Moderna on its COVID-19 vaccine for children aged 6-11: It shows 'robust response'

Cambridge-based pharmaceutical company Moderna on Monday released a statement and reported a "robust neutralizing antibody response" to its COVID-19 vaccine following its phase 2-3 trials in children aged 6-11, called the KidCOVE study. The company announced to soon submit the trial data to global regulators.

"We are encouraged by the immunogenicity and safety profile of mRNA-1273 in children aged 6 to under 12 years and are pleased that the study met its primary immunogenicity endpoints", Moderna Chief Executive Officer Stephane Bancel said in a statement.

“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", Bancel added.

Moderna phase 2-3 trails for kids vaccine manifest satisfactory results

The statement further read, "This interim analysis showed a robust neutralizing antibody response after two doses of mRNA-1273 at the 50 µg dose level with a favorable safety profile." 

In the US, the Moderna COVID-19 vaccine has been authorised for adults over the age of 18 years and has recently received consent for the third dose in some Americans.

Mild, moderate side-effects among participants: Moderna

The pharmaceutical giant maintained that the majority of the side effects in the trial, which incorporated a total of 4,753 children, were mild or moderate in severity, with fatigue, headache, fever, and pain in the site of the injection, the most common. 

"mRNA-1273 was generally well tolerated with a safety and tolerability profile generally consistent with the Phase 3 COVE study in adolescents and adults. The majority of adverse events were mild or moderate in severity. The most common solicited adverse events were fatigue, headache, fever, and injection site pain", a statement by Moderna maintained.

"Safety data continue to accrue, and the study continues to be monitored by an independent safety monitoring committee. All participants will be monitored for 12 months after their second injection to assess long-term protection and safety. These data are subject to change based on ongoing data collection", the statement added. 

As per reports, a board of FDA experts will be determining whether to authorise Pfizer and BioNTech's COVID vaccine for administering the vaccine to children aged five to 11 years.

Meanwhile, Sweden recently put into halt the application of Moderna COVID-19 vaccine for youngsters after people reported heart inflammation among grown-ups.

The study is being conducted in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH) and the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services.

Image: AP/PTI/REPRESENTATIVE IMAGE