Mexico City / 16.05.2022 19:40:40
The Moderna mRNA-1273 vaccine against covid-19 proved to be safe and effective in children from 6 to 11 years of age, according to The New England Journal of Medicine (NEJM), so it could be the candidate to immunize minors in Mexico.
The company Asofarma México will announce this Tuesday an announcement about the vaccine that is already approved for adults for emergency use.
The results of the phase 2 and 3 trial were published in which it was concluded that two 50-milligram doses of the mRNA-1273 vaccine, 28 days apart, “They were safe and effective in inducing immune responses to prevent covid-19 in children 6 to 11 years of age and, so far, 35 countries have authorized it.
“These responses were not inferior to those of young adults, who receive higher doses,” according to the study funded by the Biomedical Advanced Research and Development Authority and the National Institute of Allergy and Infectious Diseases.
“The Coronavirus Efficacy (COVE) and Teen COVE1-3 trials showed that the mRNA-1273 (Moderna) vaccine had mainly transient low-grade adverse effects and high efficacy in preventing symptomatic coronavirus disease 2019 in 12-year-olds. or more, and mRNA-1273 is approved for vaccination of adults in the United States.
“Although the highest risk of illness and death from COVID-19 occurs among older adults and populations with coexisting underlying conditionschildren are at risk of severe acute respiratory syndrome coronavirus 2 infection (SARS-CoV-2) that can lead to serious COVID-19-related outcomes, including hospitalization, use of life-sustaining interventions, and death.
“The burden of COVID-19 on children extends to social issues like school disruptions and other life disruptions that can result in long-term consequences for academic development and well-being.
“Complications of SARS-CoV-2 infection in children and adolescents may include the development of multisystem inflammatory syndrome in children (MIS-C) and sequelae, therefore these results indicate an urgent need to protect children through vaccination”, exposes the publication.
Trial participants were 6 to 11 years old, 2 to 5 years old, and 6 months to 23 months old who were enrolled at 79 sites in the United States and eight in Canada.
These were healthy children, but they were also included with stable chronic conditions, with the exception of those with hypersensitivity to the components or excipients of the vaccine.
“We plan to enroll up to 1,275 participants in the dose selection cohorts in part 1 of the trial and up to 12,000 participants (approximately 4,000 per age group) in part 2.”
“In both groups, the most common solicited systemic adverse effects were headache and fatigue” which were eliminated in up to three days.
“The efficacy of the mRNA-1273 vaccine in the trial that was shown during the delta variant outbreak in the United States and preliminary results showing neutralization of the delta variant suggest that the vaccine may provide a protective benefit in children. against the variants, findings that are consistent with those of other studies, however, the trial was conducted before the omicron variant surge, and evaluation of vaccine benefit against this variant is ongoing in the trial.”
JLMR
–
–