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View all search resultsFDA
Americas 3 years ago
US limits use of J&J's COVID vaccine on blood clot risks
The J&J shot, which received US clearance in February 2021 for adults, can be administered in cases where authorized or approved COVID-19 vaccines are not accessible or if an individual is less keen on using the other two shots, the Food and Drug Administration said.
Health 5 years ago
US approves first one-dose coronavirus vaccine
The vaccine is raising hope for a simpler mass inoculation process, given that the current two approved vaccines require two shots. It can be stored for three months at normal refrigerator temperatures and has a two-year shelf-life when frozen.
World 5 years ago
US FDA advisory panel sets stage for Moderna vaccine authorization
The committee voted 20-0 with one abstention that the benefits of the vaccine outweigh its risks in people aged 18 and older, one week after the same panel backed a similar vaccine from Pfizer Inc and German partner BioNTech SE, leading to an FDA emergency use authorization (EUA) a day later.
Health 5 years ago
FDA approves first COVID-19 test kit for home use
The single-use test, made by Lucira Health, has been given emergency use authorization for home use with self-collected nasal swab samples in individuals age 14 and older who are suspected of COVID-19 by their health care provider, the FDA said.
World 5 years ago
FDA widens US safety inquiry into AstraZeneca coronavirus vaccine: Sources
The US Food and Drug Administration has broadened its investigation of a serious illness in AstraZeneca Plc's COVID-19 vaccine study and will look at data from earlier trials of similar vaccines developed by the same scientists, three sources familiar with the details told Reuters.
