Corona vaccine for infants: biontech seeks u.s. Approval

Vaccine for infants: Biontech prepares US approval

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There is still no vaccine for children under the age of five. This could change in the USA – Biontech wants to apply for approval.

Berlin. Many parents are eagerly awaiting the opportunity to vaccinate their young Children under five years of age to be vaccinated against Corona. Now hopes are growing that the vaccine from Biontech and Pfizer will soon be available for the very young – but for the time being probably only in the U.S. In Germany, it is likely to take longer for the vaccine to be approved.

Children hit hard by wave of infection with Omikron variant. In the current weekly report of the Robert cook institute (RKI) the Seven-day incidence In the age group of zero to four years old, indicated at 989. In the previous week it had still lain with 477. For older children, the levels are still significantly higher. Read more: Biontech and Pfizer test first omicron vaccine

Vaccine for young children: approval expected in March

In the U.S., children currently account for nearly 25 percent of new infections with the corona virus caused by the Omikron variant, according to government data. Accordingly, attempts to make vaccine available to the youngest children are currently being accelerated. The manufacturers Biontech and Pfizer wanted still on Tuesday in addition with the Drug Agency FDA set the course, according to company sources. Former FDA chief Scott Gottlieb, now in Pfizer’s pay, expects emergency approval of a vaccine for ages six months to five years may be available as early as March.

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Potentially 19 million young Americans could benefit from it. Experts at the CDC expect this to add to their efforts to better manage the pandemic. In early January, more than 100.000 children under five hospitalized for Corona. More severe Disease progression in the youngest are "not as rare as thought," CDC says.

Childhood vaccine: two doses are not enough

Mainz-based Biontech and its U.S. partner Pfizer shared news about their vaccination study for children under five late last year – and it wasn’t good. In the group of two- to five-year-olds, two vaccinations did not show sufficient effect, so the study was expanded to include a third dose. Safety concerns did not exist, as the two companies emphasized.

It is possible that the dosage chosen was too low for this age group, as two doses of vaccine showed good efficacy in children six to 24 months of age. In the study received Babies and infants three micrograms of the vaccine per vaccination. For children ages five to twelve, it’s two doses of ten micrograms each. From the age of twelve, children and adolescents will receive the usual adult dose of 30 mg per injection. This might be of interest to you: EMA delays approval of Omikron vaccine

Despite the fact that it has not yet been completed Study of Biontech and Pfizer, but the Food and Drug Administration (FDA) is now pushing the pace, The Washington Post has learned. The authority wants to evaluate the results so far, based on two doses, right now and not wait until the results of the third vaccination are available. Because this is likely to drag on at least until the end of March.

However, the president of the German Society for Pediatrics and Adolescent Medicine (DGKJ), Jorg Dotsch, rejects the idea of vaccinating children twice in the hope that the study will confirm an effect after the third dose. "I don’t think vaccinating with two doses even before the study is completed is a good way for us to go," said Dotsch, who is a member of the Corona expert council of the federal government is, our editorial board. ‘If it works, you’re lucky’. If not, children will be needlessly stung twice." For that, the sick leave burden just under Omicron was not high enough to justify it.

Infants: Biontech vaccine also soon in Germany?

When asked, Biontech would not comment on whether children and adolescents in the EU the vaccine could be licensed before the final data on the effectiveness of three vaccinations are available. However, according to reports, it is unlikely in any case that the responsible European Medicines Agency (Ema) will grant approval before the study is completed.

The question does not yet arise. "In order for a vaccine to be approved in younger age groups, that is, under five years of age, companies would need to submit an application to extend their marketing approval in those age groups and provide the scientific data to support it," an Ema spokeswoman told our editorial board. "So far, no application has been submitted to the Ema for an indication extension for the use of a Covid 19 vaccine in children under five years of age." But then it could go quickly. Finally, Ema is reviewing applications for approval or extensions of approval of Covid-19 vaccines in an "accelerated procedure," according to the Federal Ministry of Health shared.

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