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 "Already over the next few weeks we will file the results of our
trial in five to 11 year olds with regulators across the world and
will request approval of the vaccine in this age group, also here in
Europe," Chief Medical Officer Oezlem Tuereci told the news weekly.
The confident statements underscore the lead that BioNTech, which
collaborates with Pfizer, holds in the race to win broad approval to
vaccinate children below the age of 12 in Western countries.
BioNTech has said it expected to file its regulatory dossier on the
five to 11 year olds in September. It has also laid out plans to
seek approval in children aged 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 its established
Comirnaty vaccine. It is currently approved for adults and
youngsters at least 12 years of age.
The raw trial data was now being prepared for a regulatory filing
and "things are looking good, everything is going according to
plan", Chief Executive Ugur Sahin told Der Spiegel.
[to top of second column] |
 Runner-up Moderna said on
Thursday a trial testing its shot in children
between six and 11 years was now fully enrolled
and that it was working on the best dosage in
another study involving infants as young as six
months. China has been ahead in
lowering the age limit of its immunisation campaign. The country's
health authorities in June approved emergency use of Sinovac's
vaccine in children as young as three years.
Chile, which has relied heavily on Sinovac's shot, this month
approved use of the vaccine in children over 6 years of age.
Israel's health ministry said in July that children as young as five
can get the Pfizer-BioNTech shot 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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