Covid vaccine, Moderna: “Safe and strong immune response in 6-11 year olds”

In children aged 6 to 11, Moderna’s Covid vaccine “shows a robust immune response” and a “favorable safety profile”. This was announced by the US company, presenting the first data from a phase 2/3 study conducted in this age group. “Positive” data, explains the company in a note. Two 50 microgram doses of the mRna-1273 vaccine were evaluated in the trial. These were “generally well tolerated and showed robust neutralizing antibody titers”. Moderna explains that the primary endpoints, the immunogenicity targets, have been met and plans to submit the results “soon, in the short term”, to the US FDA, the European Medicines Agency EMA and other regulatory agencies around the world. (continued) The interim analysis shows the results of the KidCove study in children aged 6 to less than 12 years after the two doses of 50 µg. 4,753 participants of this age group were enrolled in this cohort. In the study, the ratio of geometric means (Gmr) of neutralizing antibody titers to Sars-CoV-2, which compared the response in children to the response in young adults from the Phase 3 Cove study, was 1.5, with a rate of seroresponse of 99.3%. These results, argues Moderna, “demonstrate a strong immune response in this cohort of children one month after the second dose.” “We are encouraged by the immunogenicity and safety profile of mRna-1273 in children aged 6 and under. 12 years “, says the CEO of Moderna, Stéphane Bancel. “We look forward to applying for” approval “to regulatory authorities globally and remain committed to doing our part to help end the Covid pandemic with a vaccine for adults and children of all ages.” KidCove is a randomized, observer-blind, placebo-controlled expansion study aimed at evaluating the safety, tolerability, reactogenicity and efficacy of two 50 µg doses of mRna-1273 administered to remote healthy children. than 28 days. The study population is divided into three age groups (6 to less than 12 years, 2 to less than 6 years, and 6 months to 2 years). Today Moderna presents cohort reports aged 6 to less than 12 years. The vaccine was “generally well tolerated, with a safety and tolerability profile generally consistent with the Phase 3 Cove study in adolescents and adults. Most adverse events were mild or moderate in severity. The most common solicited adverse events were fatigue, headache, fever and injection site pain, “the note reads. Safety data continues to accumulate and the study continues to be monitored by an independent safety monitoring committee. All trial participants will be monitored for 12 months after the second injection to assess long-term protection and safety. Data collection continues. And the company plans to submit the material for peer review and publication in a magazine. The phase 2/3 study continues to enroll children aged 6 months to less than 6 years.