CNN reported on Friday that the vaccine advisers of the US Food and Drug Administration (FDA) are scheduled to meet on 26 February 2021 to discuss the potential emergency authorisation of a third COVID-19 vaccine for the US, this one made by Janssen Biotech, the vaccine division of US pharmaceutical company Johnson & Johnson.
Reportedly, as with the two currently authorised COVID-19 vaccines in the US, advisers and federal agencies are meeting over a weekend to try to get the vaccines to the US public as soon as possible.
The US FDA has already considered the advanced, Phase 3 clinical trial testing data presented by Janssen and says it shows the vaccine is safe and effective.
The Vaccines and Related Biological Products Advisory Committee (VRBPAC) is made up of vaccine experts and other medical professionals, industry and consumer representatives who will consider presentations from FDA about its findings, as well as from Janssen.
They'll also hear the latest from the Centres for Disease Control and Prevention about the spread of the virus, including worrying new variants, and on the CDC's surveillance for any safety worries from the currently authorised vaccines made by Pfizer/BioNTech and Moderna, CNN added.
Sanofi's riliprubart receives orphan drug designation in Japan for CIDP
HUTCHMED gains China approval for ORPATHYS and TAGRISSO combination in lung cancer
Mabwell and Qilu Pharmaceutical enter licence agreement for Albipagrastim alfa for Injection
FDA approval streamlines access to Bristol Myers Squibb CAR T cell therapies
Biovica secures European patent for biomarker use in immuno-oncology
Valneva signs exclusive German vaccine distribution deal with CSL Seqirus
Accord Healthcare introduces Dehydrated Alcohol Injection for cardiovascular indications
CARsgen Therapeutics' satri-cel NDA accepted by Chinese regulator
Alvotech reports positive topline results for Xolair biosimilar study
Sanofi receives FDA orphan drug designation for riliprubart in transplant rejection
Scancell expands Phase 2 SCOPE trial with new intradermal dosing arm for iSCIB1+
Telix Pharmaceuticals delivers first commercial doses from Belgian manufacturing hub