No evidence to show AZ vaccine causes clots, says UK regulator

Evidence does not suggest the AstraZeneca vaccine is the cause of blood clots, the UK regulator said.

Ireland suspended use of the jab on Sunday, out of an abundance of caution.

It followed reports of serious clotting in adults in Norway which left four people in hospital.

Irish Minister for Health Stephen Donnelly said it was a “precautionary step”.

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) said: “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.”

Countries should continue to use the vaccine, the World Health Organisation (WHO) has said, adding there was no indication of a link between the jabs and blood clots.

More than 110,000 doses have been administered in Ireland, which is about a fifth of all inoculations given to date.

Mr Donnelly said: “The decision to temporarily suspend use of the AstraZeneca Covid-19 vaccine was based on new information from Norway that emerged late last night.

“This is a precautionary step.”

Ireland’s deputy chief medical officer, Dr Ronan Glynn, said the 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 AstraZeneca.

He added: “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 National Immunisation Advisory Committee (NIAC) has recommended the temporary deferral of the Covid-19 vaccine AstraZeneca vaccination programme in Ireland.”

In a statement to RTE, AstraZeneca said an analysis of safety data covering more than 17 million doses of the vaccine administered has shown no evidence of an increased risk of the conditions concerned, and that no trends or patterns were observed in clinical trials.

It added: “In fact, the reported numbers of these types of events for Covid-19 vaccine AstraZeneca are not greater than the number that would have occurred naturally in the unvaccinated population.

“A careful review of all available safety data, including these events, is ongoing and AstraZeneca is committed to sharing information without delay.”

The European Medicines Agency (EMA) has initiated an urgent review of all blood clotting events occurring with the vaccine, to determine if there is a possible safety risk.

A statement from Ireland’s Health Products Regulatory Authority (HPRA) said: “To date, the HPRA has received a small number of reports associated with blood clots following vaccination with the AstraZeneca vaccine.

“However, it has not received any reports of the nature of those described by the Norwegian Medicines Agency.

“We will continue to monitor national reports very closely and continue to encourage the reporting of any suspected side-effect following vaccination with a Covid-19 vaccine.”

Several other European countries temporarily suspended AstraZeneca jabs.

The EMA reported one person in Austria was diagnosed with blood clots and died 10 days after vaccination, but it stressed there is “currently no indication that vaccination has caused these conditions”.

Another person was admitted to hospital in Austria with pulmonary embolism (blockage in arteries in the lungs) after being vaccinated, while one death involving a blood clot was reported in Denmark.

A 50-year-old man is also thought to have died in Italy from deep vein thrombosis (DVT), while there has been an unconfirmed report of another death in Italy.

Denmark, Norway and Iceland have said they are temporarily halting all AstraZeneca vaccinations to investigate the reports.

No new deaths with Covid-19 were reported in Ireland on Sunday.

A further 384 infections have been confirmed, the Department of Health said.