JACKSONVILLE, Fla. – Drugmaker Pfizer has again modified the protocol for its late-stage study of its vaccine against the coronavirus -- this time to include more young participants.
The company said Monday that it has received permission from the Food and Drug Administration to include adolescents aged 12 through 15 in its global COVID-19 vaccine study.
Dr. Michael Koren, the director of the Jacksonville Center for Clinical Research who is overseeing COVID-19 vaccine trials for Pfizer, said that even though his facility has not been selected as of yet to sign up children that young, the development is still encouraging.
Koren said allowing children as young as 12 to enroll in COVID-19 vaccine trials is a decision that makes sense considering data that shows children are COVID-19 superspreaders.
“Let’s just say we show that it’s safe and effective in the younger population -- but most importantly, we get information that it reduces the spread of the virus -- then a strategy from a public health standpoint could be to vaccinate kids across the board," Koren said, "That would prevent the disease from spreading in the community.”
As of Tuesday afternoon, according to the Florida Department of Health, there had been 61,849 COVID cases involving minors in the state since the pandemic began. Of that number, 779 children were hospitalized and nine died from COVID-19 complications. Those numbers are less than the number of adults who have been hospitalized or died from the virus. But while data shows older adults are more likely than children to die from the virus, News4Jax asked Koren what he would tell a worried parent to convince them to allow their 12-year-old child to be a part of a vaccine trial.
“Kids will be taking it, not so much for themselves, but to protect their parents and grandparents," Koren said.
Koren said that when it comes to vaccine trials, typical pediatric studies happen years after adult studies if it involves an illness that affects everyone and not just children.
“But in this case, we’re moving very aggressively to younger people because we’re seeing the spread pattern," Koren said.
And because it’s hard to keep children apart at school and other social settings, researchers say targeting the younger population is a better strategy for fighting the spread of the coronavirus.
Although Koren’s research facility was not selected to enroll children as young as 12 in the COVID-19 vaccine trials, he said he thinks that will soon change. As for the people who have enrolled, he said there has not been one reported complication.
New York-based Pfizer originally planned for 30,000 participants, but in September expanded that to 44,000 people. That increase was made to boost diversity in the trial population, specifically by including 16- and 17-year-old teens, as well as stable patients with some common chronic infections: hepatitis B, hepatitis C and HIV.
Pfizer’s trial also includes significant numbers of Hispanic, Black, Asian and Native American participants, plus many people aged 56 through 85. The diversity is aimed at providing information on how safe and effective the experimental vaccine is in people of different ages and backgrounds.
Looking at different vaccine trials
While a late-stage study of Johnson & Johnson’s COVID-19 vaccine candidate has been paused while the company investigates whether a study participant’s “unexplained illness” is related to the shot, Koren, who’s also directing COVID-19 vaccine trials for Moderna in addition to Pfizer, said the trials that he oversees have been able to continue because of what they are giving trial participants.
“The ones we’re involved with here are using what’s called the messenger RNA platform," Koren said. “And that does not involve injecting a virus -- just a small piece of genetic code in a fat module that tells the body what to do.”
Koren said that so far, there have not been any reported complications after giving the vaccine to Pfizer trial participants, and what Pfizer is administering is far different than what companies that have stopped vaccine trials were administering to its participants.
“The ones that had stopped are more of the traditional vaccines that actually involve injecting a virus, so both the Johnson & Johnson product, which I’m familiar with, and the AstraZeneca-Oxford product use an inactive adenovirus," Koren said.
Adenovirus is a common virus that causes illnesses such as the common cold, sore throats and pneumonia. Koren said that when an inactive adenovirus is spiked with COVID-19 , the combination produces the immunity.
“But you’re actually injecting a virus in those studies, so the devil is in the details here," Koren said.
Koren said there are 145 COVID-19 vaccines that are being studied around the world, and as many as a dozen are in the advanced stages of clinical trials.
The Associated Press contributed to this report.