Next Steps to COVID-19 Vaccine Trial: 6 Months Young Child

The COVID-19 vaccine will be tested in Colorado for 6-month-old babies by the end of October as clinical trials of the life-saving COVID-19 vaccine are ongoing.

Dr. Myron Levin Leading a children’s clinical trial of the Colorado COVID-19 vaccine modern When Novavax vaccination. The latest vaccinations will continue within the next few weeks. University of Colorado Anschutz Medical Campus In the aurora.

Clinical trials for infants Pfizer-BioNTech Seeking permission from US Food and Drug Administration (FDA) Allow children aged 5 to 11 years to receive the COVID-19 vaccine.

FDA and Centers for Disease Control and Prevention (CDC) It is hoped that the safety and efficacy of vaccines for children of that age group will be examined later this month and early November. If federal authorities give OK, about 28 million children between the ages of 6 and 11 may be immediately eligible for the COVID-19 vaccine.

The dose for children is less than the dose of vaccine that adults receive.

Levin hopes that the COVID-19 vaccine for all children in the United States will be approved by the end of this year or the beginning of 2022.

“It’s great. We continue to see the rapid success of vaccines of all ages. At the same time, these vaccines are safe, effective and important for maintaining the health of our children. It also helps to end the pandemic, “says Levin. Professor of pediatrics and medicine, and infectious disease specialists so University of Colorado School of Medicine.

“Ultimately, all age groups after 6 months will be vaccinated,” Levin said.

In general, children are less ill than adults with COVID-19. However, many people are still infected with the coronavirus, not going to school or infecting the adults around them. in the meantime, Approximately 30,000 children were hospitalized with COVID-19 in August As the highly contagious delta variant spreads. In addition to illness and hospitalization So far, 587 children have died of COVID-19. By comparison, according to the CDC, 188 children died of the flu during the 2019-2020 flu season.

Levin also said doctors are still not fully aware of how vulnerable children are to the long-term effects of COVID-19. Many adults suffer from what is known as the long COVID-19 and experience problems ranging from lung and breathing difficulties to brain fog months after their first illness. ..

According to Levin, it is much better to prevent as many COVID-19 infections as possible in both children and adults through vaccination and prevention.

Vaccination of the younger segment of the population is essential to reduce the disease and death of COVID-19.

Levin has already overseen a Colorado clinical trial of the Moderna and Novavax vaccines in older children aged 6-11 years. So far, he and his team have not seen any serious adverse effects among study participants.

“We didn’t see any unusual or unexpected reactions to the vaccine, and that’s true nationwide,” Levin said.

Currently, the team is preparing to test the vaccine on dozens of children aged 2-5 and 6 months to 2 years. Studies in both age groups, infants up to 2 years and children 2-5 years, will be held simultaneously in late October and November. Levin already has many volunteers for vaccine research in children aged 2-5 years. Parents who want to enroll their baby or toddler in a clinical trial can leave a message at 720.777.4496 or contact the research team by email. [email protected]..

As with all COVID-19 clinical trials, researchers are eager to include participants from diverse ethnic and racial backgrounds. Research participants receive some reward. In pediatric trials, some children are afraid of needles, so researchers minimize the number of times a child needs to draw blood.

Levin said early studies on babies and children show great expectations.

“They (vaccine makers) have already done preliminary research in both of these age groups to show that the vaccine is safe and immunogenic and to get the right doses for children. We need it before our children get the vaccine, “he said.

In a clinical trial testing the COVID-19 vaccine in adults, half of the participants were vaccinated and the other half were vaccinated with placebo.In Pediatric clinical trial, Participating children are much more likely to be vaccinated.

In Moderna’s clinical trial, three in four infants or children enrolled in the study will be vaccinated compared to placebo. In a Novavax study, two in three children were vaccinated against placebo.

Levin, who has tested multiple vaccines throughout his career, is convinced that the Moderna and Novavax COVID-19 vaccines are as safe as adults.

“Before new vaccines are given to children, great care is taken. They have been studied in younger populations one after another,” Levin said. “Everyone who oversees people’s clinical trials, including the government and the board of directors of Anschutz Medical Campus, must be confident that testing is in the best interests of people and that this study is worth doing. “

Rare complications of mRNA vaccines such as Moderna and Pfizer have appeared in some adolescent boys. However, government regulators and CDC experts have determined that the risk of suffering from severe cases of COVID-19 is 100 times greater than the risk of suffering from the serious side effects of these vaccines. CDC experts continue to recommend vaccines to everyone over the age of 12.

“It’s much better to get vaccinated compared to this complication,” Levin said. “COVID-19 can be a serious illness for children, and people around them don’t want to get sick.

“Everyone can get infected with COVID-19 and we want everyone to be protected,” he said.

Pfizer is currently licensed for children and adults over the age of 12, The Moderna vaccine is licensed for people over the age of 18. Novavax has been studied in the United States, but its use here has not yet been approved. It may become more popular in the coming years as it uses traditional vaccine technology rather than mRNA to fight the virus that causes COVID-19.

Levin and other vaccine experts say it helps to have multiple types and brands of COVID-19 vaccines.

“It’s always good to have multiple vaccines that have different mechanisms and can have different effects on viral variants,” Levin said.