Covid vaccine, Ema: green light for Moderna for 6-11 year olds

Green light from the European drug agency Ema to the Moderna Covid vaccine in children aged 6 to 11 years. The EU regulatory body’s Committee for Medicinal Products for Human Use (CHMP) recommended granting an extension of the indication for Spikevax * to include this age group as well. Spikevax is already authorized for administration in over 12. The dose of Spikevax intended for children – specifies Ema – is halved compared to that used in people aged 12 years or older, equal to 50 micrograms compared to 100 µg . As in the other age groups, Moderna’s vaccine is given as two intramuscular injections into the upper arm, 4 weeks apart. – showed that the immune response to the half dose of Spikevax, measured as the level of antibodies to Sars-CoV-2, is comparable to that seen with the full dose in people aged 18 to 25 years. The most common side effects in people under 12 were similar to those seen in people over 12 and include redness and swelling at the injection site, fatigue, headache, chills, nausea, vomiting, swollen or painful lymph nodes under the arm, fever, muscle and joint pain. These adverse events reported are generally mild or moderate – the agency points out – and improve within a few days of vaccination. Evidence – explains the EMA – indicates that the efficacy and safety of the Moderna vaccine in children aged 6-11. they are similar to those found in adults. The CHMP therefore concluded that “the benefits of Spikevax in this age group outweigh the risks, particularly in children with conditions that increase the risk of severe Covid-19.” The regulatory body reiterates that the safety and efficacy of the vaccine in children and adults will continue to be closely monitored, with the analysis of data from vaccination campaigns launched in EU member states through the Union pharmacovigilance system, and additional studies conducted by the company and the European authorities. The CHMP will send its recommendation to the European Commission, which will communicate the final decision. “The CHMP’s recommendation to authorize the use of our Covid-19 vaccine in children aged 6 to 11 in Europe is an important milestone. ‘efficacy and safety of our vaccine in this age group and helps keep our children safe and able to live a normal school and family life, “said Stéphane Bancel, CEO of Moderna. “We are grateful to the CHMP for the in-depth examination of our request – he adds – and we look forward to authorization from the European Commission.” Moderna’s vaccine was tested in the Phase 2/3 “KidCove” study, to evaluate the safety, tolerability, reactogenicity and efficacy of Spikevax (mRna-1273) administered to healthy children 28 days apart. The data presented at the CHMP on over 4,000 children, explains Moderna in a note, showed that vaccination of children between 6 and 11 years of age is associated with anti-Sars-CoV-2 neutralizing antibody responses that are no lower than that shown. from 18-25 year old subjects in the Cove Phase 3 study. Vaccination was generally well tolerated. The Phase 2 KidCove study of the Spikevax vaccine in children aged six months to 12 years is ongoing.