As advanced Infopa, Food and Drug Administration of the United States (FDA), This Monday approved the use of the COVID-19 vaccine developed by Pfizer and BioNtech for adolescents between the ages of 12 and 15..
Expansion of eligible people “It is a significant step in the fight against infectionSaid the commissioner of the North American health agency, Janet Woodcock.
“Today’s measures allow young people to be protected against COVID-19, Which is not a return to normalcy and an end to the infection. Since we have done all of our emergency approvals for COVID-19 vaccines, parents and guardians can be sure that the company has conducted a rigorous and comprehensive review of all available information, ”he added.
The most anticipated news: Interested parents counted the weeks Pfizer announced the results of its adolescent experiment, Which shows that the vaccine is at least as effective for adults as it is for adults. Vaccination of children is also important to increase the level of immunity of flocks in the population And hospitalization and reducing the number of deaths.
In Release, The health agency exemplifies it Centers for Disease Control and Prevention (CDC) have been reported approximately from March 1, 2020 to April 30, 2021. 1.5 million COVID-19 cases in 11 to 17 year olds, In the United States only. Children and adolescents generally have a milder COVID-19 disease study compared to adults. The Pfizer-Bioentech Covit-19 vaccine is administered in two-dose series for this age group, at three-week intervals, as a single dose and dosing regimen for those over 16 years of age.
The FDA determined that Pfizer-Bioentech Covit-19 vaccine meets legal criteria for correcting EUA, so what The known and potential benefits of this vaccine in people 12 years of age and older outweigh the known and potential risks, which supports its use in this population.
“Having a licensed vaccine for young people is an important step in continuing to reduce the massive public health burden caused by the COVID-19 epidemic,” he said. Peter Marx, MD, Director of the FDA Center for Biological Assessment. And research. “By guiding our evaluation and decision-making process through science, we can assure the general and medical community that the information available to support the emergency use of this vaccine in adults 12 years of age and older meets our strict standards.”.
The FDA has updated the information for vaccine administering health providers (vaccine providers) and recipients and caregivers, and to reflect vaccine use in adolescents. Advantages and risks of Pfizer-Bioentech vaccine COVID-19.
Bioendech and Pfizer Labs announced at the end of March that their corona virus vaccine was 100% effective among young people between the ages of 12 and 15. They hoped to start vaccinating them before the start of the next school year, It starts in the US at the end of August.
Phase III clinical trials were conducted in 2,260 adolescents in the United States. “100 showed performance% Y A strong response in the form of antibodies “The companies said in a statement.
In detail, Volunteers developed strong antibody responses and experienced the same side effects seen in 16- to 25-year-olds.
Given Children infected with the virus may be a source of COVID-19 infection, Experts agree that the herd will need to be vaccinated to achieve immunity. “Estimates of herd immunity to COVID-19 vary widely. I have seen 60 to 90 percent,” he said. Nicole Wire, Professor of Microbiology at the University of Medicine and Health Services in the Caribbean. “However, if it is close to the upper limit of that threshold, it may be due to the appearance of new strains, which can spread very easily, and then children under the age of 16 may need to be vaccinated to reach 90 percent. ”, He clarified. In this equation, not all adults are vaccinated, even with the intensity of vaccination campaigns, due to selection or health issues.
Until very recently, clinical trials did not involve people under 16; Current assets, however, already include children 12 years of age and older, with plans to evaluate minors if these tests are done correctly. “The most ethical way to do these studies is to start with older children and then gradually move on to younger children,” he said. Johann c. Bester, Director of Bioethics, University of Nevada School of Las Vegas. Drug-. The interests of the children involved should always be considered. It is important to have extra protections when conducting research with children to ensure that children’s interests are protected.
Although it is similar to adults in some respects, The biology of children and, in particular, the immune system differs significantly from that of adults. However, low rates of COVID-19 in children (they are half as likely to get it as adults), as well as specific reactions to disease such as multicast inflammatory syndrome remain unchanged. “It is important to consider that children are not the only ones who are small. Therefore, we have to work hard to evaluate the vaccine in clinical trials so that we can ensure the right dosage and the right frequency of immunizations, ”he said. Bar Creech, Director of the Vaccine Research Program at Vanderbilt University in Tennessee.