Moderna (Nasdaq:MRNA) recently announced that an investigational version of its COVID-19 vaccine for potential use in children 6 months to 6 years met its primary endpoint in a Phase 2/3 study. Two doses of the vaccine were 43.7% effective at preventing infection during the omicron wave in children aged 6 months to 2 years old. Efficacy fell to 37.5% in children aged 2 to 6.
As part of a series of Vaccine Day–themed announcements, the company said it is making progress with global regulatory submissions for the mRNA-1273 in younger children. The company hopes to receive authorization for a 25 μg two-dose primary series of the COVID-19 vaccine.
In addition, the company is vying to get FDA authorization for children 6 to 12 years old. The shot is already approved for that demographic in Europe, Canada and Australia.
In addition, an interim analysis of a Phase 2 study of influenza vaccine candidate mRNA-1010 found no significant safety concerns. Furthermore, immunogenicity data from that trial indicate that the vaccine is potentially superior to a standard-dose vaccine for influenza A strains.
Moderna has three mRNA-based influenza programs.
The company announced earlier data related to mRNA-1010 in December that indicated that the performance of the quadrivalent seasonal flu vaccine candidate appeared to be roughly in line with the performance of Sanofi’s (Nasdaq:SNY) Fluzone HD flu vaccine.
Moderna also continues to work on several COVID-19 boosters, including omicron-specific and bivalent versions. A Phase 2 U.S. study for the former is fully enrolled while the latter continues to enroll participants. In the UK, a Phase 3 study is underway testing the omicron candidates as a third or fourth dose in fully vaccinated individuals.
In addition, the company is developing a refrigerator-stable version of its COVID-19 vaccine known as mRNA-1283.
Moderna continues to develop vaccines for respiratory syncytial virus (RSV) and is developing hybrid COVID-19/flu and COVID-19/flu/RSV vaccines.
The company also is working on the vaccine candidate mRNA-1287 to protect against endemic human coronaviruses (HCoVs), which account for 10–30% of upper respiratory tract infections in adults.
Finally, Moderna is developing vaccines to treat latent viruses, including Cytomegalovirus (CMV), Epstein-Barr virus (EBV), Varicella-Zoster virus (VZV), and herpes simplex virus (HSV).
MRNA shares were up 0.12% to $178.95 in early afternoon trading.