AZN AstraZeneca PLC

By Jenny Strasburg and Giovanni Legorano 

Danish and Norwegian health officials temporarily halted the use of the Covid-19 vaccine made by AstraZeneca PLC as a precaution, as they and other European regulators investigated reports of severe blood clots in people who have received doses.

Millions of doses of the shot have been administered across the continent. Europe's top medicines watchdog said this week it hadn't found instances of serious blood clots to be more common among people who got the AstraZenica vaccine than in the general population.

Still, the Danish Health Authority said Thursday it would pause for at least two weeks the use of the AstraZeneca vaccine, jointly developed with the University of Oxford. That includes for people who have already had their first dose of the two-dose vaccine.

Danish officials cited an unspecified number of reports of severe cases of blood clots in people who received the vaccine, including one person in Denmark who died. "It cannot be concluded whether there is a link between the vaccine and the blood clots," the Danish health authority said. Norway cited Denmark's decision, saying it also doesn't have evidence to connect the health incidents to vaccination but was acting out of caution to halt use of the AstraZeneca vaccine.

Danish authorities said the European Medicines Agency -- which acts much like the Food and Drug Administration in regulating medicine across the European Union -- is investigating other, similar reports and any possible connection to the vaccine.

The European regulator said Wednesday that it was investigating several cases of multiple thrombosis, or the formation of blood clots within blood vessels, and similar conditions in people post-vaccination. It said there were 22 reported cases of "thromboembolic events" among three million people vaccinated with the AstraZeneca shot across the 27-member bloc as of March 9. That rate of serious blood clots is in line with typical levels for the general population, it said.

The relationship between Europe and AstraZeneca has been rocky since even before the vaccine gained regulatory authorization in the bloc. Several countries initially restricted the vaccine's use to younger adults but in some cases later changed course. AstraZeneca is falling short of projected deliveries to the bloc and trying to catch up, angering European leaders already under fire for the slow pace of their rollouts.

More than 11 million doses of the vaccine have been given in the U.K., government figures show. Documented reactions to the vaccine have been largely mild or moderate and have included soreness in the arm near the injection, tiredness, fever and headache, typically not lasting more than a few days.

The U.K.'s medicines regulator urged people to continue receiving the AstraZeneca vaccine, calling the Danish decision to suspend use of the shot a "precautionary measure." The U.K. regulator said there was no confirmation of a link between blood clotting and the vaccine.

The U.K. hasn't seen "excess reports," or higher-than-expected incidents, of blood clots among people who have been vaccinated with the AstraZeneca-Oxford vaccine or another made by Pfizer Inc. and BioNTech SE, according to Prof. Anthony Harnden, deputy chair of the U.K.'s primary independent committee advising the government on its vaccine rollout.

Other researchers said Thursday blood-clotting conditions regularly go undiagnosed, and that the rate of serious clotting reported among Europeans who have been vaccinated wasn't out of typical proportion or a cause of concern. Also, some scientists said the risks of severe blood clots from serious Covid -- a known symptom in some cases -- could be worse than potential risks from vaccination itself.

Denmark said it wasn't giving up on the vaccine. "It is important to emphasize that we have not opted out of the AstraZeneca vaccine, but that we are putting it on hold. There is good evidence that the vaccine is both safe and effective," said the Danish Health Authority.

A spokesman for U.K.-based AstraZeneca said Thursday that "patient safety is the highest priority," adding that regulators require stringent efficacy and safety standards for vaccines. "The safety of the vaccine has been extensively studied in phase-three clinical trials and peer-reviewed data confirms the vaccine has been generally well tolerated," he said.

Over the weekend, Austrian authorities said they suspended the use of one batch of Covid-19 vaccine from AstraZeneca as a precautionary measure after reports of one death and an illness among vaccine recipients that haven't been shown to be linked to the vaccine. Austria didn't halt use of the vaccine broadly, aside from that batch.

The batch contained 1 million doses and was doled out among 17 countries. Four countries besides Austria stopped using doses from the same batch as of Wednesday, according to the European medicines regulator.

Italy said Thursday it, too, was discontinuing the use of a different batch of the vaccine as a precaution, a move made after two people died after receiving doses, said a person familiar with the matter. Italy's medicines watchdog said it had no evidence that any serious health conditions were connected to the vaccine. The country still recommends the vaccine, and is trying to increase inoculations, which have been slow and uneven across different parts of the country.

The death cited by Austrian authorities was from severe coagulation disorders in a 49-year-old woman, Austria's Federal Office for Safety in Health Care said Sunday. Separately a 35-year-old woman developed a pulmonary embolism and is recovering, the agency said. Both women received shots in the country's Zwettl district from the same batch of vaccine, but no connection has been shown to the vaccine, the agency said Sunday.

"Currently, there is no evidence of a causal relationship with vaccination," the agency said in a statement on its website, adding that the health conditions aren't among known or expected side effects of the vaccine. The agency said that investigations are under way "to be able to completely exclude a possible connection."

The Austrian authorities said they haven't found the two women's conditions or similar blood clotting noted anywhere else in any side effect reports related to the vaccine internationally. AstraZeneca said it was supporting the investigation.

--Dominic Chopping contributed to this article.

Write to Jenny Strasburg at jenny.strasburg@wsj.com and Giovanni Legorano at giovanni.legorano@wsj.com

(END) Dow Jones Newswires

March 11, 2021 13:13 ET (18:13 GMT)

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