FDA Approves Pfizer’s COVID-19 Vaccine For Children Ages 5-11 – A Pediatrician explains how the drug has been tested for safety and effectiveness
from Debbie-Ann Shirley, University of Virginia
Elementary school children in the United States will soon be given another layer of protection to keep them safe from COVID-19.
On October 29, 2021, the Food and Drug Administration approved the emergency use of the Pfizer-BioNTech COVID-19 vaccine for children ages 5-11 years old February 26, 2021, in which members voted 17-0 for approval of the Pfizer- Shot with one abstention.
The next necessary step in the process is for that Centers for Disease Control and Prevention Issue guidance on the use of the vaccine in this age group based on FDA approval. The CDC’s Advisory Committee on Vaccination Practices is due to meet on November 2, 2021, and the agency’s official recommendation is expected that day. The introduction of Pfizer shots for children ages 5-11 will likely begin days later.
Once the CDC has made its recommendation, 28 million eligible US children in this age group have the opportunity to obtain the Pfizer shot through health departments, medical institutions, doctor’s offices and pharmacies, as well as schools and communities.
The FDA approval comes after months of pediatric clinical study Study with around 4,500 children aged 5 to 11 years. Pfizer released new data on October 22, 2021 that its vaccine is almost available 91% effective in preventing COVID-19 in this age group, with similar tolerability and antibody reactions as in older age groups.
Moderna also has published preliminary results This shows that the low-dose vaccine is safe and has a strong immune response in children aged 6-11. It plans to submit data to the FDA for review soon.
As a Pediatrician specializes in infectious diseases, I worked closely on many aspects of the COVID-19 response at the University of Virginia. I have helped take care of children with severe COVID-19 and also watched the stress on children and their families from the pandemic. Vaccines that work Teach your immune system to make disease-fighting antibodies without telling you the actual disease, have emerged as the most important tool we currently have to prevent serious COVID-19.
Learn how the COVID-19 vaccine was tested for effectiveness and safety in children, and how access to those vaccines could change the effects of COVID-19 for American children.
The Risks of COVID-19 in School-Age Children
The FDA advisory committee was open about the risks and benefits of the vaccine and the importance of the decision for younger children. Ultimately, it came to the conclusion that parents should be given the opportunity to vaccinate their children against COVID-19. A committee member – Centers for Disease Control and Prevention’s vaccine expert Amanda Cohn – found that COVID-19 was the eighth leading cause of death in children aged 5-11 over the past year. She pointed out that children continue to be hospitalized and die or otherwise suffer adverse long-term effects of a largely vaccine-preventable disease.
As of 10/21/2021 more than 6 million American children have tested positive for COVID-19. Cases in children took during the delta variant Surgewhich coincided with the opening of face-to-face schools in large parts of the country. Children now make up a quarter of that new weekly cases.
While serious illnesses and hospital stays due to COVID-19 are far less common in children than in adults, an intensive care unit and the need for invasive ventilation occur in children. It was over 1.9 million COVID-19 cases in children aged 5 to 11 years with almost 100 dead.
COVID-19 hospitalization rates in children and adolescents increased in August and September 2021 over 8,300 Children aged 5 to 11 who have been hospitalized since the start of the pandemic. Many children hospitalized with COVID-19 have pre-existing conditions, however one third of them not.
In addition, more than 5,200 children who were diagnosed with the rare but serious condition called Multisystem Inflammatory Syndrome in Children or MIS-C in the weeks following COVID-19 infection. MIS-C can cause inflammation of the heart, brain, skin, intestines, and other organs that requires hospitalization and often intensive care. The syndrome occurs most often in children 6 to 11 years of age.
The pandemic has harmed children as well socially emotional and mental wellbeing and delayed their educational progress. Safe and effective vaccines are one of the most promising ways to protect children from COVID-19, prevent it from spreading, and disrupt their school and everyday life as little as possible.
Development of COVID-19 vaccines for children
Before being used by the general public, all vaccines go through rigorous testing phases, beginning with preclinical studies in the laboratory and on animals. They then have to go through three phases of human clinical trials that allow investigators and regulators to evaluate the safety of the vaccine at each phase before testing it on larger numbers of people.
Once a vaccine has been shown to be safe and effective in adults, Attempts pass to childrenwho may differ in their reactions and immune responses to vaccines. Gradually descending by age, Pfizer studied children 12 to 15 years old before the younger age groups. The FDA expanded its emergency approval of the Pfizer COVID-19 vaccine to this age group in May 2021. The vaccine has been shown in adolescents aged 12 to 18 years Reduce hospital stays by 93% from June to September 2021.
Safety will continue to be monitored even after vaccines have been approved or approved. This enables very rare side effects that were not observed in large late-stage studies to be identified and investigated. Post-approval safety surveillance with the COVID-19 vaccines in adults and older adolescents 16 years and older quickly revealed a rare increase in inflammation of the heart known as myocarditis after COVID-19 vaccines, particularly in young men. Most of the patients responded well supportive care and improved quickly. Myocarditis can also occur with COVID-19 or as a complication of Multisystem Inflammatory Syndrome.
The Pfizer study for people under the age of 12 started with three different dosages; Ultimately, the researchers determined the optimal dosage for children ages 5-11 one third the dose administered to adults and adolescents and administered three weeks apart as a two-shot schedule.
No serious side effects related to the vaccine and no cases of myocarditis were reported. the Pfizer data also showed that the vaccine appears to give similar levels of protective antibody responses in this age group as it does in older age groups. And the antibodies produced showed the ability to neutralize the Delta variant.
Next Steps
Ongoing studies will continue to closely monitor vaccinated children to ensure safety and to gain more insight into how long immunity lasts. The results of the Pfizer vaccine study for the younger two age cohorts, the 2 to 5 years and 6 months to 2 years, are expected later that year. Testing of the Moderna and Johnson & Johnson vaccines in clinical trials in children is also ongoing.
Given that the data from the pediatric clinical trials show that the overall benefits outweigh the risks in this age group, I look forward to being one step closer to offering the COVID-19 vaccine to new eligible children and their families if the CDC recommendations allow it.
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Debbie-Ann Shirley, Associate Professor of Pediatrics, University of Virginia
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Reference: www.healthywomen.org
