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RSS FeedPosted 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 ...
Posted by Michael Wonder on 06 Jun 2022
Novavax faces high stakes FDA review this week that will decide the fate of its COVID vaccine in the U.S.
6 June 2022 - If they endorse the vaccine, the FDA will almost certainly authorise the shot for adults in the ...
Posted by Michael Wonder on 06 Jun 2022
GSK announces US FDA approval of Priorix for the prevention of measles, mumps and rubella in individuals 12 months of age and older
6 June 2022 - Priorix becomes an additional source of measles, mumps and rubella vaccine for US patients ...
Posted by Michael Wonder on 02 Jun 2022
Pfizer asks FDA to authorise COVID-19 vaccine for youngest kids
1 June 2022 - Pfizer and BioNTech announced Wednesday that they have completed their submission requesting emergency use authorisation from ...
Posted by Michael Wonder on 24 May 2022
Blue Lake Biotechnology announces FDA fast track designation for BLB-201 intranasal RSV vaccine
24 May 2022 - Blue Lake Biotechnology today announced that the U.S. FDA has granted fast track designation for BLB-201, an ...
Posted by Michael Wonder on 17 May 2022
FDA expands eligibility for Pfizer-BioNTech COVID-19 vaccine booster dose to children 5 through 11 years
17 May 2022 - Today, the U.S. FDA amended the emergency use authorisation for the Pfizer-BioNTech COVID-19 vaccine, authorising the use ...
Posted by Michael Wonder on 12 May 2022
Moderna completes FDA submission for use of COVID shot in adolescents, kids
11 May 2022 - Moderna has made all necessary submissions required by the U.S. FDA for emergency use authorisation of ...
Posted by Michael Wonder on 07 May 2022
FDA limits use of Janssen COVID-19 vaccine to certain individuals
5 May 2022 - Today, the U.S. FDA has limited the authorised use of the Janssen COVID-19 Vaccine to individuals ...
Posted by Michael Wonder on 29 Apr 2022
Moderna files for authorisation of its COVID-19 vaccine in young children six months to under six years of age
28 April 2022 - Submission to regulators globally is based on Phase 2/3 studies of mRNA-1273 in young children. ...
Posted by Michael Wonder on 27 Apr 2022
Pfizer and BioNTech submit application for U.S. emergency use authorisation for a COVID-19 vaccine booster dose in children 5 through 11 years of age
26 April 2022 - Pfizer and BioNTech today submitted an application to the U.S. Food and Drug Administration (FDA) for ...