Pfizer asks FDA to authorize omicron Covid booster shots for kids ages 5 to 11

Jack Wasserman, 6, receives a Pfizer-BioNTech coronavirus illness (COVID-19) booster vaccine in Schwenksville, Pennsylvania, U.S., May 19, 2022. 

Hannah Beier | Reuters

Pfizer on Monday requested the Food and Drug Administration to authorize its new Covid booster shots that focus on the omicron BA.5 subvariant for youngsters ages 5 to 11.

Pfizer’s software to the FDA comes earlier than medical trial outcomes of the brand new vaccines have been revealed. The firm, in an announcement, mentioned its request is predicated on human knowledge from the same vaccine that targets the omicron BA.1 subvariant and knowledge from animal research on the BA.5 shots.

Pfizer’s primary competitor on Covid shots, Moderna, requested the FDA to authorize its omicron shots for kids ages 6 by means of 17 on Friday. The Centers for Disease Control and Prevention cleared Pfizer’s omicron boosters for individuals ages 12 and older and (*11*) new shots for adults earlier this month.

The CDC, in a doc revealed earlier this month, mentioned the shots will probably develop into out there for kids as younger as 5 years previous in October. The well being company’s vaccine advisory committee has conferences scheduled for Oct. 19 and 20, the place it’s anticipated to assessment the out there knowledge on the boosters for that pediatric age group.

Officials on the FDA and CDC count on the omicron BA.5 shots will present considerably higher safety in opposition to an infection and illness this fall and winter. But U.S. well being officers have acknowledged that within the absence of human knowledge, it is unclear how way more safety the brand new vaccines will present in contrast with the previous ones.

Dr. Peter Marks, who heads the FDA’s vaccine assessment division, has mentioned the U.S. is utilizing the identical course of to swap the Covid vaccines to goal a brand new pressure that it makes use of to replace flu shots yearly. Flu shots are additionally typically cleared for use with out human knowledge.

The new boosters goal the dominant omicron BA.5 subvariant in addition to the unique pressure of Covid that first emerged in Wuhan, China, in 2019. The previous shots, which have been developed in opposition to the unique pressure of Covid, are not offering significant safety in opposition to an infection and delicate sickness as a result of the virus has mutated a lot over the course of the pandemic.

The authentic vaccines are nonetheless stopping extreme sickness, although their effectiveness in opposition to hospitalization can also be declining.

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