BioNTech- Pfizer announced Wednesday that its COVID-19 vaccine is safe and strongly protective in kids as young as 12, a step toward possibly beginning shots in this age group before they head back to school in the fall.
Eighteen adolescents who received placebo, or fake, doses became infected with the virus, they said.
Pfizer reported that it is study of 2,260 US volunteers ages 12 to 15, preliminary data indicated there were no cases of COVID-19 among fully vaccinated adolescents compared to 18 among those given dummy shots.
Pfizer says that the COVID-19 vaccine was "well-tolerated" by the age group, with participants experiencing a similar range of side effects as seen in older teens and young adults.
Most COVID-19 vaccines being rolled out worldwide are for adults, who are at higher risk from the coronavirus. Pfizer's vaccine is authorised for ages 16 and older. But vaccinating children of all ages will be critical to stopping the pandemic and helping schools, at least the upper grades, start to look a little more normal after months of disruption.
It's a small study, that hasn't yet been published, so another important piece of evidence is how well the shots revved up the kids' immune systems. Researchers reported high levels of virus-fighting antibodies, somewhat higher than were seen in studies of young adults.
Kids had side effects similar to young adults, the company said. The main side effects are pain, fever, chills and fatigue, particularly after the second dose. The study will continue to track participants for two years for more information about long-term protection and safety. Pfizer and its German partner BioNTech in the coming weeks plan to ask the US Food and Drug Administration and European regulators to allow emergency use of the shots starting at age 12.
We share the urgency to expand the use of our vaccine, Pfizer CEO Albert Bourla said in a statement. He expressed the hope of starting to vaccinate this age group before the start of the next school year" in the United States.
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