A U.S. Food and Drug Administration (FDA) official says COVID-19 vaccines for children under 12 are expected to be approved in early or mid-winter.
First reported by NBC News, it could mean that young people are vaccinated during the Christmas holidays before going back to school for the spring semester.
The unnamed official said that after the shots are cleared for emergency use for children, the agency hopes to give the shots full approval soon.
Parents and doctors are divided on whether or not to vaccinate children because, while they can contract the disease, they also account for less than 0.1 percent of all COVID-19 deaths.
FDA official said approval of COVID-19 vaccines in children under 12 is expected in early or mid-winter. Pictured: Caleb Chung receives first dose of Pfizer coronavirus vaccine or placebo as trial participant for children December 12-15, 2020
Currently, COVID-19 vaccines are only approved in the US for emergency use in children 12 years and older.
However, both Pfizer-BioNTech and Moderna are conducting clinical trials in children as young as six months old.
For Pfizer’s clinical trial, the late stages have begun with testing the vaccine in children between the ages of five and 11.
Trials for children from six months to four years old are still in their early stages and will be expanded once the researchers can determine its safety.
According to a press release, approximately 4,500 participants will be enrolled at nearly 100 clinical trial sites in 26 states, Finland, Poland and Spain.
according to clinicaltrials.gov, Pfizer’s research will work in younger children the same way it does in older children and adults.
About half of the group aged five to 11 will receive two doses 21 days apart and the other half will receive placebo injections.
The team will test the safety, tolerability and immune response generated by the vaccine, likely by measuring antibody levels in the young subjects.
Parents and doctors are divided on whether or not to vaccinate children because they are less likely to get sick than adults and account for less than 0.1% of all COVID-19 deaths
Meanwhile, Moderna plans a similar study, enrolling 6,750 children ages six months through 11 with shots 28 days apart.
The FDA is asking for four to six months of safety follow-up data when the companies submit for approval in Fall 2021, compared to the two months needed for adult trial data.
The official told NBC News that more data could speed up the full approval process for the vaccines.
Children are often the last group tested in clinical trials because they are not just small adults.
Their bodies and immune systems behave differently, meaning they may have different treatment needs.
In addition, children may require different doses or needle sizes depending on their height, weight and age. Therefore, most children are not vaccinated until safety in the adult population is well documented.
In fact, Pfizer announced that it has chosen lower doses for COVID-19 vaccine trials in children than it does for teens and adults.
Those 12 years and older will receive two doses of 30 micrograms (μg) of the vaccine,
However, children between the ages of five and 11 receive doses of 10 g and children aged six months to four years receive three g doses.
In a recent opinion poll, conducted by the Kaiser Family Foundation, parents were asked whether they would have their child vaccinated once a COVID-19 vaccine is approved and available for their child’s age group.
Only about three in ten parents – 29 percent – of children under 18 said they would have their child vaccinated ‘immediately’.
The poll also found that 15 percent only plan to vaccinate their children if the school requires it and 19 percent said their child will definitely not be vaccinated.
What’s more, although children can contract COVID-19 and pass the disease on to others, they tend not to have much willpower
More than four million children have tested positive for the virus since Thursday, according to the American Academy of Pediatrics.