Pfizer Begins Testing Its Covid Vaccine In Children Aged 5-11 As Moderna Ceo Says His Company’s Shot For Kids Will Be Available By The Early Fall

 

  • Pfizer-BioNTech announced Tuesday that it has begun late-stage clinical trials of its coronavirus vaccine in children ages five to 11.
  • Lower doses will be used for children, 10 micrograms, compared to 30 micrograms for those over 12 years of age.
  • The company says it expects to get data in the second half of 2021 and is still in the early stages of trials in children between six months and four years old.
  • On Monday, Moderna CEO Stéphane Bancel said he believes his company’s vaccine will be available to children as young as five in early fall.
  • Parents and doctors have been debating whether or not to vaccinate children because they account for only 0.1% of all COVID deaths.

Pfizer-BioNTech has entered end-stage clinical trials of coronavirus vaccines in children aged five to 11.

Just weeks after the vaccine was approved for teenagers aged 12-15 in the US, companies are now testing safety and effectiveness on younger children.

According to a press release, around 4,500 participants will be enrolled in around 100 clinical research centers in 26 states, Finland, Poland and Spain.

Trials for children aged six months to four years are still in the early stages and will expand once researchers determine safety.

The CEO of Moderna Inc says his company believes the COVID-19 vaccine should be available to five-year-old US children by the fall of this year.

Parents and doctors are debating whether or not to vaccinate children, as they account for only 0.1 percent of all COVID deaths.

According to Clinicaltrials.gov, the study that Pfizer did in younger children will work similarly to what it did in older children and adults.

About half of the five- to 11-year-olds will receive two doses 21 days apart, and the other half will receive placebo vaccines.

The team will likely test the vaccine-induced safety, tolerability and immune response by measuring antibody levels in young subjects.

Participants include brothers Russell Bright, seven, and Tucker Bright, five, who were tested at Ochsner Medical Center just outside of New Orleans, Louisiana.

The Brights had their temperature and blood pressure checked, their noses cleared and blood drawn for tests, and then either the vaccine or a placebo.

“I want to do my part and have my children do theirs,” their father, Adam Bright, told the Associated Press.

‘Both me and my wife are already vaccinated and so I thought the sooner I could get them vaccinated and feel comfortable outside without having to wear a mask, the easiest way to get it was to pass it without trying.’

Wearing a Spider-Man mask, Russell said he longs for a summer vacation that could include a water park or a longer trip, followed by a mask-free and social-distancing school.

“I look forward to seeing more of my friends and not wearing masks,” he said.

You can’t see if I’m frowning or smiling. I don’t like to wear them.

If the vaccine proves to be safe and effective, the trial will be unblinded at the six-month follow-up, meaning those receiving a placebo will be offered the vaccine.

Pfizer said researchers hope to get data from the trial in the second half of 2021.

Meanwhile, Moderna’s CEO said his company believes the COVID-19 vaccine will likely be available to five-year-olds by early autumn.

“I think autumn will be early just because we have to reduce our age very slowly and carefully,” Stéphane Bancel said at an event on social media platform Clubhouse on Monday.

Stephane Bancel

‘We expect data to be available in the September/October timeframe.’

Bancel said clinical trials in young children are taking longer because researchers need to determine appropriate doses.

Children are often the last group to be tested during clinical trials because they are not just little adults.

Their bodies and immune systems behave differently, meaning they may have different treatment needs.

What’s more, children may need different doses or needle sizes depending on their height, weight and age – so most children are vaccinated only after safety has been well documented in the adult population.

In fact, Pfizer has announced that it has chosen lower doses for COVID-19 vaccine trials in children than those given to teenagers and adults.

Those aged 12 and over receive two doses of 30 micrograms (μg) vaccine,

However, children aged five to 11 years will be given a 10 μg dose, and children six months to four years old will be given a three μg dose.

 

Moderna’s vaccine is only approved for adults, but last month clinical trials revealed safety and efficacy among 12- to 17-year-olds.

While the clinical trial has not examined efficacy, no children vaccinated contracted the virus at 14 of their second doses, while four children given a placebo later tested positive, ‘consistent with 100 percent efficacy,’ Moderna says.

However, despite the promising results, many parents are not enthusiastic about vaccinating their children.

In a recent survey conducted by the Kaiser Family Foundation, parents were asked whether they would vaccinate their children when a COVID-19 vaccine is approved and available for their child’s age group.

Just three in 10 parents – 29 percent – said they would vaccinate their children under 18 ‘immediately’.

The survey also said that 15 percent plan to vaccinate their children only if school requires it, and 19 percent say their children will definitely not be vaccinated.

What’s more, although children can catch COVID-19 and pass it on to others, they tend to be unwilling.

As of Tuesday, more than 3.97 million children have tested positive for the virus, according to the American Academy of Pediatrics.

Add Comment