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FDA allows 1st COVID-19 shots for infants, preschoolers

U.S. regulators on Friday authorized the first COVID-19 syringes for infants and preschoolers, paving the way for vaccinations to begin next week.

The actions of the Food and Drug Administration follow the unanimous recommendation of the Advisory Committee on the shots from Moderna and Pfizer. This means that American children under the age of 5 – about 18 million young people – are entitled to the injections, about 1 1/2 years after the vaccines first became available in the United States for adults who have suffered the worst during the pandemic.

There is one step left: the Centers for Disease Control and Prevention recommends how to use the vaccine and its vaccine consultants will discuss the shots on Friday and vote on Saturday. The final badge would come from the CDC CEO Dr. Rochelle Walensky.

During a hearing in the Senate on Thursday, Walensky said her staff was working over the weekend in June “because we understand how important this is for American parents.”

She said that the deaths of children due to COVID-19 were higher than is generally seen with the flu each year.

“So I really think we need to protect young children, as well as protect everyone with the vaccine and especially protect the elderly,” she said.

The FDA also authorized Moderna vaccines for school-age children and adolescents. Pfizer shots had been the only option for that age.

For weeks, the Biden administration has been preparing to release vaccines for young children, with states, tribes, community health centers and pharmacies licensed to pre-order millions of doses. The FDA’s emergency use permit allows manufacturers to start sending vaccines across the country. Vaccinations could start early next week.

Although young children generally do not get as sick from COVID-19 as older children and adults, their hospitalizations increased during the omicron wave and FDA advisers decided that the benefits of vaccination outweigh the minimum risks. Studies from Moderna and Pfizer showed that side effects, including fever and fatigue, were mostly minor.

“As we have seen with older age groups, we anticipate that the vaccines for younger children will provide protection against the most serious consequences of COVID-19, such as hospitalization and death,” FDA Secretary General Robert Califf said in a statement.

The two vaccine labels use the same technology but there is a difference.

The Pfizer vaccine for children under 5 years of age is one tenth of the adult dose. Three shots are needed: the first two at three-week intervals and the last at least two months later.

Moderna’s are two injections, each quarter of the adult dose, given at four-week intervals for children under 6 years of age.

The vaccines are for children up to 6 months. Moderna next plans to study its syringes for children up to 3 months old. Pfizer has not finalized plans for shots in younger infants. Dozens of countries, including China, are already vaccinating children under the age of five.

Dr. Beth Ebel, a professor of pediatrics at the University of Washington in Seattle, said the full-size vaccines would be especially appreciated by U.S. parents of day-care children as an epidemic could put parents off work, increasing the financial burden.

“Many will be happy and many great-grandparents will also be happy, because we have missed these children who grew up when you could not see them,” said Ebel.

FDA allows 1st COVID-19 shots for infants, preschoolers

Source link FDA allows 1st COVID-19 shots for infants, preschoolers

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