Pfizer and Moderna are expanding the sizes of their Covid-19 vaccine trials in children ages five to 11,Monday, characterizing the move as a precautionary measure to better understand rare side effects—including heart inflammation problems—that have turned up in some young people.Multiple anonymous sources toldthat vaccine makers are moving to expand their ongoing clinical trials at the request of the Food and Drug Administration .
The agency reportedly indicated the size and scope of the current studies were inadequate to detect the rare side effects of myocarditis and pericarditis that have been identified in a very small number of coronavirus vaccine recipients under 30. last month showing around 500 of the 1,200 Americans who developed heart inflammation issues after receiving mRNA vaccines were under the age of 30.
This amounts to less than 13 cases per one million second doses administered of these diseases, which—marked by symptoms like chest pain and shortness of breath—typically clear up within a few weeks, but in a small number of cases can be chronic. What To Watch For It’s currently unclear how expanding the size of the trials will impact the timeline for getting these vaccines formally approved for use in children. The FDA
earlier this month it expects the emergency authorization for Covid-19 vaccines in children under 12 to come in early to midwinter. it found a “likely association” between a rare heart inflammatory condition in young people and the coronavirus vaccine, though the reported cases were minute compared with total inoculations and the risk of getting the diseases are even greater among those with Covid-19.
Awesome!
“Rare” 😂 😂 Millions and millions of people are reporting side effects and even dying.
Studies? You mean testing, right? They're testing the gene therapy on kids.
nice
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