Moderna seeks US FDA approval for Omicron Covid booster for children over 6 years

It is anticipated that omicron boosters will be available to children no later than mid-October, pending approval by the Food and Drug Administration.

Two separate Food and Drug Administration (FDA) authorization requests were submitted by Moderna, one for adolescents and one for children ages 6–11. In the coming months, the Boston biotech company will also apply for FDA approval for the shots for infants six months to five years old.

The Centers for Disease Control and Prevention (CDC) said in a document published that it expects children to be eligible for omicron boosters by mid-October, pending FDA approval. The CDC's vaccine advisory committee meetings will occur on October 19 and 20.


According to the CDC advisory committee earlier this month, it is expected that Pfizer will ask the FDA for approval of omicron boosters in early October.

Moderna's adult omicron boosters have recently obtained FDA approval. The boosters from Pfizer were only approved for people over the age of 12.



New shots are targeted at the Omicron BA.5 subvariant and the original COVID strain that emerged in late 2019 in China. The FDA and CDC believe the new boosters offer more excellent protection against infection and disease because they target the most common strains of Omicron.

Covid has evolved so much in recent years that the old vaccines designed to fight it are no longer effective at protecting against infection and mild illness. Moreover, there is concern that the original shots are beginning to lose effectiveness at preventing hospitalizations and severe illnesses.

Though it's unclear how effective the new Omicron BA.5 boosters will be in practice, public health officials are confident in their effectiveness. Clinical trials on humans were not conducted before the shots were authorized.

FAQ

1. Which strains of Omicron are targeted in the new vaccine?
   The BA.5 variant.
2. Are old vaccine shots not enough for COVID variant Omicron?
   No, they are not proving to be as effective against the new virus variant.