Moderna says its kids COVID-19 vaccine is effective, seeks approval from FDA
The many parents anxiously waiting for a COVID-19 vaccine for their young kids got one step closer to their vax goal Wednesday with the announcement of a candidate readying for FDA approval.
Moderna announced that its lower-dose coronavirus vaccine is effective for children ages 6 months to under 6 years old. The Cambridge-based biotech pioneering mRNA vaccines also said it will seek approval for this vax from the Food and Drug Administration.
“We believe these latest results from the KidCOVE study are good news for parents of children under 6 years of age,” Moderna CEO Stéphane Bancel said. “We now have clinical data on the performance of our vaccine from infants six months of age through older adults.
“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,” Bancel added.
KidCOVE is a randomized, placebo-controlled study to evaluate the safety, tolerability and immune response of two vax doses given to healthy children 28 days apart. Overall, Moderna has enrolled about 11,700 pediatric participants in the U.S. and Canada into the trial, including about 4,200 children ages 2 to under 6 years and about 2,500 children ages 6 months to under 2 years.
In both age groups, the vax was generally well tolerated — similar to the tolerability as in children age 6 to under 12, in adolescents age 12 to 17 and in adults. The majority of adverse events were mild or moderate and were more frequently reported after the second dose.
Fever rates among vaccine recipients were along the same lines as with other commonly used and recommended pediatric vaccines, Moderna said. Also, no new safety concerns were identified in either age group.
No deaths, no myocarditis or pericarditis and no multisystem inflammatory syndrome in children were reported.
“We remain committed to helping to end the COVID-19 pandemic with a vaccine for children of all ages,” Bancel said.
In both age groups, two doses of 25 micrograms provided a similar immune response to two doses of 100 micrograms in adults age 18 to 25.
“This also predicts protection from COVID-19 and severe COVID-19 disease down to 6 months of age,” Moderna said in a statement.
In early February, Pfizer announced that it’s seeking the OK for its vax for children 6 months to 4 years old. The pharma giant that produced the first FDA-approved COVID vaccine said it’s trying to get emergency-use authorization for the under-5 age group after the feds had requested it.
The many parents anxiously waiting for a COVID-19 vaccine for their young kids got one step closer to their vax goal Wednesday with the announcement of a candidate readying for FDA approval.
Moderna announced that its lower-dose coronavirus vaccine is effective for children ages 6 months to under 6 years old. The Cambridge-based biotech pioneering mRNA vaccines also said it will seek approval for this vax from the Food and Drug Administration.
“We believe these latest results from the KidCOVE study are good news for parents of children under 6 years of age,” Moderna CEO Stéphane Bancel said. “We now have clinical data on the performance of our vaccine from infants six months of age through older adults.
“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,” Bancel added.
KidCOVE is a randomized, placebo-controlled study to evaluate the safety, tolerability and immune response of two vax doses given to healthy children 28 days apart. Overall, Moderna has enrolled about 11,700 pediatric participants in the U.S. and Canada into the trial, including about 4,200 children ages 2 to under 6 years and about 2,500 children ages 6 months to under 2 years.
In both age groups, the vax was generally well tolerated — similar to the tolerability as in children age 6 to under 12, in adolescents age 12 to 17 and in adults. The majority of adverse events were mild or moderate and were more frequently reported after the second dose.
Fever rates among vaccine recipients were along the same lines as with other commonly used and recommended pediatric vaccines, Moderna said. Also, no new safety concerns were identified in either age group.
No deaths, no myocarditis or pericarditis and no multisystem inflammatory syndrome in children were reported.
“We remain committed to helping to end the COVID-19 pandemic with a vaccine for children of all ages,” Bancel said.
In both age groups, two doses of 25 micrograms provided a similar immune response to two doses of 100 micrograms in adults age 18 to 25.
“This also predicts protection from COVID-19 and severe COVID-19 disease down to 6 months of age,” Moderna said in a statement.
In early February, Pfizer announced that it’s seeking the OK for its vax for children 6 months to 4 years old. The pharma giant that produced the first FDA-approved COVID vaccine said it’s trying to get emergency-use authorization for the under-5 age group after the feds had requested it.
