Vaccinating youth the next big step
12-15 age group soon can get Pfizer shots
Lowering the age of children who can get vaccinated for COVID-19 is important to protect their health and to slow the spread of the coronavirus, a Yale New Haven Children’s Hospital doctor said Tuesday.
The Food and Drug Administration is expected to approve the Pfizer-BioNTech vaccine for 12- to 15year-olds by next week, according to a federal official.
Yale New Haven is discussing how to roll out the shots to the younger age group, according to Dr. Thomas Murray, associate medical director for infection prevention at the children’s hospital.
“Over 20 percent of new COVID cases these days are in pediatrics, in children,” Murray said Tuesday. As of April 30, there were 150 cases of COVID, among patients at the hospital, almost all of whom are 18 and younger, he said. Thirty-seven required intensive care but there have been no deaths. He did not have numbers for the 12- to 15year-old age group but said most of the pediatric patients requiring intensive care have been teenagers.
There was one COVID patient at Yale New Haven Children’s Hospital on Tuesday, he said.
Statewide, there were 60,452 cases of COVID among those 19 and younger and five deaths, according to the state website. As of Monday, there were 340,545 total cases and 8,112 deaths in Connecticut.
There were 8,831 cases per 100,000 of those ages 10 to 19, a higher rate than 60to 79-year-olds, according to the state, and 5,429 cases per 100,000 people ages 9 and younger.
“To reduce the spread in all populations, it’s important to vaccinate children,” Murray said. “Adolescents are capable of forceful cough and spreading aerosols, so they can absolutely spread COVID.” Vaccinating younger people has “the potential to reduce transmission in the community.”
Murray said while most children do not get seriously ill with COVID, “some of the new variants, especially B.1.1.7, do tend to make children sicker.” B.1.1.7, the variant first found in the U.K., is the dominant variant in Connecticut.
He also said chronic medical conditions, such as compromised immune systems caused by cancer and Down syndrome, “could put them at risk of becoming very sick with COVID.”
Another reason to vaccinate young teens is to protect them when they play sports or join other group activities. “If you get groups of vaccinated people together, you are far less likely to have a super-spreader event,” Murray said.
Vaccinating younger age groups benefits the entire population, he said. In those who are not vaccinated, “there continues to be the risk of asymptomatic spread, and while vaccination probably doesn’t eliminate that altogether, it certainly seems to reduce it,” Murray said.
“You’re essentially giving them the opportunity to spend more time with older adults who are vaccinated and you will reduce the risk for anyone in the community that that vaccinated child comes in contact with for extended periods of time,” he said.
The Yale Center for Clinical Investigation was one of the sites where clinical trials of the Pfizer vaccine were conducted, including the 12-to-15 age group. Dr. Onyema Ogbuagu, the principal investigator, was out of the country Tuesday and unavailable
to comment, according to spokeswoman Colleen Moriarty. Ogbuagu also led Yale’s trials for the Pfizer vaccine on older age groups.
The clinical trial showed the Pfizer vaccine was 100 percent effective in that age group and Yale is beginning trials of patients from 6 months to 11 years old. “The safety profile so far for the Pfizer vaccine has been excellent, so … the benefits far outweigh the risks,” Murray said.
Pfizer told Wall Street analysts and reporters on an earnings call Tuesday the company expects to file for full FDA approval for its vaccine for people 16 to 85 this month, according to CNN. The vaccine now has emergency use authorization. Pfizer also plans to seek emergency use authorization for children ages 2 to 11 in September.
Murray said Yale New Haven Health staff are discussing how to roll out the vaccine to the younger age group.
“We’re already vaccinating 16-year-olds and I imagine this will be a similar process,” he said, and children must be accompanied by a parent, who must give consent for the vaccine.
Now, the regular vaccination sites are being used for younger people. “When you go to choose a site, you can [see] what vaccine is at that site. Any of the sites that have the Pfizer are eligible to give the vaccine to those 16 and younger,” once the FDA authorizes it, he said.
“Getting another eligible population vaccinated is a step toward getting back to some normalcy, which we all want,” Murray said.
The Center for Clinical Investigation was preparing to begin a trial of Moderna’s vaccine on children 6 months to 12 years old and on a Sanofi/GSK vaccine for adults 18 and older. Both were expected to begin early this month.
Dr. Inci Yildirim, associate professor of pediatrics (infectious diseases) at Yale School of Medicine, will lead Yale’s component of Moderna’s clinical trial of a vaccine for children 6 months to 12 years of age, according to Yale. Yale has 400 children on its waiting list and hopes to begin enrolling them this week, Yildirim said.
Called KidCOVE, the phase 2/3 trial is being conducted at about 90 sites across the U.S. and Canada and will include 6,750 children. Yildirim said the number of children who will be enrolled is unknown at this time, but they will be enrolled in three groups: 6 months to 2 years, 2 to 6 years and 6 to 12 years. She said the data will be available to submit to the FDA later this year, and “maybe early 2022 the vaccine can be available for the younger age groups.”
It is the same messenger RNA vaccine that older people have received, but the doses will be different, Yildirim said. Adults and older teens received 100 micrograms of the vaccine, but the younger children will be given doses of 25, 50 or 100 mcg. “Their immune response can be different,” so they may need a smaller dose, she said.
The vaccine also must be scheduled around routine childhood immunizations, Yildirim said, and blood draws will be limited to three over the 12 months the children are followed.
Moderna’s study is in partnership with the National Institutes of Health and the U.S. Department of Health and Human Services. Yale was not part of a previous Moderna study, of children 12 to 17 years old. “They are expected to apply to the FDA for emergency use authorization within the next two weeks for that study,” Yildirim said.