Company has reported booster details from a study of its inactivated COVID-19 candidate
Following a clinical study, Valneva’s COVID-19 booster vaccine candidate, VLA2001, has yielded more data. A subset of participants received VLA2001 following two or three doses of the mRNA COVID-19 vaccine, with or without break-through infection among 25 to 50 participants per group.
VLA2001-307 is a multi-location, open-label clinical study investigating the safety, tolerability and immunogenicity of the VLA2001 booster vaccination in participants aged 18 years and older. Approximately 275 participants – either healthy or with a stable medical condition – were enrolled in the trial.
The VLA2001 booster was given to adults at least six months after vaccination with an mRNA COVID-19 vaccine, with or without confirmed SARS-CoV-2 infection, or to unvaccinated adults at least four months after confirmation of a natural SARS-CoV-2 infection.
The data demonstrated that a booster dose of VLA2001 was well tolerated in previously Pfizer/BioNTech or Moderna-vaccinated participants. This duly confirmed the favourable safety profile of VLA2001 across all studies – including in homologous or heterologous booster situations.
In this study, an additional booster dose of VLA2001 produced a marginally increased neutralising antibody response. Previously, the company reported positive heterologous booster results following primary vaccination with AstraZeneca – in August 2022 – and positive homologous booster results at the end of December 2021.
Juan Carlos Jaramillo, Valneva’s chief medical officer, reflected: “While these latest booster results are not aligned with the encouraging homologous and heterologous booster results seen previously, we are pleased to once again confirm the favourable safety and tolerability profile of VLA2001, which was important for European Medicines Agency (EMA) and Medicines and Healthcare products Regulatory Agency (MHRA) approval.”
VLA2001 was the first COVID-19 vaccine to receive a standard marketing authorisation in Europe and the only COVID-19 vaccine to receive marketing authorisation in Europe for use as primary vaccination in people from 18 to 50 years of age.
Valneva is now seeking regulatory approval for VLA2001 as a homologous booster as well as heterologous booster in AstraZeneca-primed individuals.
