FAQs COVID-19 Vaccine

The following questions and answers have been developed by the National Immunisation Office and are included in the Clinical Guidance for COVID-19 Vaccination.

 

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.

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

Vaccination with the second dose 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.

Please refer to the clinical guidelines for details of timing of booster and immunocompromised additional doses of vaccination after breakthrough infection.

What if the second dose of COVID‐19 vaccine in the primary vaccination course is administered at less than the recommended interval

The day that the first dose of vaccine is given is day 0

Comirnaty® (Pfizer BioNTech)

If the second dose is given at an interval of less than 17 days, this this is not considered a valid dose. A third dose should be given 28 days after the second (invalid) vaccine.

If a dose is given between 17 and 27 days, this is considered a valid dose.

Spikevax® (COVID19 Vaccine Moderna)

If a dose is given at an interval of less than 24 days, it is not considered a valid dose. A third dose should be given 28 days after the second (invalid) vaccine.

If a dose is given between 24 and 27 days, this is considered a valid dose. 

Nuvaxovid® (Novavax)

If a dose is given at an interval of less than 17 days, it is not considered a valid dose. However there is no evidence of the efficacy of safety of an additional dose in these circumstances so revaccination is not advised

If a dose is given between 17 and 21 days, this is considered a valid dose.

For the primary vaccination course, what if the second dose of a COVID‐19 vaccine is administered at longer than the recommended interval?

If the interval between doses is longer than the recommended interval, the second dose should still be given. The course does not need to be restarted.

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.

What if a vaccine is given after the expiry date of 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.

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 more local reactions 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 second dose of vaccine according to the recommended schedule. This should be reported to HPRA and an incident report form completed.

What if only the diluent of Comirnaty® (Pfizer BioNTech) is given?

The diluent for Comirnaty® (Pfizer BioNTech) is sodium chloride, which is salt and purified water so no adverse reactions would be expected.

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.

What if an over‐diluted Comirnaty® (Pfizer BioNTech) vaccine is administered?

In this case, the person will not have received a sufficient dose of vaccine for protection.

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.

In settings where doses may be prepared in advance, if eight doses have been obtained from a vial, each of the syringes must be examined by another person to identify the syringe with less than 0.3ml. If all syringes contain 0.3ml then more than 1.8ml must have been added and the vial has been over-diluted.

What if a person under 12 years is given Comirnaty® 30 micorgrams/dose (Pfizer BioNTech) vaccine inadvertently?

The vaccine formulation used for adults is licensed by the EMA from age 12 years and above only.

The young person and their parent/guardians should be informed. A HSE incident form should be

completed and the incident reported to the HPRA. The young person and their parents/guardians should be advised regarding the common adverse events expected after vaccination. They should also be informed of the very rare adverse event of myocarditis and pericarditis, the symptoms to be aware of, and to seek medical attention if they develop.

What if a person under 30 years is given Spikevax® inadvertently?

If a person under the age of 30 years receives the vaccine inadvertently, an incident form should be completed. The person (and their parents/guardians if less than 16 years old) should be advised regarding the common adverse events expected after vaccination. They should also be advised of the very rare reported adverse event of myocarditis and pericarditis and the symptoms to be aware of. If the person who received the vaccine is less than 12 years of age, the incident should also be reported to the HPRA (the vaccine is not licensed for this age-group).

What if a person under 18 years is given Jcovden® (Janssen) inadvertently?

This should be reported to the HPRA and an incident form completed. The person (and their parents/guardians if less than 16 years old) should be advised regarding the common adverse events expected after vaccination.

They should be advised of Thrombosis with Thrombocytopenia syndrome (TTS) reported very rarely after vaccination, and of the symptoms to be aware of, and to seek urgent medical attention should these appear. They should also be advised of the very rare reported adverse event of capillary leak syndrome and of the symptoms to be aware of. They should also be advised of the very rare adverse event of Guillain-Barré syndrome and of the symptoms to be aware of.

What if a person aged under 12 is given Nuvaxovid® inadvertently?

This should be reported to the HPRA and an incident form completed. The person (and their parents/guardians if less than 16 years old) should be advised regarding the common adverse events expected after vaccination.

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.

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.

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.

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).

Can other vaccines be co-administered with COVID-19 vaccines for those aged 12 years and older?

Yes, other vaccines may beco-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 indifferent limbs.

The exception to this is Moneypox vaccine. There should be an interval of four weeks between monkeypox/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 monkeypox/smallpox vaccine (see Chapter 13a).

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. 

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 series, and then should be considered fully vaccinated. The minimum interval between the last vaccine dose and an EMA authorised COVID-19 vaccine is 28 days.

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 28 days.

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 

Who is recommended to receive a first COVID‐19 booster dose?

NIAC recommends people aged 12 years and over should be offered a booster dose of a COVID-19 vaccine. See Section 8 for more details.

Who is recommended to receive a second COVID‐19 booster dose?

People aged 65 years and older

People aged 50-64

People aged 12-49 with immunosuppression associated with a sub-optimal response to vaccination at the time of their primary or booster vaccination (shaded in blue in Table 5.a.2)

People aged 12-49 with underlying medical conditions associated with a high risk or very high risk of severe COVOD-19 (Shaded in white in Table 5.a.2).

People aged 12-49 who are residents of long-term care facilities

Healthcare workers, and when practicable, this should be given at the same time as seasonal influenza vaccine

Who is recommended to receive a third COVID‐19 booster dose?

People aged 65 years and older

People aged 12-49 with immunosuppression associated with a sub-optimal response to to vaccines at the time of their primary or booster vaccination  (shaded in blue in Table 5.a.2)

When practicable, the third booster dose should be given at the same time as seasonal influenza vaccine.

What are the recommendations regarding the 2nd booster m-RNA COVID-19 vaccination in pregnancy?

All pregnant women should have received a primary COVID-19 vaccination course as well as a 1st booster dose, in line with the recommendations for the general population. If a pregnant woman has not already received these vaccines, she should receive the required vaccines at the recommended intervals, which can be given at any stage of pregnancy.

Pregnant women who have already completed primary and 1st booster vaccination, are recommended a 2nd mRNA vaccine booster dose in pregnancy. The timing of this 2nd booster dose should be at 16 weeks gestation or later. This timing is to enhance protection to the mother and the infant. 

If a 1st booster mRNA vaccine dose has already been administered earlier in the pregnancy, a 2nd booster dose is not required.

Should a pregnant woman who has had COVID-19 infection during pregnancy receive a 2nd booster dose of COVID-19 in the same pregnancy?

Yes. She should receive a 2nd booster dose at least 4 months after diagnosis and at 16 weeks or more gestation. 

If a 1st booster mRNA vaccine dose has already been administered earlier in the pregnancy, a 2nd booster dose is not required.

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.

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

If a person has had laboratory confirmed (PCR) breakthrough COVID-19 infection since completion of their primary course, the additional dose should be deferred for at least 4 months after diagnosis. In exceptional circumstances a 3 month interval may be used.  If it is not possible to establish if a person had breakthrough COVID-19 infection in this timeframe, they may be vaccinated.

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 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 suboptimal response to the primary vaccination course are shaded in blue in Table 5a.2 of the Immunisation Guidelines

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 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.

However their response to the booster dose may be sub-optimal, so they are recommended to receive a 2nd booster dose, which should be given 4 months after the 1st booster dose.

The immunocompromising conditions associated with a suboptimal response to the primary vaccination course are shaded in blue in Table 5a.2 of the Immunisation Guidelines

What if an additional dose of an mRNA vaccine for immunocompromised people is given before the minimum interval? Is there a need to repeat the dose?

If the vaccine is given before the minimum interval (3 months), there is no evidence as to the safety and efficacy of giving a further dose under these circumstances to complete the primary course. The dose should not be repeated. However, a booster vaccine should still be given at the recommended interval (at least 4 months).

The person (and their parents/guardians if less than 16 years old) should be advised regarding the error and the incident reported. The error should be reported to the HPRA.

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.

What if a person is given a booster dose of 0.5mls dose of Spikevax®/Moderna instead of the recommended and licensed 0.25ml dose?

The person should be informed of the error. The error should be reported to the HPRA, and an incident form completed. The person should be informed of the risks of very rare side effects from the vaccine including myocarditis and pericarditis, and the symptoms to be aware of.

What if a person less than 30 years of age is given a booster or an additional dose of Spikevax®?

The person should be informed of the error. An incident form completed. The person should be informed of the risks of very rare side effects from the vaccine including myocarditis and pericarditis and the symptoms to be aware of.

What should I do if a person who is immunocompromised and is receiving an additional dose of Spikevax® receives a 0.25ml dose (a booster dose) in error?

If the error is discovered on the same day a further 0.25ml dose can be given and these two doses can be considered as a valid vaccine.

If the error is discovered later, they should receive the correct 0.5ml dose as soon as possible (no minimum time interval required). 

The subsequent booster dose of 0.25ml should be given at the recommended interval i.e. at least 3 months after the correct dose (or the two 0.25mls doses) is administered.

The person should be informed of the error and an incident form completed. The error should be reported to the HPRA if the person experiences an adverse event as a result.

Can Nuvaxovid® be used as an additional dose for people who have a contraindication to an mRNA vaccine or who have declined other COVID-19 vaccines?

Yes. Nuvaxovid  can be considered in these circumstances in people aged 12 years and older.

What is the recommended interval for the additional dose of Nuvaxovid?

The recommended interval is 2 months after the completion of the primary vaccination course.

Can Nuvaxovid® be used as a booster dose for people who have a contraindication to an mRNA vaccine or who have declined other COVID-19 vaccines?

Nuvaxovid can be considered in these circumstances if the person is aged 12 years or older.  However if an individual has already received 2 doses of Nuvaxovid®, there is no evidence of the efficacy or safety of a booster dose. 

If an individual has been partially or fully vaccinated with another COVID-19 vaccine as part of their primary course, an additional dose of Nuvaxovid® can be considered.

What is the recommended interval for the booster dose of Nuvaxovid?

The recommended interval is 4 months after the completion of the primary vaccination course. In exceptional circumstances, a 3 month interval may be used.

Can Nuvaxovid be used in pregnancy if there is a contraindication to an mRNA vaccine or if a person has declined other COVID-19 vaccines?

Nuvaxovid® can be considered in these circumstances.However there is limited experience with use of the vaccine in pregnant women.

Administration may be considered when the benefits outweigh the potential risks to the mother or the fetus and when mRNA vaccines are contraindicated or declined.

Go back to FAQ page

 

This page was added on 12 August 2022