Germany, Italy, France and Spain suspend AstraZeneca vaccine rollout amid blood clot concerns

Vaccine lottery strategy | EDITORIAL CARTOON - Baltimore SunThe European Union's four largest nations have suspended the use of the AstraZeneca COVID-19 vaccine after reports in some European countries of serious side effects in recipients.

Key points:

  • Italy, France, Germany and Spain have joined several other European countries in suspending the rollout of the AstraZeneca vaccine
  • AstraZeneca, the European Medicines Agency and the World Health Organization all say the vaccine is safe
  • The UK has administered millions of doses of the vaccine and says it has no concerns

But the World Health Organization urged calm, saying there was no proven link between the vaccine and reported side-effects.

Germany, Italy and France announced they would be pausing their rollout of the vaccine pending an assessment from the European Medicines Agency (EMA), which is meeting on Thursday.

Spain suspended the use of the vaccine for at least two weeks.

Cyprus and Slovenia also announced they would be putting use of the vaccine on hold until after the EMA meeting.

The moves will deepen concerns about the slow rollout of vaccines in the region, which has been plagued by shortages due to problems producing vaccines, including AstraZeneca's.

Last week Germany warned it was facing a third wave of infections, while Italy is intensifying its lockdown.

In France, hospitals in the Paris region are close to being overloaded.

French president Emmanuel Macron said his country would initially be suspending the use of the vaccine for 24 hours, but that he hoped it could resume "if the EMA gives the green light".

Denmark and Norway stopped giving the shot last week after reporting isolated cases of bleeding, blood clots and a low platelet count.

Iceland and Bulgaria followed suit before Ireland and the Netherlands announced suspensions on Sunday.

While its investigation is ongoing, the EMA currently remains of the view that the benefits of the AstraZeneca vaccine in preventing COVID-19, with its associated risk of hospitalisation and death, outweigh the risks of side effects.

Germany's health minister Jens Spahn echoed Mr Macron in saying that the move was precautionary, and said it came following a recommendation from Germany's vaccine authority, the Paul Ehrlich Institute.

"The background is new reports of cases of thrombosis which are in temporal connection with an AstraZeneca vaccination," Mr Spahn said.

"In light of these newly reported cases, the Paul Ehrlich Institute today re-evaluated the situation and recommended a suspension of vaccinations and further analyses."

Italy said its halt was a "precautionary and temporary measure" pending the EMA's ruling.

Austria and Spain have stopped using particular batches and prosecutors in the northern Italian region of Piedmont earlier seized 393,600 doses following the death of a man hours after he was vaccinated.

Piedmont was the second Italian region to do so after Sicily, where two people died shortly after having their shots.

WHO says there is 'no evidence' illnesses are linked to vaccine

The World Health Organization appealed to countries not to suspend vaccinations against the disease that has caused more than 2.7 million deaths worldwide.

"As of today, there is no evidence that the incidents are caused by the vaccine and it is important that vaccination campaigns continue so that we can save lives and stem severe disease from the virus," WHO spokesman Christian Lindmeier said.

Australia has secured 53.8 million doses of the AstraZeneca vaccine, 50 million of which will be made in Australia by medical giant CSL.

The United Kingdom, which has administered millions of doses of the AstraZeneca vaccine, said it had no concerns, while Poland said it thought the benefits outweighed any risks.

The EMA has said that as of March 10, a total of 30 cases of blood clotting had been reported among close to 5 million people vaccinated with the AstraZeneca shot in the European Economic Area, which links 30 European countries.

The UK's Medicines and Healthcare products Regulatory Agency (MHRA), which was the first in the world to approve the AstraZeneca vaccine for use, said it was closely reviewing the reports but urged people to continue to get their shots.

"Blood clots can occur naturally and are not uncommon," Dr Phil Bryan, head of vaccine safety at the MHRA, said in a statement.

"More than 11 million doses of the COVID-19 vaccine AstraZeneca have now been administered across the UK, and the number of blood clots reported after having the vaccine is not greater than the number that would have occurred naturally in the vaccinated population.

"We are working closely with international counterparts in understanding the global safety experience of COVID-19 vaccines and on the rapid sharing of safety data and reports."

Review shows no increased risk to blood clots: AstraZeneca

Earlier AstraZeneca said a review of safety data had shown no evidence of an increased risk of blood clots

AstraZeneca's review, which covered more than 17 million people vaccinated in the United Kingdom and European Union, came before Germany, Italy and France announced their measures.

"A careful review of all available safety data … has shown no evidence of an increased risk of pulmonary embolism, deep vein thrombosis or thrombocytopenia, in any defined age group, gender, batch or in any particular country," the company said.

AstraZeneca said 15 events of deep vein thrombosis and 22 events of pulmonary embolism had been reported so far.

Other licensed COVID-19 vaccines have reported similar rates of clotting in patients who have been vaccinated, according to AstraZeneca.

The company said additional tests were being carried out and said none of the re-tests had shown cause for concern.

A monthly safety report would be made public in the next week, AstraZeneca said.

The AstraZeneca vaccine, developed in collaboration with Oxford University, has been authorised for use in the European Union and many countries, including Australia, but has not yet been approved by US regulators.


Source: https://www.abc.net.au/news/2021-03-16/germany-italy-france-suspend-use-of-astrazeneca-covid-vaccine/13251544

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