BioNTech to seek vaccine approval for 5-11 year olds soon – Spiegel

FRANKFURT, Sept. 10 (Reuters) – BioNTech (22UAy.DE) to seek worldwide approval to use its COVID-19 vaccine in children as young as five over the coming weeks and preparations for ‘A launch is on track, the two senior executives of the biotech company told Der Spiegel.

“Already in the coming weeks, we will be filing the results of our trial in children aged five to 11 with regulators around the world and seeking vaccine approval in this age group, also here in Europe,” he said. said Chief Medical Officer Oezlem Tuereci. weekly news.

The confident statements highlight the advance that BioNTech, which works with Pfizer (PFE.N), is in the race to gain broad approval to immunize children under 12 in Western countries.

BioNTech said it plans to file its five- to 11-year regulatory filing in September. He also made plans to seek approval in children aged 6 months to 2 years later this year.

Tuereci also told Spiegel that final production steps are being adjusted to bottle a lower-dose pediatric version of its established Comirnaty vaccine. It is currently approved for adults and youth 12 and older.

Raw data from the trial was now being prepared for regulatory filing and “things are looking good, everything is going according to plan,” GM Ugur Sahin told Der Spiegel.

Finalist Moderna (MRNA.O) said on Thursday that a trial testing his injection in children aged six to 11 is now fully enrolled and that he is working on the best dosage in another study involving infants as young as six months.

China has been ahead in lowering the age limit for its vaccination campaign. The country’s health authorities in June approved 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 Sinovac’s vaccine, this month approved the vaccine for use in children over 6 years of age. Read more

Israel’s health ministry said in July that children as young as five can be vaccinated with Pfizer-BioNTech if they suffer from conditions that make them particularly vulnerable to COVID-19.

Reporting by Ludwig Burger, editing by Emma Thomasson, Douglas Busvine, Elaine Hardcastle

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