Fair 38°
Tag:

European Medicines Agency

News
COVID-19: Pfizer Asks FDA For Emergency Use Authorization Of Vaccine For Children Under 5 COVID-19: Pfizer Asks FDA For Emergency Use Authorization Of Vaccine For Children Under 5
Covid-19: Pfizer Asks FDA For Emergency Use Authorization Of Vaccine For Children Under 5 New York-based Pfizer and its European partner BioNTech has requested that the Food and Drug Administration (FDA) expand the use of its COVID-19 vaccine to include children between the ages of 6 months and 5 years old, officials announced. On Tuesday, Feb. 1, citing a host of clinical trials, the pharmaceutical company announced it is seeking emergency use authorization (EUA) to admit the vaccine to a wider range of children. Currently, the vaccine is only approved for children 5 years old and older. Pfizer said that it plans to complete its EUA submission “in the coming days,” and has alre…

SHARE

by Zak Failla
News
COVID-19: Recall Issued For Free Self-Testing Kits COVID-19: Recall Issued For Free Self-Testing Kits
Covid-19: Recall Issued For Free Self-Testing Kits Orange County’s Department of General Services has announced that the Flowflex antigen rapid test kits the county distributed to residents have been recalled by the manufacturer. The kits were distributed to residents on Thursday, Jan. 13 in the Towns of Wallkill and New Windsor, said Justin Rodriguez, spokesman for Orange County.  “The vendor represented that the kits were FDA authorized for U.S. markets,” said James Burpoe, Orange County’s Commissioner of General Services. “We have learned they are not FDA authorized but are European Medicines Agency approved for distribution in…

SHARE

by Kathy Reakes
News
COVID-19: Moderna Asks FDA To Approve Vaccines For Those Ages 12 To 17 COVID-19: Moderna Asks FDA To Approve Vaccines For Those Ages 12 To 17
Covid-19: Moderna Asks FDA To Approve Vaccines For Those Ages 12 To 17 Moderna has requested an emergency use authorization from the Food and Drug Administration (FDA) for its COVID-19 vaccine in adolescents between the ages of 12 and 17. The company announced that clinical trials have shown that the vaccine has a 93 percent efficacy rate among adolescents, and has been proven to be safe. If approved, it would be the second COVID-19 vaccine authorized for adolescents, joining the Pfizer-BioNTech vaccine, which was given the green light for use earlier this month. In their study, Moderna found no cases of COVID-19 in participants who received two doses of th…

SHARE

by Zak Failla