Pfizer-BioNTech has entered late-stage clinical trials of their
Just a few weeks after the shot was approved for teens ages 12 to 15 in the U.S., the companies are now testing safety and efficacy on younger children.
Around 4,500 participants will be enrolled at nearly 100 clinical trial sites in 26 states, Finland, Poland and
Trials for kids as young as six months to four years old are still in early stages and will expand once the researchers can determine safety.
It comes as Moderna Inc’s CEO says he believes his company’s COVID-19 jab should be available for U.S. children as young as age five by fall of this year.
Parents and doctors have been debating about whether or not to inoculate children because they make up just 0.1 percent of all COVID deaths.
Pfizer-BioNTech announced on Tuesday they have begun late-stage clinical trials of their coronavirus vaccine in children ages five to 11. Pictured (from left to right): Russell Bright, 7; Tucker Bright, 5; and dad Adam Bright pose at Ochsner Medical Center in Louisiana as Pfizer’s late-stage trials in children begin, June 7
Lower doses will be used for kids, 10 micrograms, compared to the 30 micrograms that those ages 12 and above receive. Pictured: Pfizer announces the late-stage clinical trials in children
About half of the ages five-to-11 group will receive two doses 21 days apart and the other half will be given placebo shots.
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 being tested at Ochsner Medical Center, just outside New Orleans in Louisiana.
The Brights had their temperatures and blood pressure checked, their noses swabbed and blood drawn for tests, and then were given a shot of either the vaccine or a placebo.
‘I want to do my part and have my kids do their part,’ their father, Adam Bright, told the
‘Both me and my wife are already vaccinated, and so the sooner I can get them vaccinated and to feel comfortable being outside, not having to wear a mask, I thought the easiest way to get it is to go through the trial.’
Russell, who was wearing a Spiderman mask, said he longs for a summer vacation that can include the water park or a longer trip – and then school without masks and social distancing.
‘I’m looking forward to seeing my friends more and not wearing masks,’ he said.
‘You can’t see if I’m making a frown or a smile. I don’t like to wear them.’
Provided the vaccine is proven to be safe and effective, the trial will be unblinded at the six-month follow-up, meaning those who received the placebo will be offered the vaccine.
Pfizer says researchers hope to have 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 for kids as young as five years old by early fall. Pictured Stéphane Bancel on CNBC in April 2021
Parents and doctors have been debating about whether or not to inoculate children because they make up just 0.1% of all COVID deaths. Pictured: Eloise LaCour, three, gets either a vaccine or placebo as part of Phase 1 clinical trials of use of the Pfizer-BioNTech vaccine
Meanwhile, Moderna’s CEO says he believes his company’s COVID-19 vaccine will likely be available to children as young as age five by early fall.
‘I think it’s going to be early fall, just because we have to go down in age very slowly and carefully,’ Stéphane Bancel said on Monday during an event hosted on the social media platform Clubhouse.
‘We anticipate data available in the September/October time frame.’
Bancel said that clinical trials in small children take longer because researchers have to determine the appropriate dosages.
Children are often the last group to be tested during clinical trials because they are not merely little adults.
Their bodies and immune systems behave differently, meaning they might have different treatment needs.
What’s more, children may need different doses or needle sizes depending on their height, weight and age – which is why most children are only vaccinated after safety has been well-documented in the adult population.
In fact, Pfizer announced that it selected lower doses for COVID-19 vaccine trials in children than are given to teenagers and adults.
Those aged 12 and older receive two 30 microgram (μg) doses of the vaccine,
However, children between ages five and 11 will be given 10 μg doses and kids from six months to four years old will receive three μg doses.
Moderna’s vaccine has only been approved for adults, but revealed last month that clinical trials showed safety and efficacy among 12-to-17-year-olds.
Although the clinical trial did not examine efficacy, no children who were given the immunization fell ill with the virus within 14 of their second dose while four children given the placebo later tested positive, which Moderna says is ‘consistent with a vaccine efficacy of 100 percent.’
However, despite the promising results, many parents are not enthusiastic about vaccinating their children.
In a recent
Only about three in 10 parents – 29 percent – of children under 18 said they would get their child vaccinated ‘right away.’
The poll also found 15 percent only plan to vaccinate their children if the school requires it and 19 percent said their child will definitely not be getting vaccinated.
What’s more, although children can contract COVID-19 and pass the disease on to others, they tend to not get very will
More than 3.97 million children have tested positive for the virus as of Tuesday, according to the American Academy of Pediatrics.