The company is developing a single combination vaccine to cover SARS-CoV-2, influenza, and respiratory syncytial virus (RSV) as well as another candidate for endemic human coronaviruses.
During its third annual Vaccines Day on Thursday, Moderna announced developments of its new vaccine programs and reviewed data of its vaccines.
In terms of new vaccine programs, the company is developing its mRNA-1230 vaccine to cover SARS-CoV-2, influenza, and respiratory syncytial virus (RSV) as well as another candidate, mRNA-1287, for endemic human coronaviruses: HCoV-229E, -NL63, -OC43 and -HKU1.
"We are pleased to add a combination respiratory vaccine candidate against three of the leading causes of respiratory disease in older adults, and a vaccine against all four of the endemic human coronaviruses as part of our strategy to address the substantial global burden of respiratory infections," Moderna President Stephen Hoge, MD, said in a statement. "Our goal is to develop vaccines to address respiratory infections, and eventually combine many into a single annual booster vaccine with the aim of reducing the significant morbidity and mortality caused by these viruses."
The company has been utilizing a mRNA technology platform for multiple disease states, and have investigational vaccines in various phases of development and study.
Moderna believes the mRNA platform can transform the vaccine market because of the technology’s ability to develop candidates faster, combine vaccines, and can target difficult viral targets.
"We believe our mRNA platform disrupts the traditional vaccines market and as indicated in our Vaccines Day announcements, we expect to bring many more safe and effective vaccines to market," Moderna Chief Executive Officer Stéphane Bancel, said. "There is an opportunity for Moderna to positively impact public and global health, and with 31 active development programs, 19 of which are in the clinic, we expect to address several critical unmet medical needs with the power of our mRNA platform."
COVID-19 and Influenza Combination Vaccine and Latent Viruses Candidates
The company said it expects to be in a phase 1 trial this year for its influenza and COVID-19 combination vaccine, mRNA-1073. The strategy is to study the COVID-19 and influenza vaccine candidate, and will compare it to the COVID-19 vaccine (mRNA-1273) and standalone influenza vaccine (mRNA- 10101).
In addition, the company’s pipeline has latent virus vaccines including Herpes Simplex Virus-1, Herpes Simplex Virus-2, Varicella zoster virus, Epstein-Barr Virus, and Cytomegalovirus.
HIV Vaccine Candidates
This year, the company has announced the launch of 2 investigational HIV vaccine trials. In January, the company announced it began a phase 1 clinical trial, called IAVI G002, which builds upon the response observed in a proof-of-concept trial and will determine whether HIV immunogens delivered via mRNA can induce specific B-cell responses to manipulate their maturation toward neutralizing antibody development (bnAb), which is widely considered a goal of HIV vaccination.
IAVI G002 is enrolling 56 healthy, HIV-negative adult volunteers across 4 sites in the United States. Of the total number of participants, 48 will receive 1 or 2 doses of eOD-GT8 60mer mRNA Vaccine (mRNA-1644) and 32 of the volunteers will receive the boost Core-g28v2 60mer mRNA Vaccine (mRNA-1644v2-Core). The study authors plan to have 8 volunteers receive the boost alone and all participants will be observed for safety for 6 months post-vaccination. The participants’ immune responses will be measured in molecular detail to determine the success of the targeted responses.
Just last week, Moderna announced it had begun another phase 1 HIV vaccine trial. This trial is an open-label, multicenter, randomized study (HVTN 302), and will evaluate the safety and immunogenicity of their experimental HIV trimer mRNA vaccine (mRNA-1574). The trial is expected to enroll approximately 100 HIV-negative adults, aged 18 to 55 years.
COVID-19 Vaccine Updates
On Wednesday, Moderna reported data from an ongoing study that 2 doses of their COVID-19 vaccine in children at 6 months and under 6 years of age demonstrated robust neutralizing antibody titers, meeting the study's primary endpoint. The dosing was at 25 μg, which is half the antigen amount of the adult population being utilized for vaccination, yet had a similar amount of titers.
The company also announced it initiated a submission to the FDA for emergency use authorization of mRNA-1273 in children who are 6 years of age to under 12 years.
No timeline has been provided for the EUA. The next FDA VRBPAC meeting is scheduled for April 6 and will cover the following topics:
The FDA notes that no vote is planned for the meeting and that they would not be discussing any product-specific applications.