BioNTech will soon apply for the vaccine for children ages 5-11-Spiegel

FRANKFURT, Sept. 10 (Reuters) – BioNTech (22UAy.DE) will apply for worldwide approval to use the COVID-19 vaccine in children up to five years old in the coming weeks and preparations for its launch are in way, the two top executives of the biotechnology firm told Der Spiegel.

“Already in the coming weeks we will present the results of our trial in children aged five to eleven with regulators from around the world and we will request the approval of the vaccine in this age group, also here in Europe,” he said. the chief physician Oezlem Tuereci. the news weekly.

The confident statements underscore the advantage that BioNTech, which collaborates with Pfizer (PFE.N), maintains in the race for broad approval to vaccinate children under 12 in Western countries.

BioNTech has said it expects to present its regulatory dossier to young people aged five to eleven in September. It has also established plans to ask for approval from children 6 months to 2 years later this year.

Tuereci also told Spiegel that final production steps were being adjusted to bottle a lower-dose pediatric version of his established Comirnaty vaccine. It is currently approved for adults and young people at least 12 years old.

Gross trial data was being prepared for a regulatory filing and “things are looking good, everything is going according to plan,” chief executive Ugur Sahin told Der Spiegel.

The second-ranked Modern (MRNA.O) said Thursday that a trial to test its shot on children between the ages of six and eleven was already fully enrolled and that it was working on the best dose in another study with babies up to six months.

China has made progress in lowering the age limit of its vaccination campaign. The country’s health authorities approved in June the emergency use of the Sinovac vaccine (SVA.O) in children as young as three years old. Read more

Chile, which has relied heavily on the shooting of Sinovac, approved this month the use of the vaccine in children over 6 years old. Read more

Israel’s health ministry said in July that children up to five years of age can receive the Pfizer-BioNTech shot if they suffer from conditions that make them particularly vulnerable to COVID-19.

Report by Ludwig Burger, edited by Emma Thomasson, Douglas Busvine, Elaine Hardcastle

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