US FDA authorises Covid-19 vaccines for youngest children

The US Food and Drug Administration (FDA) on Friday authorised two Covid-19 vaccines for children aged five and under, opening the door for vaccinating millions of the youngest American children.

The agency authorised Pfizer-BioNTech's vaccine for children aged six months to four years, and Moderna Inc's shot for those six months to 17 years. The Pfizer vaccine is already authorised for use in children and teens over the age of five.

The vaccines could be rolled out for the under-five age groups as early as next week, White House officials have said, and pharmacy chains have conveyed that they are ready to distribute the shots.

An advisory panel of the US Centers for Disease Control and Prevention, which first needs to make its recommendation on the use of the shots, is scheduled to meet on Friday and Saturday.

While many American parents are eager to vaccinate their children, it is unclear how strong the demand will be for the shots. The Pfizer/BioNTech vaccine was authorised for children ages five to 11 in October, but only about 29 percent of that group is fully vaccinated, according to federal data.

"Those trusted with the care of children can have confidence in the safety and effectiveness of these Covid-19 vaccines and can be assured that the agency was thorough in its evaluation of the data," FDA commissioner Robert Califf said in a statement.

Public health officials and experts say that even though a large portion of small children was infected during the winter surge due to the Omicron variant of the coronavirus, natural immunity wanes over time and vaccinations should help prevent hospitalizations and deaths when cases rise again.

The companies had presented data showing that there were no new safety concerns in that age group and the vaccines generated a strong immune response.

- Reuters