According to the company, two doses of 25 micrograms of Covid-19 vaccine for children aged 6 months to 5 years is similar to two doses of 100 micrograms of vaccine for adults aged 18 to 25 years. An immune response was obtained and the benefits given to young adults were also given to young children.
Two doses of the vaccine are given to the child at 28-day intervals.
According to a company news release published Wednesday, the data showed a “strong neutralizing antibody reaction” and a “favorable safety profile.”
Based on the data, Moderna said it would ask the US Food and Drug Administration to allow the vaccine to be used in this younger age group in the coming weeks.
“Given the need for a vaccine against COVID-19 in infants, we are working with the US FDA and regulatory agencies around the world to submit these data as soon as possible,” Moderna said. CEO Stéphane Bancel said. “I believe these latest results are … good news for parents of children under the age of six.”
The vaccine was not very effective in preventing Covid-19 infection caused by the Omicron mutant, which was predominant in the United States during the study. The efficacy of children from 6 months to 1 year was 43.7%. The effectiveness of children aged 2 to 5 years was 37.5%. Modana said the decline in efficacy was still statistically significant, consistent with how vaccinated adults ingested the Omicron variant.
Moderna said he is preparing to assess the potential for booster shots targeting the original strain of the virus and Omicron variants in all children over 6 months of age.
The data is based on a group of 6,900 children from 6 months to 5 years old. The majority of side effects were mild or moderate and were more frequent after the second injection. Moderna stated that there were no deaths and no cases of myocarditis or pericarditis were reported. Myocarditis is inflammation of the muscles of the heart, and pericarditis is inflammation of the inner wall of the heart.
Moderna also announced that it has begun filing with the FDA for an emergency use authorization for its Covid-19 vaccine for children ages 6-11. A child of that age will get two shots of a larger 50 microgram version of the vaccine. Moderna also said it provided the FDA with additional follow-up data on vaccines for children aged 12 to 17 years. Children of that age will be vaccinated twice with a larger 100 microgram version of the vaccine.
Last month, the FDA postponed a meeting of vaccine advisors to consider the Pfizer / BioNTech Covid-19 vaccine for children under the age of five and requested additional data on the third dose. The two companies say they expect the data to be ready by early April.