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43°
Thursday, nov 14
Tag:
Phase 3 trial
News
Pfizer Asks FDA To Approve Emergency Use Of COVID Vaccine In Kids 12-15
Pfizer and BioNTech on Friday asked the Food and Drug Administration to expand emergency use authorization of the COVID-19 vaccine to include children ages 12 to 15. The request comes following the Phase 3 trial in children ages 12 to 15, which demonstrated 100 percent efficacy and robust antibody response after vaccination. The companies plan to request similar rulings by other regulatory authorities worldwide in coming days. "The hope of starting to vaccinate this age group before the start of the next school year," CEO Albert Bourla previously said in a statement. According t…
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J&J: Mystery Illness Pauses Largest COVID Vaccine Trial
A mystery illness suffered by a participant has put the largest COVID-19 vaccine trial on hold, drug maker Johnson & Johnson announced. The New Jersey-based company – which sought 60,000 volunteers mostly over 60 – didn’t describe the illness or identify the patient in any way. “We must respect this participant's privacy,” J&J said in a statement. “We're also learning more about this participant's illness, and it's important to have all the facts before we share additional information.” J&J said it would provide transparent updates throughout the development of the randomized, …