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Ema: 'No restrictions on Astrazeneca, the benefits outweigh the risks'

2021-04-07T15:58:36.422Z

The Agency report: 'Rare events' of cerebral thrombosis 'are very rare side effects'. 'As of March 22, 18 deaths'. 'The link between events and age has not been demonstrated'. 'There will be no restrictions'. 'A mix of vaccines could work for us to wait for the data.' At the 18 summit of EU ministers (ANSA)



"There are no generalized risks in administering the Astrazeneca vaccine, so we did not find it necessary to recommend specific measures to reduce the risk."

So the managers of the EMA at the press conference.

The leaflet will be updated.

"Rare events" of cerebral thrombosis "are very rare side effects" of the vaccine, "the benefits outweigh the risks".

Furthermore, "no link with age was shown" between the rare thrombosis events and the AstraZeneca vaccine.

"So far, the majority of reported cases have occurred in women under the age of 60 within 2 weeks of vaccination. Based on the evidence currently available, the specific risk factors have not been confirmed."

'Immediately see the doctor if symptoms after AstraZeneca'

 - "People who have received the vaccine should seek medical help immediately if they develop symptoms of combination of blood clots and low platelets" writes the EMA noting that "the PRAC noted that the clots blood occurred in the veins of the brain (cerebral venous sinus thrombosis, CVST) and abdomen (splanchnic vein thrombosis) and arteries, along with low platelet levels and sometimes bleeding. "

'No link between events and age demonstrated'

 - "No link with age has been shown" between rare events of trobosis and the AstraZeneca vaccine.

This was stated by the director of the EMA, Emer Cooke.

'As of March 22, 18 deaths from rare thrombosis'

 - The EMA Safety Committee (PRAC) carried out an in-depth analysis of 62 cases of cerebral venous sinus thrombosis and 24 cases of abdominal venous thrombosis reported in the database on the safety of EU medicines (EudraVigilance) as of March 22, 2021, 18 of which were fatal.

The EMA notes it in the note on the AstraZeneca vaccine, underlining that "the cases came mainly from spontaneous reporting systems of the EEA and the United Kingdom, where about 25 million people had received the vaccine".

'Rare case-like events induced by heparin'

- "A plausible explanation for the rare side events" occurring after the administration of AstraZeneca "is an immune response to the vaccine leading to a condition similar to that sometimes seen in patients treated with heparin , called heparin-induced thrombocytopenia, "explained the director of the EMA, Emer Cooke.

'No restrictions for the AstraZeneca vaccine'

 - "There are no generalized risks in administering the vaccine, so we did not find it necessary to recommend specific measures to reduce the risk," EMA officials said at a press conference. 

Ema obliges AstraZeneca to have extensive risk studies

 - "Ema's safety committee will force AstraZeneca to have robust studies to understand more about the risk effects" of its vaccine.

This was stated by the head of the EMA data analysis task force, Peter Arlett, speaking at a press conference.

The Anglo-Swedish company will have to do "laboratory studies to try to better understand the effect of vaccines on coagulation, examine existing data from close clinical trials to assess if there is more information on possible risks and also conduct epidemiological studies," he said. Arlett pointed out.

'Mortality risk from Covid much higher' 

 - "The risk of mortality from Covid is much greater than the risk of mortality from side effects" that can occur following vaccination.

This was stated by the director of the EMA, Emer Cooke, reiterating that "side effects" caused by vaccines "are very rare".

"We must repeat the message that vaccines will help us in the fight against Covid and we must continue to use them," he added.

'Vaccine mix could work, we wait for data' 

- "On the vaccine mix" there are "no data available yet but we are waiting to receive them", the use of different vaccines when dual administration is required "could be effective".

This was stated by the chairman of the EMA safety committee, Sabine Straus, responding to reporters.

"What we do know about the" rare thrombosis "cases is that they occurred after the first dose," Straus stressed, explaining that there is still not much information available on the possible side events that occurred following the second dose.

An extraordinary videoconference meeting of EU health ministers was convened for 6 pm to discuss vaccination campaigns in light of the new decision of the European Medicines Agency (EMA) risk assessment commission (Prac) on the vaccine by AstraZeneca. 

Extraordinary videoconference meeting of EU health ministers, today at 6pm

, to discuss vaccination campaigns in light of the new decision of the European Medicines Agency (EMA) risk assessment commission (Prac) on the AstraZeneca vaccine.

This was announced by the Portuguese presidency of the EU Council on Twitter.

Source: ansa

All life articles on 2021-04-07

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