(Alliance News) - Comments by the European Medicines Agency, or EMA, on the AstraZeneca PLC vaccine are "encouraging," French President Emmanuel Macron and Italian Prime Minister Mario Draghi said Tuesday.
"Today's preliminary statements from EMA are encouraging," they said in a statement released by Draghi's office, which added that they are ready to resume AstraZeneca jabs if the vaccine is cleared by the EU regulator.
The EU's drug regulator said earlier Tuesday it remained "firmly convinced" of the benefits of AstraZeneca's coronavirus vaccine despite several countries suspending its use over blood clot fears.
"We are still firmly convinced that the benefits of the AstraZeneca vaccine in preventing Covid-19 with its associated risk of hospitalisation and death outweigh the risk of these side effects," European Medicines Agency chief Emer Cooke told an online press conference.
"At present there is no indication that vaccination has caused these conditions. They have not come up in the clinical trials and they are not listed as known or expected side effects," Cooke added.
Clinical trials had shown "very small numbers of blood clot developments", she added.
Some 30 cases of blood clots had been reported to the EMA by March 10 among almost five million people vaccinated, but additional cases had been reported over the weekend, Cooke said.
According to AstraZeneca, about 17 million people in the EU and the UK have received a dose of the vaccine, with fewer than 40 cases of blood clots reported to date.
The Amsterdam-based EMA's safety committee was meeting Tuesday to assess new information and would reach a conclusion at a special meeting on Thursday, Cooke said.ÂÂ
They would then "advise us on whether there are any further actions that need to be taken", she said, without specifying what the measures could be.
Several European countries, including Germany, France, Italy, Spain, Denmark and Norway, have suspended rollout of the vaccine.
World Health Organization experts are also meeting on Tuesday to discuss the vaccine.
The EMA approved the AstraZeneca vaccine for people of all ages on January 29.
But its rollout was troubled from the start, with several countries initially saying it should not be used on older people.
Seaprately, EU's medicines regulator is probing serious side effects of "all vaccines".
"We are looking at adverse events associated with all vaccines," Cooke said when asked if it was probing the Pfizer Inc-BioNTech SE and Moderna Inc vaccines as well, following reports of clotting with those jabs in the US.
"At the moment the correct focus, because of the reported incidents in Europe, is on AstraZeneca," she told a press conference.
"But we have looked at the background rates of all the vaccines currently in circulation and it looks like there are similar numbers coming in across the world. But that is something that will have to be evaluated by our (safety) committee."
source: AFP
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