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Pfizer has asked the FDA to approve omicron Covid booster shots for children aged 5 to 11.

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

On May 19, 2022, in Schwenksville, Pennsylvania, U.S.A., 6-year-old Jack Wasserman received a coronavirus disease (COVID-19) booster vaccine from Pfizer-BioNTech.

Reuters | Hannah Beier

On Monday, Pfizer submitted an application to the FDA for approval of its new Covid booster shots, which protect children aged 5 to 11 against the omicron BA.5 subvariant.

Pfizer has applied to the FDA before publishing the findings of clinical trials for the new vaccinations. According to a business statement, human data from a comparable vaccination targeting the omicron BA.1 subvariant and data from animal trials on the BA.5 shots form the basis of the company’s request.

On Friday, Moderna, Pfizer’s major competitor on Covid injections, submitted a request to the FDA to approve its omicron shots for children and adolescents 6–17 years old. Pfizer’s omicron boosters for those aged 12 and above, as well as Moderna’s new shots for adults, were given the go light by the CDC earlier this month.

In a report released earlier this month, the CDC indicated that the vaccine might be made available to children as young as 5 in October. The vaccine advisory council for the health department will be meeting on October 19 and 20 to discuss the existing information regarding boosters for children of that age.

The Food and Drug Administration and the Centers for Disease Control and Prevention believe that the omicron BA.5 shots will greatly increase immunity to infectious diseases this fall and winter. However, American health experts have admitted that without human data, it’s unknown how much more protection the new vaccines will provide compared to the old ones.

To upgrade the Covid vaccines to target a new strain, the United States is following the same procedure it employs to update the flu shots annually, as stated by Dr. Peter Marks, who heads the FDA’s vaccine review section. Vaccines against the flu are frequently approved for use in the absence of human data.

The new boosters are designed to counter the Covid strain that arose in Wuhan, China in 2019 and its dominant omicron BA.5 subvariant. The virus has changed so much over the course of the pandemic that the previous shots, which were produced against the initial strain of Covid, no longer provide effective protection against infection and moderate illness.

The initial vaccines still do a good job of avoiding serious illness, albeit they are becoming less effective in preventing hospitalizations as well.

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