Note – Because covid is a relatively new disease, the layout is different. This section addresses covid vaccination for pregnant women. Although it is recommended for babies from six months, it is not officially on the childhood schedule.
Health Freedom Ireland (HFI) encourages you to become fully informed about vaccines and the associated illnesses so that you can give informed consent if you choose to vaccinate yourself or your child(ren). This information is for educational purposes only and is not intended as medical advice. HFI is simply bringing this information to you – we neither recommend nor advise against vaccination.
What is Covid-19?
COVID-19 (coronavirus disease 2019) is an acute respiratory illness caused by SARS-CoV-2, a coronavirus strain among seven coronaviruses known to infect humans. Other coronavirus infections include those due to seasonal (common cold) coronaviruses. Approximately 33% of SARS-CoV-2 infections are asymptomatic [Oran et al, The Proportion of SARS-CoV-2 Infections That Are Asymptomatic, ACPJournals.org, 2021] (never develop symptoms). However, when symptoms do occur, they happen 2–14 days after infection 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. Most people’s symptoms are short-lived, but some do have prolonged symptoms.
Overall, more than 99.6% of people infected with SARS-CoV-2 recover. The strongest risk factors for fatal COVID-19 are age, obesity and underlying medical conditions. In people younger than 70 the infection fatality rate (IFR) ranges from 0.00% to 0.31% (survival rate range 100% to 99.69%)[Ioannidis, Infection fatality rate of COVID-19 inferred from seroprevalence data, 2021].
Covid-19 and Pregnancy
Pregnancy is considered a state of partial immune suppression. Because of this, pregnant women are more vulnerable to viral infections and more likely to have a severe illness.
Covid placentitis, or SARS-CoV-2 placentitis, is a rare condition that has caused foetal distress and stillbirth in a number of women who had Covid-19. It occurs within seven to 21 days of the infection. By January 2022, five stillbirths and two newborn deaths have been conclusively linked to Covid-19 [Irish Examiner, Five stillbirths, two newborn deaths conclusively linked to Delta variant, Jan 2022]. To put this in context, there are approximately 60,000 babies born annually in Ireland.
You can find more information on the effects of Covid during pregnancy in the UCC study, Bringing the impact of COVID-19 in pregnancy out of the shadows (https://www.ucc.ie/en/npec/roicovid-19study/).
Do the HSE recommended a vaccine for covid during pregnancy?
Comirnaty – (Pfizer/BioNTech) – 2 doses recommended for primary dose.
Nuvaxovid can be recommended if you choose not to have an mRNA vaccine.
Adapted mRNA vaccine is recommended as a booster dose for additional protection against variants.
Does the Covid-19 vaccine / booster guarantee protection from Covid-19?
- you can still get covid after vaccination.
- it may reduce severity of disease in some, however, does not prevent you transmitting covid to others.
- according to the Centre for Disease Control in US (CDC), the latest variant of covid-19 is labelled BA.2.86. BA.2.86 may be more capable of causing infection in people who have previously had COVID-19 or who have received COVID-19 vaccines.
Is the Covid-19 vaccine safe?
Like all medicines, vaccines come with side effects, sometimes very serious. Research is needed to determine whether the benefits outweigh the risks.
Side effects are on the HSE website:
- Myocarditis / pericarditis up to 1 in 10,000 per dose (greater risk for young men)
- severe allergic reaction, loss of sensation, heavy menstrual bleeding -frequency unknown
As of 22nd September, 2023, 5,173,795 adverse events (including 6,344 spontaneous abortions, 588 foetal deaths and 259 stillbirths) have been reported on the World Health Organisation Vigiaccess database for Covid-19 vaccines.
The Covid 19 vaccines are licensed under emergency use authorisation (EUA) in US and conditional marketing authorisation in the EU. This means approval was fast-tracked without the need for clinical trial data normally required.
Omicron and recent bivalent booster vaccine have been authorised by the FDA and EMA based on trials on mice only [NBC FDA to authorize new covid booster without trials in people].
COVID-19 vaccine mRNA is not confined to the injection site as first thought,and has been detected in breastmilk [Hanna et al, Biodistribution of mRNA COVID-19 vaccines in human breast milk, Lancet, 2023].
This is the first time mRNA technology has been used in vaccines so long term effects remain unknown.
Clinical trials for pregnant women
- Pregnant and breastfeeding women were excluded from the original Pfizer [Polack et al, Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine, NEJM, 2020] and Moderna [Baden et al, Efficacy and Safety of the mRNA-1273 SARS-CoV-2 Vaccine, NEJM, 2020] phase III clinical trials. Therefore, the vaccine was being recommended before there was any trial data supporting their safe use in pregnancy.
- As of July 2023, a small trial consisting of 348 pregnant women (<10% of original planned number of 4,000) has been carried out. However, data is incomplete [To Evaluate the Safety, Tolerability, and Immunogenicity of BNT162b2 Against COVID-19 in Healthy Pregnant Women 18 Years of Age and Older, clinical trials.gov].
- All participants were in their third trimester, meaning there is no data for the early, most vulnerable stages of development of the foetus.
- Of the 348 women in the trial, Pfizer only reported on the birth of 335 live babies. Of the 13 pregnancies unaccounted for, Pfizer reported one foetal death (stillbirth) in the vaccine group and the outcome of the other 12 pregnancies remains unknown.
- Next batch of trial results due in July 2024.
- Moderna is also conducting a clinical trial of its mRNA vaccine in pregnancy, but no data is available.
Vaccine efficacy – Absolute Vs Relative Risk Reduction
- Overall benefit or absolute risk reduction (ARR) of vaccination with primary doseof Pfizer Comirnaty is 0.84% and Moderna, 1.2% [COVID-19 vaccine efficacy and effectiveness—the elephant (not) in the room, Lancet, 2021].
- The relative risk reduction (RRR) is 95%, which is the figure that forms the basis of the statement that the vaccine is 95% effective.
- To understand the true risk of a medicine or vaccine, one needs both the ARR and the RRR. To clarify, calculations of both ARR and RRR are outlined below.
