Comirnaty, the Pfizer/BioNTech COVID-19 vaccine, appears to be well tolerated and generating a robust immune response in children between 5 and 11, according to the drug makers. They plan to submit their results for health regulators' consideration as soon as possible.
The findings come from a Phase2/3 clinical trial that included 2,268 participants who were 5 to 11 years of age. They tested a two-dose regimen for children, three weeks apart. Each dose is one-third of what has been given to anyone over the age of 12. One month after the second dose, the immune response from the children was similar to the one seen from teens and young adults, who were used as a control group.
Pfizer and BionNTech are now planning to submit the data to the US Food and Drug Administration (FDA), European Medicines Agency (EMA), and other health regulators for Emergency Use Authorization, which is just as rigorously tested, but the application-to-roll-out is much quicker. The regulators will assess the quality of the clinical trial and decide if and when to recommend the vaccine to children. The full study, which includes children as young as six months, will be published by the end of the year.
“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, said in a statement. “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.”
During the current wave of COVID-19 infection spreading through the US, a much higher number of children have been infected. In total, the US has had almost 5.3 million cases of COVID-19 in children, with over 243,000 new cases in the first week of September alone. That week and the previous one were responsible for an increase of 10 percent in the number of cases in children since the beginning of the pandemic.
“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.
“Since July, pediatric 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.”