The FDA hopes to approve a COVID-19 vaccine for young adolescents.
Currently, the Pfizer-BioNTech vaccine is only approved for people over 16 years of age.
They are also studying how the vaccine works for children under 6 months of age.
The Food and Drug Administration (FDA) hopes to authorize the Pfizer-BioNotech COVID-19 vaccine for children aged 12 to 15 years and adolescents early next week.
This is according to federal officials who spoke to The New York Times.
In early April, Pfizer-BioNTech requested an amendment to the existing Emergency Use Authority (EUA) to expand the use of this under-aged vaccine.
Right now, his vaccine is only approved for people over 16 years of age in the United States.
The FDA is currently reviewing data submitted by Pfizer and BioNotech.
The companies reported in late March that a phase 3 clinical trial involving 2,260 12- to 15-year-olds had the vaccine with 100 percent efficacy in this age group. It was also well tolerated.
Adolescents receiving the vaccine caused strong antibody responses, similar to those seen in earlier trials between 16 and 25 people.
“This is welcome news,” Dr. Said Christina Johns, PM Pediatrics Senior Medical Advisor. “It is important to keep in mind the group of children, especially 12- to 15-year-olds, not only in terms of being at risk for acquiring, but also spreading, COVID-19 infection.”
The initial EUA for the vaccine was the trusted source after a public meeting of the FDA’s Vacancy and Related Biological Products Advisory Committee (VRBPAC) in December 2020.
Because the new request includes amendments to the existing EUA, a further meeting of the agency’s vaccine advisory committee is not expected.
After the FDA amends the EUA, the Vaccine Advisory Committee of the Centers for Disease Control and Prevention will meet to decide whether the use of the vaccine will be recommended in 12- to 15-year-olds.
The meeting is likely to take place immediately after the FDA decision.
Pfizer’s pediatric study is currently enrolling children between the ages of 6 months to 11 years. A teenage trial of Modern is underway and is recruiting children aged 6 months to 11 years for a second study.
Comprehensive Benefits of Children’s Vaccination
Although children and adolescents are less likely to be hospitalized or die from COVID-19, their risk is not zero.
“This age group is still at risk of developing long-term symptoms [after coronovirus infection], such as fatigue, headaches, and heart problems, which can range from weeks to months according to one study. Reliable source, Dr. Christina Said Mazon, a pediatrician with Nuance Health.
“Children and adolescents may develop multivast inflammatory syndrome, even after having asymptomatic cases of COVID-19,” she said.
This inflammatory condition reliable source, also known as MIS-C, can affect a child’s heart, lungs, kidneys, brain, skin, eyes, and gastrointestinal organs.
In addition, the inability to go to school in person, walking with friends, playing group games or doing other activities has little effect on children’s physical and mental health.
A Medical Epidiologist at Cornell University, Drs. Isaac Wefuse said that the Pfizer-BioNotech vaccine for children between 12 and 15 years old should “persuade parents and communities to open all kinds of activities for this age group”. “And children will be more likely to have a normal school year in the fall, which is really important.”
Vaccination of children and adolescents due to COVID-19 is seen as increasing the immunity of the population against coronaviruses and reducing the number of hospitalizations and deaths.
Although more than 105,000 Americans have been fully vaccinated, about 44 percent of adults have not yet received a single dose.
The more people vaccinated, the greater protection for the community. Research suggests that people who are vaccinated are less likely to pass the virus on to others, although scientists continue to study it.
“Children can spread the virus to others,” Vesuse said. “And we know that there are a lot of adults who have not yet been vaccinated who are at risk.”
Weisquez says that in particular, vaccinating children who live in the majority of households can protect adults in that household, especially those who do not get vaccinated or whose immune system is weak.
Finally, vaccinating more Americans can help the country to come out on the other side.
“The more we vaccinate and protect the population against coronovirus, the more likely we are to get out of the epidemic more quickly,” said Pediatrician and Medical Director of Coastal Children’s Dr. Steven Ablovit said.
However, he says that one of the challenges of the Pfizer-BioNotech vaccine is its ultra-cold storage requirements, which limit the extent to which it is distributed.
Ablowitz said, “Community health centers and medical schools are not going to give up vaccines.”
Extreme cold storage is a major challenge for home centers. “” Parents would be more comfortable if their child was vaccinated at the pediatrician’s office, not at the pharmacy or stadium. “
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Vaccine S has low penetration in many countries
With much of the world’s struggle to vaccinate its high-risk population, expanding the reach of the Pfizer-BioNotech vaccine for children and adolescents in the United States – who have a lower risk of critical illness – has already raised some questions Huh.
Natalie Dean, PhD, assistant professor of biostatistics at the University of Florida, wrote on Twitter, “The imminent FDA authorization of the vaccine for 12–15-year-olds is big news, and teenagers should be able to use the vaccine.” “But in the short term, we have to grapple with the ethics of vaccinating teenagers ahead of high-risk adults in other countries.”
By mid-April, nearly half of the COVID-19 vaccine dose had gone to high-income countries, The Washington Post reported.
Johns says that it is important to vaccinate vulnerable populations not only in the United States, but also in other countries. However, she thinks that these efforts can happen with vaccination of children and adolescents in this country.
“We know that children are an important component to being close to herd immunity,” she said. “This is a situation where these things need to happen in parallel.”
The Kaiser Family Foundation recently outlined the actions the US government can take to ensure that COVID-19 vaccines have equal access across all countries.