BioNTech/Pfizer vaccine ‘safe and effective’ for children under twelve

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BioNTech and Pfizer are moving quickly to seek approval for their Covid-19 vaccine for use in children following positive trial results. In the pivotal trial involving five- to 11-year-olds, the vaccine was well tolerated and produced a strong immune response, both companies said Monday. The data will now be submitted to the European Medicines Agency (EMA), the U.S. Food and Drug Administration (FDA) and other regulatory agencies worldwide. “After submission of the data, I expect the approval process to be completed about four weeks later, so the approval could be at the end of October, beginning of November,” pediatrician Reinhold Kerbl said as reported by Kleine Zeitung last week.

These are the first results from a pivotal trial for a Covid-19 vaccine for children under 12. In the study, Biontech and Pfizer tested a dosage of their already-approved vaccine of ten micrograms, which is one-third of the adult dose. Two doses were administered 21 days apart. The vaccine for over-twelve-year-olds and adults, respectively, provides for a dosage of 30 micrograms. The immune response in children at the lower dosage was comparable to that observed in a previous study of 16- to 25-year-olds, he said – as were side effects. The study involved 2,268 children ages five to 11.

Covid infections rise in younger age groups
“Since July, Covid 19 cases among children in the United States have increased by about 240 percent. This underscores the need for vaccination,” Pfizer CEO Albert Bourla said. He said the study results provide a strong basis to seek approval for the vaccine in children ages five to 11. “Our plan is to submit them to the FDA and other regulatory agencies as soon as possible.”

BioNTech and Pfizer plan to release data on the use of the vaccine in children aged six months to five years in the fourth quarter of this year. The vaccine had been approved for use in children and adolescents aged 12 years and older in the U.S. and EU in May.