The European Medicines Agency has recommended the authorization of two new medicines against the coronavirus for people at risk of severe disease.
In a statement on Thursday, the EU drug regulator said it had concluded that the monoclonal antibody treatments -- a combination of casirivimab and imdevimab, and the drug regdanvimab -- have both been proven to significantly reduce the risk of hospitalization and death in patients vulnerable to serious COVID-19.
Read more at:
EU authorizes 2 medicines for people at risk of severe COVID-19 | CTV News
Showing posts with label Approves. Show all posts
Showing posts with label Approves. Show all posts
11/11/21
11/8/21
USA: CDC approves Pfizer's COVID vaccine for kids 5 to 11 in the U.S.
U.S. health officials on Tuesday gave final approval to Pfizer's kid-sized COVID-19 shot, a milestone that opens a major expansion of the nation's vaccination campaign to children as young as five.
The U.S. Food and Drug Administration (FDA) already authorized the shots for children ages five to 11 — doses just one-third of the amount given to teens and adults. But the U.S. Centers for Disease Control (CDC) formally recommends who should receive FDA-cleared vaccines.
The announcement by CDC director Dr. Rochelle Walensky came only hours after an advisory panel unanimously decided Pfizer's shots should be opened to the 28 million youngsters in that age group.
Read more at: CDC approves Pfizer's COVID vaccine for kids 5 to 11 in the U.S. | CBC News
The U.S. Food and Drug Administration (FDA) already authorized the shots for children ages five to 11 — doses just one-third of the amount given to teens and adults. But the U.S. Centers for Disease Control (CDC) formally recommends who should receive FDA-cleared vaccines.
The announcement by CDC director Dr. Rochelle Walensky came only hours after an advisory panel unanimously decided Pfizer's shots should be opened to the 28 million youngsters in that age group.
Read more at: CDC approves Pfizer's COVID vaccine for kids 5 to 11 in the U.S. | CBC News
1/29/21
EU approves AstraZeneca coronavirus vaccine
COVID-19 Vaccine AstraZeneca is now authorised across the EU. This follows the granting of a conditional marketing authorisation by the European Commission on 29 January 2021.
EMA has recommended granting a conditional marketing authorisation for COVID-19 Vaccine AstraZeneca to prevent coronavirus disease 2019 (COVID-19) in people from 18 years of age. This is the third COVID-19 vaccine that EMA has recommended for authorisation.
EMA’s human medicines committee (CHMP) has thoroughly assessed the data on the quality, safety and efficacy of the vaccine and recommended by consensus a formal conditional marketing authorisation be granted by the European Commission. This will assure EU citizens that the vaccine meets EU standards and puts in place the safeguards, controls and obligations to underpin EU-wide vaccination campaigns.
Read more at: EU approves AstraZeneca coronavirus vaccine | News | DW | 29.01.2021
EMA has recommended granting a conditional marketing authorisation for COVID-19 Vaccine AstraZeneca to prevent coronavirus disease 2019 (COVID-19) in people from 18 years of age. This is the third COVID-19 vaccine that EMA has recommended for authorisation.
EMA’s human medicines committee (CHMP) has thoroughly assessed the data on the quality, safety and efficacy of the vaccine and recommended by consensus a formal conditional marketing authorisation be granted by the European Commission. This will assure EU citizens that the vaccine meets EU standards and puts in place the safeguards, controls and obligations to underpin EU-wide vaccination campaigns.
Read more at: EU approves AstraZeneca coronavirus vaccine | News | DW | 29.01.2021
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