Pfizer-BioNTech has begun late-stage clinical trials of their coronavirus vaccine in children between the ages of five and 11.
Just weeks after the injection was approved in the US for teens ages 12 to 15, the companies are now testing its safety and efficacy in younger children.
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.
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.
It comes as the CEO of Moderna Inc says he believes his company’s COVID-19 shot should be available to U.S. children as young as five by the fall of this year.
Parents and doctors have debated whether or not to vaccinate children, as they account for just 0.1 percent of all COVID deaths.
Pfizer-BioNTech announced Tuesday that they have begun late-stage clinical trials of their coronavirus vaccine in children ages five to 11. Pictured (left to right): Russell Bright, 7; Tucker Bright, 5; and father Adam Bright pose at Louisiana Ochsner Medical Center as Pfizer’s advanced pediatric studies begin June 7
Lower doses will be used for children, 10 micrograms, compared to the 30 micrograms given to children 12 years of age and older. Pictured: Pfizer Announces Late Stage Clinical Trials in Pediatrics
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.
Among the participants are siblings Russell Bright, age seven, and Tucker Bright, age five, who are undergoing testing at Ochsner Medical Center, just outside of New Orleans in Louisiana.
The Brights had their temperature and blood pressure checked, their noses and bloods drawn for testing, and then either an injection of the vaccine or a placebo.
“I want to do my part and let my kids do their part,” their father, Adam Bright, told the… Associated Press.
“Both me and my wife are already vaccinated, so the sooner I can get them vaccinated and feel comfortable being outside, without having to wear a mask, I thought the easiest way to get it is to go through the to test.’
Russell, who wore a Spiderman mask, said he longs for a summer vacation that could include the water park or an extended trip — then to school without masks and social distancing.
“I look forward to seeing my friends more and not wearing masks,” he said.
‘You can’t tell if I’m frowning or smiling. I don’t like to wear them.’
Provided the vaccine is found to be safe and effective, the study will be unblinded after six months, meaning those who received the placebo will receive the vaccine.
Pfizer says researchers hope to have the data from the trial in the second half of 2021.
On Monday, Moderna CEO Stéphane Bancel said he believes his company’s vaccine will be available to children as young as five by early fall. Pictured Stéphane Bancel on CNBC in April 2021
Parents and doctors have debated whether or not to vaccinate children, as they account for only 0.1% of all COVID deaths. Pictured: Caleb Chung receives first dose of Pfizer coronavirus vaccine or placebo as trial participant, December 2020
Meanwhile, Moderna’s CEO says he believes his company’s COVID-19 vaccine will likely be available to children as young as five in the early fall.
“I think it’s early autumn just because we have to age very slowly and carefully,” Stéphane Bancel said at an event on the social media platform Clubhouse on Monday.
‘We expect data to be available in the period September/October.’
Bancel said clinical trials in small children are taking longer because researchers need to determine the correct dosages.
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 studies 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.
Moderna’s vaccine is only approved for adults, but revealed last month that clinical trials have shown safety and efficacy in 12- to 17-year-olds.
Although efficacy was not examined in the clinical trial, no children who received the immunization became ill with the virus within 14 of their second dose, while four children who received the placebo later tested positive, which Moderna says is “consistent with a vaccine effectiveness of 100 percent’. .’
However, despite the promising results, many parents are not enthusiastic about vaccinating their children.
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 3.97 million children have tested positive for the virus as of Tuesday, according to the American Academy of Pediatrics.