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Green light from Ema to J&J vaccine. ‘Benefits outweigh risks’ – Europe

Towards giving priority to use of Johnson & Johnson Covid vaccines for people over 60 years of age. This will be the direction of the Department of Health and Aifa following today’s announcement by the EMA, recognizing a possible link between vaccines and some of the rare cases of thrombosis reported in the United States, as happened. out for the AstraZeneca vaccine. Also for the second drug, in Italy, an indication is preferred for people over 60 years of age, as rare cases of thrombosis have also been reported for AstraZeneca in younger subjects.

The European Drug Administration (EMA) recognizes the “possible” cause-and-effect links between the Johnson & Johnson vaccine and the “very rare” cases of cerebral thrombosis that have occurred in the United States. However, we read a note from the EU authority that the benefits outweigh the risks.

Ema points out that when using Janssen, Johnson & Johnson vaccines, “benefits outweigh risks”. A note from the EU Agency said, at the end of the serological assessment, after very rare cases of brain thrombosis in the United States.

All rare cases of cerebral thrombosis “occurred in people younger than 60 years of age within three weeks of vaccination” with Johnson & Johnson serum, “mostly in women. Based on current evidence. Yes, specific risk factors have not been confirmed, “writes the European Medicines Agency.

“The European Drug Agency’s (EMA) safety committee concludes that the warning about abnormal blood clots with low platelets” should be added to the product “leaflet” information for the Johnson & Johnson Janssen vaccine. “In addition, the events should be listed on the very rare side effects of vaccines.”

“The rare event cases examined after J&J vaccination are very similar to those occurring with the Covid-19 vaccine developed by AstraZeneca.” “The scientific evaluation of the EMA is the basis for the safe and effective use of Covid-19 vaccine. The EMA recommendations are the basis for each of the EU member states to carry out their national immunization campaigns. These recommendations can vary from country to country. for national needs and circumstances, “read the note from the EMA.

“EMA & Johnson investigations of the Johnson & Johnson vaccine are continuing and the pharmaceutical company will be required to further investigate. The European Agency has also conducted thrombosis case studies through two rounds.” research association. ” Hence, the CEO of EMA, Emer Cooke.

“There is a strong and clear association between vaccination” with Johnson & Johnson sera and cases of cerebral thrombosis very rare. This was made clear by the chairman of the pharmacovigilance committee of Ema, Sabine Straus.

The EMA confirmed that “the risk-of-benefit profile remains positive. Johnson & Johnson remains committed to delivering 200 million doses of its vaccine to the European Union, Norway and Iceland”. This was stated in a note by J&J, noting that they will continue their shipments of vaccines to the EU.

The Science-Engineering Committee (CTS) of the Italian Pharmaceutical Authority (Aifa) meets today to review Johnson & Johnson’s anti-Covid vaccine, after the European Medicines Agency (Ema) recognized the links. “possible” causes and outcomes between vaccines and “very rare” events of cerebral thrombosis occurring in the US. The vaccine was suspended by the company itself for its European vaccination campaign after reporting adverse events in the US.

“I welcome the EMA’s announcement about the safety of the Johnson & Johnson vaccines. This is good news for vaccination campaigns across the EU.” So the president of the European Commission, Ursula von der Leyen, on Twitter.

Ema’s agreement with Johnson & Johnson is positive news as it continues to “accelerate” the anti-Covid vaccination campaign in the EU. “Our goal is to be able to vaccinate more than 70% of adults by mid-July.” This was told by EU Commissioner in charge of internal markets Thierry Breton to SkyTg24, emphasizing that “we have caught up” at the start of the campaign.



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