Denmark suspends AstraZeneca COVID shots for two weeks after blood clot reports

Denmark is suspending for two weeks the use of AstraZeneca's Covid-19 vaccine shots after reports of the formation of blood clots in some who have been vaccinated, including one death in Denmark, Danish authorities said on Thursday.

The move comes after one person in Denmark who was given the AstraZeneca shot formed a blood clot and died, the Danish Health Authority said.

Austria has stopped using a batch of AstraZeneca shots while investigating a death from coagulation disorders and an illness from a pulmonary embolism.

"Both we and the Danish Medicines Agency have to respond to reports of possible serious side effects, both from Denmark and other European countries," the director of the Danish Health Authority, Soren Brostrom, said in a statement.

"It is currently not possible to conclude whether there is a link. We are acting early, it needs to be thoroughly investigated," Health Minister Magnus Heunicke said on Twitter.

The vaccine would be suspended for 14 days. The health agency did not give details of the Danish blood clot victim.

Some health experts said there was little evidence to suggest the vaccine should not be administered and that the cases of blood clots corresponded with the rate of such cases in the general population.

"This is a super-cautious approach based on some isolated reports in Europe," Stephen Evans, professor of pharmacoepidemiology at the London School of Hygiene & Tropical Medicine, told Reuters .

"The problem with spontaneous reports of suspected adverse reactions to a vaccine are the enormous difficulty of distinguishing a causal effect from a coincidence," he said.

AstraZeneca on Thursday told Reuters in a written statement “the safety of its vaccine had been extensively studied in human trials and peer-reviewed data had confirmed the vaccine was generally well tolerated.

The drugmaker said earlier this week its shots were subject to strict and rigorous quality controls and that there had been"no confirmed serious adverse events associated with the vaccine". It said it was in contact with Austrian authorities and would fully support their investigation.

The European Union's drug regulator, the European Medicines Agency (EMA), said on Wednesday there was no evidence so far linking AstraZeneca to the two cases in Austria.

It said the number of thrombo-embolic events - marked by the formation of blood clots - in people who have received theAstraZeneca vaccine is no higher than that seen in the general population, with 22 cases of such events being reported among the 3 million people who have received it as of March 9.

EMA was not immediately available for comment on Thursday.

Four other countries - Estonia, Lithuania, Luxembourg and Latvia - have stopped inoculations from the batch while investigations continue, the EMA said.

The batch of 1 million doses went to 17 EU countries.

"We do not think that there is sufficient evidence to stop vaccination with AstraZeneca's vaccine," Veronica Arthurson,head of drug safety at the Swedish Medical Products Agency, told Newsagency TT .

The Danish Medicines Agency said it had launched an investigation into the vaccine together with corresponding agencies in other EU countries as well as the EMA.

"It is important to emphasise that we have not opted out of using the AstraZeneca vaccine, but that we are putting it on hold," Brostrom said.

So far, 136,090 Danes have received a shot with AstraZeneca's vaccine in a country of 5.8 million. The Nordic country, which also uses vaccines from Pfizer-BioNTech and Moderna, is set to receive 2.6 million doses from AstraZeneca over the coming months.

Denmark's Health Authority said it had pushed back the final date for when it expects all Danes to have been fully vaccinated by four weeks to Aug. 15 as a result of the vaccine suspension.

Spain On Thursday said it had not registered any cases of blood clots related to AstraZeneca's vaccine so far and would continue administering the shots.

Italy bans AstraZeneca batch following two deaths in Sicily

Italian health authorities have ordered the withdrawal of a batch of AstraZeneca coronavirus vaccine following the deaths of two men in Sicily who had recently been inoculated, a source close to the matter said on Thursday.

Italy's medicines authority Aifa confirmed that it was halting the use of a batch of doses as a "precautionary" measure, adding that no link had been established between the vaccine and subsequent "serious adverse events".

It did not specify what incidents it was referring to.

However, the source said health authorities moved following the deaths this month of Stefano Paterno, a 43-year-old navy officer, and Davide Villa, a 50-year-old policeman, who had both received shots from AstraZeneca's ABV2856 batch.

Paterno died of a suspected heart attack on Tuesday, the day after his shot. Villa died at the weekend, some 12 days after his inoculation.

Local newspapers said he fell ill within 24 hours of his injection, and reported that doctors had diagnosed a deep vein thrombosis, which later resulted in a brain haemorrhage.

Italy's move came hours after Denmark and Norway announced they were temporarily suspending the use of AstraZeneca's vaccine shots after reports of the formation of blood clots in some who have been vaccinated.

AstraZeneca on Thursday told Reuters in a written statement the safety of its vaccine had been extensively studied in human trials and peer-reviewed data had confirmed the vaccine was generally well tolerated.

The drugmaker said earlier this week its shots were subject to strict and rigorous quality controls and that there had been "no confirmed serious adverse events associated with the vaccine".

EU told to expect no AstraZeneca vaccines from US in near future

In a different development, Washington has told the European Union that it should not expect to receive AstraZeneca Covid-19 vaccines manufactured in the United States any time soon, two EU sources said on Thursday, in a new blow to the bloc's supplies.

The US message could complicate vaccination plans in the 27-nation bloc, which has been grappling since January with delays in deliveries from vaccine makers.

"The US told us there was no way it would ship AstraZeneca vaccines to the EU," said a senior official directly involved in EU-US talks.

AstraZeneca told the EU earlier this year it would cut its supplies in the second quarter by at least half to less than 90 million doses, EU sources told Reuters, after a bigger reduction in the first three months of the year.

Later, however, AstraZeneca offered to partly plug the gap with vaccines produced outside Europe, including in the United States.

A senior EU diplomat said that the European Commission told member states' diplomats at a meeting in Brussels on Wednesday that the bloc should not expect any exports from the United States "at this point in time".

"Basically the situation is such that any exports are tricky, but there is a willingness to talk," the diplomat said.

AstraZeneca declined to comment and the White House had no immediate comment

It is not known what is behind the possible move on exports. It is unclear whether AstraZeneca is producing much vaccine in the US or if the US would apply a restrictive measure on trade. AstraZeneca's vaccine has not yet been approved for use in the United States.

The move comes after Austria stopped using a batch of AstraZeneca shots while investigating a death from coagulation disorders and an illness from a pulmonary embolism.

Asked about vaccine talks with the United States, European Commission spokesman Eric Mamer said on Thursday: "Whatever the legal situation in the United States, we want to work on the ground with the United States to keep the supply chains open."

"We're not going to give a blow-by-blow account of the discussions that are taking place with our American partners."

But the EU's executive did not reply to specific questions about a possible move on exports from the United States.

The US stance could jeopardise AstraZeneca's attempts to bring deliveries closer to its contractual obligation with the EU of 180 million doses in the second quarter.

US President Joe Biden said on Wednesday the US government will first give Americans Covid-19 vaccines, but any surplus would be shared with the world.

AstraZeneca's Covid-19 vaccines are produced in the United States in a plant near Baltimore run by Catalent, which is listed in the EU supply contract with AstraZeneca as a "back-up supply site" and has been authorised by the EU drugs regulator as a manufacturer of vaccine ingredients.

The head of the European Commission, Ursula von der Leyen, had a call with Biden last week, which was followed this week by a meeting between EU industry commissioner Thierry Breton and White House Covid-19 response coordinator, Jeffrey Zients.

In both talks, vaccines were discussed, according to EU statements issued afterwards.

Talks with the US on vaccines were continuing, with new calls expected this week, one EU official said.

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