AZN AstraZeneca PLC

By Jenny Strasburg and Giovanni Legorano 

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

Denmark's health authority said it will pause use of the AstraZeneca vaccine, jointly developed with the University of Oxford, for at least two weeks. That includes a halt 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 in a statement. 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.

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 those reports and any possible connection to the vaccine. The European regulator has said it is investigating an unspecified number of cases of multiple thrombosis, or the formation of blood clots within blood vessels, and other similar conditions. It said so far it had found instances of serious blood clots to be no more common among vaccinated people than in the general population.

The regulator said there were 22 reported cases of "thromboembolic events" among three million people vaccinated with the AstraZeneca shot across the bloc as of March 9. That rate of serious blood clots is in line with typical levels for the general population, it said.

Millions of additional doses of the vaccine have been given in the U.K. 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.

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," according to a statement from the Danish National Board of Health.

An AstraZeneca spokesman 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," the spokesman 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 death cited by Austrian authorities was from severe coagulation disorders in a 49-year-old woman, and separately a 35-year-old woman developed a pulmonary embolism and is recovering, Austria's Federal Office for Safety in Health Care said Sunday. 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," and the health conditions aren't among known or expected side effects of the vaccine, the agency said in a statement on its website. It added that investigations are under way "to be able to completely exclude a possible connection." The Austrian authorities said at the time they so far hadn'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 10:49 ET (15:49 GMT)

AstraZeneca (NASDAQ:AZN)
Historical Stock Chart
Von Jun 2024 bis Jul 2024

AstraZeneca (NASDAQ:AZN)
Historical Stock Chart
Von Jul 2023 bis Jul 2024