More nations halt AstraZeneca use
Germany, France, Italy pause vaccine amid clotting scare
Germany, France and Italy temporarily suspended the use of AstraZeneca’s COVID-19 vaccine Monday, joining a growing list of nations that paused use of the vaccine in recent days over concerns that it might be tied to blood clots.
Public health agencies, including the World Health Organization, say that millions of people have received the vaccine without experiencing clotting issues, and they caution that experts have not found a causative link between the vaccine and the conditions.
The company has also defended the vaccine as safe.
The safety scare is a setback for AstraZeneca’s vaccine, which has already struggled with a perception that it is a less desirable shot because it had a lower overall efficacy rate in clinical trials than some others.
There is, however, extensive data showing that the vaccine is safe and effective, and especially good at preventing severe illness and death.
In many places across the world, it is the only shot available.
Public health experts expect medical conditions to turn up by chance in some people after they get any vaccine. In the vast majority of cases such illnesses have nothing to do with the shots.
Scientists also worry that suspensions could feed vaccine hesitancy at a time when some European countries are entering a third wave of the virus, and
the world is in a race to inoculate as many people as possible, as dangerous virus variants proliferate.
The European Medicines Agency and other regulators are investigating whether there is evidence of any link between the vaccine and blood clots.
On Monday, the EMA reiterated its position that the benefit of the AstraZeneca vaccine outweighs the risk posed by possible side effects.
And officials with the WHO emphasized that the regulators’ investigations are precautionary
and cover the batches of vaccines produced in Europe — not the ones made in South Korean and Indian facilities.
“While we need to continue to be very closely monitoring this, we do not want people to panic,” said Dr. Soumya Swaminathan, chief scientist at the WHO. For the time being, she said, the WHO advises countries to continue vaccinating citizens with the AstraZeneca vaccine.
Tedros Adhanom Ghebreyesus, director-general of the WHO, added that reviews of vaccine side effects are not unusual.
“It’s routine practice to investigate them, and it shows that the surveillance system works and that effective controls are in place,” he said.
AstraZeneca defended its product Sunday, saying that the company is continually monitoring its safety.
“Around 17 million people in the EU and U.K. have now received our vaccine, and the number of cases of blood clots reported in this group is lower than the hundreds of cases that would be expected among the general population,” said Ann Taylor, the
company’s chief medical officer.
In France, President Emmanuel Macron said Monday that the country would stop using the vaccine pending an assessment by the EMA on its use.
“The decision that was taken, in accordance with our European policy, is to suspend AstraZeneca vaccinations as a precaution, with the hope of quickly picking them up again if the European Medicines Agency permits it,” Macron said at a news conference in southwestern France.
In Italy, the decision was also “precautionary and temporary,” the Italian Medicines Agency said in a statement, adding that it, too, was waiting for more from the EMA.
In Germany, the health minister, Jens Spahn, said the country’s decision to temporarily suspend administration of the vaccine was “purely precautionary.”
The decision came after the national health regulator saw the need for further studies before its use could be continued “based on new reports of thrombosis in the cerebral nerves in connection with the vaccine in Germany and Europe.”
Last week, the regulator, which is responsible for approving medicines and vaccines for use in the country, had stood by the AstraZeneca shot, saying that although 11 incidents of blood clotting, including four resulting in death, had been reported in the course of administering about 1.2 million vaccines, they had no indication that the clots were caused by the vaccine.
Indonesia and the Netherlands also suspended the use of AstraZeneca’s vaccine, citing reports of unusual blood clotting problems among a few people who recently received the shots in Norway.
Blood clots, particularly if they are large, can damage tissue or organs like the lungs, heart or brain. Severe cases can be fatal, but people with small clots can often be treated outside a hospital with prescription drugs.
Over the weekend, Norway said that four people who received a dose of the AstraZeneca vaccine had experienced blood clotting issues and all had low platelet counts.
The virus has infected more than 120 million people worldwide and killed over 2.6 million, according to Johns Hopkins University.