FAQs COVID-19 Vaccine

The following questions and answers have been developed by the National Immunisation Office. 

What is the name of the new COVID-19 vaccine introduced in December 2023?

The National Immunisation Advisory Committee (NIAC) has recently recommended the introduction of the adapted COVID-19 vaccine Nuvaxovid® XBB.1.5 vaccineas a booster COVID-19 vaccine for individuals aged 12 years and older.

Back to top  

What is the licensed indication for Nuvaxovid® XBB.1.5 vaccine?

Nuvaxovid® XBB.1.5 vaccine is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2, in individuals 12 years of age and older.

Back to top  

What is NIAC recommendation for the vaccine?

The Nuvaxovid® XBB.1.5 vaccine should be used for booster vaccination only.

Back to top  

When should Nuvaxovid® XBB.1.5 vaccine be used as a booster COVID-19 vaccine?

NIAC advise if there is a contraindication or precaution to an adapted mRNA vaccine, or a person has chosen not to receive an mRNA COVID-19 vaccine, Nuvaxovid XBB.1.5 vaccine may be used as an alternate booster COVID-19 vaccine.

Back to top  

Can Nuvaxovid® XBB.1.5 (0.5ml) 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 booster COVID-19 vaccine, including Nuvaxovid XBB.1.5

Back to top  

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.

Back to top  

Is Nuvaxovid® XBB.1.5 vaccine under medicinal monitoring?

Yes, this medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions to the HPRA.

Back to top  

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.

Back to top  

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.

Back to top 

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.

Back to top  

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.

Back to top  

What are the common adverse events associated with Nuvaxovid® XBB.1.5 vaccine?

Local:

Very common: injection site pain, tenderness

Common: injection site erythema, swelling 

General:

Very common: arthralgia, fatigue, headache, malaise, myalgia, nausea, vomiting

Common: pyrexia, pain in extremity

Very Rare: Myocarditis and pericarditis

A full list of adverse reactions may be found in the Summary of Product Characteristics (SmPC) for Novavax® (Nuvaxovid) XBB.1.5. https://www.ema.europa.eu/en/documents/product-information/nuvaxovid-epar-product-information_en.pdf

Back to top  

Is VidPrevtyn Beta® vaccine still available?

No, VidPrevtyn Beta® protein subunit vaccine is no longer available.

Back to top  

Is Novavax® (Nuvaxovid) vaccine still available?

No, Novavax® (Nuvaxovid) original subunit vaccine is not available since 31 August 2023.

Back to top  

What new COVID-19 vaccine was introduced in September 2023?

The National Immunisation Advisory Committee (NIAC) recommended the introduction of the COVID-19 vaccine Comirnaty® Omicron XBB.1.5 30 micrograms (0.3ml) for those aged 12 years and older.

Back to top  

What kind of vaccine is Comirnaty® Omicron XBB.1.5?

Comirnaty® Omicron XBB.1.5 is an adapted COVID-19 mRNA vaccine.

Back to top  

What is the licensed indication for Comirnaty® Omicron XBB.1.5?

Comirnaty® Omicron XBB.1.5 30 micrograms (0.3ml) 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 should be used for booster vaccination only.

Back to top  

When should Comirnaty® Omicron XBB.1.5 vaccine be used as a booster COVID-19 vaccine?

Comirnaty® Omicron XBB.1.5 30 micrograms (0.3ml) vaccine is the preferred mRNA booster vaccine for those aged 12 years and older. If Comirnaty® Omicron XBB.1.5 vaccine is unavailable, then Comirnaty® Original/Omicron BA.4-5 vaccine for those aged 12 years and older may be used as an alternate booster vaccine (provided that no contraindications or precautions to receipt of mRNA vaccines are present).

Back to top   

What is the current recommended primary vaccination series schedule for mRNA COVID‐19 vaccines for anyone aged 12 to 29 years?

For those aged 12 to 29 years an interval of 8 weeks between the first and second doses of an mRNA COVID-19 vaccine is now recommended. A minimum interval of 3 weeks may be used if there is urgency to achieve protection.  Of note: Those aged under 30 years who receive the primary course at less than the recommended 8-week interval should be advised of the potential increased risk of myocarditis.

Back to top  

What is the current recommended primary vaccination course schedule for mRNA COVID‐19 vaccines for anyone aged 30 years and older?

For those aged 30 years and older an interval of 4 weeks between the first and second doses of an mRNA COVID-19 vaccine is recommended. A minimum interval of 3 weeks may be used if there is urgency to achieve protection.

Back to top  

What is the recommended primary vaccination series schedule for mRNA COVID‐19 vaccines for those with immunocompromise associated with a sub-optimal response to vaccination?

Recommended intervals for the extended primary series for those with immunocompromise aged 5 years and older:

Three doses, with a four-week interval between dose one and two, and eight weeks between dose two and dose three. i.e.:

  • An interval of 4 weeks between the first and second doses of an mRNA vaccine is now recommended (a minimum interval of three weeks may be used if there is urgency to achieve protection)
  • This is then followed by the additional dose (or third dose of the extended primary vaccination series). The additional dose should be given 8 weeks after the second vaccine dose (the minimum interval is 4 weeks).

Back to top  

What is the recommended interval for a first booster dose?

For those who are eligible and have not yet received a first booster COVID-19 vaccine dose, a first booster dose is recommended 4 months after the most recent COVID-19 vaccine dose or SARS-CoV-2 infection.

Back to top  

What is the recommended interval for a further booster vaccine (i.e. any booster vaccine after the first COVID-19 booster vaccine) for those aged 50 years and older?

In April 2023, the NIAC recommended an interval of 6 months (following any previous COVID-19 vaccine dose or infection) for a further booster of COVID-19 vaccine in Spring and Autumn 2023 for those aged 50 years and older who are eligible. In exceptional circumstances a 3-month interval may be used. 

The interval between the primary course and the 1st booster COVID-19 vaccine remains at 4 months.

Of note: For information on the recommended intervals in pregnancy please see the FAQ below entitled ‘What are the latest recommendations regarding primary COVID-19 vaccination and booster COVID-19 vaccination in pregnancy?’

Back to top  

What is the recommended interval for a further booster vaccine (i.e. any booster vaccine after the first COVID -19 booster vaccine) for those aged 5 to 49 years?

In April 2023, the NIAC recommended an interval of 9 months (following any previous COVID-19 vaccine dose or infection) for a further booster COVID-19 vaccine in Spring and Autumn 2023 for those aged 5 to 49 years who are eligible. However, for those aged 5 years and older with immunocompromise associated with a suboptimal response to vaccination an interval of 6 months (following any previous COVID-19 vaccine dose or infection) is recommended. In exceptional circumstances a 3-month interval may be used.

The interval between the primary course and the 1st booster COVID-19 vaccine remains at 4 months. 

Of note: For information on the recommended intervals in pregnancy please see the FAQ below entitled ‘What are the latest recommendations regarding primary COVID-19 vaccination and booster COVID-19 vaccination in pregnancy?’

Back to top  

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. The primary schedule may be given at any stage in pregnancy with an interval as recommended in Table 5a.1 of Chapter 5a of the Immunisation Guidelines for Ireland.

For pregnant adolescents and adults, a COVID-19 booster vaccine is recommended once in pregnancy. If a pregnant person has not had a previous COVID-19 booster, the first booster dose is recommended at least four months after their last COVID-19 vaccine dose or COVID-19 infection. For pregnant women who have had a previous booster prior to pregnancy, they should receive a booster once in pregnancy at an interval of six months or more since their last booster dose or COVID-19 infection. Booster doses can be given at any stage in pregnancy but ideally should be given between 20-34 weeks. 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 booster dose within the same pregnancy may be considered if six months has elapsed since their last booster dose or COVID-19 infection.

Back to top  

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.

Back to top  

What if somebody is diagnosed with COVID‐19 infection after a first dose of vaccine of the primary vaccination series?

Those who have had COVID-19 infection after their first dose of COVID-19 vaccine should be given the subsequent dose at least four to eight weeks (age dependent) after diagnosis or onset of symptoms.

For more information, see Chapter 5a of the Immunisation Guidelines for Ireland.

Back to top  

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.

Back to top  

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.

Back to top  

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.

Back to top  

Does a woman who wishes to conceive need to leave any interval after getting COVID‐19 vaccines before getting pregnant?

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.

Back to top   

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.

Back to top  

What size needle should be used to vaccinate people with an elevated BMI?

If it is available, it is recommended to use a 23‐25 gauge 40mm needle when vaccinating females >90kg and males >120kg. If a 38‐40 mm needle is not available, a 23‐25 gauge 25mm needle should be used.

(As an example, the quadrivalent inactivated influenza flu vaccine that is licensed and used in Ireland and in Europe comes in a prefilled syringe with a fixed needle attached, and the needle is not the longer 40mm in length).

Back to top 

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).

Back to top  

What is the recommended minimum interval between 1st and 2nd dose of a heterologous primary course (2 different vaccines)?

The recommended minimum interval between a 1st and 2nd dose in a heterologous primary course is 28 days. 

Back to top  

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.

Those who have partially completed a COVID-19 vaccine course with a vaccine authorised by the FDA, MHRA or recommended by WHO should be offered an EMA authorised COVID-19 vaccine to complete the course, and then should be considered fully vaccinated. The minimum interval between the last vaccine dose and an EMA authorised COVID-19 vaccine is four weeks.

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 complete course of an EMA authorised COVID-19 vaccine. The minimum interval between the last dose and an EMA authorised COVID-19 vaccine is four weeks. 

FDA: https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/covid-19-vaccines

MHRA: https://www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency

WHO:https://www.who.int/groups/strategic-advisory-group-of-experts-on-immunization/covid-19-materials 

HSE NIO: https://www.hse.ie/eng/health/immunisation/hcpinfo/covid19vaccineinfo4hps/who-approved-vaccines

Back to top  

What is the advice for timing of the first 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 booster dose should be deferred for at least 4 months.  In exceptional circumstances a 3-month interval may be used.

Back to top  

What is the advice for timing of a further mRNA booster dose in someone who has had a breakthrough COVID-19 infection since receiving their last booster dose?

If a person has had laboratory confirmed (PCR) breakthrough COVID-19 infection/ antigen positive infection with symptoms since receiving their last mRNA booster dose, their next mRNA booster dose may be administered as follows:

  • for those aged 50 years and older an interval of 6 months is recommended following any previous COVID-19 vaccine dose or infection
  • for those aged 5 and older with immunocompromise associated with a suboptimal response to vaccination, an interval of 6 months is recommended following any previous COVID-19 vaccine dose or infection
  • for those aged less than 50 years an interval of 9 months is recommended following any previous COVID-19 vaccine dose or infection
  • a minimum interval of 3 months is permissible in exceptional circumstances e.g., heightened epidemiologic risk or for operational reasons.

Back to top  

What is the advice for timing of an additional dose (or third dose of the extended primary series) of vaccine for an immunocompromised person who has had a breakthrough infection since completing their primary vaccination course?

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 first 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 extended primary series after an interval of 4-8 weeks.

Back to top  

What if a person becomes immunocompromised after receiving their 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 are recommended an additional dose (also known as the third dose of the extended primary series) 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

Back to top   

What if a person is immunocompromised at the time that they receive the 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 are recommended an additional dose (also known as the third dose of the extended primary series) to enhance their response to the primary vaccination course. It is 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

Back to top   

What if an mRNA 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.

Back to top  

Is myocarditis or pericarditis after an mRNA vaccine or Nuvaxovid vaccine a contraindication to having a further dose of these vaccines?

No, 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.

Back to top  

Which mRNA vaccine should I use as a booster dose?

Irrespective of the vaccine type used in the primary schedule, mRNA vaccines are the preferred vaccines as boosters. All approved mRNA vaccines may be used as booster doses as they have demonstrated effectiveness against severe COVID-19 disease.

However, adapted mRNA vaccines are preferred if available as follows:

  • Aged 5-11:
    • Comirnaty® Omicron XBB.1.5 10 micrograms (0.2ml) [if this vaccine is not available then Comirnaty®Original/Omicron BA.4-5 10 micrograms (0.2ml) may be used as an alternate booster vaccine in this age group].
  • Aged 12 years and older:  
    • Comirnaty® Omicron XBB.1.5 30 micrograms (0.3ml) [if this vaccine is not available then Comirnaty®Original/Omicron4-5 30 micrograms (0.3ml) may be used as an alternate booster vaccine in this age group].

Back to top  

Can adapted mRNA vaccines be used for a primary course?

Only Comirnaty® Original/Omicron BA.4-5 30 micrograms (0.3ml) for those aged 12 years and older and Comirnaty® Original/Omicron BA.4-5 10 micrograms (0.2ml) for those aged 5-11 years may be used for a primary vaccination course.

All other adapted mRNA vaccines are only recommended for use as booster doses.

Back to top  

 

Go back to FAQ page

 

This page was updated on 15 December 2023