Meissa Vaccines announced that the FDA has cleared the company’s IND for a Phase 1 clinical study of its MV-014-212 intranasal live attenuated vaccine candidate against SARS-CoV-2. The company announced that it had held a pre-IND meeting with the agency regarding an intranasal vaccine against SARS-CoV-2 in June 2020. The Phase 1 study is expected to enroll 130 healthy adults aged 18-69 who will receive a single dose of the intranasal vaccine. designed to evaluate the safety, tolerability, and immunogenicity of a single intranasal dose of MV-014-212 in 130 healthy adult participants between the ages of 18 and 69 years. Enrollment is expected to begin by the end of this month.
Meissa co-founder and CEO Martin Moore commented, “Compared to injected vaccines, intranasal vaccines have greater potential to stop the transmission of SARS-CoV-2. Furthermore, a single intranasal dose of Meissa’s COVID-19 vaccine candidate, MV-014-212, may be sufficient to generate durable immunity against SARS-CoV-2 and its variants. We think Meissa’s intranasal COVID-19 vaccine candidate can be a globally accessible, end-game vaccine.”
Chief Scientific Officer Roderick Tang said, “We are encouraged by the potential of our intranasal COVID-19 vaccine candidate. We have positive preclinical data on the safety and efficacy of MV-014-212. In addition, we have clinical data demonstrating a mucosal immune response from our intranasal RSV vaccine candidate built on the same technology platform. This intranasal RSV vaccine is now in Phase 2 and has been well-tolerated in healthy individuals to date, including young children. We hope to quickly confirm clinical tolerability and immunogenicity of MV-014-212, so we can accelerate the development of an intranasal live attenuated vaccine against COVID-19.”
Read the Meissa Vaccines press release.
