Resumption of the AstraZeneca Vaccine

Friday 19th March 2021 

The HSE will resume administering the AstraZeneca vaccine tomorrow (Saturday), following the recommendation from the National Immunisation Advisory Committee (NIAC) and the deputy Chief Medical Officer that use of the vaccine should recommence.

 According to Dr. Colm Henry, Chief Clinical Officer, HSE: “We welcome the review by the European Medicines Agency and the positive outcome.  We will now put in place the updated information and advice recommended by NIAC, and begin rescheduling vaccinations starting with a relatively modest number tomorrow (Saturday)”.

‘We know there are huge benefits in terms of preventing serious illness and hospitalisations, even after the first dose for all vaccines, including the AstraZeneca vaccine.  We are already seeing very positive and significant changes in terms of reported COVID-19 cases in healthcare workers and vulnerable groups. There are clear benefits for this vaccine in protecting against serious illness from Covid-19.”

Our priority is to restart the administration of the AstraZeneca vaccine, in as safe and timely a manner as possible.  We plan to administer the AstraZeneca vaccine over this weekend in our acute hospital settings.

HSE Advice on the AstraZeneca Vaccine:

  • People being invited for vaccination are at high risk of COVID-19 disease and we advise that you attend your appointment to receive this vaccine as soon as it is offered to you.
  • Only those who have had anaphylaxis following a previous dose of the vaccine or any of its constituents (including polysorbate 80), should not receive it.
  • People are advised to delay the vaccine if they have an acute illness with a fever.
  • You should also delay vaccination if you have received another vaccine within the last 14 days or if you have had COVID-19 disease within the past 4 weeks.
  • Second Dose: You should get your second dose of COVID-19 Vaccine AstraZeneca® 12 weeks after your first dose. There are no appointments scheduled yet for second doses. You will be contacted for an appointment for your second dose. We recommend that you receive your second dose of vaccine when this is offered to you.

There are a number of common side effects after having the AstraZeneca Vaccine with more than 1 in 10 experiencing the following:

  • feeling tired
  • tenderness, bruising, pain, redness or itching in the arm where they had the vaccine injection
  • headache
  • muscle pain
  • joint pain
  • nausea, diarrhoea or vomiting
  • fever (temperature of 38 degrees Celsius or above)

The EMA review concluded that the AstraZeneca Vaccine is not associated with an increased overall risk of blood clotting disorders.

The EMA noted very rare cases of unusual blood clots accompanied by low levels of blood platelets (components that help blood to clot) after vaccination. The reported cases were almost all in women under 55. Due to the rarity of the events, and the fact that COVID-19 itself causes hospitalisations related to clotting problems, it was not possible to confirm or exclude a link to the vaccine.

However, EMA recommended that people are aware of the following symptoms after receiving the AstraZeneca Vaccine and are advised to seek prompt medical assistance and mention your recent vaccination:

  • breathlessness
  • pain in the chest or stomach
  • swelling or coldness in an arm or leg
  • severe or worsening headache or blurred vision after vaccination
  • persistent bleeding
  • multiple small bruises, reddish or purplish spots, or blood blisters under the skin

The EMA and the NIAC have concluded that because COVID-19 can be so serious and is so widespread, the benefits of the vaccine in preventing this disease outweigh the risks of side effects, including the extremely small possibility of these very rare unusual blood clots.

ENDS

Notes to Editors

The EMA safety committee carried out a comprehensive review of these rare cases of blood clots. Around 20 million people in the UK and EEA had received the COVID-19 Vaccine AstraZeneca® as of March 16 and EMA had reviewed only 7 cases of unusual blood clots in multiple blood vessels (called disseminated intravascular coagulation, DIC) and 18 cases of blood clots in the veins of the brain called CVST

Overall the number of blood clots reported after vaccination, both in studies before the vaccine was rolled out in countries and in the reports after rollout of vaccination campaigns (469 reports, 191 of them from the EEA), was lower than that expected in the general population. This allows the EMA safety committee to confirm that there is no increase in overall risk of blood clots.

There have been very rare cases of unusual blood clots accompanied by low levels of blood platelets (components that help blood to clot) after vaccination. The reported cases were almost all in women under 55 years of age. The reason why cases happened in women under 55 years isn’t known, but it may be because healthcare workers are being vaccinated, who are often younger women.

The EMA and the NIAC have concluded that because COVID-19 can be so serious and is so widespread, the benefits of the vaccine in preventing it outweigh the risks of side effects, including the extremely small possibility of these very rare unusual blood clots.

The EMA are continuing to review and monitor the vaccine and if new information becomes available, this will be communicated

People who receive the vaccine should be aware of the symptoms and signs of blood clots and seek urgent medical attention if they experience them.

Q&A 

When will people be invited for their vaccine?

The groups who were affected by the pause in using this vaccine are Group 2 - frontline healthcare workers, and Group 4 – people who have conditions that put them at very high risk if they get COVID-19. Our services are now working to reschedule vaccination clinics for these groups, and will be in touch with colleague, or patients, to organise those appointments.

It is expected that vaccination with the AstraZeneca vaccine will recommence from Saturday, March 20th in some hospitals.

Within Group 4, work has continued this week to identify people who are due to be invited for vaccines. The HSE and the wider health sector is working to invite people for vaccines, primarily through our hospital services, and our wider disability and mental health sector. We may also seek to contact people through their GPs, and through public information and advertising.

For now, we ask people in this group to not take any action – the HSE or your healthcare team will be in touch with you when your vaccine is available.

What should I do if I am invited to receive COVID-19 Vaccine AstraZeneca® vaccine in the next few days?

We would advise that you attend your appointment to receive this vaccine as soon as it is offered to you. Anyone being invited for vaccination is at high risk of COVID-19 disease because they are a healthcare worker or live in a residential setting or are at high risk or serious illness and hospitalisation if they get COVID-19.

The European Medicines Agency (EMA) and NIAC have concluded that the benefits of the vaccine continue to outweigh the risks of side effects, including the extremely small possibility of developing unusual blood clots.

Where can I get more information before I attend my appointment?

Read NIAC’s Recommendations for the use of COVID-19 AstraZeneca vaccine

Read the Patient Information leaflet After your COVID19 Vaccine AstraZeneca (PDF, size 210.6 KB, 2 pages)

Read the HSE Information leaflet Important Information about COVID19 Vaccine AstraZeneca (PDF, size 396.3 KB, 12 pages)

Is there anyone who should not get the COVID-19 Vaccine AstraZeneca® vaccine?

There has been no change to the advice about who can get the COVID-19 Vaccine AstraZeneca®. The only people who should not receive the vaccine are those who have had anaphylaxis (serious allergic reaction) following a previous dose of the vaccine or any of its ingredients (including polysorbate 80).

People are advised to delay the vaccine if they are sick with a fever (temperature of 38 degrees Celsius or above). You should also delay vaccination if you have received another vaccine within the last 14 days or if you have had COVID-19 disease within the past 4 weeks.

What if I recently had a blood clot or I am on blood thinning treatments?

You can still have the COVID-19 Vaccine AstraZeneca® if you have recently had a blood clot or are on blood thinning treatments. There is no reason to delay vaccination. Like everyone who gets the vaccine, you should be aware of the symptoms to look out for.

What if I have a condition or I am on a treatment that may make me more likely to get a blood clot?

You can still have the COVID-19 Vaccine AstraZeneca®. There is no reason to delay vaccination. Like everyone who gets the vaccine, you should be aware of the symptoms to look out for.

Can pregnant women receive COVID-19 vaccine AstraZeneca?

Yes pregnant women can receive COVID-19 vaccine AstraZeneca. There is no reason to delay vaccination. They should be aware of the symptoms to look out for as listed above. Recommendations of the NIAC should be followed in relation to vaccination in pregnancy.

What if people are taking the contraceptive pill, the contraceptive patch or the contraceptive ring (Nuvaring)?

You can still have the COVID-19 Vaccine AstraZeneca®. There is no reason to delay vaccination. Like everyone who gets the vaccine, you should be aware of the symptoms to look out for as listed above.

What if there is a history of blood clots in the family?

You can still have the COVID-19 Vaccine AstraZeneca®. There is no reason to delay vaccination. Like everyone who gets the vaccine, you should be aware of the symptoms to look out for.

Can people choose to get a different vaccine instead of the COVID-19 Vaccine AstraZeneca®?

At this time, supplies of the vaccines are limited so it is not possible to offer people a choice of COVID-19 vaccine. We recommend that people accept the vaccine that is offered to you to ensure you can be protected from COVID-19 as early as possible.

What about second doses of COVID-19 Vaccine AstraZeneca® vaccine?

People should get their second dose of COVID-19 Vaccine AstraZeneca® 12 weeks after your first dose. There are no appointments scheduled yet for second doses. You will be contacted for an appointment for your second dose. We recommend that you receive your second dose of vaccine when this is offered to you.

What are the symptoms people should watch out for that may mean a blood clot?

If you get any of the following symptoms:

  • breathlessness
  • pain in the chest or stomach
  • swelling or coldness in an arm or leg
  • severe or worsening headache or blurred vision after vaccination
  • persistent bleeding
  • multiple small bruises, reddish or purplish spots, or blood blisters under the skin please seek prompt medical assistance and mention your recent vaccination.

The very rare blood clots were usually reported within 14 days of getting the COVID-19 Vaccine AstraZeneca®. You should watch out for these symptoms in the weeks after your vaccination.

Should people take aspirin before or after vaccination?

No, these are very rare blood clotting conditions and aspirin would not have a beneficial effect. People should be advised that they do not need to start aspirin treatment before or after vaccination.

Patients should continue to take all prescribed medication unless advised by their medical practitioner.

What are the common side-effects of symptoms people may get after receiving COVID-19 Vaccine AstraZeneca® vaccine?

We know that side effects of COVID-19 Vaccine AstraZeneca® usually happen in the first couple of days after the vaccine, and go away after a few days

After the AstraZeneca COVID-19 vaccine, more than 1 in 10 people may experience:

  • feeling tired
  • tenderness, bruising, pain, redness or itching in the arm where they had the vaccine injection
  • headache
  • muscle pain
  • joint pain
  • nausea, diarrhoea or vomiting
  • fever (temperature of 38 degrees Celsius or above)

More than one in 100 people may have redness or swelling where they had the injection.

It is common to develop a fever (temperature of 38 degrees Celsius or above) after any vaccination. This usually happens within 2 days (48 hours) of getting the vaccine. It usually goes away within 2 days.

If you feel uncomfortable, take paracetamol or ibuprofen following the instructions on the box or leaflet.

Last updated on: 19 / 03 / 2021