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The FDA authorizes Pfizer-BioNTech boosters for children ages 5 to 11.




The Food and Drug Administration approved booster shots of the Pfizer-BioNTech vaccine on Tuesday for children 5 to 11, the latest in a series of actions aimed at strengthening declining protection against coronavirus vaccine infection.

More than eight million of the 28 million children in that age group in the United States have received two vaccine shots, and will now be eligible for the extra dose at least five months after their second shot. The Centers for Disease Control and Prevention is considered very likely to recommend the booster dose after an advisory committee of external experts has met to discuss it on Thursday.

That would make all Americans 5 and older eligible for a booster shot. But booster intake has been much slower than public health experts had hoped; Many parents have been reluctant to vaccinate children in this age group at all.

Although they have been eligible for Covid shots since November, only 29 percent of 5- to 11-year-olds have received two doses. Another six percent or so have received one shot.

In a statement, Dr. Robert M. Califf, FDA Commissioner, said: “While Covid-19 has been largely less severe in children than adults, the Omicron wave has seen more children become sick with illness and hospitalization, and children may also experience long-term effects, even after initial mild illness. “

Some experts have suggested that because children ages 5 to 11 received a much lower starting dose than older children or adults, they especially need a booster shot. A study conducted by New York researchers found that for children 5 to 11, the effectiveness of the Pfizer vaccine against infection dropped to 12 percent from 68 percent four to five weeks after the second dose.

Another CDC study found that two Pfizer doses reduced the risk of Omicron infection by 31 percent among those 5 to 11, compared with a 59 percent reduction in risk among those 12 to 15. Dr. Peter Marks, the FDA’s top vaccine regulator, said that “emerging data suggest that vaccine efficacy against Covid-19 decreases after the second dose of the vaccine” in all age groups.

The newly approved booster dose has the same strength as the first two shots. Pfizer has said that their clinical trial data showed that the extra shot gave a strong immune response in the age group, and generated neutralizing antibodies against both the Omicron variant and the original version of the virus. No new safety signals were observed, according to the company.



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