In the Phase 2/3 study, two 50μg doses of mRNA-1273 were generally well tolerated and showed superior neutralising antibody titres


Moderna Covid-19 vaccine candidate mRNA-1273. (Credit: Mufid Majnun from Pixabay.)

Moderna has unveiled positive interim data for its Covid-19 vaccine candidate mRNA-1273, in children aged six to below 12 years, from the Phase 2/3 KidCOVE trial.

KidCOVE is a randomised, observer-blind, placebo-controlled expansion study to evaluate the safety, tolerability, reactogenicity and effectiveness of mRNA-1273 in healthy children.

In the interim analysis, two shots of mRNA-1273 at the 50µg dose level, administered 28 days apart, showed superior neutralising antibody responses with a favourable safety profile.

The SARS-Cov-2-neutralising antibody geometric mean ratio (GMR) in children was comparable to that observed in young adults from the Phase 3 COVE study.

The vaccine was generally well tolerated with consistent safety and tolerability profile with the Phase 3 COVE study, with mild or moderate adverse events.

Moderna intends to use the data to seek regulatory approval from the US Food and Drug Administration (FDA), European Medicines Agency (EMA) and other global regulators.

Moderna chief executive officer Stéphane Bancel said: “We are encouraged by the immunogenicity and safety profile of mRNA-1273 in children aged six to under 12 years and are pleased that the study met its primary immunogenicity endpoints.

“We look forward to filing with regulators globally and remain committed to doing our part to help end the Covid-19 pandemic with a vaccine for adults and children of all ages.”

In a separate development, the European Medicines Agency (EMA)’s committee for medicinal products for human use (CHMP) has recommended the approval of Moderna’s Covid-19 vaccine booster dose in the European Union (EU).

The booster shot 50µg dose was indicated for people aged 18 years and above, administered at least six months after the initial vaccination.

It follows the recent recommendation of the US Centres for Disease Control and Prevention’s (CDC) advisory committee for use of a booster dose of the Moderna Covid-19 vaccine.

CDC indicated the vaccine for people aged 65 and above, at-risk population aged 18 to 64, and for people aged 18 to 64 who are often exposed to SARS-CoV-2.

EMA’s positive opinion is based on scientific evidence, including a data analysis from the Phase 2 clinical study of mRNA-1273.

The data analysis was amended to offer a booster dose of mRNA-1273 at the 50µg dose level to interested participants 6-8 months following their second dose.

Bancel added: “This recommendation is supported by clinical evidence that a 50µg booster dose induces a strong immune response against Covid-19.

“We thank the EMA and the CHMP for their review. We believe that mRNA vaccines are well-positioned to adapt to the evolving epidemiology of SARS-CoV-2. We are grateful for the opportunity to provide individuals in the EU with another layer of protection.”