Pharmaceutical giants are now seeking authorisation from the FDA to administer Covid-19 vaccines to school children under 12 and above 4 years of age.
Pfizer Inc. and BioNTech SE on Monday announced positive results from Phase 2/3 trials showing administering a smaller dose of the Covid-19 vaccine is safe and effective in children aged 5 to 11 years.
The pharmaceutical giant said in its latest report that the results of the trial showed a “favourable safety profile and robust neutralising antibody responses in children 5 to 11 years of age using a two-dose regimen of 10 µg administered 21 days apart, a smaller dose than the 30 µg dose used for people 12 and older.
“The 10 µg dose was carefully selected as the preferred dose for safety, tolerability and immunogenicity in children 5 to 11 years of age. These are the first results from a pivotal trial of a Covid-19 vaccine in this age group.”
The data, provided based on more than 2,200 children, will be submitted to the US Food and Drug Administration (FDA) and other health regulators “as soon as possible,” the companies said.
Pfizer Chairman and CEO Albert Bourla said last week the company might share its latest findings with authorities by the end of this month.
“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,” said Bourla.
The need to vaccinate younger children has in recent weeks become a hot topic especially as children around the world return to schools following the summer holidays.
“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,” said Dr. Ugur Sahin, CEO and co-founder of BioNTech.
“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.”
The findings demonstrated a strong immune response for the aforementioned group one month after the second dose was adminstered.
“This compares well (was non-inferior) to the GMT of 1146.5 (95% CI: 1045.5, 1257.2) from participants ages 16 to 25 years old, used as the control group for this analysis and who were administered a two-dose regimen of 30 µg,” according to the report.
Meanwhile, detected side effects were similar to those observed in participants aged between 16 to 25.
“Pfizer and BioNTech plan to submit data from the full Phase 3 trial for scientific peer-reviewed publication,” the companies said.
So far, the FDA has authorised the administering of the Pfizer-BioNTech coronavirus vaccine for kids as young as 12, while Moderna’s and Johnson & Johnson’s vaccines have been authorised only for adults.
In Qatar, the Ministry of Public Health (MoPH) Covid-19 has started administering vaccine booster doses for high-risk individuals with plans to expand the campaign to the rest of the public.
The FDA advisory committee on Friday recommended the booster shots to be only administered to those aged 65 and older as well as other vulnerable groups.
Pfizer is expected to release clinical trial data on vaccine efficacy in children aged 6 months to 5 years old by the end of October.