The following questions and answers have been developed by the National Immunisation Office.
What is the name of the new COVID-19 vaccine being introduced in September 2023?
The National Immunisation Advisory Committee (NIAC) has recently recommended the introduction of the COVID-19 vaccine Comirnaty® Omicron XBB.1.5 30 micrograms (0.3ml) for those aged 12 years and older.
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What kind of vaccine is Comirnaty® Omicron XBB.1.5?
Comirnaty® Omicron XBB.1.5 is a COVID-19 mRNA vaccine.
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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.
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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).
Of note: The National Immunisation Advisory Committee (NIAC) recommends the preferential use of Comirnaty® Omicron XBB.1.5 30 micrograms (0.3ml) for booster vaccination of those aged 12 years and older when it becomes available in Ireland. In the interim, Comirnaty® Original/Omicron BA.4-5 30 micrograms (0.3ml) for those aged 12 years and older should continue to be used.
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What kind of vaccine is VidPrevtyn Beta®?
VidPrevtyn Beta® is a protein subunit vaccine.
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What is the licensed indication for VidPrevtyn Beta®?
VidPrevtyn Beta® vaccine is indicated as a booster for active immunisation to prevent COVID-19 for those aged 18 years and older who have previously received an mRNA or adenoviral vector COVID-19 vaccine.
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When does the NIAC recommend the use of VidPrevtyn Beta® vaccine as a booster COVID-19 vaccine?
If there is a contraindication or precaution to an mRNA vaccine or Nuvaxovid, or a person has chosen not to receive these vaccines, VidPrevtyn Beta® may be used as an alternate booster vaccine.
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How is VidPrevtyn Beta® presented?
VidPrevtyn Beta® (Sanofi GSK) is presented as two multidose vials, one containing 2.5ml of the antigen solution and one containing 2.5ml of the adjuvant emulsion. These two multidose vials (antigen vial and adjuvant vial) must be mixed before use.
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How many doses of VidPrevtyn Beta® should there be after reconstitution of the 2 vials?
After mixing, the vaccine vial contains 10 doses of 0.5 ml. If more than ten 0.5ml doses can be safely and accurately withdrawn from a vial, they can be used as valid vaccines.
The product must be used within six hours, if stored at +2°C to + 8°C and protected from light.
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Does VidPrevtyn Beta® contain latex?
Latex is not used to manufacture VidPrevtyn Beta vaccine. Does VidPrevtyn Beta® contain preservatives? VidPrevtyn Beta does not contain preservatives.
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Is VidPrevtyn Beta® subject to additional monitoring?
Yes, VidPrevtyn Beta® 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 https://www.hpra.ie/homepage/about-us/report-an-issue/covid-19-vaccine-adverse-reaction.
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What is the efficacy of VidPrevtyn Beta® vaccine?
The efficacy is inferred based on immunobridging of responses to previously authorised COVID-19 vaccines to which vaccine efficacy has been established. In clinical trials compared with Comirnaty®, superiority of neutralising antibody titres against Omicron BA.1 were demonstrated for VidPrevtyn Beta® 28 days following a dose. Neutralising antibody responses against Delta were also higher in VidPrevtyn Beta recipients.
Booster responses to VidPrevtyn Beta were demonstrated in those aged 18 years and older who had received a primary course of either Comirnaty®, Spikevax®, Vaxzevria®, or JCOVDEN® vaccine.
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What are the contraindications to VidPrevtyn Beta® vaccine?
Anaphylaxis following a previous dose of the vaccine or any of its constituents including polysorbate 20 or octylphenol ethoxylate.
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What are the common adverse events associated with VidPrevtyn Beta® vaccine?
Local:
Very common: injection site pain
Common: injection site erythema, swelling
General:
Very common: headache, malaise, chills, myalgia and arthralgia
Common: pyrexia, fatigue, nausea, diarrhoea.
A full list of adverse reactions may be found in the Summary of Product Characteristics (SmPC) for Vidprevtyn Beta.
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What is the new recommended primary vaccination series schedule (April 2023) 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.
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What is the new recommended primary vaccination course schedule (April 2023) 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.
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What is the new recommended primary vaccination series schedule (April 2023) 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).
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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.
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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.
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What is the recommended interval for a further booster vaccine (i.e. any booster vaccine after the first COVID -19 booster vaccine) for those under 50 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 under 50 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.
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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. 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 persons 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.
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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 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.
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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 being reported.
Trial data of Nuvaxovid® showed that higher doses of the vaccine 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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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).
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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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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.
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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.
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.pdf
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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.
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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.
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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.
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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 National Immunisation Advisory Committee (NIAC) Immunisation Guidelines for Ireland.
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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 National Immunisation Advisory Committee (NIAC) Immunisation Guidelines for Ireland.
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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.
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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.
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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].
Of note: The National Immunisation Advisory Committee (NIAC) recommends the preferential use of new Comirnaty® Omicron XBB adapted monovalent vaccines for booster doses when they become available in Ireland. In the interim, bivalent Comirnaty® Original/Omicron BA.4-5 mRNA COVID-19 vaccines should continue to be used.
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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.
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What if a person is given an adapted vaccine as a primary course?
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 the primary vaccination course in the appropriate age groups for which these vaccines are licensed.
If any of the other adapted COVID-19 vaccines are inadvertently given as a primary course, then the person (or the parent/guardian if aged <16) should be informed of the error, an incident form completed and the error should be reported to the HPRA.
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This page was updated on 12 September 2023
