COVID-19 Vaccination Programme questions and answers

COVID-19 is more serious in older people and in people with certain underlying health conditions. This winter it is expected that many respiratory infections, including COVID-19 and flu may be circulating at high levels – this may put increasing pressure on hospitals and other health care services. For these reasons, the Joint Committee on Vaccination and Immunisation (JCVI), recommend a dose of the coronavirus (COVID-19) vaccine is offered this autumn to people aged 65 and over, residents and staff in care homes, anyone aged 6 months and over in a clinical risk group (including pregnant women), frontline health and social care staff, carers and those aged 12 years and over who live with someone who has a weakened immune system’

The autumn programme is targeted at those at high risk of the complications of COVID-19 infection, who may not have been vaccinated for a few months. As the number of COVID-19 infections may increase over the winter, a dose of vaccine this autumn should help to reduce your risk of being admitted to hospital with COVID-19. The vaccine may also provide some protection against mild COVID-19 infection but such protection does not last for long.

You may also be eligible for the flu vaccine as part of the autumn programme. If you're offered both vaccines, it's safe to have them at the same time.

For more information, please see the following leaflet: COVID-19: A guide to the autumn booster (hscni.net)

Most people will be offered the vaccine through primary care (their GP surgery or a participating community pharmacy).

Your GP will get in touch with you to invite you for vaccination if you are

• aged 65 years and over
• aged 16 to 64 and in a clinical risk group (includes being pregnant)
• aged 16 to 64 and a carer
• aged 16 to 64 and a household contact of someone who is immunosuppressed

You can get the COVID-19 vaccine from a community pharmacy if you are:

• a care home resident or staff
• a frontline HSC worker
• aged 65 years and over
• aged 18 to 64 and in a clinical risk group (includes being pregnant)
• aged 18 to 64 and a carer
• aged 18 to 64 and a household contact of someone who is immunosuppressed

For the latest details of where to get your vaccine and for details on how to book your appointment please see the following link: https://www.nidirect.gov.uk/articles/get-covid-19-vaccination-and-booster-northern-ireland  

HSC Trusts are also offering vaccines to:

• frontline HSC workers
• those aged six months to 15 years of age in a clinical risk group
• those aged 12 to 15 years of age who are carers
• those aged 12 to 15 years of age who are household contacts of someone who is immunosuppressed
• pregnant women through maternity services
• those who are housebound (nursing teams will visit the patient at home)

You will be given a vaccine made by Pfizer BioNTech (known as Comirnaty), Moderna (known as Spikevax) or Sanofi Pasteur (known as VidPrevtyn Beta). Some vaccines are updated forms of the vaccines used in previous campaigns and produce slightly higher levels of antibody against some strains of the latest COVID-19 variants.

As it is not possible to predict which variants of COVID-19 will be circulating each winter, the Joint Committee on Vaccination and Immunisation (JCVI) have advised that any of these updated vaccines can be used.

You will be offered the right vaccine for you at the right time. Please accept the vaccine that is offered to you as soon as you are able to – it is important to have your vaccination to build up your protection against severe illness before the winter.

All vaccines used in the Northern Ireland programme are safe and very effective; they provide high levels of protection against hospitalisation and severe illness.

Anyone aged less than 12 years of age will receive specific infant and paediatric formulations of the Comirnaty (Pfizer BioNTech) vaccine.

If for any reason you are one of a small number of people who cannot receive an mRNA vaccine and require an alternative vaccine, you should speak with your GP who will discuss your options further with you and provide you with a letter for you to receive an alternative vaccine if this is required. These vaccines are usually administered at your local HSC Trust.

Vaccines teach your immune system how to protect you from diseases. It's much safer for your immune system to learn this through vaccination than by catching the diseases and attempting to treat them. Vaccines also produce a much stronger response from our immune system when compared to the response seen after COVID-19 infection alone.

Vaccines can reduce or even eradicate some diseases, if enough of the population are vaccinated. Since vaccines were introduced, diseases like smallpox and polio that used to kill or disable millions of people are no longer present in the UK.

The long-term response to the pandemic and beyond requires a safe and effective vaccine to be available for all who need it. It’s a way to keep you, your friends and family safe

To be eligible to be vaccinated as part of the Northern Ireland vaccination programme you have to be registered with a GP in Northern Ireland.

If you are not registered with a GP in Northern Ireland but live here or are temporally a resident in Northern Ireland, you should contact the Department of Health on COVID-19VaccinationProgramme@health-ni.gov.uk  and they will advise you how you can be vaccinated.

Further information on the COVID-19 vaccination programme in Northern Ireland can be found here.

Vaccines available for use in Northern Ireland are:

• the latest variant version of the Comirnaty (Pfizer BioNTech) vaccine
• the the latest variant version of the Spikevax (Moderna) vaccine
• the VidPrevtyn Beta (Sanofi Pasteur) vaccine

AstraZeneca and Novavax vaccines are no longer being supplied for routine use in the UK. When mRNA vaccines are not considered clinically suitable, VidPrevtyn Beta (Sanofi Pasteur) COVID-19 vaccine may be used for vaccination of adults.

Children aged between 5 and 11 years who are eligible will receive the latest variant version of a paediatric formulation of the Comirnaty (Pfizer BioNTech) vaccine unless contraindicated. Infants aged 6 months to 4 years of age who are eligible will receive the latest variant version of an infant formulation of the Comirnaty (Pfizer) vaccine.

All vaccines available in Northern Ireland have completed a full programme of research, including considerations of vaccine efficacy and safety. The vaccines have been reviewed by the Medicines and Healthcare Products Authority (MHRA) and the European Medicines Agency (EMA) both of which have granted approval and licencing of the three vaccines as they meet the required effectiveness and safety standards. The safety and effectiveness of all vaccines in use are continually monitored by the medicine’s regulatory organisations.  

Other vaccines are also being developed; they will only become available once they have been thoroughly tested to make sure they are safe and effective.See here for more information on the NI COVID-19 Vaccination Programme

Northern Ireland operates a system of informed consent for vaccinations. Vaccinations are not compulsory.

The offer of a primary course to the wider population, as it was during the pandemic, has now ceased.

The aim of the programme remains the prevention of severe illness (hospitalisations and deaths) arising from COVID-19. During the current phase of pandemic recovery, and while the virus continues to circulate and cause illness, the objective is to continue to focus the offer of vaccination on those at greatest risk of serious disease and who are therefore most likely to benefit from vaccination.

In May 2023, The Joint Committee on Vaccination and Immunisation (JCVI) advised that primary course of COVID-19 vaccination should consist of only a single dose of COVID-19 vaccine. Eligibility for the offer of primary vaccination will be the same as for autumn 2023 campaign.

There are a small number of people who may continue to require more than one primary dose of COVID-19 vaccination, for example people who are severely immunosuppressed. Your GP or specialist will be able to advise if this applies to you.

If you have not yet received a COVID-19 vaccination and think you may be eligible, speak to your GP or local participating community pharmacy.

You should follow existing advice to reduce the spread of COVID-19 as this will enable you to avoid becoming ill with COVID-19 or other respiratory illnesses, before and after vaccination. Your vaccinator will provide advice on how long you may need to wait after the vaccine before going home and any other important information. Don’t forget to bring your proof of eligibility along to your appointment (for example a letter from your doctor, or photo ID).

None of the COVID-19 vaccines currently approved for use in Northern Ireland are live vaccines. They are therefore suitable to use in people who are pregnant and those who are immunosuppressed, although those with a weakened immune system may not respond as well and other measures to reduce risk will need to continue to be observed.

Many of the ingredients found in the COVID-19 vaccines can also be found in food. This includes, for example, sugars, acidity regulators, fats, and salts. 

The vaccines do not include common allergens, such as latex, milk, lactose, gluten, egg, maize/corn, or peanuts.

The Pfizer BioNTech and Moderna COVID-19 vaccines are mRNA (messenger ribonucleic acid) vaccines. They contain the genetic sequence (mRNA) for the spike protein which is found on the surface of the SARS-CoV-2 virus, wrapped in a lipid envelope (referred to as a nanoparticle) to enable it to be transported into the cells in the body.

None of the vaccines against COVID-19 contain gelatine. The vaccines currently used in the UK do not contain alcohol.

Recipient information including a full list of ingredients for all of the approved vaccines can be found at:

• Comirnaty (Pfizer BioNTech) Comirnaty Omicron XBB.1.5 30 micrograms/dose dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified) - Patient Information Leaflet (PIL) - (emc) (medicines.org.uk)
• Spikevax (Moderna) pil.15085.pdf (medicines.org.uk)
• VidPrevtyn Beta (Sanofi Pasteur) https://www.medicines.org.uk/emc/files/pil.14450.pdf

For information on the current vaccination campaign, including information on different age groups please see the following link:

• https://www.nidirect.gov.uk/articles/get-covid-19-vaccination-and-booster-northern-ireland

If you are unwell, wait until you have recovered to have your vaccine. There is no need to wait four weeks after having had COVID-19 infection, provided you are feeling well. You should not attend a vaccine appointment if you think you could be infectious to others.

Yes. All vaccines and medicines have some side effects although not everybody will get them.

Mild flu-like symptoms, including headache, chills and fever remain the most common side effects of all COVID-19 vaccines. These generally appear within a few hours of vaccination, and resolve within a day or two. These types of reactions reflect the normal immune response triggered by the body to a vaccine. You can manage common side effects with rest, plenty of liquids and taking paracetamol to manage headaches and fever, if needed.

Vaccines are the best way to protect people from COVID-19 and have already saved tens of thousands of lives. Everyone should continue to get their vaccination when invited to do so unless specifically advised otherwise by their doctor.

Over 5.5 billion people had received at least one COVID-19 vaccine around the world by March 2023, providing ‘real-life’ evidence about their safety. Like all medicines, the safety of vaccines, including COVID-19 vaccines is being continuously monitored. Regulators will continue to review any emerging safety data and the health of participants from the original clinical trials is followed up for a number of years.

Serious side effects due to COVID-19 vaccines are rare. If you are worried about your side effects, contact your GP and let them know about your recent vaccination.

It is now well recognised that infection with coronavirus (COVID-19) can cause myocarditis and pericarditis, which can lead to inflammation of the heart. Myocarditis is an inflammation of the heart muscle, and pericarditis is an inflammation on the lining outside of the heart. 

Very rarely cases of heart-related side effects, such as pericarditis and myocarditis (inflammation of the heart) have also been reported after COVID-19 vaccines. Most of these cases have been mild and recovered quickly with rest, or minimal treatment. Like with COVID-19 infection, myocarditis and pericarditis after a COVID-19 vaccine has been reported slightly more often in younger men (those aged under 40). This rare event usually occurs a few days after the second or subsequent vaccinations although some cases have occurred after the first dose.

If you experience new onset chest pain, shortness of breath or feelings of having a fast-beating, fluttering or pounding heart within 10 days of receiving a COVID-19 vaccine you should seek urgent medical assistance. Make sure you tell your doctor about your vaccination so that they can assess you properly.

A past medical history of myocarditis or pericarditis that is not related to COVID-19 vaccination does not prevent an individual receiving a COVID-19 vaccine.

The underlying reason for these conditions following administration of a COVID-19 vaccine is being investigated and there is currently no evidence that people with a history of myocarditis or pericarditis are at increased risk of a recurrence following COVID-19 vaccination.

The risks and benefits of COVID-19 vaccination should be discussed between you and your doctor(s) so that you can make an informed decision.

There is no evidence that strenuous exercise increases the risk of developing myocarditis following vaccination. You can resume your usual activities if you feel well. This includes exercise that you would normally do.

If you feel unwell or very tired, then you should rest until you feel better. If you develop chest pain, palpitations or dizziness you should seek medical attention.

If you have been diagnosed with myocarditis or pericarditis, you should follow the advice of your doctor/medical team about when to start exercising again.

A condition involving serious thromboembolic (blood clotting) events accompanied by thrombocytopenia (low platelets), has been reported after AstraZeneca and Johnson and Janssen COVID-19 vaccines. The condition is rare, and tending to present with unusual forms of clotting. This condition is known to occur naturally although the underlying risk factors have not yet been fully established.

The AstraZeneca COVID-19 vaccine was used in previous COVID-19 vaccination campaigns; however, it is no longer available for use in the UK COVID-19 vaccination programme.

There is currently no evidence to suggest this rare event of thrombosis (blood clotting) accompanied by thrombocytopenia (low platelets) occurs following administration of the Pfizer BioNTech, Moderna or Sanofi Pasteur COVID-19 vaccines, which are currently available in the UK.

Further investigations are underway to understand the biological mechanisms of the reported events, and whether the association is related to the vaccine platform (the way in which the vaccine delivers the antigen) or some other immunological mechanism (the individual’s immune response).

Thromboses (blood clots) have been reported after natural COVID-19 infection and more than a fifth of hospitalised patients with COVID-19 have evidence of blood clots.

Yes.

There is no evidence that those with a prior history of blood clots or known risk factors for blood clots are more at risk of developing a clot after receiving a COVID-19 vaccine.

For most individuals with past clotting episodes and those diagnosed with thrombophilia, the risk of recurrent blood clots due to COVID-19 infection remains far greater. Therefore, eligible individuals with such a history should be vaccinated with any of the available vaccines (provided they are not otherwise contra-indicated).

There are very few individuals who cannot receive the COVID-19 vaccines.

The vaccine should not be given to those who have had a previous systemic allergic reaction (i.e. more serious than just a local reaction, including immediate-onset anaphylaxis) to:

• A previous dose of the same COVID-19 vaccine
• Any component (ingredient) of the COVID-19 vaccine being offered

Or to individuals with severe illness and/or a high fever on the day of vaccination.

The Pfizer and Moderna vaccines contain polyethylene glycol (PEG), which is from a group of known allergens commonly found in medicines and in some household goods and cosmetics. Known allergy to PEG is extremely rare but people with this allergy should not receive the Pfizer BioNTech or Moderna vaccine. Patients with undiagnosed PEG allergy may have a history of unexplained anaphylaxis or of anaphylaxis to multiple classes of drugs. The VidPrevtyn Beta (Sanofi Pasteur) vaccine does not contain PEG and is a suitable alternative for people aged 18 years and over. Medicines containing PEG include some tablets, laxatives, depot steroid injections, and some bowel preparations used for colonoscopy.

Any queries or concerns over previous or current allergies should be discussed with your specialist/GP who will be able to advise which COVID-19 vaccine you can have,

Yes, it is safe for you to have a COVID-19 vaccine. You will need to tell your vaccinator that you have a bleeding condition / are on blood thinners or other medications used to treat disorders of the blood, so that they can decide which method is best to administer your vaccine.

Individuals with bleeding disorders who are on medications should check with their GP or specialist to check when they can go for their vaccination. If you receive medication/ treatment to reduce bleeding, for example treatment for haemophilia, vaccination can usually be scheduled shortly after such medication/treatment is given.

Individuals on stable anticoagulation therapy, including individuals on warfarin who are up-to-date with their scheduled INR testing and whose latest INR is within the safe range can receive the vaccines unless they have other contraindications, as discussed above.

You may get more bruising from the vaccination if you have a blood clotting problem or are on blood thinners, and may be advised to apply firm pressure without rubbing to the vaccine site for a little bit longer.

Current evidence shows that natural immunity following COVID-19 infection will begin to wane (decrease) over time. Therefore, if you are eligible for a COVID-19 vaccine you should attend even if you have tested positive for COVID-19 in the past or have tested positive for COVID-19 antibodies.

Vaccines produce a much stronger response from our immune system when compared to the response seen after COVID-19 infection alone.

There are some treatments that have been proven to make a difference, for example the antiviral drug, Remdesivir, can reduce the length of illness. Two steroid drugs, dexamethasone and hydrocortisone, have been shown to save lives but only in people who are seriously ill in hospital.

A new drug Molnupiravir has recently become available in the UK for the treatment of mild to moderate COVID-19 disease in people with at least one risk factor for developing severe disease such as obesity, old age, diabetes or heart disease.

Further drug treatments are available for individuals who are immunosuppressed and contract COVID-19, your GP/hospital doctor will be able to provide more information on these treatments.

For further details see:

• Treatments for coronavirus (COVID-19) - NHS (www.nhs.uk)

Ultimately, prevention is better than getting the illness and needing treatment. A vaccine can prevent you from getting COVID-19, lessen the impact of the disease and slow it spreading. This will help stop others getting it too and passing it on.

The vaccine trials have included individuals of all ages up to over 80 years of age. The trials also included those with co-morbidities as well as healthy persons. 

The Pfizer BioNTech vaccine has been approved for use in persons aged 12 years and above and for those aged 6 months-11 years but at smaller doses. This vaccine is therefore the preferred vaccine in children and young people under 18 years.

No.

None of the vaccines can tamper with or change your DNA.

The Pfizer-BioNTech and Moderna vaccines are the mRNA-based COVID-19 vaccines currently being used in the UK.

These vaccines work by introducing a molecule (the mRNA) into the body which instructs the body’s cells to build a protein similar to those proteins found in the virus that causes COVID-19. This protein is then recognised by the immune system enabling it to produce antibodies to protect the body against COVID-19 infection.

To put it a different way, the mRNA from these vaccines is read by our cells (similar to us reading an instruction manual) enabling those cells to make specific proteins which in turn mount an immune response in the body, helping to protect us against the COVID-19 infection. The mRNA is destroyed within days by your body. It cannot be incorporated into your DNA, it works only as an instruction manual.

The purpose of the vaccines is to protect us from becoming seriously ill and or hospitalised as a result of COVID-19 infection. The COVID-19 vaccines have and continue to save lives across the world but they do not fully protect against the spread of the virus. 

For more information see:

• Monitoring reports of the effectiveness of COVID-19 vaccination - GOV.UK (www.gov.uk)

Gluten is a family of proteins found in certain cereal grains. The COVID-19 vaccines currently available do not contain gluten.

Whether or not diagnosed with coeliac disease, people who have had an allergic reaction to a previous dose of COVID-19 vaccine, or a component (ingredient) of the COVID-19 vaccine should not be given the vaccination. Anyone due to receive their vaccine should continue with their appointment and discuss any questions, serious allergies or any other medical conditions with the healthcare professional before having the vaccine.

No.                

The COVID-19 vaccines teach our bodies to protect us against coronavirus disease. They produce a protective immune, antibody, response which can be measured by blood tests (serology) only.

The COVID-19 vaccines do not affect PCR or lateral flow results. These tests detect viral RNA proteins in the nose and throat produced as a result of COVID-19 infection. In other words, they check for active disease rather than immunity produced as a result of the vaccines.

See Coronavirus disease (COVID-19): Vaccines (who.int) for more information.

The current vaccines have demonstrated significant levels of protection against severe disease and hospitalisation but no vaccine provides 100% protection. However, as more people in the population are vaccinated the risks of COVID-19 circulating should decrease, protecting those who are vulnerable to COVID-19 or who are unable to have the vaccine.

For this reason, all eligible individuals are strongly advised to book their autumn vaccination, as booster doses have been shown to reinforce significant levels of protection. For more full details on eligibility and where to get vaccinated see:

• Get a COVID-19 vaccination and booster in Northern Ireland | nidirect

For more related resources, see:

COVID-19 Vaccination Programme information materials | HSC Public Health Agency (hscni.net)

Yes.

You can still catch COVID-19 after vaccination. The maximum level of protection from the COVID-19 vaccines can take several weeks to build up after your vaccination, meaning that you could still develop the infection during this time.

COVID-19 vaccines have repeatedly been shown to be highly effective at protecting against serious and symptomatic disease, including hospitalisation, but no vaccine is 100% effective.

Emerging variants (mutations of the original strain of the virus) with increased infectivity can lead to more ‘break through infections’ (i.e. vaccinated persons who test positive for COVID-19) however even with the different variants, all COVID-19 vaccines currently in use in Northern Ireland, have maintained high levels of protection against severe disease and hospitalisation, in persons who have received their booster doses. This includes persons over the age of 50 years old (JCVI statement on the adult COVID-19 booster vaccination programme and the Omicron variant: 7 January 2022 - GOV.UK (www.gov.uk)).

The total duration of protection from COVID-19 vaccines remains under investigation.

For full details on the COVID-19 booster programme please see:

• Get a COVID-19 vaccination in Northern Ireland | nidirect

A COVID-19 vaccine is only approved once it has met strict standards of safety, quality and effectiveness as set out by the independent Medicines and Healthcare products Regulatory Agency (MHRA) and the European Medicines Agency (EMA).

There may be a misconception that vaccine research takes a long time but it isn’t just the research that takes the time – it’s all the steps beforehand, like getting funding and approval.

COVID-19 vaccines have been developed at speed because the UK Government has funded trials to get them up and running quickly.

The MHRA and Health Research Authority have sped up the process of approval – administrative paperwork that used to take months which is now being done in days. This has brought down the time for delivery of the clinical trials. Processes have also been streamlined and now run in parallel.

The length of the trials themselves has not been shortened, and the usual safety measures remain in place.

New technology has also helped, enabling vaccines to be manufactured quickly, and vaccines are also being produced in advance meaning that they are available as soon as they are approved.

For more helpful resources please see:

• Coronavirus disease (COVID-19): Vaccines (who.int)

There are very few individuals who cannot receive any of the COVID-19 vaccines. Where there is doubt, rather than withholding vaccination, appropriate advice should be sought from the relevant specialist, or from the local immunisation or health protection team, to allow individuals to make an informed decision.

The vaccines currently available in the UK are not live vaccines, and so are safe for people with disorders of the immune system such as immunosuppression and also for anyone who is pregnant or breast feeding or anyone who is thinking about getting pregnant.  

The vaccine should not be given to those who have had a previous systemic allergic reaction (i.e. more serious than just a local reaction, including immediate-onset anaphylaxis) to:

• A previous dose of the same COVID-19 vaccine
• Any component (ingredient) of the COVID-19 vaccine being offered

Or to individuals with:

• Severe illness and/or a high fever on the day of vaccination.

The Pfizer BioNTech and Moderna vaccines contain polyethylene glycol (PEG), which is from a group of known allergens commonly found in medicines and also in household goods and cosmetics. Known allergy to PEG is extremely rare but people with this allergy should not receive the Pfizer BioNTech or Moderna vaccine. Patients with undiagnosed PEG allergy may have a history of unexplained anaphylaxis or of anaphylaxis to multiple classes of drugs. The VidPrevtyn Beta (Sanofi Pasteur) vaccine does not contain PEG and is a suitable alternative for people aged 18 years and over. Medicines containing PEG include some tablets, laxatives, depot steroid injections, and some bowel preparations used for colonoscopy.

Individuals with any further queries or concerns should discuss these with their specialist/GP who will be able to advise which COVID-19 vaccine is suitable.

No.

Both the COVID-19 and seasonal flu vaccination programmes are important for individual and public health, especially over winter 2023 to 2024

Initially data on co-administration of COVID-19 with other vaccines was limited. In the absence of such data first principles, based on the wider UK routine vaccination schedule experience, suggest that interference between inactivated vaccines with different antigenic content is likely to be limited. Based on this experience with other vaccines, any potential interference is most likely to result in a slightly attenuated immune response to one of the vaccines. There is no evidence of any safety concerns, although it may make the attribution of any side effects more difficult. Similar considerations apply to co-administration of inactivated (or non-replicating) COVID-19 vaccines with live vaccines such as MMR or the live (nasal) flu vaccine.

Yes.

All pregnant women are encouraged to get vaccinated.

In line with the advice from the Royal College of Obstetricians and Gynaecologists (RCOG), Royal College of Midwives (RCM) and the Joint Committee for Vaccination and Immunisation (JCVI), all pregnant and eligible breast feeding women should be offered the COVID-19 vaccine, including  booster dose(s) as appropriate.

In December 2021, following the recognition of pregnancy as a risk factor for severe COVID-19 infection and poor pregnancy outcomes during the pandemic, pregnancy was also added as a clinical risk group.

For further information please see:

• COVID-19 vaccines, pregnancy and breastfeeding (rcog.org.uk)
•  RCM should-iget-the-covid-vaccine.pdf (rcm.org.uk)
• COVID-19 vaccination: a guide on pregnancy and breastfeeding - GOV.UK (www.gov.uk)

The Pfizer/BioNTech COVID-19 and Moderna vaccines are currently the preferred vaccines of choice for pregnant women because of their more extensive use in pregnancy

Hundreds of thousands of pregnant women in the UK and the USA have been vaccinated so far (mostly with the Pfizer/BioNTech COVID-19 and Moderna vaccines) with no safety issues raised. Vaccine trials in pregnant women are ongoing. Please see below for more details:

• COVID-19 Vaccine Pregnancy Registry | Vaccine Safety | CDC
• COVID-19 vaccines, pregnancy and breastfeeding (rcog.org.uk)
• Latest data reinforces the safety of COVID-19 vaccinations in pregnant women - GOV.UK (www.gov.uk)

Please find the JCVI advice in regard to pregnant women HSS MD 84 2021 JCVI ADVICE THAT PREGNANT WOMEN OF ANY AGE SHOULD BE CONSIDERED AS A CLINICAL RISK GROUP FOR COVID-19

COVID-19 vaccines do not affect fertility.

There are no plausible mechanisms by which any of the COVID-19 vaccines could affect fertility in women or men.

The British Fertility Society, Royal College of Obstetricians and Gynaecologists and Association of Reproductive and Clinical Scientists have all confirmed  that there is absolutely no evidence, and no theoretical reason, that any of the COVID-19 vaccines can affect the fertility of women or men.

Further information can be found at: 

• COVID-19 vaccines, pregnancy and breastfeeding (rcog.org.uk) Royal College of Obstetricians and Gynaecologists FAQs
• Covid-19-Vaccines-&-Fertility.pdf (britishfertilitysociety.org.uk)

People of reproductive age are advised to get the vaccine as soon as they receive their invitation for vaccination. This includes those who are trying to have a baby as well as those who are thinking about having a baby, whether that is in the near future or in a few years’ time, as well as those people undergoing fertility treatment

There have been unfounded rumours circulating widely that COVID-19 vaccines could cause infertility because of similarities in the spike protein of SARS-CoV-2 and proteins in cells in the placenta. There are no similarities between these proteins that could feasibly cause the immune system to affect the placenta. There is also no evidence that the immune response to the spike protein – either from infection with COVID-19 itself, or from the vaccine – has had any effect on the placenta or pregnancy outcomes.

Social media posts claiming that the ‘head of Pfizer research’ said the company’s COVID-19 vaccine would cause infertility in women have been shared widely. The person referred to is a former employee of Pfizer who left the company in 2011 and who has shared misinformation about COVID-19 in the past.

The Royal College of Obstetricians and Gynaecologists, and the Royal College of Midwives have released a statement on this (19/01/2021). Both also cover it in their FAQs:

•  Statement from RCM and RCOG on COVID-19 vaccinations, fertility and pregnancy

While the PHA is not affiliated with the following fact checking websites, they have information addressing the false claims which may be useful for helping you to make an informed decision and providing reassurance:

• www.snopes.com/fact-check/covid-vaccine-female-sterilization/?mc_cid=639a39a608&mc_eid=38e9f8ee6f
• https://fullfact.org/health/vaccine-covid-fertility/

Yes.

The British Fertility Society and Royal College of Obstetricians and Gynaecologists (RCOG) have produced helpful advice for those going through or planning to go through IVF.

More detailed information can be found here:

• Covid-19-Vaccines-&-Fertility.pdf (britishfertilitysociety.org.uk)
• COVID-19 vaccines, pregnancy and fertility | RCOG

Frequently asked questions for patients on Coronavirus (COVID-19) | Human Fertilisation and Embryology Authority (hfea.gov.uk)

Yes.

If a woman finds out she is pregnant after she has started a course of vaccine, she should complete the vaccination course as normal.  

The Pfizer/BioNTech and Moderna vaccines are currently the preferred vaccines of choice for pregnant women because of their more extensive use in pregnancy (see no. 40). For full clinical guidance see:

• COVID-19: the green book, chapter 14a - GOV.UK (www.gov.uk)

Further information can be found at the following links:

• COVID-19 vaccines, pregnancy and breastfeeding (rcog.org.uk)
• RCM should-iget-the-covid-vaccine.pdf (rcm.org.uk)

A range of menstrual disorders have been reported after all the COVID-19 vaccines which are currently in use in the UK, including heavy bleeding, delayed periods and unexpected vaginal bleeding.  The number of reports of menstrual disorders and vaginal bleeding is low in relation to both the number of females who have received COVID-19 vaccines to date and the background rate of menstrual disorders generally.

The Medicines and Healthcare Regulatory Authority (MHRA) has reviewed reports of menstrual disorders and unexpected vaginal bleeding suspected as adverse reactions (side effects) to vaccination with Pfizer BioNTech, AstraZeneca and Moderna COVID-19 vaccines. These reports have also been reviewed by independent experts of the Commission on Human Medicines’ COVID-19 Vaccines Benefit Risk Expert Working Group and members of its Medicines for Women’s Health Expert Advisory Group.

Evidence from the most recent review suggested a possible association between the Pfizer BioNTech and Moderna COVID-19 vaccines and heavy menstrual bleeding. The events were mostly non-serious and were temporary in nature. The rigorous evaluation completed to date does not support a link between COVID-19 vaccines and other changes to menstrual periods. There is no evidence to suggest that COVID-19 vaccines will affect fertility and your ability to have children.

Whilst uncomfortable or distressing, period problems are extremely common and stressful life events can disrupt menstrual periods. Changes to the menstrual cycle have also been reported following infection with COVID-19 and in people affected by long-COVID. General advice about period problems and/or unexpected vaginal bleeding is available from the NHS website: Periods - NHS (www.nhs.uk).

It is important that anyone experiencing changes to their periods that are unusual for them, persist over time, or has any new vaginal bleeding after the menopause, reports this to their doctor.

The MHRA will continue to closely monitor reports of menstrual disorders and vaginal bleeding with COVID-19 vaccines.

As with any suspected side effects from the COVID-19 vaccines, including those in relation to menstrual disorders, please continue to report via the Yellow Card scheme here.

The Royal College of Obstetricians and Gynaecologists have issued this statement:

• RCOG/FSRH respond to reports of 30,000 women’s periods affected after COVID-19 vaccine

Vaccines are very safe. The COVID-19 vaccines have undergone multiple stages of testing to ensure their safety, including trials in tens of thousands of volunteers with differing ages and comorbidities (underlying illnesses). As with all medicines, side effects can occur after getting a vaccine. However, these are usually very minor and of short duration, such as a sore arm or a mild fever. More serious side effects are possible, but extremely rare.  

An uncommon side effect is swollen glands in the armpit or neck on the same side as the arm where you had the vaccine. This can last for around 10 days, but if it lasts longer see your doctor. If you are due for a mammogram then you should mention that you have had the vaccine when you attend.

Worldwide, there have also been rare cases of inflammation of the heart called myocarditis or pericarditis, reported after the Pfizer/BioNTech, Moderna and the AstraZeneca COVID-19 vaccines. These cases have been seen mostly in younger men several days after their second vaccination dose. Most of these individuals recovered following rest and simple treatments.

Symptoms of myocarditis and pericarditis include new onset of chest pain, shortness of breath or feelings of a fast-beating, fluttering, or pounding heart. Should you develop any one or more of these symptoms after your COVID-19 vaccination, you should urgently seek medical assistance.

You can report side effects that you are concerned about to the COVID-19 vaccination, or any other medicine or vaccine, through the MHRA Yellow Card Scheme at:

Yellow Card Scheme - MHRA

The ‘Give Hope’ campaign:

The ‘Give Hope’ campaign has been organised by Your Neighbour, a movement of more than 1,100 churches from over 40 denominations in the UK created to respond to the COVID-19 pandemic. The campaign is supporting efforts by the NHS and public health officials to encourage greater take-up of the vaccine by BAME people and to dispel the myths around it: 

• Vaccine give hope — YourNeighbour.org | Equipping Churches in the Covid-19 Crisis

The Give Hope campaign has the backing from over 40 denominations in the UK including the Church of England, Anglican, Salvation Army, Baptist, Pentecostal, Evangelical, Redeemed Christian Church of God and black majority churches.

Do the vaccines contain human or animal products?

The Medicines and Healthcare products Regulatory Agency (MHRA) have confirmed that the Pfizer/BioNTech and Moderna COVID-19 vaccines do not contain any components of animal origin and that none of the vaccines given contain fetal cells in their ingredients.

The following guide contains information on how vaccines are made and what human and animal products are used: 

• www.gov.uk/government/publications/use-of-human-and-animal-products-in-vaccines

The Northern Ireland Department of Health released a statement on 23/08/2021 confirming that the COVID vaccines currently in use in NI do not contain fetal cells. The full statement can be found here:

• https://www.health-ni.gov.uk/news/covid-19-fact-file-vaccines-are-pro-life

The moral issues around the use of vaccines grown on fetal cell lines have been discussed within the Catholic Church. The Church notes that the cells lines are distant from the initial termination, and states that acceptance of such vaccines where there is no appropriate alternative does not signify cooperation with abortion:

• Note on the morality of using some anti-Covid-19 vaccines (21 December 2020) (vatican.va) 

The British Islamic Medical Association:

The British Islamic Medical Association have statements on all of the COVID-19 vaccines currently in use in the UK, encouraging those eligible to get vaccinated at:

• Clinical leaders encourage Muslims to get vaccinated :: Black Country ICB

The Orthodox Union:

The Orthodox Union have also made a statement regarding the COVID-19 vaccine and have said that they strongly encourage all those eligible to access the vaccine to do so: 

Orthodox Union Guidance Regarding Coronavirus - Orthodox Union (ou.org)

The Pfizer-BioNTech and Moderna COVID-19 vaccines do not contain any meat derivatives or porcine products.

The Medicines and Healthcare products Regulatory Agency (MHRA) have confirmed that the Pfizer/BioNTech COVID-19, AstraZeneca and Moderna vaccines do not contain any components of animal origin.

One of the COVID-19 vaccines used as an mRNA alternative, VidPrevtyn Beta, manufactured by Sanofi/GSK) contains an oil derived from shark.

This guide contains information on how vaccines are made and what human and animal products are used: 

• www.gov.uk/government/publications/use-of-human-and-animal-products-in-vaccines

Any person with a history of anaphylaxis to any component (ingredient) of the vaccine should not receive it. A second dose of the vaccine should not be given to those who have experienced anaphylaxis to the first dose of it. Advice should be sought from an Allergy Specialist in this situation.

If you had a reaction to the first dose of the COVID-19 vaccine, inform your vaccinator or GP as you may require a prolonged observation period or they may need to seek advice from an Allergy Specialist.

The Pfizer BioNTech and Moderna vaccines contain polyethylene glycol (PEG), which is from a group of known allergens commonly found in medicines and also in household goods and cosmetics. Known allergy to PEG is extremely rare but people with this allergy should not receive the Pfizer BioNTech or Moderna vaccine. Patients with undiagnosed PEG allergy may have a history of unexplained anaphylaxis or of anaphylaxis to multiple classes of drugs.  The VidPrevtyn Beta (Sanofi Pasteur) vaccine does not contain PEG and may be a suitable alternative for people aged 18 years and over.

Medicines containing PEG include some tablets, laxatives, depot steroid injections, and some bowel preparations used for colonoscopy.

You can still have the COVID-19 vaccine if you have an allergy to penicillin, latex, insect stings, dust mites, and food including nuts and eggs, as long as you are not allergic to any component of the vaccine.

For full clinical guidance see:

• Guidance overview: COVID-19: the green book, chapter 14a - GOV.UK (www.gov.uk)

Recipient information including ingredients for all of the approved vaccines can be found at:

• Comirnaty (Pfizer BioNTech) Comirnaty Omicron XBB.1.5 30 micrograms/dose dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified) - Patient Information Leaflet (PIL) - (emc) (medicines.org.uk)
• Spikevax (Moderna) pil.15085.pdf (medicines.org.uk)

There is specific advice on the COVID-19 vaccines for transplant patients, patients on the transplant list and living donors at the following link: 

• www.odt.nhs.uk/covid-19-advice-for-clinicians/#vaccine

There is no evidence to indicate that drinking alcohol within the recommended weekly limits will have any impact on the vaccine’s effectiveness.

Yes.

The JCVI has stated that there is clear evidence that certain Black, Asian and minority ethnic (BAME) groups have higher rates of infection, and higher rates of serious disease, morbidity and mortality due to COVID-19.

Researchers at the University of Oxford have identified a gene that doubles the risk of developing lung failure and death in people who are infected with SARS-Cov-2 virus (COVID-19). This gene is carried by more than 60% of people with a South Asian ancestry and it is also carried by around 15% of people with a European ancestry. The leader of the research team (Prof James Davies) has said: "Although we cannot change our genetics, our results show that the people with the higher risk gene are likely to particularly benefit from vaccination."

In addition, we know that certain health conditions are also associated with increased risk of serious disease, and these health conditions are often found at increased numbers in certain BAME groups.

The ‘Give Hope’ campaign has been organised by Your Neighbour, a movement of more than 1,100 churches from over 40 denominations in the UK created to respond to the COVID-19 pandemic. The campaign is supporting efforts by the NHS and public health officials to encourage greater take-up of the vaccine by BAME people and to dispel the myths around it: 

· Vaccine give hope — YourNeighbour.org | Equipping Churches in the Covid-19 Crisis

The Give Hope campaign has the backing from over 40 denominations in the UK including the Church of England, Anglican, Salvation Army, Baptist, Pentecostal, Evangelical, Redeemed Christian Church of God and black majority churches.

It is also clear that societal factors, such as occupation, household size, deprivation, and access to healthcare can increase susceptibility to COVID-19 and result in worse outcomes following infection. 

Make sure you are on your guard against scams. Scammers often make contact by email, phone calls, text messages, social media posts and even calling at your door and may ask for money.

There have been reports of scams relating to the COVID-19 vaccine. In Northern Ireland COVID-19 vaccines will only be available through the Health and Social Care (HSC) service. Remember:

• HSC will NEVER ask you for your bank account or card details.
• HSC will NEVER ask you for your PIN or banking password.
• HSC staff will NEVER arrive unannounced at your home to administer the COVID-19 vaccine.
• HSC will NEVER ask you to prove your identity by sending copies of personal documents such as your passport, driving licence, bills or pay slips. 

If you receive a call/text/email claiming to be a COVID-19 vaccine booking line asking for your bank details or for money this is a scam. Never give out your bank details over the phone or email to an unknown, unverified source.

More information on spotting fraud and scams is available at:

•  How to spot a scam | nidirect

Information on COVID-19 Vaccine Fraud provided by Action Fraud can be found at the following link: 

• Coronavirus vaccine scams warning | Action Fraud

If you receive a call you believe to be fraudulent, end the call by hanging up immediately.

If you are concerned/suspicious about an email you have received, forward the email to: report@phishing.gov.uk so these scams can be identified and stopped.

If you are concerned/suspicious about a text message you have received, alert Action Fraud by forwarding the text message to the number 7726. Forwarding the message is free of charge.

When you forward the suspicious message to 7726 you will receive a reply asking for the number which sent you the suspicious text. Provide the phone number from which you received the suspicious text and Action Fraud will follow up with the mobile phone provider.

If you believe you are a victim of a fraud, please report this to Action Fraud as soon as possible by calling 0300 123 2040 or visiting www.actionfraud.police.uk.