Pfizer/BioNTech have announced that their mRNA COVID-19 vaccine proved safe and effective in the phase 2/3 trials in children aged five to 11 years old.
The biotech company said a two-dose regimen of 10 µg administered 21 days apart showed a favourable safety profile and robust neutralising antibody responses in school-age children one month after the second dose.
“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, Chairman and Chief Executive Officer, Pfizer.
He said, since July, pediatric cases of COVID-19 have risen by about 240% in the United States, highlighting the need for vaccination in young children.
The clinical trials enrolled up to 4500 children ages six months to 11 years of age in the United States, Finland, Poland, and Spain from more than 90 clinical trial sites. The study was designed to evaluate the safety, tolerability, and immunogenicity of the Pfizer mRNA vaccine on a two-dose schedule in three age groups: ages six months to two years, ages two to five and ages five to 11 years.
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The five to 11 years age group, which included over 2200 participants, received a smaller dose than that used for people 12 and older (10 µg versus 30 µg). Yet, they showed antibody responses comparable to those recorded in older children.
The mRNA vaccine was well tolerated, with side effects generally comparable to those observed in older age groups.
Pfizer/BioNTech plans to submit data for the school-age group to regulatory authorities in the next few weeks, and they expect to have results for children six months to five years of age before the end of the year.
“The safety profile and immunogenicity data in children aged five 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,” said Dr Ugur Sahin, CEO and co-founder of BioNTech.
“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.”
Australian Chief Nursing and Midwifery Officer Alison McMillan welcomed the news in a press conference on Tuesday. She said Australia is ready and prepared to expand the vaccine rollout to younger children.
In Australia, the Pfizer COVID-19 vaccine is already available for children aged 12 and older. Health Minister Greg Hunt has encouraged Pfizer to apply to Australian authorities at the same time as it applies for approval in the United States.