Pharmaceutical company Pfizer and biotechnology company BioNTech said on Friday they had applied for approval of their Covid-19 vaccine for children aged five to 11 in the European Union (EU).
If EU regulators agree, it will be the first option for younger children in the EU to be immunized against Covid-19.
Pfizer and BioNTech said they had also submitted data to the European Medicines Agency (EMA) from the final phase of a study involving more than 2,200 children aged between six months and 11 years.
Children have received a lower dose than adults.
The results show a “strong immune response” in children, companies said in a statement. The vaccine has also been shown to be safe.
No Covid-19 vaccine is currently approved for use in children under 12 years of age in the EU and North America.
Pfizer and BioNTech and Moderna vaccines are approved in the EU for use in children over 12 years of age.
Pfizer and BioNTech this month asked the US Food and Drug Administration to approve the use of the vaccine in children aged five to 11 years.
The majority of the EU’s adult population is immunized, but many countries are experiencing increasing outbreaks among children. Schools are generally open, but rules on wearing masks and social distancing are often not consistent enough.
The World Health Organization (WHO) has stated that vaccination of children is not a priority, as children have a much lower risk of serious illness or death. The WHO has repeatedly urged the governments of rich countries to share their vaccine stocks with poor countries, rather than expanding the availability of vaccines in their countries to immunize the world’s populations at risk.
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