BioNTech to seek approval soon for vaccine for 5-11 year olds-Spiegel (updated)
10/09/2021 11:35
(Adds background)
FRANKFURT, Sept 10 (Reuters) - BioNTech 22UAy.DE is set to
request approval across the globe to use its COVID-19 vaccine in
children as young as five over the next few weeks and
preparations for a launch are on track, the biotech firm's two
top executives told Der Spiegel.
"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 PFE.N , 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.
Runner-up Moderna MRNA.O 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 SVA.O vaccine in children
as young as three years. urn:newsml:reuters.com:*:nL3N2NM447
Chile, which has relied heavily on Sinovac's shot, this
month approved use of the vaccine in children over 6 years of
age. urn:newsml:reuters.com:*:nL1N2Q818E
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)
((ludwig.burger@thomsonreuters.com; +49 30 220133634; Reuters
Messaging: ludwig.burger.thomsonreuters.com@reuters.net))