Health The FDA authorizes the Covid-19 vaccine for infants

The FDA authorizes the Covid-19 vaccine for infants


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However, shots cannot be given until vaccine advisers at the US Center for Disease Control and Prevention vote on whether to recommend them – a vote is scheduled for Saturday – and CDC Director Dr. Rochelle Valensky has signed that recommendation. The White House has said that vaccinations for young children could begin next week.

The Moderna vaccine is now authorized for use in children aged 6 months to 17 years and Pfizer / BioNTech for children aged 6 months to 4 years. About 17 million children under the age of 5 are now eligible for the Covid-19 vaccine.

“Many parents, caregivers and physicians are waiting for the vaccine for infants and this action will help protect children up to 6 months. As we have seen in older adults, we expect that vaccines will provide protection for infants. Hospitalization and death, “said FDA Commissioner Dr. Robert M. Said Calif. News publication. “Those who believe in the care of children can be confident in the safety and effectiveness of these COVID-19 vaccines and can be assured that the agency was thorough in evaluating the data.”

Previously, the Pfizer / Biotech vaccine was authorized for people 5 and older and approved for people 16 and older, and the modern vaccine was only for adults.

The director of the FDA’s Center for Biologics Evaluation and Research, Dr. Peter Marks called the Covid-19 vaccine a “milestone” for young people.

“Lowering the age limit for these vaccines is a milestone as we work through this,” Marx said Wednesday at a meeting of the FDA’s Vaccines and Related Organic Products Advisory Committee.

At that meeting, the committee members voted unanimously in favor of increasing the authorization to include children up to 6 months.

“It is very important to vote for the authorization of two vaccines that protect children up to 6 months of age from this deadly disease,” said Dr. Archana Chatterjee, dean of the Chicago Medical School at Rosland Franklin University, said. .

She compared the day to December 2020, when the first Covid-19 vaccine was authorized for adults and older adolescents.

Committee member of the Precision Vaccine Program at Boston Children’s Hospital, Dr. Offer Levy said: “I’m really glad we reached this stage.

“I remember our first vote a year ago or on the first Pfizer authorization,” Levy said. “I was one of the 17 votes in favor. I remember that initial discussion – however, whether to include 16- and 17-year-olds. At that time, it was a controversial topic that was being discussed. We’re recommending authorization for six months, so we’ve come a long way. “

Will the youngest children be vaccinated?

While many public health experts are concerned that the Covid-19 vaccine is now authorized for young adults, parents of these children may not take their children for vaccination.

The Covid-19 vaccine is already slowly being used in children in the United States.

“It is very important to have vaccine options for the youngest children; however, we have seen relatively low use of covid vaccines in children between the ages of 5 and 12, and so my concern is that this proportion is lower among the youngest children. It may be less than desirable, “said Dr. John H. Snyder, director of the Center for Virology and Vaccine Research at the Beth Israel Decones Medical Center in Boston. Dan Baruch told CNN on Wednesday.

They felt as if the world had left them behind: raising children with epidemics

Baruch, who was not involved in the FDA’s decision, helped develop and study the Johnson & Johnson Covid-19 vaccine.

He said there is an “ideal” difference in how many adults are fully vaccinated compared to children and adolescents.

Children between the ages of 5 and 11 were the most recent group to be eligible for vaccination in November. But only 29% of these children have been fully vaccinated through their two-dose primary series in the United States. According to the CDCCompared to:
  • 60% adolescents 12 to 17
  • 64% of adults between the ages of 18 and 24
  • 67% adults 25 to 39
  • 75% adults 40 to 49
  • 82% adults 50 to 64
  • 94% adults 65 to 74
  • 88% of adults aged 75 and over

“We are planning and preparing a rollout of pediatric vaccines. Of course, there is a lot of work to be done to see the use of this vaccine. Some surveys and surveys have revealed that the number is declining. , “Said Laurie Tremmel Freeman, chief executive officer of the National Association of County and City Health Officers.

The Biden administration has developed a Covid-19 vaccination plan for children under 5 years of age
Accordingly a The Kaiser Family Foundation’s Vaccine Monitor SurveyPublished in May, only 18% of parents of children under 5 said they would vaccinate their child against covid-19 as soon as the vaccine became available.

“I think for some people the more the epidemic is in the rearview mirror – or the more they believe – the less they will be forced to do it and so we have a big campaign of public health education ahead of us.” Freeman said. “Also, local health departments will try to understand the landscape of their community, including how many providers, pediatricians and pharmacies have actually signed up to vaccinate.”

‘Benefits obviously outweigh risks’

According to FDA authorization, the Moderna vaccine can be given as a two-dose primary series, each dose in 25 micrograms, to infants and children aged 6 months to 5 years. For older children aged 6 to 11, the dose is administered at 50 micrograms.

Pfizer / Biotech vaccine caps are being filled for young children.

The Pfizer / BioNTech vaccine can now be given as a three-dose primary series, 3 micrograms in each dose, to infants and children aged 6 months to 4 years.

FDA advisers voted in favor of authorizing the Moderna Covid-19 vaccine for 6-17 year olds

The FDA’s vaccine consultants have determined that the benefits of both vaccines outweigh the risks and that they are “well tolerated” in children who have received the vaccine in clinical trials.

“The benefits seem to outweigh the risks, especially for young children who may be in kindergarten or group childcare,” said committee member Oveta Fuller, an associate professor of microbiology and immunology at the University of Michigan Medical School. Modern vaccines.

Committee member Dr. Art Rangold added that while the risk of Kovid-19 hospitalization and death is lower for young children than for adults, children are already vaccinated, which lowers their risk.

Opinion: Pediatricians weigh in as the U.S. grows inches closer to the covid vaccine for its youngest children

“If we have a vaccine that has more benefits than risks, then making it available to the public is a reasonable option. Hospital admissions for illnesses like these are close to zero, said Rangold, of the University of California, Berkeley.

Compared to influenza-related deaths and hospitalizations, the number of Kovid-19 hospitalizations and deaths in children is alarming and very high, Marx said.

“Still, during the Omicron wave, there was a relatively high rate of hospitalization during this period,” he said. “The hospitalization rate is really staggering, and if you compare it to a terrible influenza season, it’s even worse.”

The death toll for children aged 4 and under in the first two years of the pandemic is “far more alarming than we’ve ever seen with influenza,” Marx said.

“We are facing a problem where I think we have to be careful not to be numb to the infant mortality rate due to the large number of elderly deaths here. Every life is important,” he added. . “

He further added that the Covid-19 vaccine is an intervention similar to the influenza vaccine, which is widely used and accepted to prevent death in all ages.

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