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Pfizer Begins Vaccine Trials on 3 to 11-Year-Olds in the US

Army Spc. Angel Laureano holds a vial of the COVID-19 vaccine, Walter Reed National Military Medical Center, Bethesda, Md., Dec. 14, 2020. (DoD photo by Lisa Ferdinando)

The American pharmaceutical giant Pfizer announced it is now expanding its coronavirus vaccine clinical trials for children ages 3 to 11 years old in the quest to make the vaccine available to school-aged youngsters as soon as possible.

Children aged 12 and up began receiving the vaccine during the week of May 10 in the United States in five centers across the country.

Some medical professionals are calling this new push “the final frontier” as the product is trialed on the very young for the first time ever.

Pfizer’s CEO is Thessaloniki-born Dr. Albert Bourla, who joined the company almost thirty years ago.

The 2-year-long study involves a subset of children who will receive the COVID-19 vaccine, with a second, control group will receive a placebo or saline injections as part of the Phase 2 out of 3 total trials.

Importantly, however, breaking from practice so far, the amount of vaccine administered to the young children will be just a third of the adult dose.

“I’m looking forward to going back to my teacher”

Two of the children taking part in the groundbreaking trials were 8-year-old Max Perales and his sister Zoe Perales, who is just six. They received their injections at Stanford university earlier this week and spoke to reporters from San Francisco’s ABC 7 News afterward about their hopes for a post-pandemic world.

Asked what he was hoping to do after he was fully inoculated, Max stated “Going back to baseball and soccer maybe. How about jiu-jitsu and martial arts? I have a couple suits that probably don’t fit me anymore.”

Next to him, Zoe piped up, saying “I’m looking forward to going back to my teacher.”

Pfizer’s newest trial is focused not only on detecting the antibody response to the coronavirus vaccine, but also verifying if the decreased dosage produces enough immunity for this age cohort.

Children 3 to 11 years of age will be injected with just 10 micrograms in each vaccine dose, as opposed to the 30 micrograms all those 12 and older received when they were inoculated.

Data to be submitted by the Fall

Dr. Yvonne Maldonado, Stanford’s Professor of Global Health and infectious diseases, stated to ABC 7 “We are hoping to enroll enough children to get safety data and antibody response data in the next couple weeks, so that we can then get second doses in and submit this information to the FDA by the fall.

“We would love to see a vaccine for 5 – 12-year-olds as safe and effective by fall, so kids can go back to school with vaccine coverage,” said Maldonado.

Although the number of coronavirus cases is falling precipitously nationwide and the vaccine rollout for the older set has been stellar in the United States, lingering unrest is still on the horizon as youngsters go unvaccinated amongst older, vaccinated people who for the most part are unmasked now in the US.

Children are far from immune to the virus although their statistics for serious disease and complications put them at the bottom of the ladder regarding vaccine access, with older Americans and those with complicating health factors inoculated first.

US Centers for Disease Control Director Dr. Rochelle Walensky had earlier stated that in the month before the Pfizer vaccine was authorized for people as young as 12, the agency observed “troubling data” regarding adolescents who had been hospitalized with severe Covid-19.

Dr. Yvone Maldonado is the principal investigator at Stanford University’s School of Medicine for the Pfizer trial. She said the School has seen enormous interest in young families who want their children to be part of the trials.

“These are families that are coming forward. We are not advertising. They are coming forward and volunteering,” she noted to interviewers.

“We would love to enroll more, but in order to get these vaccines trials done we are limited, and we certainly have hundreds of people more than we can accommodate, if not thousands,” Maldonado added.

“Just not seeing any major concerns” with vaccine

Asked if there were any concerns regarding vaccinating children as young as five, Maldonado was reassuring, replying “We are just not seeing any major safety concerns. We know these vaccines do not cause cellular or DNA damage, which is one of the areas that people have been talking about. That is not happening.”

The vaccine investigator said the children taking part in the study will be monitored for two years during this process.

“(We) watch them in the clinic for several hours, and then every day they would be sending us information about how they are doing, and they will come back for visits as well,” she stated.

The Kaiser Permanente medical system enrolled approximately 75 children ranging from 5 to 11 years of age for this Pfizer trial. Eleven-year-old Luci Guardino was the very first to receive the shot on Tuesday of this week.

“Starting yesterday and this morning my arm did feel a little bit heavy, but I don’t feel sick or anything,” she told interviewers on Wednesday.

The Pfizer company states that it anticipates having the initial results of the children’s trials in September. But naturally they have their sights set on the next group — the tiniest patients of all — those down to the age of two, who will take part in the next test of the vaccine.

Dr. Nicola Klein, the principal investigator for the Northern California trials, is getting ready for that all-important stage — which will be followed by the ultimate test, proving the vaccine is safe in children as young as six months of age.

“We are still arranging logistics for a younger age group. Younger than 5, but that is still a little bit of a work in progress still for the next several weeks,” Dr. Klein stated to reporters.

Families still will not know for the next six months if their children were or were not actually vaccinated with the Pfizer COVID-19 vaccine. After the trials are over, all those who received the placebo injection will have a chance to receive the actual vaccine after that six-month period.

As the trial continues, physicians believe that Pfizer will submit an emergency authorization, just as they have for all other age groups, for children who are 5 to 11 years of age soon.

“At least by what Pfizer Biotech has publicly stated is that they were planning to make this available in the fall. Submit authorization to the FDA,” Dr. Klein stated.

For now, the CDC is recommending that all students in the United States keep their masks on at school for the remainder of the 2020/2021 academic year.

As the vaccine trials roll onward, however, and the product has been proven 100% safe in all children who have received it so far, the prospects for a much easier and more normal school year in 2021/2022 are becoming rosier all the time.

We could have a vaccine for tots under five as early as the end of the year, according to doctors at Stanford who spoke to reporters.

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