Αποτελέσματα Αναζήτησης
9 Σεπ 2024 · We conducted a systematic review of evidence on the efficacy and safety of a two-dose regimen (10 µg per dose) of Pfizer-BioNTech COVID-19 vaccine in children aged 5─11 years. We assessed outcomes and evaluated the quality of evidence using a modified GRADE approach.
FDA Authorizes Updated (Bivalent) COVID-19 Vaccines for Children Down to 6 Months of Age. The FDA amended the emergency use authorizations (EUAs) of the updated (bivalent) Moderna and...
6.2 FDA guidance for industry related to COVID-19 vaccines ..... 15 6.3 Regulatory considerations for clinical development of COVID-19 vaccines in children ..15
30 Δεκ 2021 · On October 29, 2021, the Food and Drug Administration (FDA) amended the Emergency Use Authorization (EUA) for Pfizer-BioNTech COVID-19 (BNT162b2) mRNA vaccine to expand its use to children aged 5–11 years, administered as 2 doses (10 μg, 0.2mL each) 3 weeks apart (1).
19 Οκτ 2023 · FDA is issuing this guidance to assist sponsors in the clinical development and licensure of vaccines for the prevention of Coronavirus Disease 2019 (COVID-19) which is caused by severe acute...
30 Ιουν 2022 · On June 17, 2022, the Food and Drug Administration (FDA) issued Emergency Use Authorization (EUA) amendments for the mRNA-1273 (Moderna) COVID-19 vaccine for use in children aged 6 months–5 years, administered as 2 doses (25 µg [0.25 mL] each), 4 weeks apart, and BNT162b2 (Pfizer-BioNTech) COVID-19 vaccine for use in children aged 6 months ...
14 Ιουλ 2022 · In anticipation of the next wave or variant, unvaccinated individuals continue to be the most vulnerable to severe disease. Vaccination remains the single best way to protect all children aged 5 to 11 years against COVID-19, including the prevention of MIS-C, hospitalization, and severe disease.
