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.
Relay Therapeutics wins FDA breakthrough status for zovegalisib in breast cancer treatment
DATROWAY receives US priority review for first-line metastatic triple negative breast cancer
Valneva and Instituto Butantan launch pilot chikungunya vaccination campaign in Brazil
Lupin launches Dasatinib tablets in US market
WuXi Biologics enters into licence and research service agreement with Vertex Pharmaceuticals
Natera submits Signatera CDx PMA to FDA for bladder cancer use
Pharming receives FDA complete response letter for paediatric Joenja application
Astrazeneca Imfinzi perioperative regimen gains positive EU CHMP opinion in early gastric cancer
I Peace generates human iPS cells from NKT cells and offers them for research use
Trace Biosciences' IND application for nerve-specific imaging agent approved by FDA
Frontage expands early phase clinical research capabilities across US and China
AstraZeneca agrees obesity and type 2 diabetes collaboration with CSPC
Ascletis Pharma Inc reports topline results from Phase III open-label study of denifanstat
Innovative Molecules GmbH completes Phase 1 clinical development programme for adibelivir
MicuRx Pharmaceuticals' IND application for MRX-5 cleared by FDA