AstraZeneca vaccine roll out to continue in north while suspended in south of Ireland

The Department of Health in the north issued a statement reassuring people that officials have taken expert advice which concurs with the World Health Organisation and other bodies that the use of the vaccination should continue.

A number of countries across Europe including the Republic of Ireland have suspended use however following concerns that a small number of vaccinated people who were later found to have blood clots. This is a precautionary measure and there is no confirmed evidence of any link, as AstraZeneca has stated.

The Northern Ireland health service administers COVID-19 vaccines under the expert direction of the MHRA (Medicines and Healthcare products Regulatory Agency).

The MHRA is the UK regulatory body for medicines and approves vaccines for public use when it is satisfied on grounds of safety and effectiveness. On Thursday, the MHRA advised the public to continue getting their COVID-19 vaccines.

Health Minister Robin Swann and the Department of Health sought an update from the MHRA on Sunday, in light of the temporary AstraZeneca halt announced by the Republic of Ireland.

The MHRA advised: “We are aware of the action in Ireland. We are closely reviewing reports but given the large number of doses administered, and the frequency at which blood clots can occur naturally, the evidence available does not suggest the vaccine is the cause.”

In line with MHRA guidance, the roll-out of Northern Ireland’s vaccination programme will continue.

The Department in the north said: “AstraZeneca vaccines are helping to protect the most vulnerable in our community from COVID-19, saving lives and reducing hospitalisation levels.”

Earlier today the Department also confirmed: “Vaccination centres are being migrated to AstraZeneca vaccine deployment for first doses, to maximise use of available Covid-19 vaccine supplies in NI.

“That means that increasingly, the same vaccine will be provided by GPs and the centres. Anyone who received the Pfizer vaccine as a first dose will still receive the Pfizer vaccine for their second dose.”

Meanwhile south of the border, Deputy Chief Medical Officer, Dr. Ronan Glynn said on Sunday: “Following new information received from the Norwegian Medicines Agency on Saturday evening 13 March and following discussions with the Health Products Regulatory Authority (HPRA), the National Immunisation Advisory Committee (NIAC) has recommended that the administration of COVID-19 Vaccine AstraZeneca be temporarily deferred from this morning, Sunday 14 March.

“This recommendation has been made following a report from the Norwegian Medicines Agency of four new reports of serious blood clotting events in adults after vaccination with COVID-19 Vaccine AstraZeneca. It has not been concluded that there is any link between the COVID-19 Vaccine AstraZeneca and these cases. However, acting on the precautionary principle, and pending receipt of further information, the NIAC has recommended the temporary deferral of the COVID-19 Vaccine AstraZeneca vaccination programme in Ireland.”

A total of 117,000 doses of COVID-19 Vaccine AstraZeneca have been administered in the south of Ireland to date.

The Irish government said European Medicines Agency (EMA) is already investigating a number of reports of thromboembolic events following vaccination with COVID-19 Vaccine AstraZeneca. Further information is expected from the EMA in the next few days, which will include a review of these additional events.

In a statement, AstraZeneca said: “Following a recent concern raised around thrombotic events, AstraZeneca would like to offer its reassurance on the safety of its COVID-19 vaccine based on clear scientific evidence. Safety is of paramount importance and the Company is continually monitoring the safety of its vaccine.

“A careful review of all available safety data of more than 17 million people vaccinated in the European Union (EU) and UK with COVID-19 Vaccine AstraZeneca has shown no evidence of an increased risk of pulmonary embolism, deep vein thrombosis (DVT) or thrombocytopenia, in any defined age group, gender, batch or in any particular country.

“So far across the EU and UK, there have been 15 events of DVT and 22 events of pulmonary embolism reported among those given the vaccine, based on the number of cases the Company has received as of 8 March. This is much lower than would be expected to occur naturally in a general population of this size and is similar across other licensed COVID-19 vaccines. The monthly safety report will be made public on the European Medicines Agency website in the following week, in line with exceptional transparency measures for COVID-19.

“Furthermore, in clinical trials, even though the number of thrombotic events was small, these were lower in the vaccinated group. There has also been no evidence of increased bleeding in over 60,000 participants enrolled.”

Ann Taylor, its Chief Medical Officer, said: “Around 17 million people in the EU and UK have now received our vaccine, and the number of cases of blood clots reported in this group is lower than the hundreds of cases that would be expected among the general population. The nature of the pandemic has led to increased attention in individual cases and we are going beyond the standard practices for safety monitoring of licensed medicines in reporting vaccine events, to ensure public safety.”

The vaccine company added: “In terms of quality, there are also no confirmed issues related to any batch of our vaccine used across Europe, or the rest of the world. Additional testing has, and is, being conducted by ourselves and independently by European health authorities and none of these re-tests have shown cause for concern. During the production of the vaccine more than 60 quality tests are conducted by AstraZeneca, its partners and by more than 20 independent testing laboratories. All tests need to meet stringent criteria for quality control and this data is submitted to regulators within each country or region for independent review before any batch can be released to countries.

“The safety of the public will always come first. The Company is keeping this issue under close review but available evidence does not confirm that the vaccine is the cause. To overcome the pandemic, it is important that people get vaccinated when invited to do so.”