Moderna said Monday that a low dose of its COVID-19 vaccine is safe and appears to work in children ages 6 to 11, while the manufacturer joins its rival. Pfizer to move toward expanding vaccines for children.
Pfizer’s vaccine doses for children are closer to widespread use. They are being evaluated by the Food and Drug Administration for youth of nearly the same age group, from 5 to 11 years, and could be available in early November. The company’s vaccine is already licensed for anyone over the age of 12.
Moderna has yet to get the go-ahead to offer her vaccine to teens, but she is studying lower doses in younger children while she waits.
The researchers tested two injections for children ages 6 to 11, given one month apart, containing half the dose given to adults. Preliminary results showed that vaccinated children developed virus-fighting antibodies similar to the levels young adults produce after undiluted injections, Moderna said in a news release.
The study involved 4,753 children from 6 to 11 years old who received the vaccine or sham injections. Modern He said that, like adults, vaccinated youth had temporary side effects including fatigue, headache, fever and pain at the injection site.
The study was too small to detect extremely rare side effects, such as the inflammation of the heart that sometimes occurs after vaccines Modern or Pfizer, mainly among young men.
Moderna did not elaborate and did not send its data to a scientific journal, but said it plans to share the interim results with the FDA and global regulators soon.
The study is still ongoing and the company cannot calculate the effectiveness of the vaccine in preventing infections in children unless there are enough COVID-19 cases to compare the rates between vaccinated and unvaccinated participants.
The FDA has yet to rule on the company’s request to expand its vaccines to young people ages 12 to 17, although some countries have approved Moderna’s vaccines for adolescents.
But the United States is expected to begin vaccinating children under 12 years of age sometime next month, if the FDA approves low-dose Pfizer vaccine for children ages 5 to 11.
Pfizer reported last week that its children’s doses were shown to be nearly 91% effective in preventing COVID-19 symptomatic in that age group, even when the extra-contagious delta variant was spreading widely.
FDA advisers will weigh Pfizer’s evidence in a public meeting on Tuesday. If the agency authorizes Pfizer’s children’s vaccines, the Centers for Disease Control and Prevention the following week are scheduled to recommend who should receive them.
Voice of america