Italy recommends AstraZeneca only for over-60s after EMA review

Italy recommends the AstraZeneca coronavirus vaccine only for people aged over 60 from now on, an ordinance by the Health Ministry showed.

The decision came after the European Medicines Agency (EMA) on Wednesday stated possible links between this vaccine and rare cases of blood clots, following a safety review on Thursday, Xinhua news agency reported.

The ruling was issued over the night after a meeting between Health Minister Roberto Speranza and the country’s top health experts counselling the government in the coronavirus emergency.

The note contained a recommendation, not a ban on the AstraZeneca vaccine (now renamed Vaxzeria) for specific groups of age.

“A preferential use (of the vaccine) is recommended in people aged over 60. On the basis of the data available so far, those who have already received a first dose of the Vaxzevria vaccine can complete the cycle with the same drug,” it said.

The ministerial note also said the Italian Medicines Agency (AIFA) in cooperation with the EMA “will continue a thorough evaluation of any safety signal, also in order to provide further recommendations.”

On Wednesday, the European drug regulator’s safety committee said that “unusual blood clots with low blood platelets should be listed as very rare side effects of Vaxzevria (formerly Covid-19 Vaccine AstraZeneca).”

They came to this conclusion after a safety review on 86 cases (18 of which fatal) that occurred in continental Europe and in the UK, mostly in people under 60 years of age and especially in women, within two weeks from the first jab.

However, the EMA also noted that “the reported combination of blood clots and low blood platelets is very rare, and the overall benefits of the vaccine in preventing Covid-19 outweigh the risk of side effects.”

Up to April 8, Italy has administered 11.7 million doses of the vaccines authorized in the country, including 3.9 million doses of AstraZeneca, according to government data. Some 3.6 million people have received both vaccine jabs.

Globally, 269 candidate vaccines are still being developed — 85 of them in clinical trials — in countries including Germany, China, Russia, Britain, and the United States, according to information released by the World Health Organization on April 2.