WASHINGTON (AP) – Federal health officials said Sunday that doses of the Pfizer COVID -19 vaccine appear to be safe and effective for children under 5 years of age, a significant step toward the long -awaited decision. start vaccination. The youngest American children.
The Food and Drug Administration released Pfizer’s review ahead of Wednesday’s meeting, at which outside experts will vote on whether staff are ready for the nation’s 18 million children, infants and preschoolers. Children under 5 years of age are the only group not yet eligible for COVID-19 vaccination in the United States
Last week, the FDA released a similar review of Moderna footage on children under 6 years old.
If regulators lay off staff of one or both companies, vaccination could begin next week when drug manufacturers are ready to quickly dispense government -mandated doses. Parents have been lobbying federal officials for months to protect their babies as more and more adults are taking off their masks and rejecting other public health measures.
Although only 3% of COVID cases in the United States are in the 6 -month to 4 -year age group, hospitalization and mortality rates in this group are higher than in older children, according to in the FDA review, one of the reasons. why experts say, This is the protection of this group. It’s important.
The FDA said children who received the Pfizer vaccine during the trial developed high levels of anti-virus antibodies that would likely protect them from the corovirus. This is a major barrier to getting FDA approval. But further analysis revealed a big difference, with stronger results for Pfizer.
The Pfizer vaccine, given as a triple series, was found to be 80% effective in preventing COVID-19 symptoms, although this calculation was based only on 10 analyzed cases in study participants. The figure may change as Pfizer’s research continues.
The two-dose series of Moderna is only 40% to 50% effective in preventing milder infections, although the strikes of the two companies were tested during pandemics at different times when different another option is applied. Moderna started to test the amplifier for the small ones.
On Wednesday, the FDA asked an independent group of vaccine experts to review data from both companies before voting. The FDA is not required to follow the group’s recommendations, but the process is seen as an important step in public staff review.
The FDA is expected to make an official decision after a full -day meeting on Wednesday. Next step: The Centers for Disease Control and Prevention, which recommends the use of vaccines, will invite their panel of experts to discuss which children need to be vaccinated.
It is not clear how much will be needed initially for staff. According to a recent survey, one in five parents of a young child has only 1 of their children vaccinated. Vaccines have been available to older students in the U.S. since November, but less than a third of children ages 5 to 11 have received the two recommended doses, according to government data.
For children, each company offers different doses and number of doses, from 6 months to 4 years for Pfizer and up to 5 years for Moderna.
Pfizer and its partner BioNTech plan to offer two doses between three weeks, followed by a third at least two months later, one-tenth of each adult dose. Pfizer is currently the only company to have a vaccine for COVID-19 for older children in the United States.
Moderna seeks FDA clearance for two injections, a quarter of each adult dose, at approximately four-week intervals.
The FDA currently allows the Moderna vaccine to be used only in adults. But in some countries, full doses are allowed for those of average size and children between the ages of 6 and 11, a step the FDA is also considering.
More than 30,000 American children under the age of 5 have been hospitalized because of COVID-19, according to U.S. health officials, and nearly 500 corovirus deaths have been reported in this age group.
The government allowed pharmacies and states to start ordering full-size doses last week, with 5 million initially available, half made by Pfizer and half by Moderna.
The Associated Press Department of Health and Science receives support from the Science Education Department of the Howard Hughes Medical Institute. AP is solely responsible for all content.
Source: Huffpost
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