The National Immunisation Advisory Committee (NIAC) welcomes the outcome of the European Medicine Agency’s investigation. The EMA confirmed that the benefits of the AstraZeneca vaccine in protecting from COVID-19 related serious illness and hospitalisation outweigh any risks associated with the vaccine. NIAC strongly encourages those who are due to receive the vaccine in the following days and weeks to take this opportunity to protect themselves from serious illness. The best vaccine that anyone can receive is the one that they can receive soonest.
In light of the EMA findings, the NIAC has made the following recommendations to the Department of Health:
The administration of the AstraZeneca vaccine should be recommenced for use in all those aged 18 and over.
Healthcare professionals and vaccine recipients should be informed that very rare, complicated clotting events have been reported in a small number of people who have recently received the AstraZeneca vaccine.
Healthcare professionals should be alert to the signs and symptoms of blood clots and/or low platelet count and report any suspected adverse reactions to the Health Products Regulatory Authority (HPRA).
Recipients of the AstraZeneca vaccine should be advised to seek immediate medical attention if they develop symptoms such as shortness of breath, chest pain, leg swelling and/or persistent abdominal pain within weeks of vaccination. Additionally, anyone with neurological symptoms including severe or persistent headaches (particularly 3 days after vaccination) or blurred vision after vaccination, or who develop skin bruising beyond the site of vaccination, should seek prompt medical attention. These rare events have usually occurred within 14 days of receiving the AstraZeneca vaccine, particularly 3 days or more after.
Healthcare professionals should seek early expert advice from the National Coagulation Centre about specialised testing and treatment options for any patients presenting with these events within weeks following the AstraZeneca vaccine.
NIAC will continue to monitor evidence on COVID-19 vaccines.
Professor Karina Butler, Chair of NIAC said: “The safety of vaccines is paramount. The public should be reassured by the swift and thorough investigations into a very small number of serious but very rare adverse events. Because COVID-19 can be so serious and is so widespread, the EMA found that the benefits of this vaccine outweigh the risks of these very rare events.
“Problems with clotting are commonly seen in those with severe COVID-19 disease. They can also occur by chance in the general population. The EMA found no evidence that the vaccine caused these reported events and are continuing investigation into a possible association.
“These events have predominantly occurred in women under 55 years of age. However, as this may reflect targeted vaccination of healthcare workers to date, NIAC recommends that appropriate guidance be made available to all vaccine recipients and healthcare providers.
“The public should be reassured by the fact that over 20 million doses of this vaccine have been given in the EEA and the UK providing protection to those who have received it. We are seeing that the rate of infections and hospitalisations are beginning to reduce amongst those who are vaccinated. The best vaccine that anyone can received is the one that they can get soonest” Prof Butler said.
NIAC includes representatives from Department of Health, HSE, the National Immunisation Office, the Health Products Regulatory Authority (HPRA),the Irish College of General Practitioners (ICGP) the Health Protection Surveillance Centre (HPSC), the National Virus Reference Laboratory (NVRL UCD), representatives from the Faculties and Institutes of the Royal College of Physicians of Ireland, RCSI, the Infectious Diseases Society, the Nursing and Midwifery Board and two representatives of the public.
This group of experts meet to consider new evidence about vaccines and provide advice to the Chief Medical Officer and the Department of Health. The Department and the Minister for Health make policy decisions on vaccines which are implemented by the HSE.