Moderna Studies COVID-19 Vaccine Candidate in Pediatric Population

March 30, 2021 - Moderna recently announced that the first participants were dosed in the Phase 2/3 study of its COVID-19 vaccine candidate, mRNA-1273, in children six months to up to 12 years of age. 

The study, called the KidCOVE study, is being conducted in collaboration with the National Institute of Allergy and Infectious Disease (NIAID) and the Biomedical Advanced Research and Development (BARDA). 

“We are pleased to begin this Phase 2/3 study of mRNA-1273 in healthy children in the U.S. and Canada and we thank NIAID and BARDA for their collaboration,” Stéphane Bancel, chief executive officer of Moderna, said in the announcement. 

“It is humbling to know that 53 million doses have been administered to people in the U.S. We are encouraged by the primary analysis of the Phase 3 COVE study of mRNA-1273 in adults ages 18 and above and this pediatric study will help us assess the potential safety and immunogenicity of our COVID-19 vaccine candidate in this important younger age population,” Bancel continued. 

The two-part Phase 2/3 study is an open-label, dose-escalation, and age de-escalation study, as well as a randomized, observer-blind, and placebo-controlled expansion study. 

Researchers will evaluate the safety, tolerability, reactogenicity, and effectiveness of two doses of mRNA-1273 in 6,750 pediatric participants in the US and Canada. The doses will be given 28 days apart. 

In part one, participants over two years will receive one to two dose levels at 50 micrograms or 100 micrograms. Younger participants will receive one of three dose levels, 25 micrograms, 50 micrograms, or 100 micrograms. 

Researchers will conduct an interim analysis to determine which dose will be used in Part 2, which will be the placebo-controlled expansion of the study.

In the second part, participants will be followed for one year after the second vaccination. Vaccine effectiveness will be determined by achieving a correlate of protection, or through immunobridging to the young adult (18 to 25 years of age), a Moderna spokesperson explained. 

Additionally, evaluation of vaccine safety and reactogenicity is also a primary endpoint of the study. 

In mid-November, Moderna reported that mRNA-1273 proved 95 percent effective in a Phase 3 clinical trial. 

The analysis was based on 95 cases and showed a point estimate of vaccine efficacy of 94.5 percent. The second endpoint analyzed was severe COVID-19 cases; in which there were 11 severe cases. 

A month later, an analysis found that mRNA-1273 was over 94.1 percent effective against the coronavirus. The results were based on a total of 196 cases, of which 185 were in the placebo group and 11 were in the vaccine group.

Due to the success of mRNA-1273 in both the trial and analysis, Moderna launched the first study of the vaccine in adolescent patients two weeks later. 

The randomized, controlled Phase 2/3 study will evaluate the safety and immunogenicity of two vaccinations of mRNA-1273 in 3,000 participants aged 12 to under 18 years of age. The vaccinations will be given 28 days apart. 

The company said that it anticipates results this spring, with the goal of using mRNA-1273 in adolescents in advance of the 2021 school year. 

And just last month, Moderna said it will make new capital investments to increase global manufacturing capacity of mRNA-1273. 

The investments will help to increase capacity at its owned and partnered manufacturing facilities, which will ensure a significant boost in its capacity to produce the vaccine. 

Moderna expects about another 1.4 billion doses of mRNA-1273 globally by 2022, assuming a 100-microgram dose.