The vaccine-producing company Moderna stated on Monday that the interim results of a Phase 2/3 trials have proven that their Covid-19 vaccine was well-tolerated and helped in inducing a great response from the immune system in children between the ages of six and eleven years.
In the trial, around four thousand seven hundred children between the ages of six and eleven years took part, and they were given two doses of 50-micrograms at a gap of twenty-eight days, which is less than the dosage given to adults, which is 100-microgram.
Moderna Claims Its Vaccine Is Well-Tolerated And Gives Robust Immune
The response of the antibodies in younger children was compared to the response of antibodies in young adults in the Phase 3 trial of the company.
It was found that a “strong immune response” developed in that group of younger children, one month after receiving the second dose.
The absolute data has not yet been published or reviewed. Though, it is speculated that younger kids could get a Covid-19 vaccine within some weeks.
Generally, consistent tolerability and safety were found within the vaccine with its Phase 3 study conducted in adolescents and adults. The company stated that all the harmful effects that were reached by anyone only reached a mild or moderate level of severity. They said that the only severe effects that took place were already speculated, such as fatigue, headache, fever, and pain in the injection site.
According to Moderna, the results of these data with all the information would be submitted to the US Food and Drug Administration, European Medicines Agency, and other global medicine regulators “in the near term”.
The Moderna vaccine is currently available for people eighteen years in age and older. The company had requested authorization for emergency use for children between the ages of twelve and seventeen in June, but the FDA has not yet considered giving authorization to that age group.
Moderna has stated that they are still in the process of monitoring the participants, including those of the younger age groups that have volunteered to participate in the trial.
The Next Step For Vaccine For Younger Children
There are chances that younger children can be given eligibility to get the Covid-19 vaccine within the coming weeks as another vaccine-making company, Pfizer, has requested emergency use authorization for its vaccine for children between five and eleven years of age.
The advisory board committee of the Food and Drug Administration would conduct a meeting on Tuesday to discuss the authorization of Pfizer and BioNTech’s Covid-19 vaccine to be granted for the young age group of children. If it gets the approval for authorization, then it would be the first vaccine that is made available for children.
The Pfizer Covid-19 vaccine is already authorized for children between twelve and fifteen years of age and it is approved for people who are sixteen years of age and older.
If the votes of the FDA committee get to be in its favor, then the FDA will finally decide whether to authorize it or not.
Then after that, it would pass on to the US Centers for Disease Control and Prevention’s advisory committee that would meet on the 2nd and 3rd of November, and finally vote for its recommendation. In the end, it would be in the hands of CDC director Dr. Rochelle Walensky to accept or make some changes in the committee’s recommendation.