Pfizer and BioNTech's coronavirus vaccine is safe and provokes a strong antibody response in 5- to 11-year olds, the companies said Monday, releasing their first results for this age group.
Pfizer and BioNTech plan to file the data in a "near-term" submission for emergency use with the Food and Drug Administration, the latest sign that the Delta variant's rise and increasing Covid-19 cases among young children have alarmed health officials. The companies said they will also ask the European Medicines Agency and other regulators to update their authorizations "as soon as possible.
“Since July, pediatric cases of COVID-19 have risen by about 240 percent in the U.S., underscoring the public health need for vaccination," Pfizer CEO Albert Bourla said in a statement. "These trial results provide a strong foundation for seeking authorization of our vaccine for children 5 to 11 years old, and we plan to submit them to the FDA and other regulators with urgency.”
The request was intended to increase the likelihood of identifying rare but potentially serious side effects in younger children, given cases of heart inflammation called myocarditis detected in predominantly males under 30 who received one of the two messenger RNA vaccines — the Pfizer-BioNTech and Moderna shots.
My nine year old niece is in Emory trials. Had a mild fever the next day and a little tired. Day after - good to go. Second shot same thing. She is so happy!!
Stop trying to undo Chantix damages on Wall Street by pumping out this 'announcement'
Just prepare them for the 3 day whole body ache that followes the inoculation. Cause it did me dirty.
My son is 3 years old and paid my doctor to vaccinate him. He is doing alright btw. He got pfizer, biontech AND moderna. Half his face is paralyzed but he now looks like Sylvester Stallone, so it's all good.
I don’t quite follow or understand all the processes. But I don’t quite understand how BioNTech’s vaccination can be used on children without FDA approval. Some help please?
But it may not be appropriate. Medically, speaking. Share holders insist it’s needed
'The companies have not released detailed data from the study, nor have they published the findings in a peer-reviewed journal.'
sure if it’s leaving them with fewer antibodies then ever before
The notion that the new vaccine is a one-size-fits-all solution to the problem of Covid is simply ridiculous. The FDA approval process has been very limited. There are various factors that make it difficult to determine whether a given vaccine is safe.
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Pfizer COVID-19 vaccine works in younger children, drugmaker saysPfizer says its COVID-19 vaccine is safe and likely to work in younger children, and it's planning to ask for permission to use it in kids as young as 5 good Likely. Disgusting
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