Pfizer Asks FDA To Authorize For Covid Booster For Healthy Children Ages 5-11

Pfizer said it wants to expand its COVID-19 booster shots to healthy elementary-age children and asks approval from FDA.

US health authorities already urge everyone over the age of 12 to get a booster dose for the best protection against newer variants and recently gave those over 50 the option of a second booster.

Now Pfizer says new data shows that healthy children ages 5 to 11 could benefit from another child-sized injection.

In a news release, Pfizer and its partner BioNTech said that in one small study, 140 young people who had received two injections received a booster six months later. But a closer look at 30 of the children found a 36-fold boost in virus-fighting antibodies, levels high enough to combat the super-contagious omicron variant. The researchers found that the additional injection generally hastened their immune response.

The information has not been published or reviewed by independent experts.

Pfizer tested the booster for healthy children while omicron was booming this winter. In comparison, COVID-19 cases are now at much lower levels in the US. In recent weeks, an even more contagious version of omicron has been called BA.2 variant. It has become the dominant type locally and around the world.

In the coming days, the pharmaceutical companies like Pfizer, BioNTech plan to petition the FDA to authorize a booster for healthy children ages 5 to 11. They also plan to share the information data with European regulators and others.

The vaccines are commonly less effective against the omicron variant than earlier versions of the coronavirus but still offer strong protection against severe disease. While COVID-19 is more dangerous to adults, young people can get very sick. But regulators will have to decide if healthy elementary school children need a booster and when.

Pfizer’s vaccine shots are the only vaccine available for American children. Persons 5 to 11 years of age receive one-third of the dose given to everyone over 12 years. Over a quarter of the youngest age group received two doses since vaccination opened in November, shortly before omicron arrived.

The US has not yet allowed vaccines for children under five. However, certain children ages 5 to 11 those with severely weakened immune systems. They are already supposed to get three doses to give that high-risk group a better response chance.