocompetent adults and children aged 5 years and above, if they have received one authorised COVID-19 vaccine already they are considered immune
- Those who have received a partial or complete course of COVID-19 vaccine not authorised by the FDA, MHRA or recommended by WHO should be offered a course of an EMA authorised COVID-19 vaccine. The minimum interval between the last COVID-19 vaccine dose and an EMA authorised COVID-19 vaccine is four weeks. For immunocompetent adults and children aged 5 years and above, a single dose of COVID-19 vaccine is recommended.
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What is the advice for timing of an mRNA booster dose in someone who has had a breakthrough infection since completing their primary vaccination course?
If a person has had laboratory confirmed (PCR) breakthrough COVID-19 infection/ antigen positive infection with symptoms since completion of their primary course, the mRNA seasonal booster dose should be deferred for at least 6 months. In exceptional circumstances a 3-month interval may be used.
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What is the advice for timing of a third vaccine dose (if recommended by a specialist) for an immunocompromised person who has had a breakthrough infection?
If those who are immunocompromised have SARS-CoV-2 infection more than seven days after the second vaccine dose, a third dose of the primary series is not required. They should proceed to their seasonal booster dose as per Table 5a.1 of the National Immunisation Advisory Committee (NIAC) Immunisation Guidelines for Ireland. For those with infection within seven days of their second dose they should complete the third dose after an interval of 8 week)
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What if a person becomes immunocompromised after receiving their seasonal COVID -19 vaccine booster dose - do they then need an additional dose as well?
No. Individuals with immune compromise at the time of primary COVID-19 vaccination may have a sub-optimal response to the vaccine. They may be recommended a third dose of the extended primary series if advised by their specialist to enhance their response to the primary vaccination course. It is a person’s condition at the time that they receive the primary vaccination course that determines whether or not they need an additional dose.
The immunocompromising conditions associated with a sub-optimal response to the primary vaccination course are shaded in blue in Table 5a.2 of the Immunisation Guidelines
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What if an mRNA seasonal booster dose is given before the minimum interval? Is there a need to repeat the dose?
If the vaccine is given before the minimum interval there is no evidence as to the safety and efficacy of giving a further dose under these circumstances. The dose should not be repeated.
The person (and their parents or guardian if less than 16 years old) should be advised regarding the error and the incident reported. The error should be reported to the HPRA.
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Is myocarditis or pericarditis after an mRNA vaccine or Nuvaxovid® vaccine a contraindication to having a further seasonal booster dose of these vaccines?
NIAC now advise that any person with a diagnosis of myocarditis or pericarditis after any COVID-19 vaccine should be referred to a Cardiologist for advice before proceeding with any further COVID-19 vaccination. Myocarditis is no longer a contraindication to further doses of either the mRNA or Nuvaxovid® vaccines but these vaccines may only be administered after a Cardiologist has reviewed the patient and recommended the vaccine.
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What if the vaccine leaks during administration?
If some of the vaccine leaks out of the syringe during administration this is not a valid dose. A further dose of the vaccine should be administered at a separate site at the same visit.
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What if a vaccine is given after the expiry date or after the use before or discard time?
If a vaccine is given after the expiry date or after the use before or discard date and time it is considered an invalid dose, and the dose should be repeated that day or as soon as possible.
This should be explained to the person and a correctly diluted dose of the vaccine should be given as soon as possible. This should be reported to HPRA and an incident report form completed.
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What if the whole multi-dose vial of vaccine is administered instead of the recommended dose?
Trial data showed that higher doses of vaccine were not harmful but the person is more likely to have a local reaction with very painful arms at injection site being reported.
Trial data showed that higher doses of the COVID-19 vaccines were not harmful but the person is more likely to have more local and systemic reactions (malaise, fatigue, myalgia, headache, arthralgia and fever) when a higher second dose was given.
The person should be reassured that this is not harmful but that they are more likely to experience the adverse events as above.
They should be given their next dose of vaccine according to the recommended schedule. This should be reported to HPRA and an incident report form completed.
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Does a woman who wishes to conceive need to leave any interval after getting COVID‐19 vaccines before getting pregnant?
It is not necessary to leave any interval after having the vaccine and becoming pregnant.
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Can COVID‐19 vaccines affect fertility?
There is no biologically plausible reason why the vaccines would affect fertility. The vaccines cannot interact with a person’s DNA. The EMA licensed documentation states that animal studies do not indicate direct or indirect harmful effects on fertility.
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Where can COVID‐19 vaccine be given in the event that a person cannot receive the vaccine in the deltoid muscle?
In the event that a person cannot receive the vaccine in the deltoid muscle, the vaccine can be given into the vastus lateralis muscle of the thigh.
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Can other vaccines be co-administered with COVID-19 vaccines for those aged 12 years and older?
Yes, other vaccines may be co-administered with COVID-19 vaccine or at any interval. If other vaccines are being given at the same time as COVID-19 vaccines it is preferable to give them in different limbs.
The exception to this is mpox (formerly known as monkeypox)/smallpox vaccine. There should be an interval of at least four weeks between mpox/smallpox vaccine and a subsequent COVID-19 vaccine because of the unknown risk of myocarditis. No interval is required between a COVID-19 vaccine and a subsequent mpox/smallpox vaccine (see Chapter 13a of the Immunisation Guidelines).
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This page was updated on 16 April 2024
