WASHINGTON, June 13 (BNA) – Child-sized doses of Pfizer’s COVID-19 vaccines appear safe and effective for children under five, federal health officials said Sunday, a major step toward a long-overdue decision to begin vaccinating the youngest American. children.
The Food and Drug Administration published its analysis of Pfizer’s dose before a meeting Wednesday where outside experts will vote on whether the shots are ready for the 18 million children, toddlers and preschoolers. Children under five are the only group not yet eligible for COVID-19 vaccination in the United States
Late last week, the U.S. Food and Drug Administration published a similar analysis of Moderna shots for children under six, the Associated Press reported.
If regulators remove the shots by one or both companies, vaccinations could begin as soon as next week as drug companies prepare to ship government-requested doses quickly. Parents have been lobbying federal officials for months to allow them to protect their young children as more adults abandon masks and forego other public health precautions.
While only about 3% of COVID cases in the United States fall in the 6 months to 4 year age group, hospitalization and death rates in this group are higher than those of older children, according to a U.S. Food and Drug Administration analysis — one reason why Experts say that protecting this group is important.
The US Food and Drug Administration said that children who received Pfizer shots during testing developed high levels of anti-viral antibodies that are expected to protect them from the coronavirus. This is the basic threshold required to win an FDA license. But additional testing revealed key differences, with stronger results for Pfizer.
The Pfizer vaccine, given as a series of three shots, has been shown to be 80% effective in preventing symptoms of COVID-19, although that calculation was based on only 10 diagnosed cases among study participants.
The number could change as the Pfizer study continues.
It is not clear how much demand this will initially be on the footage. A recent study suggests that only one in five parents of young children will get their children vaccinated right away. Vaccines have been available since November to older US schoolchildren, but less than a third of those ages 5 to 11 have gotten the two recommended doses, according to government figures.
Pfizer and partner BioNTech plan to offer two shots three weeks apart, followed by a third at least two months later — each one-tenth of the adult dose. Pfizer is currently the only company with a COVID-19 vaccine for older children in the United States.
More than 30,000 American children under the age of 5 have been hospitalized with COVID-19 and nearly 500 coresCoronavirus deaths have been reported in that age group, according to US health officials.
MI