Moderna will ask the US Food and Drug Administration for authorization for the Covid-19 vaccine, in pediatric doses, for children under 6 years of age. The results of the trials carried out by the US group show a certain efficacy against infections and no safety problems.
However, these are not comparable efficacy numbers to those found in adults and adolescents. And some concerns in this sense, of a lower protection in the specific range 2-6 years, it had actually long since emerged. The effectiveness is in fact of 37.5% just for children aged 2 to 6 and up to 43.7% for those from 6 months to 2 years, therefore even smaller. However, the blood samples taken from the small participants in the trials showed a “robust neutralizing antibody response in both age groups“.
“Given the need for a Covid-19 vaccine in infants and young children, we are working with the US FDA and regulators globally to present this data as soon as possible,” he said. Stéphane Bancel, CEO of Moderna, in the press release announcing the new results. For the higher age groups, while Moderna is authorized in the United States only for ages 18 and up, and the company will now ask for authorization also for the age group from 6 to 18, in Europe it is already authorized from 6 years of age, in Italy from the age of 12 (from the age of 5 the use of Pfizer-Biontech is foreseen for now) but in all probability the use of Spikevax will also come.
The dose provided for the little ones is only 25 micrograms per dose, a quarter of that for adults but still slightly less than that of Pfizer, which contains 30 micrograms of mRna. Of course the company is also considering one booster dose for the little ones and data on the effectiveness of the booster, particularly against Omicron and its sub-lineages, are expected in April. In all likelihood it will take some time before the authorization of the FDA, which has always shown itself to be more skeptical and wait-and-see for the youth groups. Undoubtedly, the authorization and data will also be submitted to the EMA. And so the season of immunization of infants and children can also begin.
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Source: Vanity Fair
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