A phase 2 study of Moderna’s vaccine candidate for coronavirus disease 2019 (COVID-19), mRNA-1273, is expected to start shortly following the Food and Drug Administration’s review of the Company’s Investigational New Drug (IND) application.
The novel lipid nanoparticle-encapsulated mRNA-based vaccine encodes for a prefusion stabilized form of the spike (S) protein of SARS-CoV-2, the virus that causes COVID-19. The vaccine is currently being evaluated in a phase 1 trial sponsored by the National Institutes of Health (NIH).
Moderna’s phase 2 trial, which will enroll 600 participants, is expected to begin soon. In addition, a protocol for a phase 3 study is being finalized with the expectation that the trial could potentially begin in early summer 2020.
“With the goal of starting the mRNA-1273 pivotal phase 3 study early this summer, Moderna is now preparing to potentially have its first [Biologics Licence Application] approved as soon as 2021,” said Stéphane Bancel, Moderna’s Chief Executive Officer. “We are accelerating manufacturing scale-up and our partnership with Lonza puts us in a position to make and distribute as many vaccine doses of mRNA-1273 as possible, should it prove to be safe and effective.”
Additionally, Pfizer and BioNTech recently announced that the first participants have been dosed in the US phase 1/2 clinical trial evaluating multiple mRNA-based vaccine candidates in the BNT162 vaccine program. The trial will evaluate the safety, immunogenicity and optimal dose of 4 mRNA vaccine candidates and is expected to enroll 360 healthy individuals in 2 age groups (18-55 years and 65-85 years).
In the first stage of the trial, the 18-55 year old cohort will be immunized; older adults will receive the vaccine once an optimal dosing level in the younger cohort has been established. Sites currently dosing participants include NYU Grossman School of Medicine and the University of Maryland School of Medicine; enrollment is expected to begin shortly at the University of Rochester Medical Center/Rochester Regional Health and Cincinnati Children’s Hospital Medical Center.
“We are optimistic that advancing multiple vaccine candidates into human trials will allow us to identify the safest, most effective vaccination options against COVID-19,” said CEO and Co-founder of BioNTech, Ugur Sahin.
Pfizer and BioNTech are working to increase supply of the vaccine in anticipation of a successful clinical program.