FDA approves Pfizer’s Covid bivalent booster for babies six months and older, saying the shot “remains the best defense against disease”
The Food and Drug Administration (FDA) now recommends that children six months and older receive the bivalent Covid booster.
The change was made on Tuesday. Now the booster offered to young children after the original three-dose regimen will be the bivalent injection, which has been adapted into Omicron.
The original shots released in late 2020 were adapted to the Wuhan strain that broke out earlier that year. Since then, the virus has evolved to evade it.
Officials also say that children who received the three doses of the original vaccine more than two months ago can now receive a fourth bivalent vaccine.
There are questions about whether children in this age group need the vaccines, and studies find they are at little risk from the virus. Uptake has also been low so far.
Under new FDA recommendations, the booster shot for children under six will now be replaced by Pfizer’s bivalent shot (file photo)
“Currently available data show that vaccination remains the best defense against severe illness, hospitalization and death caused by COVID-19 in all age groups,” Dr. Peter Marks, who oversees vaccinations, said in a statement. vaccines at the FDA.
“We encourage all eligible individuals to ensure 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 in making its decision.
In the first, 24 participants between the ages of six months and two years received the injection.
No major adverse events were reported, but some of the children suffered: irritability, drowsiness, redness at the injection site, pain and swelling, decreased appetite, fatigue, and fever.
A second trial of children between the ages of two and four years collected data from 36 children. The results were almost identical.
However, it is not clear how many children will end up receiving the vaccine.
According to official data from the Centers for Disease Control and Prevention (CDC), only four percent of children under two years of age, and 5.7 percent between two and four years of age, have received it.
The lack of demand is largely due to the low risk many children face from the virus.
A 2021 University of Utah study found that 50 percent of pediatric Covid cases are asymptomatic.
The study was done before the milder variant of Omicron emerged, meaning the risk of children even feeling symptoms is probably lower now.
Children may also be less likely to spread the virus when infected, as a German study found that they shed as little as 25 percent of the virus particles as adults.
Data released by New York state officials late last month also found that the shot was only 12 percent effective in preventing Covid infection in children ages five to 11.