Pfizer-BioNTech says its COVID vaccine is safe for children between 5 and 11

Pfizer-BioNTech will seek regulatory approval from EMA and the FDA for a lower dose COVID vaccine to be used in children between the ages of 5 and 11

Pfizer-BioNTech has successfully tested a low dose COVID-19 vaccine in children between 5 and 11
Pfizer-BioNTech has successfully tested a low dose COVID-19 vaccine in children between 5 and 11

Results from a vaccine trial show that Pfizer-BioNTech’s COVID jab is safe and effective in children under 12 years of age, the companies said on Monday.

The companies now plan to submit the data for regulatory approval to the European Medicines Agency and the American Federal Drug Agency.

“In participants 5 to 11 years of age, the vaccine was safe, well tolerated and showed robust neutralizing antibody responses,” the companies said.

Results in children under 5 years of age are expected as soon as later this year.

The results of the trial show a favourable safety profile and robust neutralizing antibody responses in children 5 to 11 years of age using a two-dose regimen administered 21 days apart. Children were administered a smaller dose than that used for people 12 and older.

“The antibody responses in the participants given the smaller dose were comparable to those recorded in a previous Pfizer-BioNTech study in people 16 to 25 years of age immunized with a larger dose,” the companies said.

These are the first results from a trial of a COVID-19 vaccine in this age group.

So far, the Pfizer-BioNtech vaccine, known commercially as Comirnaty, can be administered to anyone aged 12 and older.

“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 authorisation, especially as we track the spread of the Delta variant and the substantial threat it poses to children,” Albert Bourla, chairman and CEO of Pfizer, said.

“We are pleased to be able to submit data to regulatory authorities for this group of school-aged children before the start of the winter season,” Dr Ugur Sahin, CEO and co-founder of BioNTech added.

Malta has vaccinated more than 90% of residents aged 12 and older. Elderly in homes have also received a third booster jab and by the end of this month, people aged 70 and over in the community will also start receiving the booster jab.