COVID-19 vaccines for children under 12: When are they coming?

Children under 12 years old are not eligible for the vaccines eight months after adults began to receive COVID-19 vaccinations.
Many parents worry that their children will get sick or get sick from it.

COVID-19 can be passed on from one child to another. Children are much less likely to get seriously ill than adults. According to the American Academy of Pediatrics, approximately 4.5 million children in America have been infected by COVID-19 since 2001.

This number has increased in recent years, but children make up a greater proportion of the seriously ill. The highly contagious delta variant is responsible for the majority of infections in the United States. According to the American Academy of Pediatrics, approximately 180,000 children were infected within the last week.

We answer many common questions regarding young children and COVID-19 vaccinations.

Which age groups can receive COVID-19 vaccinations at the moment?

The Pfizer BioNTech vaccine, now known as Comirnaty, is available to adults and children over 12 years old.

Because of the incomplete studies on children, only adults can receive the Moderna or Johnson & Johnson vaccines.

Indira Cisneron holds German Vazquez, her son, while she waits to receive her first COVID-19 vaccination shot. Her other son Gabriel Vasquez (left), is waiting in southwest Detroit.

Why isn't COVID-19 available for children under 12 years old?

Traditionally, drug studies begin with adults, and then they move on to adolescents, then onto children, and finally, younger children. Because drugs have been proven safe and effective in all three groups, it is important that the drug be studied in adulthood.

Large clinical trials with COVID-19 vaccines in adults and in the case Pfizer BioNTech in older teens took place in second half last year. Studies in younger teens began earlier in this year.

Continue reading: Although the FDA has approved Pfizer's vaccine for adults, it is still not recommended to be vaccinated with children under 12.

Colleges are now requiring the COVID-19 vaccination. Some colleges are beginning to expel unvaccinated students.

What is the status of clinical trials for younger children?

Continue the story

The vaccines of all three companies are being studied in children by the following: first, adolescents, then 5-to-11-year-olds, then 2-to-5-year-olds and then infants 6 months old and up. The protection that mothers who were vaccinated may be available to younger babies is believed to extend to their children. The Centers for Disease Control and Prevention suggested last week that pregnant women get vaccinated in order to protect themselves against serious COVID-19 infections. Their unborn child would also be protected.

The vaccines had been proven safe and effective in thousands of adults so the children's studies were allowed to be conducted at a smaller scale, ranging from 3,000 to 4,000 instead of 30,000 to 40,000.

COVID-19 is less common in children than it is in older adults. The risks of becoming seriously ill with COVID-19 generally decline with age. Regulators want to ensure that vaccines are safe enough for all ages.

The benefits of the Pfizer BioNTech vaccine for adolescents aged 12-15 years were deemed superior by advisory panels from the CDC and Food and Drug Administration.

Pfizer-BioNTech stated that its study of children aged 5-11 years should be completed in the fall and younger children in the spring.

Moderna's trials began several months after Pfizer BioNTech. It is therefore likely that it will complete its trials later than expected, although it has not yet released a specific timetable.

The company demonstrated that its vaccine is safe and highly effective in adolescents with the May test. The study revealed that none of the 3,700 volunteers aged 12-17 years old were fully vaccinated against the virus.

J&J has not yet begun its studies in minors. However, it is currently in active discussions and negotiations with FDA to start four trials with at least 4,500 children. The first trial in adolescents aged 12-17 years is scheduled to start this fall. Other trials will follow.

What date will the COVID-19 vaccine become available to children under 12 years old?

According to Dr. Peter Marks who is the head of the FDA division responsible for reviewing vaccines, the FDA requires more long-term data from children than adults.

Although the FDA has not yet given an estimate of how long it will take to review the research request, previous emergency use authorization requests took as long as eight weeks. This suggests that vaccines may not be available for grade schoolers until late this year or early next.

The goal is for 2- to 5-year-olds to be able get shots by the spring or winter 2022.

Dr. Peter Marks, Director, Center for Biologics Evaluation and Research at the Food and Drug Administration, speaks during a hearing on the Covid-19 response on Capitol Hill on March 18, 2021 in Washington, D.C. Dr. Anthony Fauci was present before a joint hearing of house committees to establish a timeline for the vaccination of children against COVID-19.

What is the recommended vaccine dose for adults and children?

Dosage for children younger than 12 years old is the same as for adults. This is one of the issues being investigated in the trials.

Pfizer-BioNTech reported that 112 children were given doses of 10, 20 or 30 micrograms during early trials. The youngest children could also be given 3 micrograms.

They are currently testing 10 micrograms for 5- to 11-year olds, and 3 micrograms for children younger than 5. Adults and adolescents receive 30 micrograms.

Is the COVID-19 vaccination safe for children?

The vaccines are as safe in adolescents as they are for adults. Teens may experience side effects such as fatigue, pain, and fevers.

After vaccination, the risk of myocarditis (heart inflammation) appears to be higher among younger people, especially males.

Keep your guard up: CDC studies reveal waning COVID vaccine efficacy, as the delta variant sweeps US

Parents should consider vaccinating their children as soon as possible.

Legally, the Pfizer BioNTech vaccine can now be prescribed to anyone by doctors, even young children, because it has been approved by the FDA.

However, the FDA and top pediatricians have warned that giving shots designed for adults to children younger than 12 is a bad idea.

According to the American Academy of Pediatrics (AAP), the dose may be higher than needed, leading to unwanted side effects. The FDA has been asked to speed up the authorization of shots for children younger than six years old.

Contact Karen Weintraub at kweintraub@usatoday.com.

USA TODAY's coverage of patient safety and health is possible in part thanks to a grant from Masimo Foundation for Ethics, Innovation and Competition in Healthcare. Editorial input is not provided by the Masimo Foundation.

This article was originally published on USA TODAY: Is COVID vaccine safe to use with children? How can children get it? What should you know