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RSS FeedPosted 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 ...
Posted by Michael Wonder on 20 Jul 2022
Statement by President Joe Biden on FDA and CDC authorising Novavax’s COVID-19 vaccine for adults
19 July 2022 - Today is another step forward in our nation’s fight against the virus. Following an independent scientific review ...
Posted by Michael Wonder on 13 Jul 2022
FDA authorises emergency use of Novavax COVID-19 vaccine, adjuvanted
13 July 2022 - Today, the U.S. FDA issued an emergency use authorisation for the Novavax COVID-19 vaccine, adjuvanted for the ...
Posted by Michael Wonder on 09 Jul 2022
Pfizer and BioNTech announce U.S. FDA approval of their COVID-19 vaccine Comirnaty for adolescents 12 through 15 years of age
8 July 2022 - Approval of the two dose primary series is based on the totality of data through six months ...
Posted by Michael Wonder on 22 Jun 2022
U.S. FDA approves Merck’s Vaxneuvance (pneumococcal 15 valent conjugate vaccine) for the prevention of invasive pneumococcal disease in infants and children
22 June 2022 - Clinical data supporting approval demonstrated non-inferior immune responses for all serotypes shared with PCV13 following a four ...
Posted by Michael Wonder on 18 Jun 2022
Moderna receives FDA authorisation for emergency use of its COVID-19 vaccine for children 6 months of age and older
17 June 2022 - mRNA-1273 has been administered to millions of children and adolescents over the age of 6 worldwide, ...
Posted by Michael Wonder on 18 Jun 2022
Pfizer-BioNTech COVID-19 vaccine receives FDA emergency use authorisation for children 6 months through 4 years of age
17 June 2022 - In a Phase 2/3 clinical trial, the Pfizer-BioNTech COVID-19 vaccine elicited a strong immune response in this ...