FDA approves Pfizer’s bivalent Covid booster for babies as young as six months – injection ‘remains best defense against disease’

FDA approves Pfizer’s bivalent Covid booster for babies as young as six months – injection ‘remains best defense against disease’

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

The change took place on Tuesday. Now the booster injection offered to young children under the original three-dose regimen will be the bivalent injection adapted for Omicron.

The original shots, released in late 2020, were aimed at the Wuhan strain that broke out earlier in the year. The virus has since evolved to evade it.

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

There are questions about whether children in this age group need the shots at all, and studies show they have little risk from the virus. Utilization has also been low so far.

Under new FDA recommendations, the booster vaccine for children under the age of six is ​​now being replaced by Pfizer’s bivalent vaccine (file photo).

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

“We encourage all eligible individuals to ensure their vaccinations are up to date with a bivalent COVID-19 vaccine.”

The booster was originally approved for young children in December, although the move was met with little fanfare.

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

The FDA based its decision on two successful, albeit relatively small, studies.

In the first, 24 participants were injected between six months and two years.

No major side effects were reported, but some children experienced symptoms such as irritability, drowsiness, redness at the injection site, pain and swelling, decreased appetite, fatigue and fever.

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A second study of children between the ages of two and four collected data from 36 children. The results were almost identical.

However, it is unclear how many children end up getting the shot.

According to official data from the Centers for Disease Control and Prevention (CDC), only 4 percent of children under the age of two and 5.7 percent between the ages of two and four are infected.

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

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

The study was carried out before the advent of the milder Omicron strain, meaning that children are now likely to be less at risk of experiencing any symptoms.

Children may also be less likely to spread the virus if they are infected. A German study shows that as adults they release only 25 percent of the virus particles.

Data released by New York state officials late last month also showed that the injection was only 12 percent effective at preventing Covid infection in children between the ages of five and 11.

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