Moderna aims to submit a request to the US Food and Drug Administration (FDA) for emergency use authorization (EUA) of its COVID-19 vaccination among children aged six months to five years by the end of the month, according to a company spokeswoman (Apr. 20).
All of the COVID-19 vaccine's components are completely safe. Almost all of the constituents of COVID-19 vaccinations are fats, sugars, and salts, which can be found in a variety of meals.
In the "coming weeks," the pharmaceutical company plans to file a request to the Food and Drug Administration for approval of a two-dose, 25 microgram-each shot, which accounts for 25% of the first two doses given to adults, according to the company.
In a press release, Moderna CEO Stephane Bancel stated, "We now have clinical performance data of our vaccine from infants six months of age via older adults." "Given the critical need for a COVID-19 vaccine in infants and young children, we are collaborating with the US FDA and regulators worldwide to complete these data as soon as possible."
Moderna claimed two doses of 25-microgram Spikevax showed "a significant neutralizing antibody response" in two age groupings, as well as a "favorable" safety profile, in a phase 2/3 experiment called KidCOVE.
Spikevax induced anti-coronavirus immune responses that were "comparable to" the high dose in adults in both children aged 6 months to 2 years old and those aged 2 to 6. In these age categories, the experiment achieved its primary purpose.
During Moderna's pediatric trial, the Omicron variant predominated, and the drugmaker reported that two doses were around 38% effective in preventing infections in children aged two to five years, and 44% effective in children aged six months to under two years.
The only category of Americans who are not yet eligible for COVID-19 vaccine is children under the age of five.
There were no deaths reported, and no symptoms of myocarditis (heart inflammation) as a side effect. (Myocarditis has been reported infrequently after vaccination with the COVID vaccines from Pfizer and Moderna.)
Pfizer and BioNTech announced last week that a third dosage of the COVID-19 vaccine provided considerable protection against the Omicron form in healthy youngsters aged five to eleven years old.
The U.S. Food and Drug Administration authorized a third dose of the Pfizer-BioNTech vaccine earlier this year for immunocompromised children aged 12 to 15 and those aged five to eleven.
