The FDA’s decision comes after its own committee of independent vaccine expertsElected unanimously to recommend shots After evaluating their safety and effectiveness during an all-day meeting open to the public on Wednesday.
The FDA authorized Pfizer’s three-dose vaccine for children 6 months to 4 years old and Moderna’s two-dose vaccine for children 6 months to 5 years old. Children under the age of 5 were the only people left in the US who were not eligible to be vaccinated. Many parents have been waiting months for the FDA to authorize vaccines for their children.
FDA also authorized on Friday Moderna Vaccines for Kindergarten through High Schoolers, Previously, Pfizer’s vaccine was the only COVID shot available for this age group.
However, there is still one more step to be taken to start immunization of children below 5 years of age. The Centers for Disease Control and Prevention committee will meet on Saturday to vote on guidelines for pharmacies and doctors’ offices. CDC director Dr. Rochelle Valensky would then have to sign off on those guidelines before children can start receiving the shots.
The White House expects vaccinations to begin as soon as Tuesday. According to Dr Ashish Jha, who oversees the Biden administration, appointments may be limited initially, but every parent who wants to get their child vaccinated should be able to do so within weeks. covid answer.
The federal government has provided 10 million Pfizer and Moderna supplements to state and local officials.
Dr. Arnold Monto, acting chairman of the FDA committee, said the agency takes longer to authorize shots for infants through preschoolers than for other ages because they are a vulnerable group that needs special care to ensure Required that the shots were safe and effective. ,
Although COVID is generally less severe in children than in adults, the incidence of hospitalizations of children under 5 years of age increased during the winter omicron wave, which affects the highest levels of the epidemic. According to the CDC, since January 2020, Covid has killed more than 200 children aged between six months and five years.
Pfizer and Moderna’s vaccines for infants through preschoolers vary in the number of shots they use, level of dosage, and eligibility age to receive them. The Pfizer vaccine also appeared to be more effective than Moderna’s shots with children under age 5, although the data are preliminary.
The Pfizer vaccine is given in three doses to children aged 6 months to 4 years. The shots are dosed at 3 micrograms, which is one-tenth of the level adults get. The three shots were about 75% effective at preventing infection with Omicron in children 6 months to 2 years old and 82% effective in children 2 to 4 years old.
However, it is important that parents who opt for Pfizer ensure that their children get a third shot for protection against the virus. The two doses were about 14% effective in preventing infection for children under 2 years of age, and 33% effective for children 2 to 4 years of age.
Moderna vaccine is given in two doses to children aged 6 months to 5 years. The shots are dosed at 25 micrograms, which is a quarter of the level adults get.
Moderna’s vaccine was about 51% effective in preventing infection with Omicron for children 6 months to 2 years of age, and about 37% effective for children 2 to 5 years of age. However, the company expected the vaccine to provide stronger protection against serious disease because children who received two doses had higher antibody levels than adults.
According to the FDA, the most common side effects from vaccines were injection site pain, irritability and crying, loss of appetite, and trouble sleeping. Very few children who received either shot developed fevers over 102 degrees Fahrenheit, and there were no cases of myocarditis, a type of heart inflammation, in Pfizer or Moderna’s trials.