News round-up by DDW’s Megan Thomas for 23-27 August
The Covid-19 pandemic has undoubtedly put virology back on the drug discovery map and this week, DDW’s Megan Thomas has rounded up five stories which show updates and advancements in the fight against the virus.
1. Moderna’s Covid-19 vaccine maintains antibodies against variants
New data has been published on the durability of the Moderna Covid-19 vaccine in generating neutralising antibodies against variants. The manuscript was published in Science.
2. Valneva begins submission to MHRA for its Covid-19 vaccine
Valneva has begun a rolling submission for initial approval of its Covid-19 vaccine candidate, VLA2001, with the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK. VLA2001 is a whole virus, inactivated, adjuvanted vaccine candidate and is the only vaccine candidate of this type currently in clinical trials in Europe.
3. Full FDA approval for Pfizer-BioNTech Covid-19 vaccine
The US Food and Drug Administration (FDA) has approved the Biologics License Application for the Pfizer-BioNTech Covid-19 vaccine. It will now be marketed as Comirnaty for the prevention of Covid-19 disease in individuals 16 years of age and older. It is the first COVID-19 vaccine to be granted approval by the FDA.
4. First doses issued in trial evaluating EOM613 in Covid-19 patients in Brazil
EOM Pharmaceuticals has dosed the first patient in R1: RESCUE, a proof-of-concept Phase I/IIa open-label multi-centre clinical study in Brazil to evaluate safety, tolerability, and preliminary efficacy of EOM613 in hospitalised Covid-19 infected patients with severe symptoms.
5. Moderna submits BLA to FDA for Covid-19 vaccine
Moderna has completed the rolling submission process for its Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for the full licensure of the its Covid-19 vaccine for active immunisation to prevent Covid-19 in individuals 18 years of age and older. As part of the completed BLA submission, Moderna has requested Priority Review designation.
