Wednesday 14th April

CFI Update: AstraZeneca Vaccine Guidance

Updated AstraZeneca Vaccine Guidance and information for those who have received their first dose of the AstraZeneca Vaccine

The National Immunisation Advisory Committee (NIAC) have issued new guidance for the use of the AstraZeneca vaccine in Ireland. All of the authorised COVID-19 vaccines available in Ireland are highly effective in preventing hospitalisation and severe COVID-19 disease. The European Medicines Agency recently concluded an investigation into a number of reports of very rare, unusual blood clots occurring with low platelets in people following vaccination with the AstraZeneca COVID-19 vaccine. These rare events are estimated to occur between 4 and 10 in every 1 million people. NIAC and HIQA (the Health Information and Quality Authority) looked at the risks and benefits of the AstraZeneca vaccine in the Irish context. The potential risk of any vaccine-associated harm must be balanced against the disease risk and availability of alternative mitigation strategies, including the availability of other vaccines. The risk/benefits of the AstraZeneca vaccine may vary by age.

As alternative COVID-19 vaccines are available NIAC has revised the recommendations for use of this vaccine.

  • The AstraZeneca vaccine is not recommended for those aged under 60 years including those with medical conditions with a very high or high risk of severe COVID-19 disease
  • A second dose of the AstraZeneca vaccine should not be given to anyone who developed unusual blood clots with low platelets after the first dose

For people who have already received a first dose of the AstraZeneca vaccine

  • People who are aged 60 and older should receive their second dose 12 weeks later as scheduled
  • People who are aged under 60 years:
    • With a very high-risk or high-risk medical condition should receive their second dose 12 weeks later as scheduled
    • Without a very high risk or high-risk medical condition should have the scheduled interval between doses extended to 16 weeks to allow further assessment of the benefits and risks as more evidence becomes available

The full NIAC recommendations can be found here.
 

AstraZeneca Side Effects

Vaccination with the AstraZeneca vaccine is highly effective and substantially reduces the risk of severe COVID-19 disease across all age groups. Like all medicines, vaccines can cause side effects. Most of these side effects are moderate and short-term. Not everyone will get side effects.

There are common side effects that people may experience after the AstraZeneca vaccine.

More than 1 in 10 people may experience:

  • Feeling tired
  • Tenderness, bruising, pain, redness or itching in the arm that you got the vaccine injection in
  • Headache
  • Muscle pain
  • Joint pain
  • Nausea, diarrhoea or vomiting
  • Fever


Unusual blood clots

There have been some very rare cases of unusual blood clots (thromboembolism) along with low levels of platelets (thrombocytopenia) reported among people who have received the AstraZeneca vaccine.

These very rare cases of unusual blood clots along with low levels of blood platelets have been seen in less than 1 in 100,000 people after vaccination with the AstraZeneca COVID-19 vaccine.

Although very rare, people who have received the AstraZeneca vaccine should be aware of the symptoms to look out for.

Get urgent medical help if you get any of these symptoms in the weeks after the AstraZeneca COVID-19 vaccine:

  • Breathlessness
  • Pain in the chest or stomach
  • Leg swelling
  • Severe or worsening headache or blurred vision
  • Persistent bleeding, under the skin where there was no previous injury
  • Multiple small bruises, reddish or purplish spots, or blood blisters under the skin
     

Does the vaccine cause these rare side effects?
A causal relationship between the vaccine and the occurrence of very rare, unusual blood clots with low platelets is considered plausible but is not confirmed. The EMA has concluded that unusual blood clots with low blood platelets should be listed as very rare side effects of the AstraZeneca vaccine.


Can I get a second dose of a different vaccine?
The NIAC recommendations currently state that anyone with an underlying medical condition that puts them at high, or very high risk from COVID-19 disease, who have received their first dose of AstraZeneca should continue to take their second dose of the AstraZeneca vaccine 12 weeks later as scheduled.

(A second dose of the AstraZeneca vaccine should not be given to anyone who developed unusual blood clots with low platelets after the first dose)

Getting a second dose of the vaccine is important to provide both the extent and duration of protection that was seen in the clinical trials.

There are clinical trials ongoing which are looking at the safety and efficacy of people receiving a second dose of vaccine different to their first dose. For example, one of the mRNA vaccines (Pfizer BioNTech or Moderna) after their first dose of AstraZeneca. These trials are ongoing and the data is not yet available. In addition, some countries have decided to use an mRNA vaccine instead of the second dose of AstraZeneca. The data from the clinical trials and the experiences of other countries will be reviewed by NIAC on an ongoing basis and may inform future changes to the current guidance.
 

I have not received a COVID-19 vaccine yet, which vaccine will I get now?
People aged under 60 with underlying medical conditions will now be offered one of the other available vaccines instead of the AstraZeneca vaccine. The other vaccines currently available in Ireland are the Pfizer BioNTech vaccine and the Moderna vaccine

Information on both can be found by clicking on the Vaccine  name below