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RSS FeedPosted by Michael Wonder on 24 Sep 2022
Moderna asks FDA to authorise omicron Covid boosters for children as young as 6 years old
23 September 2022 - The Centers for Disease Control and Prevention, in a document published Tuesday, said it expects children to ...
Posted by Michael Wonder on 07 Sep 2022
Statement by President Biden on FDA and CDC authorising updated COVID-19 vaccines
6 September 2022 - This week, we begin a new phase in our COVID-19 response. We are launching a new ...
Posted by Michael Wonder on 07 Sep 2022
FDA grants breakthrough therapy designation to Pfizer’s Group B Streptococcus vaccine candidate to help prevent infection in infants via immunisation of pregnant women
7 September 2022 - Pfizer today announced that its investigational Group B Streptococcus vaccine candidate, GBS6 or PF-06760805, received breakthrough ...
Posted by Michael Wonder on 31 Aug 2022
FDA authorises Moderna, Pfizer-BioNTech bivalent COVID-19 vaccines for use as a booster dose
31 August 2022 - Today, the US FDA amended the emergency use authorisations of the Moderna COVID-19 Vaccine and the Pfizer-BioNTech ...
Posted by Michael Wonder on 29 Aug 2022
FDA expected to authorise Moderna, Pfizer-BioNTech Omicron boosters
29 August 2022 - The move would set the stage for the Biden administration to begin offering the reformulated vaccine shortly ...
Posted by Michael Wonder on 25 Aug 2022
FDA plans to authorise bivalent boosters by Labor Day, sources say
24 August 2022 - The FDA plans to authorise updated versions of Pfizer-BioNTech’s and Moderna’s Covid boosters around Labor Day, ...
Posted by Michael Wonder on 23 Aug 2022
Moderna completes application to US FDA for emergency use authorisation of omicron-targeting bivalent COVID-19 booster vaccine, mRNA-1273.222
23 August 2022 - Clinical data available for Moderna's bivalent COVID-19 booster vaccines have met all primary endpoints and support ...
Posted by Michael Wonder on 22 Aug 2022
Pfizer and BioNTech submit application to U.S. FDA for emergency use authorisation of Omicron BA.4/BA.5 adapted bivalent COVID-19 vaccine
22 August 2022 - Companies have rapidly scaled production and stand ready to deliver doses of Omicron BA.4/BA.5 adapted bivalent vaccines ...
Posted by Michael Wonder on 18 Aug 2022
Valneva initiates rolling submission of FDA biologics license application for its single shot Chikungunya vaccine candidate
18 August 2022 - Valneva today announces that it has initiated rolling submission of the biologics license application to the ...
Posted by Michael Wonder on 15 Aug 2022
Novavax submits application to the U.S. FDA for emergency use authorisation for Novavax COVID-19 vaccine, adjuvanted as a booster in adults aged 18 and older
15 August 2022 - If authorised, Novavax' vaccine would be the first protein-based COVID-19 booster for adults. ...
Posted by Michael Wonder on 10 Aug 2022
FDA authorises emergency use of Jynneos vaccine to increase vaccine supply
9 August 2022 - Today, the U.S. FDA issued an emergency use authorisation for the Jynneos vaccine to allow health care ...
Posted by Michael Wonder on 08 Aug 2022
Monkeypox vaccines: here’s how many have been shipped and where as White House declares public health emergency
8 August 2022 - The US Government has shipped more than 602,000 doses of Jynneos monkeypox vaccines—the only shot specifically approved ...
Posted by Michael Wonder on 05 Aug 2022
FDA considering dividing Jynneos doses into fifths to increase vaccine supply
5 August 2022 - The Biden administration is considering splitting doses of the smallpox vaccine, which are being used to ...
Posted by Michael Wonder on 04 Aug 2022
Vaxcyte provides positive regulatory updates for VAX-24 adult and paediatric programs
4 August 2022 - Company receives FDA fast track designation for VAX-24 in adults. ...
Posted by Michael Wonder on 31 Jul 2022
FDA provides update on agency response to monkeypox outbreak
29 July 2022 - Today, the U.S. FDA is providing an update on its multi-pronged response to monkeypox in the United ...