The tune is now known, the soloist too. The Pfizer laboratory announced, Monday, September 20, above all its competitors, that its messenger RNA vaccine against Covid-19 was safe and effective in children aged 5 to 11. As for adults and adolescents, the American group and its German partner BioNTech are preparing to submit, ” by the end of the month “, a request for provisional authorization from the Food and Drug Administration (FDA), the US health authority. As in previous times, the results were given by simple press release, pending more complete data or a scientific article.
The pharmaceutical giant, however, provided a number of details. First the dose: the children received two injections of 10 micrograms of active principle, three weeks apart, three times less than that injected into adults and adolescents. Previous studies had shown that the full dose could cause more serious side effects in children. According to the press release, the 2,268 “volunteers” aged 5 to 11 presented reactions “Comparable” to those of their elders with the complete formula. In other words, the vaccine seems to them ” sure “ and “Well tolerated”.
In addition, the statement added, the children tested exhibited an immune response. ” robust “. One way to conclude on the effectiveness of the vaccine. The laboratory has in fact not compared, as previously during phase 3 of the clinical trials, the number of sick people in two samples of volunteers, one vaccinated and the other unvaccinated. The method would be, it is true, inoperative since most of the infected children show no or very few symptoms. It is therefore impossible to know to what extent the vaccine reduces the risk for a child of falling ill, or of being hospitalized. Instead, the company compared the mean titer of neutralizing antibody in young volunteers, one month after the administration of the second dose, to that of a control group of some 1,100 adolescents aged 16 to 25 years old. received a full dose. A method already used in vaccine development and which has received, in principle, the approval of regulatory authorities. However, the immune response of children appears “Not inferior”, welcomes the laboratory.
This announcement is part of a larger program of clinical trials conducted by Pfizer in young children. Two groups of “volunteers” aged 2 to 5 years and 6 months to 2 years are currently monitored by the pharmaceutical giant and its ally BioNTech. For these last two samples, the results are announced for “The fourth quarter”.
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