{"id":16461,"date":"2021-07-13T14:13:30","date_gmt":"2021-07-13T10:13:30","guid":{"rendered":"http:\/\/geworld.ge\/en\/?p=16461"},"modified":"2022-06-11T07:34:20","modified_gmt":"2022-06-11T03:34:20","slug":"eu-regulator-mrna-coronavirus-vaccines-possibly-linked-to-heart-swelling","status":"publish","type":"post","link":"https:\/\/geworld.ge\/en\/eu-regulator-mrna-coronavirus-vaccines-possibly-linked-to-heart-swelling\/","title":{"rendered":"EU regulator: mRNA coronavirus vaccines possibly linked to heart swelling"},"content":{"rendered":"\n

The regulator\u2019s safety committee analyzed 145 cases of myocarditis and 138 cases of pericarditis after the BioNTech\/Pfizer vaccine.<\/strong><\/p>\n\n\n\n

The mRNA vaccines from BioNTech\/Pfizer and Moderna are possibly linked to rare cases of heart inflammation, according to analysis of 321 cases post-vaccination released Friday by the European Medicines Agency<\/a>.<\/p>\n\n\n\n

Myocarditis and pericarditis are inflammatory conditions of the heart, with symptoms including breathlessness, palpitations and chest pain.<\/p>\n\n\n\n

The safety committee PRAC analyzed 145 cases of myocarditis and 138 cases of pericarditis after the BioNTech\/Pfizer vaccine. For Moderna\u2019s jab, PRAC analyzed 19 cases of each condition.<\/p>\n\n\n\n

By the end of May, around 177 million doses of the BioNTech\/Pfizer vaccine and 20 million doses of Moderna\u2019s had been given in the European Economic Area.<\/p>\n\n\n\n

PRAC recommended updating the product information to include this side effect and raise awareness among health care staff and vaccine recipients.<\/p>\n\n\n\n

The committee also recommended restricting the Johnson & Johnson vaccine marketing authorization so that people with a history of capillary leak syndrome don’t receive it. It advised adding a side effect warning for the serious condition, in which fluid leaks from small blood vessels causing swelling, low blood pressure, blood thickening and low blood albumin levels.<\/p>\n\n\n\n

Three of such cases have been reported to the EMA, one in a person with prior history of the syndrome, following the Johnson & Johnson jab. All cases occurred within two days of vaccination; two of the three died. As of June 21, 18 million doses of the single-shot vaccine have been administered worldwide.<\/p>\n\n\n\n

Finally, PRAC advised that the product information for the Oxford\/AstraZeneca vaccine include a warning to raise awareness of cases of Guillain-Barre syndrome (GBS) that might have been reported following vaccination.<\/p>\n\n\n\n

The syndrome causes nerve inflammation and can result in pain, numbness, muscle weakness and difficulty walking.<\/p>\n\n\n\n

Currently, available data “neither confirms nor rules out a possible association with the vaccine,” PRAC said. But given the seriousness of GBS, it advised warning people of cases.<\/p>\n\n\n\n

This article is part of POLITICO\u2019s premium policy service: Pro Health Care. From drug pricing, EMA, vaccines, pharma and more, our specialized journalists keep you on top of the topics driving the health care policy agenda. Email pro@politico.eu<\/a> for a complimentary trial.<\/p>\n\n\n\n

\nhttps:\/\/www.politico.eu\/\n<\/div><\/figure>\n","protected":false},"excerpt":{"rendered":"

The regulator\u2019s safety committee analyzed 145 cases of myocarditis and 138 cases of pericarditis after the BioNTech\/Pfizer vaccine. The mRNA vaccines from BioNTech\/Pfizer and Moderna are possibly linked to rare cases of heart inflammation, according to analysis of 321 cases post-vaccination released Friday by the European Medicines Agency. Myocarditis and pericarditis are inflammatory conditions of the […]<\/p>\n","protected":false},"author":2,"featured_media":16462,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[6],"tags":[],"aioseo_notices":[],"_links":{"self":[{"href":"https:\/\/geworld.ge\/en\/wp-json\/wp\/v2\/posts\/16461"}],"collection":[{"href":"https:\/\/geworld.ge\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/geworld.ge\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/geworld.ge\/en\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/geworld.ge\/en\/wp-json\/wp\/v2\/comments?post=16461"}],"version-history":[{"count":1,"href":"https:\/\/geworld.ge\/en\/wp-json\/wp\/v2\/posts\/16461\/revisions"}],"predecessor-version":[{"id":16463,"href":"https:\/\/geworld.ge\/en\/wp-json\/wp\/v2\/posts\/16461\/revisions\/16463"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/geworld.ge\/en\/wp-json\/wp\/v2\/media\/16462"}],"wp:attachment":[{"href":"https:\/\/geworld.ge\/en\/wp-json\/wp\/v2\/media?parent=16461"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/geworld.ge\/en\/wp-json\/wp\/v2\/categories?post=16461"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/geworld.ge\/en\/wp-json\/wp\/v2\/tags?post=16461"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}