Health
The FDA Panel recommends COVID vaccine for 6-month-old children
The youngest children in the United States will soon have access to two COVID-19 vaccines.
Wednesday’s panel of experts unanimously found that Moderna’s vaccine is safe for children aged 6 months to 6 years. Provided protection against COVID-19. In a vote one hour later, the Commission voted to support the Pfizer-BioNTech vaccine for children aged 6 months to 5 years.
If the decision is endorsed by the Food and Drug Administration Commissioner, and the Centers for Disease Control and Prevention, the vaccine will be available to infants as soon as Tuesday.
Although young children are largely immune to the exacerbations of COVID-19, they can still be seriously ill and more than 200 people have died of infections. According to the data presented by the Food and Drug Administration..
According to the FDA, half of the infants hospitalized with COVID-19 had no pre-existing symptoms before becoming ill.
Because the risk of COVID-19 infection in infants is relatively low, the risk of side effects from the vaccine must also be low to justify the use of the vaccine.
Members of the committee said they would like to give their parents the option to vaccinate their youngest child.
Dr. James Hildress, Chief Executive Officer of Mehary, said: Nashville Medical College. “For parents who choose to do so, especially for parents of children who have a fundamental condition, this is the choice they should have and they are pleased to have it.”
Dr. Jayport Neu, an allergist at Children’s Mercy Hospital in Kansas City, Missouri, said the Commission’s decision hopes to help parents who have lived for fear of their children being infected with COVID-19. Stated. “This will certainly alleviate many of their concerns,” said Portnoy, the Commission’s patient representative. “I think it was the right vote.”
Vaccines have long been available to Americans of all ages, except for infants under 6 months of age who can be protected by vaccination during pregnancy.
Almost exactly 18 months ago, the same committee voted to approve the vaccine for adults, first from Pfizer and then from Moderna.
“Basically, all Americans are now able to choose vaccination,” said Dr. Arnold Monto, an infectious disease epidemiologist at the University of Michigan at Ann Arbor and chair of each conference.
The Commission voted 21-0 that Moderna’s vaccine meets the FDA’s standards for safety and efficacy in youngest children and its benefits outweigh the risks. They y Voted the same way to support the Pfizer-BioNTech vaccine.
Adding a layer of confusion to parents, Moderna studied vaccines with two doses, but Pfizer-BioNTech needs three vaccines to provide adequate protection during the Omicron wave. I found that.
Although the current review includes only two doses, Moderna recipients may need a third shot to receive protection against the variants currently in circulation.
The two vaccines were studied separately and cannot be compared directly.
Committee members said they were worried that the Pfizer-BioNTech vaccine would not provide much protection until after the third dose. Moderna shots may provide more protection faster.
Moderna shots are given every 4 weeks. This means that your child may have some protection from infection and serious illness by midsummer. On the other hand, with the Pfizer-BioNTech vaccine, children must be vaccinated twice every 3 weeks and wait until the third vaccination (about 3 months) after 8 weeks.
Dr. Paul Offit, a vaccine expert at the Philadelphia Children’s Hospital, said he believes Pfizer BioNTech may have chosen a dose that is too low for these infants. He said parents were worried that the two doses would protect their children and that they would be less likely to take precautions to prevent COVID-19.
The FDA Commissioner must approve either vaccine before it becomes available. This is expected to be done almost immediately by him.
This time a second expert advisory board for the CDC will consider the same vaccine on Saturday. If the CDC director approves the shot, it is set to roll out on Tuesday.
The Biden administration has already allowed up to 10 million vaccine pre-orders for young children, with half of Moderna and half of Pfizer-BioNTech starting Tuesday at pediatrician offices, pharmacies, clinics and some libraries. It will be available. Museums and other venues for children.
The government pre-purchases vaccines, so parents do not have to pay for them.
Also from Tuesday, parents are expected to have access to Moderna’s vaccine for older children. So far, only Pfizer-BioNTech has been available to children, but this week the FDA Advisory Board said the benefits of Moderna’s vaccine outweigh the risks. The FDA Commissioner is expected to approve the Vaccine and CDC Advisory Board to review it on Friday.
Vaccines available for children are the same as for adults, but at lower doses.
For the Pfizer-BioNTech vaccine, adults receive 30 micrograms twice at 3-week intervals. Boosters will continue after at least 5 months.. Adolescents receive the same dose, but children aged 5 to 11 receive three 10 microgram doses on the same schedule, and children aged 6 months to 5 years receive three 3 microgram doses.
For the Moderna vaccine, adults are given a dose of 100 micrograms twice a month, with 50 micrograms of booster immunization at least 6 months later. Once the shot and booster are approved, the adolescent will have the same dose and schedule.
Children aged 6 to 11 will eventually receive two initial doses of 50 micrograms and a boost of 25 micrograms, while younger children will receive two doses of 25 micrograms followed by 10 micrograms. Receive boost immunity.
Committee members spent much of Wednesday’s Q & A period trying to understand whether one COVID-19 vaccine was more effective for younger children than the other, but eventually lacked data. I was dissatisfied with it.
Both vaccines appear to be safe, and short-term side effects such as fever and malaise are fairly common, but there is no evidence of more serious side effects that are rarely seen in adults: severe allergic reactions and myocarditis. , Myocardial swelling.
Like adults, infants generally had many side effects after the second dose, unless they had previously been infected with COVID-19 when they felt more of an effect on the first dose. Otherwise, there was no difference in safety between children infected with COVID-19 prior to vaccination, and it appeared that protection against the virus was enhanced based on the level of protective antibody. ..
The study of small children was relatively small, so 5,000 People who have been vaccinated at least once in the Moderna trial and 3,000 in the Pfizer-BioNTech trial may experience these rare side effects as more children are vaccinated.
As with adults and older children, it is unclear how long the COVID-19 vaccine will be protected or whether more booster immunity is needed.
The two companies will continue to study the effects of the vaccine on infants, including healthy children with weakened immunity.
Dr. Archana Chatterjee, a committee member who is an expert in pediatric infectious diseases and dean of the Chicago Medical College, is convinced that both vaccines are safe and effective based on the data presented by the company and analyzed by the FDA. I said there is.
“As a pediatrician, today is a deficit day for me,” Chatterjee said. “It is very important to be able to vote for approval of two vaccines that protect children up to 6 months of age from this deadly virus.”
Contribution: Elizabeth Wise
Please contact Karen Weintraub ([email protected]).
Health and patient safety coverage at USA TODAY is partially made possible by grants from the Masimo Foundation for ethics, innovation and competition in health care. The Masimo Foundation does not provide editorial input.
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