Pfizer and BioNTech to seek approval to vaccinate children after Covid study

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Pfizer (NYSE:PFE) Inc and BioNTech’s intend to apply for approval for their Covid-19 vaccine to be given to children after a trial showed it to be safe and rapidly built up resistance to the virus.


Children received two doses of the vaccine 21 days apart in what was the first major trial of a covid vaccine for those under the age of 12,


Antibody responses in the participants were comparable to those recorded in a previous Pfizer (NYSE:PFE)-BioNTech study in people 16 to 25 years of age immunised with three times larger doses, said the firms.


The two companies added they intend to submit the data to the FDA, EMA and other regulatory agencies around the world as soon as possible.


“Over the past nine months, hundreds of millions of people ages 12 and older from around the world have received our COVID-19 vaccine.


“We are eager to extend the protection afforded by the vaccine to this younger population, subject to regulatory authorization, especially as we track the spread of the Delta variant and the substantial threat it poses to children,” said Albert Bourla, Pfizer (NYSE:PFE)’s chairman and chief executive.


“Since July, pediatric cases of COVID-19 have risen by about 240 percent in the U.S. – underscoring the public health need for vaccination.


“These trial results provide a strong foundation for seeking authorization of our vaccine for children 5 to 11 years old, and we plan to submit them to the FDA and other regulators with urgency.”


Ugur Sahin, CEO and co-founder of BioNTech, added: “The safety profile and immunogenicity data in children aged 5 to 11 years vaccinated at a lower dose are consistent with those we have observed with our vaccine in other older populations at a higher dose.”


Some 2,268 children were treated in the study.

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