Moderna on Thursday called on U.S. regulators to approve the low-dose vaccine of its COVID-19 for children under 6 years old, a long-awaited step toward the potential opening of summer to millions of children.
Disappointed families are hoping for the opportunity to protect the country’s young children as people around them use masks and other public health measures, even as corovirus infectious mutants continue to spread.
Moderna provided data to the Food and Drug Administration, which hopes to show that two low-dose injections can protect infants, children and preschoolers, although not as effectively at omicron growth as before in a pandemic.
“There is a significant unmet medical need for these children,” Drs. Paul Burton, medical director of Moderna, at The Associated Press. Two childish shots “will keep them safe. I think, it is likely that over time they will require additional doses. But we do it ”.
Now only children over the age of 5 can be vaccinated using a competing vaccine at Pfizer in the United States, leaving 18 million young children vulnerable.
Whether it’s company vaccines or both, Dr. Peter Marks, head of vaccine at the FDA, said the agency will “act quickly without sacrificing our standards” to decide if the full -dose dose is safe and effective.
Although there have been questions about what has been required for so long, Marx told lawmakers this week that the FDA will not review a product until the manufacturer has completed its application. The FDA will publicly review the evidence with its scientific advisers before making a decision, and Marx said many meetings will be held to cover a variety of potential applications.
“It’s necessary to have proper testing so that parents can trust any vaccine that we deserve,” Marx told the Senate committee.
If the FDA issues vaccinations for toddlers, the Centers for Disease Control and Prevention must recommend who needs them: all children or those at highest risk of COVID-19.
Many parents are desperate for the vaccine to reach the scientific milestone first.
“We’re late because everyone else is moving on,” said Megan Dunfi-Daly, a marine biologist at Duke University whose 6-year-old daughter was vaccinated but was 3 years and 18 months old. Children are part of the Pfizer process.
The family continued to cover themselves with face masks and other precautions until it became clear whether the men had received the real vaccine or dummy vaccine. If it turns out they weren’t protected in the Pfizer studio and modern footage was deleted, Dunphy-Daly said she was looking for them for her children.
“I feel so relieved to hear that my children have been vaccinated and the risk of serious infections is very low,” she said.
Some parents have even asked the government to allow families to select staff before all the evidence is available.
“It’s almost impossible to avoid this Covid strain,” said Dana Walker, the mother of an 8-month-old baby, with tears in her eyes at the CDC meeting last week. “Cut the bureaucrat and let the parents protect their children.”
The FDA will face some tough questions.
In a study of children aged 6 months to 5 years, two injections of Moderna-a quarter of each regular dose-produced high levels of anti-virus antibodies, and the same number was shown to protect young people, he said. Barton. There were no serious side effects, and the vaccinations resulted in less fever than other standard vaccinations.
But the vaccine has been shown to be 40% to 50% effective in preventing COVID-19 symptoms at the time of diagnosis. Burton blamed the ability of the omicron variant to partially block vaccine immunity, noting that uninfected adults showed less effectiveness against milder omicron infections. Although none of the children had a serious illness during the study, he said high levels of antibodies are available to protect against more serious illness, and the company will evaluate the children’s booster dose.
Another problem: right now in the United States the Moderna vaccine is limited to adults. Other countries have extended the strike to children under 6 years of age. But a few months ago the FDA expressed concern about a rare side effect, inflammation of the heart, in young men, and did not stop the first pediatric applications of Moderna.
Burton said the FDA may consider its vaccine for children of all ages, but it may also open up especially to younger children who have no other choice. He said safety data from the millions of older children who have received Moderna vaccinations abroad should help reassure parents.
Although COVID-19 is generally not as dangerous in adolescents as in adults, some become severe or die. Approximately 475 children under the age of 5 have died from COVID-19 since the pandemic began, according to the CDC, and child hospitalization has risen for omicron.
However, it is not known how many parents want to vaccinate younger children. Less than one -third of children between the ages of 5 and 11 received two immunizations and 58% of children between the ages of 12 and 17.
The Associated Press Department of Health and Science receives support from Howard Hughes Medical Institute’s Department of Science Education. AP is solely responsible for all content.
Source: Huffpost
