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Moderna to seek FDA approval for COVID-19 vaccines for children under 6
"Given the need for a vaccine against COVID-19 in infants and young children, we are working with the U.S. FDA and regulators globally to submit these data as soon as possible," Chief Executive Stéphane Bancel said in a statement
• Children were only given 25% of vaccines that were given to adults
• Although the efficacy rate is below 45%, no severe cases of COVID-19 were reported in the trial
On Wednesday, Moderna Inc (NASDAQ: MRNA) said it will seek U.S. Food and Drug Administration (FDA) authorization for its COVID-19 vaccine for children between 6 months and 6 years old.
"Given the need for a vaccine against COVID-19 in infants and young children, we are working with the U.S. FDA and regulators globally to submit these data as soon as possible," Chief Executive Stéphane Bancel said in a statement.
Based on second and third phase drug trial data, the company said 25 micrograms of its vaccines to children generated a similar immune response it recorded when inoculated with 100 micrograms of drugs among adults.
Mid and last phase drug trial data
Moderna said it conducted a test among 2,500 children ages six months to under two years and 4,200 children ages 2 to under 6 years old. The children were given two doses of its vaccine 28 days apart.
The pediatric doses "showed a robust neutralizing antibody response", with "a favorable safety profile," the drugmaker said.
Although the efficacy was nearly 44% in children 6 months to 2 years old and about 38% in children from 2 to under 6, no severe cases of COVID-19 were reported.
Moderna's COVID-19 vaccine could be the first shot for children under the age of 5 in the United States if FDA approves the drug.
Picture Credit: Financial Express
