Although there were no pregnant or breastfeeding women in the clinical trial,  the HSE recommends covid-19 vaccine during pregnancy.  A booster dose is recommended for pregnant women if it is more than 6 months since infection or vaccination. One of the following two vaccines are recommended:

• Comirnaty adapted mRNA vaccine manufactured by Pfizer
• Nuvaxovid manufactured by Novavax

Although the efficacy and safety of this injection have not been specifically evaluated in immunocompromised individuals, the HSE also advises the injection for immunocompromised babies from 6 months of age. The covid-19 vaccine is no longer recommended for healthy individuals under 60 years of age.  

This article provides an overview of the potential risks associated with both the vaccine and covid-19 itself for pregnant women and for children, helping you make an informed decision.

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Disease versus Vaccine Risk Summary

Risk from covid disease
Risk of admission to intensive care unit (ICU) Between 2022 and March 2024 one admission for covid-19 during pregnancy in available data. No ICU data for under 5s. Risk of covid placentitis No reported cases for 2023 or 2024. Risk of death from covid-19 No deaths reported for pregnant women 2020 to 2023. No deaths reported for under 5s.
Note – Covid vaccines do not stop you getting or transmitting covid.

Risk from Pfizer Comirnaty Omicron adapted
Primary course (2 doses for age 5+, 1 dose 6 months to 4) and booster recommended for some people (as per Comirnaty Omicron patient information leaflet Sept 2024)

Observed side effects post administration of Comirnaty (post marketing)

Severe allergic reaction Extensive swelling of the vaccinated limb Swelling of the face (may occur in patients who have had facial dermatological fillers) A skin reaction that causes red spots or patches on the skin, that may look like a target or “bulls-eye” with a dark red centre surrounded by paler red rings (erythema multiforme) Unusual feeling in the skin, such as tingling or a crawling feeling (paraesthesia) Decreased feeling or sensitivity, especially in the skin (hypoaesthesia) Heavy menstrual bleeding (most cases appeared to be non-serious and temporary in nature)

Risk Category	Observed Side Effects
Up to 1 in 10,000 (0.01%)	Inflammation of the heart muscle (myocarditis) or inflammation of the lining outside the heart (pericarditis) which can result in breathlessness, palpitations or chest pain
Up to 1 in 1,000 (0.1%)	Temporary one-sided facial drooping Allergic reactions such as hives or swelling of the face
Up to 1 in 100 (1%)	Feeling unwell, feeling weak or lack of energy/sleepy Arm pain Insomnia Injection site itching Allergic reactions such as rash or itching Decreased appetite Dizziness Excessive sweating, night sweats
Up to 1 in 10 (10%)	Injection site redness Nausea, vomiting Enlarged lymph nodes (more frequently observed after a booster dose)
More than 1 in 10 (10%)	Injection site: pain, swelling Tiredness, headache Muscle pain, joint pain Chills, fever Diarrhoea

Some other special warnings and precautions

Hyperventilation or stress-related reactions in association with vaccination process. Efficacy and safety has not been assessed in immunocompromised individuals and may be lower in immunocompromised individuals. No data are available yet regarding the use of Comirnaty Omicron XBB.1.5 during pregnancy or breastfeeding. Increased risk of myocarditis and pericarditis after vaccination with Comirnaty, some cases requiring intensive care and fatal cases have been seen.

Risk from Nuvaxovid covid vaccine
Primary course (2 doses for age 5+, 1 dose 6 months to 4) and booster recommended for some people (as per Nuvaxovid package leaflet Nov 2024)

Frequency not known – cannot be estimated from available data
Severe allergic reaction Unusual feeling in the skin, such as tingling or a crawling feeling (paraesthesia) Decreased feeling or sensitivity, especially in the skin (hypoaesthesia) Inflammation of the heart muscle (myocarditis) or inflammation of the lining outside the heart (pericarditis) which can result in breathlessness, palpitations or chest pain

Risk Category	Observed Side Effects
Up to 1 in 100 (1%)	Enlarged lymph nodes High blood pressure Itchy skin, rash or hives, redness of the skin, chills
Up to 1 in 10 (10%)	Redness or swelling where the injection is given Fever (>38°C) Pain or discomfort in the arm, hand, leg and/or foot (pain in the extremity)
More than 1 in 10 (>10%)	Headache Feeling sick (nausea) or getting sick (vomiting) Tenderness or pain where the injection is given Muscle ache Generally feeling unwell

Other special warnings and precautions (also from SmPC Doc)
Risk of myocarditis and pericarditis after vaccination with Nuvaxovid. Vaccination in pregnancy should only be considered when the potential benefits outweigh any potential risks for the mother and fetus. Unknown whether Nuvaxovid is excreted in human milk.

Adverse Events on WHO Vigiaccess Reporting System As of July 2024, over 5.6 million adverse events have been reported for covid vaccines.

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What is covid-19?

Covid-19 is a respiratory illness caused by SARS-CoV-2, a coronavirus strain among seven coronaviruses known to infect humans. Symptoms are mostly short lived and range from mild to severe fever or chills, difficulty breathing, fatigue, muscle or body aches, headache, loss of taste or smell, sore throat, nasal congestion, nausea, vomiting or diarrhoea. Those most at risk from covid-19 are the elderly, those deficient in vitamin D and those suffering from obesity and underlying medical conditions. A pooled analysis of 40 studies found that the infection fatality rate (IFR) / survival rate, in the absence of vaccination or prior infection was as follows:

A recent large-scale study indicates that pregnant patients are at lower risk for mortality and severe outcomes than non-pregnant patients for COVID-19 infections.

What is covid placentitis?

Covid-19 placentitis is a rare but serious condition in which the placenta becomes inflamed following a covid-19 infection, especially in the later stages of pregnancy. This inflammation can lead to severe placental damage, compromising its ability to support the fetus and, in extreme cases, resulting in stillbirth.

In Ireland, clusters of COVID-related placentitis were first identified in early 2021 during the Alpha and Delta variant waves. However, through 2024, fewer cases have been reported in Ireland, likely due to widespread immunity, as well as decreased severity with subsequent variants like Omicron. ​ There is no specific data on placentitis cases in Ireland in reports from the Health Protection Surveillance Centre (HPSC), which might support this trend.

COVID-19 Intensive care (ICU) admission and risk of death

There is very limited data on admission to intensive care (ICU) for covid for children and pregnant women. Vaccination status is not included on Health Protection Surveillance Centre (HPSC) ICU admissions data. The following freedom-of-information request to the HSE confirmed no deaths were reported in notified cases of COVID-19 in pregnant women during 2020-2023.

Does the COVID-19 vaccine guarantee protection from covid-19?

No. Current data does not support that covid 19 vaccines have been successful in reducing infection during pregnancy. Conversely, infections seem to spike following the injection.

• Throughout the pandemic, studies across geographic regions found that the mRNA COVID-19 vaccines are associated with negative effectiveness after four to six months. As efficacy waned, studies showed that COVID-19 injected individuals developed an increased risk for infection .
• This letter to the BMJ references many scientific reports outlining waning immunity and negative effectiveness of COVID-19 injections.
• The claim that inoculations were safe and showed 95% efficacy referred to relative risk reduction. Absolute Risk Reduction was only 0.84% .
• There are currently limited data to inform whether boosters offer any substantial protection against circulating variants. The stated target of these adapted injections is the Omicron variant which may not be the dominant strain anymore.

Covid-19 Vaccine Safety Data

In today’s environment of censorship and misinformation, finding balanced information on vaccine safety can be challenging. Many scientific studies are authored by individuals who may have conflicts of interest, making it hard to discern reliable information. Furthermore, the term “unvaccinated” can be ambiguous; for instance, it often includes individuals who have received only one dose or who were fully vaccinated less than 14 days prior. Below is a compilation of concerns that may not be easily accessible:

Pfizer Comirnaty Initial Clinical Trial

The Pfizer documents , with data from the clinical trial and subsequent safety review data, released under court order and now available to the public highlight the following:

• no pregnant or lactating women in the clinical trial
• no children under 16 in the clinical trial
• while covid infections decreased, there was a significant increase in other non-covid illnesses in the vaccinated group
• overall deaths were higher in those vaccinated
• 1,223 deaths in the first 3 months of emergency use
• the injection was never tested for transmission

The safety of adapted vaccines is inferred from safety data of the prior vaccines and has been authorised by the FDA and EMA based on trials on mice only . Other issues of concern are as follows:

• unknown risk of potential adverse impacts with each additional dose of the mRNA COVID-19 vaccine; currently individuals may have received 5 to 7 doses (and counting) of the vaccine over a 3-year period.
• presents a risk of subclinical and clinical myocarditis and other cardiovascular conditions among otherwise healthy individuals.
• associated with an increased risk of postural orthostatic tachycardia syndrome (POTS).
• may be associated with an increased risk of autoimmune diseases including systemic lupus erythematosus (SLE), rheumatoid arthritis, and psoriasis
• Elevated levels of mRNA and spike protein persist among some individuals for an indefinite period, which may carry health risks.
• potential DNA integration pose unique and elevated risk to human health and to the integrity of the human genome, including the risk that DNA integrated into sperm or egg gametes could be passed onto offspring of mRNA COVID-19 vaccine recipients.
• multiple incidences of menstrual irregularities and vaginal bleeding have been reported to V-Safe, a voluntary smartphone-based active surveillance system for monitoring COVID-19 vaccine safety in the USA.
• This two part study Part I and II found unacceptably high breaches in safety signals after COVID-19 vaccination in pregnant women and is calling for a halt to the vaccination campaign for pregnant women.
• A recent German study found that excess mortality increased the higher the vaccination rate. An analysis of stillbirths showed exactly the same pattern.

WHO Vigiaccess Adverse Events Reporting System

As of November 2024, over 5.7 million adverse events have been reported for COVID-19 vaccines on WHO Vigiaccess, including 30,694 deaths (listed under General disorders and administration site conditions), 279,263 reproductive system and breast disorders and 13,928 pregnancy, puerperium and perinatal conditions (7,427 abortions, 630 foetal deaths and 269 stillbirths).

Covid 19 vaccine side effects mainly affect European females between 18 and 44 years (illustrated in the vigiaccess charts below)

US Vaccine Adverse Events Reporting System (VAERS)

On the VAERS US database for reporting side effects, miscarriages and stillbirths increased sharply following the rollout of the covid vaccines.

What are the vaccine ingredients?

Vaccine	Ingredients as listed on patient information leaflets
Comirnaty Omicron XBB.1.5 Covid-19	Active substances: raxtozinameran Other ingredients: genetically modified mRNA, ((4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate) (ALC-0315), 2-[(polyethylene glycol)-2000]-N,N-ditetradecylacetamide (ALC-0159), 1,2-Distearoyl-sn-glycero-3-phosphocholine (DSPC), cholesterol, trometamol, trometamol hydrochloride, [popup_anything id=”3109″], water for injections.
Nuvaxovid Covid-19	Active substances: SARS-CoV-2 (Omicron JN.1) spike protein (produced in insect cells by recombinant DNA technology) Other ingredients: disodium hydrogen phosphate heptahydrate, sodium dihydrogen phosphate monohydrate, disodium hydrogen phosphate dihydrate, [popup_anything id=”4326″], [popup_anything id=”2983″], cholesterol, phosphatidylcholine (including all-rac-α-Tocopherol), [popup_anything id=”3626″], [popup_anything id=”4327″], [popup_anything id=”4794″] (for the adjustment of pH), [popup_anything id=”4793″] (for the adjustment of pH)