Moderna has initiated its submission process for the evaluation of a booster dose of its Covid-19 vaccine at the 50µg dose level, to the US Food and Drug Administration (FDA).
In the coming days, the company expects to submit data to the European Medicines Agency (EMA) and other regulatory authorities globally.
Moderna CEO Stéphane Bancel said: “Our submission is supported by data generated with the 50 µg dose of our Covid-19 vaccine, which shows robust antibody responses against the Delta variant.
“We remain committed to staying ahead of the virus and following the evolving epidemiology of SARS-CoV-2. We will continue to generate data and transparently share to support governments and regulators as they make evidence-based decisions regarding future vaccination strategies.”
The company has amended the Phase II study of the Moderna COVID-19 Vaccine (mRNA-1273) to offer a booster dose at the 50µg dose level to interested participants six months following their second dose (n=344).
Moderna’s Covid-19 vaccine is an mRNA vaccine against the disease encoding for a prefusion stabilised form of the Spike (S) protein.
The FDA authorised the emergency use of the vaccine in individuals 18 years of age or older, last December.
Health agencies in over 50 countries granted authorisation to Moderna’s Covid-19 vaccine in adults.
In a separate development, the FDA is set to hold a virtual meeting on 17 September of its Vaccines and Related Biological Products Advisory Committee to discuss the matter of additional doses of Covid-19 vaccines.
It will also discuss the Pfizer-BioNTech supplemental Biologics License Application in specific for administration of a third dose of Comirnaty (COVID-19 Vaccine, mRNA) in individuals aged 16 years and above.
FDA Center for Biologics Research and Evaluation director Peter Marks said: “The administration recently announced a plan to prepare for additional Covid-19 vaccine doses, or ‘boosters,’ this fall, and a key part of that plan is FDA completing an independent evaluation and determination of the safety and effectiveness of these additional vaccine doses.
“The FDA is evaluating data submitted by Pfizer-BioNTech in a supplemental Biologics License Application for its Covid-19 vaccine and will discuss it with the agency’s advisory committee to inform our decision-making.”