A staff member prepares a syringe of Biontech and Pfizer’s Comirnaty vaccine adapted to the Omicron-BA.1 variant on the Mainz vaccination center.
Sebastian Christoph Gollnow | dpa | Image Alliance | Getty’s paintings
US Food and Drug Administration on Tuesday authorized (*5*)by Pfizer an omicron booster for children under five who’ve previously been vaccinated with three doses of the corporate’s original vaccine.
Children six months to 4 years of age who’ve accomplished a three-dose primary immunization course with Pfizer and BioNTech’s original monovalent injections greater than two months ago can now receive a single booster dose of the updated injection. The latest injection is bivalent, meaning it targets the unique Covid strain as well as the BA.4 and BA.5 omicron.
Pfizer’s entry-level range for toddlers consists of three doses, while competitor Moderna’s entry-level range for the identical age group is barely two.
Since December, children on this age group who received two doses of Pfizer’s original vaccine were eligible to receive an omicron booster as their third injection or final primary dose. The agency noted that children who received the omicron vaccine as a third dose aren’t currently eligible for a bivalent booster, but should still be protected against a severe case of Covid-19.
The latest authorization applies to young children who received three doses before the brand new injection was available.
“Today’s approval gives parents and guardians of children 6 months to 4 years of age who received a three-dose primary batch of Pfizer-BioNTech COVID-19 monovalent vaccine the chance to update their child’s protection by receiving a booster dose with Pfizer-BioNTech COVID-19 vaccine. bivalent,” Peter Marks, director of the FDA’s Center for Biological Evaluation and Research, said in a statement.
The agency’s decision is aimed toward higher protecting young children after a gruesome winter season that saw hospitals overflowing with babies affected by a number of respiratory illnesses, including Covid, RSV and flu.
The FDA said the choice was based partially on data from clinical trials of 60 children within the age group who had previously received three doses of Pfizer’s original vaccine and one dose of the corporate’s latest booster. One month after the children received the omicron booster, they showed an immune response to each the unique Covid strain and omicron BA.5 and BA.5