Pfizer-BioNTech file for emergency use approval for its Covid booster for children aged 5-11

New Delhi

Seeking to fight the recent Covid subvariants of Omicron, US pharma giant Pfizer on Monday sought emergency authorisation for its COVID-19 booster dose for school-age children aged 5 to 11. 

In its request to the  US Food and Drug Administration (FDA), Pfizer and its vaccine development partner, the German firm BioNTech, sought for Emergency Use Authorization (EUA) for a 10-microgramme dose of the vaccine. The booster shot targets the original Covid strain as well as the Omicron variant and its subsequent BA.4 and BA.5 subvariants.

According to studies, the BA.4 and BA.5 subvariants currently make up nearly 90 per cent of all new cases in the US. If the bivalent booster is authorised by the FDA, it will need to clear one last hurdle of the Centers for Disease Control and Prevention (CDCP), which is USA's main federal health agency. 

Read more: What is Khosta-2, the 'vaccine-resistant' severe Covid-like virus scientific community is panicking about?

Currently, US FDA has authorised a 15 microgrammes bivalent booster dose of the vaccine to anyone 12 years old or older. 

While the Covid cases are waning in the country, FDA Commissioner Robert Califf believes that the US may "enter yet another surge as we spend more time indoors later this fall and winter."

Read more: US approves Moderna and Pfizer shots targeting omicron variant of Covid

According to data released by the CDCP, over 616 million vaccine doses have been administered across the USA till now. Meanwhile, over 1.24 million children above the age of five have been inoculated with at least one dose since June 18, 2022. As for the booster shots, 4.4 million people in the states have received the updated booster dose. 

The two companies also earmarked that they will be applying for a similar approval for the European continent in the coming days. 

"An application to extend the Omicron BA.4/BA.5-adapted bivalent vaccine marketing authorization to include children ages 5 through 11 years will be submitted to the European Medicines Agency (EMA) in the coming days," read the joint statement from Pfizer and BioNTech. 

(With inputs from agencies)

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