Pfizer said its Covid-19 vaccine also works in children under 12

The experimentation, with two doses but with lower doses, gave good results. The publication of the research is awaited. In the United States, the green light for use could arrive as early as the end of October

(photo: Getty Images) For some time we have been wondering when vaccines against Covid-19 would also be available for children under 12 years old. Now the pharmaceutical company Pfizer has announced, through a press release, that its mRna vaccine, developed together with BioNTech, was found to be safe and effective even in the age group from 5 to 11 years. The announcement concerns the results of a phase 3 clinical study (the last stage of the trial) which involved thousands of children, including a group under the age of 5 (but for the very little ones you will still have to wait one / two months to get the data).

The company has announced that it is about to present the results to the attention of the regulatory agencies of the United States and the European Union, respectively the Food and Drug Administration (Fda) and the European Medicines Agency (Ema), to obtain the marketing authorization for the product. This approval could come by the end of October, according to US health authorities. While in Europe the timelines are likely to be a bit longer, with the availability of the vaccine in late 202 1 or early 2022.

Pfizer's announcement

At the moment the data are not yet published but taken from the statements reported by Pfizer, so we will have to wait for the dissemination to confirm the conclusions and for more details (even in the past there were announcements which were then followed by the papers). In the request for authorization to the FDA, the Pfizer and BioNTech companies will gradually insert the new data available. Immediately afterwards they plan to proceed in a similar manner with Ema as well.

The study, still ongoing, involved nearly 4,500 children from 6 months to 11 years, of which nearly 2,300 in the age group from 5 to 11 years. Pfizer and BioNTech companies are the first to make this announcement concerning the pediatric age, but the Modern pharmaceutical company is also moving forward with the experimentation of the mRna vaccine on children.

The dose is more low

The mRna vaccine - which we recall, is the same already used for adults and adolescents - was found to be safe, well tolerated and effective in generating a solid antibody response. Two more doses will still be needed but what changes is the dosage. In children, to have this excellent reaction of the immune system, a dose equal to one third of that used in adolescents and adults, ie 10 micrograms (µg) instead of 30, is sufficient.

Already from the previous phase of the experimentation this quantity was optimal and therefore the researchers chose to test a dose of 10 µg in children aged 5 to 11 years, always with a booster at about 21 days (and two doses of 3 µg in children). The levels of neutralizing antibodies to Sars-Cov-2 with two doses of 10 µg are comparable with those detected in the age group from 16 to 25 years with a dosage of 30 µg. Therefore a lower dose for children aged 5 to 11 is preferable in terms of safety, tolerability and immunogenicity.


School - 17 Sep

Minister Bianchi, do you open the data on coronavirus infections at school this year?


No, it is not young people's contacts that favor the spread of Covid-19


TikTok is under investigation in Europe for how it treats children's data

Topics

Children Coronavirus Vaccine coronavirus Modern vaccine Pfizer BioNTech vaccine globalData.fldTopic = "Children, Coronavirus, Coronavirus Vaccine, Modern Vaccine, Pfizer BioNTech Vaccine"

This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivs 3.0 Unported License.