Pfizer plans to release data from its study of children under five by the end of the year. It is not clear how this change will delay the drive to vaccinate young children.

Pfizer said Friday it is changing its plans and testing three doses of its COVID-19 vaccine on children and preschoolers instead of the usual two doses. The addition of an additional dose came after an initial analysis found that children aged 2 to 4 years did not have as strong an immune response as would be expected for especially lower doses.

Pfizer plans to release data from its study of children under five by the end of the year. It is not clear how this change will delay the drive to vaccinate young children.

Pfizer and partner BioNTech said that if the three-dose study is successful, they plan to apply for emergency authorization sometime in the first half of 2022.

A child-sized version of the Pfizer vaccine is already available for children ages 5 to 11, which is one-third of the dose given to anyone else 12 years old or older. For children younger than 5 years old, Pfizer is testing a smaller dose, just 3 mcg or one-tenth of the adult dose.

Researchers analyzed a subset of children in the study a month after their second dose to see if the toes had developed levels of anti-virus antibodies that were similar to teens and young adults who get regular injections.

Young people under the age of two had similar levels of antibodies, but the immune response in children aged 2 to 4 years was lower, Katherine Jansen, head of vaccine research at Pfizer Inc., said Friday in a call with investors.

So the study is being expanded to evaluate three of those very low doses in children under the age of five. This third shot will come at least two months after the second dose for young children. The companies said no safety concerns were identified in the study. Jansen cited other data showing that a booster dose for people 16 and older restores strong protection, a leap in immunity that scientists hope will also help stave off the new omicron variant.

The companies are also preparing to test a booster dose for children aged 5 to 11, who are now getting two doses of the vaccinations. They are testing different dosage options for the teen tonic. If additional pediatric testing is successful, Jansen said, “we will have a consistent three-dose vaccine approach for all ages.”

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