Wednesday brought some potentially positive news for the parents and caregivers of young children who have been waiting for an effective vaccine. Moderna announced Wednesday that its two-dose vaccine for children under the age of 6 appeared safe and produced strong levels of antibodies that correlate with effectiveness in adults. The company will ask the FDA to approve the vaccine in the coming weeks.
The trial involved 6,700 children under the age of 6 years old and involved 2,200 children six months to 2 years and 2,500 children 2 years to under 6 years. Two 25-microgram doses of vaccine were given to the children, a quarter of the adult dose, which was given 28 days apart. For which vaccine is already approved, neutralizing antibody levels in the children met or exceeded those seen in adults ages 18 to 25.
The trial looked at efficacy against infections and severe disease when compared to the wave of omicron coronaviruses. The Phase III trial data showed that the vaccine was effective in preventing omicron infections in children ages 6 months to 2 years and in children 2 years to under 6 years.
Moderna reported that the secondary endpoint of vaccine efficacy confirms statistically significant but lower efficacy against COVID-19 as expected during the omicron wave. The company didn't give 888-353-1299 888-353-1299 888-353-1299 888-353-1299 888-353-1299 888-353-1299 888-353-1299 888-353-1299 888-353-1299 888-353-1299 888-353-1299 888-353-1299 888-353-1299 888-353-1299 888-353-1299 888-353-1299 888-353-1299 888-353-1299 888-353-1299 888-353-1299 888-353-1299 888-353-1299 888-353-1299 888-353-1299 888-353-1299 888-353-1299 888-353-1299 888-353-1299 888-353-1299 888-353-1299 888-353-1299 888-353-1299 888-353-1299 888-353-1299 888-353-1299 888-353-1299 888-353-1299 888-353-1299 888-353-1299 888-353-1299 888-353-1299 888-353-1299 888-353-1299 888-353-1299 888-353-1299 888-353-1299 888-353-1299 888-353-1299 888-353-1299 888-353-1299 888-353-1299 888-353-1299 It defined statistical significance as having a 95-percent confidence interval with a lower bound of anything greater than zero, suggesting that there may be wide intervals and case numbers too small to calculate more accurate efficacy estimates.
The company reported that the children in the trial who werevaccinated or unvaccinated did not develop severe disease or die. Moderna was unable to assess efficacy against those outcomes.
The profile of the vaccine looked similar to what has been seen in adults. The side effects were mild to moderate and more common after the second dose. It was similar to what was seen in other vaccines. In the study, 17 percent of children ages 6 months to 2 years and 15 percent of children 2 years to under 6 years reported having a cold. Only a few children in each age group reported a high temperature. There were no reports of myocarditis or pericarditis in children.
AdvertisementThe results from the KidCOVE study are good news for parents of children under 6 years of age. We now have data on the performance of the vaccine in infants and older adults.
The company said that it expected to file those submissions in the coming weeks, as well as start the submission process for a two-dose vaccine for children ages 6 years to under 12. Australia, Canada, and Europe have approved the vaccine for that age group.
Moderna's news could be a relief to parents and caregivers of children under six years of age. The vaccine efficacy estimates are not ideal, but the doses may offer baseline protection from severe outcomes, which could be critical for higher-risk children. Parents and caregivers have had to wait for updates on the progress of their children's vaccine, and have been on a roller coaster ride of updates from Pfizer and BioNTech.
In December, the companies announced that their two-dose vaccine did not meet the primary goal of their study, which was to produce weak antibody levels in young children. The companies said they would add a third dose to the trial to increase the levels.
The omicron wave hit young children harder than previous waves. Pfizer and BioNTech announced in January that they would try to move forward with just two doses of their vaccine, after seeing more case data from their trial. The companies and the FDA backtracked on the plan a few weeks later. They decided to wait for the data from the third dose because of undisclosed trial data. The earliest availability of the vaccine could be in May if the results go well.
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