Summary:
New Delhi, Sep 20 (PTI) Global pharma major Pfizer and BioNTech SE on Monday said trial results of COVID-19 vaccine showed that it is safe and produced robust neutralizing antibody response in children aged five to 11 years, and they plan to seek regulatory approvals as soon as possible.
Children aged five to 11 years were given a two-dose regimen of 10 microgrammes (µg) administered 21 days apart, a smaller dose than the 30 µg dose used for people 12 years and older, the companies said in a joint statement.
"In participants 5 to 11 years of age, the vaccine was safe, well tolerated and showed robust neutralizing antibody responses," the statement said.
The companies plan to submit these data to the US Food and Drug Administration (FDA), European Medicines Agency (EMA) and other regulators as soon as possible, the statement said.
"Since July, paediatric cases of COVID-19 have risen by about 240 percent in the US – 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," Pfizer Chairman and Chief Executive Officer Albert Bourla said.