No evidence to show AstraZeneca Covid vaccine causes clots, says UK regulator

There is no evidence that the AstraZeneca vaccine is the cause of blood clots, according to the UK regulator.

Ireland suspended the use of the shock on Sunday out of caution.

Reports of severe clots in adults in Norway followed, with four people remaining in hospital.

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

The UK Medicines and Health Products Regulator (MHRA) said: “We are aware of what is happening in Ireland.

“We are carefully reviewing the reports, but given the large number of doses given and the frequency with which blood clots can occur naturally, the evidence available does not suggest that the vaccine is the cause.”

Countries should keep using the vaccine, the World Health Organization (WHO) said, adding there was no evidence of a link between the bumps and the blood clots.

More than 110,000 doses have been given in Ireland, about one fifth of all vaccinations given to date.

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

“This is a precautionary step.”

Irish Deputy Chief Medical Officer, Dr. Ronan Glynn said the recommendation was made following a report by the Norwegian Medicines Agency on four new reports of serious blood clotting events in adults following vaccination with AstraZeneca.

He added: “It was not concluded that there was a link between the Covid-19 vaccine AstraZeneca and these cases.

“However, on a precautionary basis and pending further information, the National Immunization Advisory Committee (NIAC) has recommended that the vaccination program against the Covid-19 vaccine AstraZeneca in Ireland be temporarily postponed.”

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

It added: “In fact, the reported number of these types of events for the Covid-19 vaccine AstraZeneca is no greater than the number that would have naturally occurred in the unvaccinated population.

“A careful review of all available safety data, including these events, is in progress and AstraZeneca is committed to providing information promptly.”

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

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

“However, it has received no reports of the type described by the Norwegian Medicines Agency.

“We will continue to monitor the national reports very closely and continue to promote the reporting of suspected side effects after vaccination with a Covid-19 vaccine.”

Several other European countries have temporarily suspended AstraZeneca shocks.

The EMA reported that a person in Austria was diagnosed with blood clots and died 10 days after vaccination. However, she stressed that “there is currently no evidence that vaccination caused these conditions”.

Another person was hospitalized in Austria after vaccination with pulmonary embolism (blockage of the pulmonary arteries), while one death with a blood clot was reported in Denmark.

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

Denmark, Norway and Iceland have announced that they will temporarily stop all AstraZeneca vaccinations to investigate the reports.

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