The “shortcut” that the FDA evaluates for more COVID-19 vaccines for adolescents

The United States health regulatory agency, the FDA, today warned in a Release What children in clinical trials testing COVID-19 vaccines should be monitored for at least two months to detect side effects, suggesting that the agency consider a “shortcut” or faster way to clear the injection for emergency use than established for full approval.

The United States Food and Drug Administration. said on Friday that he was complete the data review as quickly as possible, possibly within weeks rather than months.

The FDA last month granted full approval for the use of the Pfizer BioNTech vaccine in people 16 years of age and older. on the basis of a follow-up of six months after the start of the trial. The injection was cleared in December for emergency use based on a shorter two-month follow-up.

The agency is under pressure to approve a vaccine for children under 12 amid an increase in infections caused by the spread of the Delta coronavirus variant in the United States., a phenomenon that interrupted the reopening of schools.

Pfizer and its partner BioNTech, as well as Moderna, are competing to submit clinical data aimed at obtaining regulatory approval for their vaccines in children under 12 years of age.

The Pfizer / BioNTech vaccine is currently licensed for use in children 12 to 15 years of age in the United States..

Pfizer said it plans to release the data needed to approve the five and 11-year-old children during the month. and you might request emergency use shortly thereafter. The drugmaker said data for children two and under five could arrive soon after.

For children between six months and two years old, Pfizer said it may have safety and immunogenicity data as early as October or November.

Moderna said Thursday that she had fully enrolled participants in a trial testing her injection in children between the ages of six and 11. and that he was still conducting dose selection studies for younger age groups.

Recently accessed for Infobae, Rodrigo Sini from Almeida, since São Paulo, Brazil, Director of Vaccine Medical Affairs for Latin America Pfizer, said about this type of “shortcuts”: “To advance in pediatric vaccination, there is today in Latin America a regulatory framework that is important: In countries such as Brazil, Uruguay and Chile, use of the Pfizer-Biontech messenger RNA platform vaccine is already approved for use from 12 years of age.. To lower the age, we need to collect more information not only from children, but also from other vulnerable populations. When we talk about a study from 6 months to 12 years, we have to do Phase I, Phase II and Phase III. We are now in Phase II / III because we have already obtained results in Phase I. Even with a better understanding of the tolerability and safety characteristics, in the different age groups”.

Vaccinate pediatrics, yes or no? Infectious disease experts gather evidence that “The health benefits of universal immunization of children and youth under 18 against COVID-19 do not outweigh the potential risks”. Scientists have also considered that the risk of prolonged COVID although it exists is very low in children.

Accessed in July by Infobae, Omar Tabacco (MN 174475), pediatrician and president of the prestigious Argentinian Pediatric Society (SAP) proposed to vaccinate pediatrics to reduce the transmissibility of the virus and at the same time as an element of protection for “vulnerable patients or with comorbidities” .

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