Modern submitted a request for authorization from your Covid-19 vaccine for children between 6 and 11 years before the European regulator, announced on Tuesday the American biotechnology company.
The dose of two injections, given four weeks apart, was adapted to 50 micrograms, instead of the 100 micrograms used in older people.
“We are happy to announce the presentation of this variant to the EMA,” the European Medicines Agency, said in a statement Stéphane Bancel, head of Modern. “This marks our first request for use in this age group,” he noted.
The Moderna vaccine It is currently authorized for those over 12 years of age by the EMA. But many countries, including France on Monday, advised against using Modern in minors of a certain age (30 years in France), due to concerns about the risks of myocarditis.
This side effect has been detected mainly in adolescents and young adults, especially men.
At the end of October, Modern announced positive results in its clinical trials for children ages 6 to 11, in which the vaccine elicited “a strong immune response” with “robust” antibody levels.
On Tuesday, the company released more details, saying that two weeks after the first dose, the vaccine was 100% effective against confirmed symptom-causing Covid-19 cases (such as fever, cough, loss of taste …), or one of those symptoms and pneumonia. However, these results remain preliminary.
The EMA also studies data from Pfizer, who asked for a request for approval of his vaccine for children ages 5 to 11. That first review could end in December, as reported last week.
The vaccine Pfizer It has already been authorized for that age group in the United States, where Moderna’s is not approved at the moment but after 18 years of age.
The company announced at the end of October that it would not submit its application for the 6 to 11-year-old age group to the US drug agency (FDA) until the entity completes its review of the immunizer for 12 to 17-year-olds.
The FDA has delayed approval of the vaccine for Modern for the 12 to 17-year-old population to give themselves time to better assess the risks of myocarditis. That evaluation can last until January 2022.
Reference-www.eleconomista.com.mx