FDA approves Pfizer’s bivalent Covid booster for babies as young as six months — saying the shot ‘remains the best defense against disease’

The Food and Drug Administration (FDA) now recommends children as young as six months old receive the bivalent Covid booster.

The change was made Tuesday. Now, the booster offered to young children after the original three dose regimen will be of the bivalent shot, which was tailored towards Omicron.  

The original shots rolled out in late 2020 were tailored to the Wuhan strain that erupted early that year. The virus has since evolved to evade it.

Officials also say that children who received all three doses of the original vaccine more than two months ago can now receive a fourth, bivalent, shot.

There are questions swirling over whether children in this age group need the shots at all, with studies finding they suffer little risk from the virus. Uptake has also been low so far.

‘Currently available data show that vaccination remains the best defense against severe disease, hospitalization and death caused by COVID-19 across all age groups,’ Dr Peter Marks, who oversees vaccines at the FDA, said in a statement.

‘We encourage all eligible individuals to make sure that their vaccinations are up to date with a bivalent COVID-19 vaccine.’

The booster was initially approved for young children in December, though the move came with little fanfare. 

Children who have received the original three doses are eligible for the booster at least two months later.

The FDA cites two successful, albeit relatively small, trials for its decision.

In the first, 24 participants between six months and two years old received the shot.

There were no major adverse events reported, but some of the children suffered included: irritability, drowsiness, injection site redness, pain and swelling, decreased appetite, fatigue, and fever.

A second trial of children between the ages of two and four years old gathered data from 36 children. The results were nearly identical.

It is unclear how many children will actually end up receiving the shot, though.

According to official data from the Centers for Disease Control and Prevention (CDC) only four percent of children under two, and 5.7 percent between two and four, have received it.

The lack of demand is largely fueled by the low risk many children face from the virus.

A study from the University of Utah in 2021 found that 50 percent of pediatric Covid cases are asymptomatic. 

The study was performed before the more-mild Omicron variant emerged, meaning the risk for children to even feel symptoms is likely lower now.

Children may also be less likely to spread the virus when infected, with a German study finding that they release as little as only 25 percent of virus particles as adults do.

Data revealed by New York state officials at the end of last month also found that the shot was only 12 percent effective at preventing Covid infection for children aged five to 11.