Pfizer vaccine appears safe for children 5-11 years old, study finds – deadline

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The first results of an expected study on the effectiveness of the Pfizer-BioNTech Covid vaccine in children aged 5 to 11 were published today, and the first results look promising.

In the second of three phases, the pharmaceutical giants enrolled 2,268 participants aged 5 to 11 in the United States, Finland, Poland and Spain. While people aged 12 years and older received doses of 30 µg (micrograms), patients in the new study received a dose of 10 µg in a two-dose schedule.

The trial demonstrated a strong immune response in the group of children one month after the second dose. This compares well – or was “not inferior,” the companies said – to results seen in participants aged 16 to 25, who were used as a control group for analysis and were given a two-dose regimen of 30 µg. The vaccine was also well tolerated in the younger age group, with side effects generally comparable to those seen in participants aged 16 to 2, the companies said.

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The study is designed to test “safety, tolerability and immunogenicity” in children. The companies plan to share their findings with the U.S. Food and Drug Administration, the European Medicines Agency and other regulators as soon as possible.

The news comes as millions of children across the country and the world return to school for the fall semester.

“In the past nine months, hundreds of millions of people aged 12 and over around the world have received our Covid-19 vaccine,” said Albert Bourla, CEO of Pfizer. “We look forward to extending the protection offered by the vaccine to this younger population, subject to regulatory approval, especially as we follow the spread of the Delta variant and the substantial threat it poses to patients. children. Since July, pediatric cases of Covid-19 have increased by around 240% in the United States, underscoring the public health need for vaccinations. These trial results provide a solid basis for seeking approval for our vaccine for children aged 5 to 11, and we plan to submit them to the FDA and other regulatory agencies as a matter of urgency. “

Said Dr Ugur Sahin, CEO and Co-Founder of BioNTech: “We are delighted to be able to submit data to regulatory authorities for this group of school-aged children before the start of the winter season. 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.


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