FDA Cleared Pfizer-BioNTech COVID-19 Vaccine in Adolescents 12-15 Years in the United States

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source: cnbc.com

Janet Woodcock, the commissioner of the North American country's health agency, said population expansion was an important step in the fight against the epidemic.

As Infobae announced, the United States Food and Drug Administration (FDA) approved this Monday using the COVID-19 vaccine developed by Pfizer and BioNTech in adolescents between 12 and 15 years old.

The expansion of the eligible population" is a significant step in the fight against the pandemic," said the commissioner of the North American country's health agency, Janet Woodcock.

Today's measures allow the younger population to be protected against Code 19, which is not close to returning to normalcy and eradicating the epidemic. Parents and guardians can be assured that the agency has carried out a rigorous and comprehensive review of all available information, as we have done with all our emergency approvals for the COVID-19 vaccine," he added.

The long-awaited news: anxious parents have been counting down the weeks since Pfizer announced the results of their teen trial, indicating that the vaccine in this age group is at least as much. It is as effective as it is in adults. Vaccinating children against polio is also key to increasing the level of herd immunity in the population and reducing hospital admissions and deaths.

In the report, the World Health Organization highlights that from March 1, 2020, to April 30, 2021, the Centers for Disease Control and Prevention (CDC) will provide approximately 1.5 million vaccines to people aged 11 to 17 19 cases have been reported. Only in the United States. Children and adolescents usually have a milder course of COVID-19 than adults. The Pfizer-BioNTech COVID-19 vaccine will be administered in this age group as a series of two doses, three weeks apart, the same dose and dosing regimen for those over 16 years of age.

The FDA is committed to ensuring that the Pfizer Biotech CoVID-19 vaccine meets EUA modification standards. This vaccine's known and potential benefits to people 12 years of age or older far outweigh the known and potential risks that support its use in this population.

Getting a licensed vaccine for the younger population will continue to reduce the public health burden caused by the COVID-19 epidemic, said PD Marks, director of the FDA's Center for Biological Diagnosis and Research. This is an important step. As science guides our diagnostic and decision-making processes, the FDA can reassure the public and the medical community that the available data support the emergency use of this vaccine in our population of 12 years and older. The rigs meet our strict standards.

The FDA has updated fact sheets for healthcare providers that provide information on vaccines (vaccine providers) and recipients and carers to reflect the use of vaccines in adolescents. Provides, including the benefits and risks of the vaccine. Pfizer Biotech Co.

Biotech and Pfizer Laboratories announced in late March that their Coronavirus vaccine had shown 100 percent efficacy in young people between the ages of 12 and 15. They can start vaccinating them before the start of the next school year, which begins in late August in the United States.

Clinical trials conducted in the United States on 2,260 Phase III adolescents showed "100 of performance and strong antibody reactions," the companies said in a statement.

As detailed, the volunteers developed severe antibody reactions and experienced about 16 of the same side effects that occur in people between the ages of 16 and 25.

Because children with the virus can be a source of COVID-19 infection, experts agree that vaccines may need to be added to protect the herd. "Estimates of herd survival from COVID-19 vary widely. I've seen between 60 and 90 percent," said Nicole Connie, professor of microbiology at the Caribbean University of Medicine and Health Services. However, if it is close to the upper limit of this threshold, possibly due to the appearance of new forms, which can spread more easily, then the probability is less than 16 years to reach 90%. Older children will need to be vaccinated, "he said." In this equation, it is important to consider that not all adults can be vaccinated, even if the intensity of vaccination campaigns. Be it by choice or due to health complications.

So far, clinical trials have not included people under 16. Although existing assets already include children aged 12 and over, there are plans to estimate the youngest age if the trials are going well. John C. Bester, director of bioethics at the University of Las Vegas Nevada School, said the most ethical way to teach these is to start with older children and then gradually move on to younger ones. Medicine-. It is important to have extra safety precautions when researching with children to ensure that their interests are protected.

Although in some cases, like adults, the biology of children and, in particular, the immune system may differ significantly from that of adults. Nevertheless, the lowest rates of COVID-19 in children (they are half as old as adults) as well as specific reactions to the disease, such as multi-system inflammatory syndrome, persist. Therefore, we must work hard to test the vaccine in clinical studies to ensure we have the right dose and the right frequency of immunizations," said Buddy Creech Make it. Vaccine research program at Vanderbilt University in Tennessee.