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The FDA approves Pfizer, Moderna vaccines for children aged 6 months

Vials with labels for Pfizer-BioNTech and Moderna vaccines for coronavirus disease (COVID-19) can be seen in this illustrative photo taken on March 19, 2021.

Dado Ruvich Reuters

The Food and Drug Administration on Friday approved Moderna and Pfizer’s Covid-19 vaccines for children under 6 months of age, making almost everyone in the United States eligible for vaccination.

The FDA’s decision comes after a panel of independent vaccine experts voted unanimously to recommend the vaccines, after weighing their safety and effectiveness during a full-day meeting Wednesday that was open to the public.

The FDA has approved the three-dose Pfizer vaccine for children 6 months to 4 years of age and the Moderna two-dose vaccine for children 6 months to 5 years of age. Children under the age of 5 were the only people left in the United States who did not qualify for vaccination. Many parents wait months for the FDA to approve vaccines for their children.

The FDA on Friday also approved Moderna vaccines for children in kindergarten to high school. Previously, the Pfizer vaccine was the only Covid vaccine available for this age group.

However, one more step remains before vaccinating children under 5 years of age. The Committee on Centers for Disease Control and Prevention will meet on Saturday to vote on guidelines for pharmacies and doctors’ offices. CDC Director Dr. Rochelle Valensky must then sign these guidelines before children can receive the vaccines.

The White House expects vaccinations to begin immediately on Tuesday. Meetings may be limited at first, but any parent who wants to vaccinate their child should be able to do so within weeks, according to Dr. Ashish Ja, who is monitoring Covid’s reaction to the Biden administration.

The federal government has made 10 million doses of Pfizer and Moderna available to state and local governments.

Dr Arnold Monto, acting chairman of the FDA committee, said the agency had taken longer to authorize injections for preschool babies than other ages because they were a vulnerable group that required special care. to make sure vaccines are safe and effective.

Pfizer and Moderna vaccines for infants and preschool children differ in the number of vaccines they use, the dosage level and the age at which they are eligible to receive them. The Pfizer vaccine has also been shown to be more effective than the Moderna vaccine in children under 5 years of age, although preliminary data are available.

The Pfizer vaccine is given in three doses to children from 6 months to 4 years of age. The injections are dosed at 3 micrograms, one tenth of what adults receive. Three injections were approximately 75% effective in preventing omicron infection in 6-month-old to 2-year-old children and 82% effective in 2- to 4-year-old children.

However, it is crucial that parents who choose Pfizer make sure that their children receive the third injection to protect against the virus. Two doses are only about 14% effective in preventing infection in children under 2 years of age and 33% effective in those aged 2 to 4 years.

Moderna vaccine is given in two doses to children from 6 months to 5 years of age. The injections are dosed at 25 micrograms, a quarter of the level that adults receive.

The Moderna vaccine was about 51% effective in preventing omicron infection in children aged 6 months to 2 years and about 37% effective in children aged 2 to 5 years. However, the company expects the vaccine to provide strong protection against severe disease, as children had higher levels of antibodies than adults who received two doses.

The most common side effects of vaccines are injection site pain, irritability and crying, loss of appetite and drowsiness, according to the FDA. Very few children who receive one of the two injections develop a fever higher than 102 degrees Fahrenheit, and there are no cases of myocarditis, a type of heart inflammation, in the Pfizer or Moderna trials.

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