For schools, parents, vaccine approval for kids a waiting game
Some look forward to vaccine after trial yields promising results, others still hesitant
Parents, schools and communities wait on standby as Pfizer and BioNTech move toward approval requests to use their COVID-19 vaccine for children under 12 years old.
The companies announced on Monday the results from a vaccination trial that showed a “favorable safety profile” and “robust” responses in children 5 to 11 years old. The trial demonstrated the successful use of a two-dose regimen of 10 micrograms administered 21 days apart — this is a smaller dose than the 30 micrograms used for eligible people 12 and older.
Since July, pediatric cases of COVID-19 have risen by about 240 percent in the United States, according to Albert Bourla, chairman and CEO of Pfizer, and now the pharmaceutical company plans to share its data with the U.S. Food and Drug Administration in hopes for full approval of the vaccine for children 5 to 11 years old by the end of the year.
In response to the recent findings, the state Department of Education said that “increasing vaccination rates within our communities continues to be one of the best ways we can protect ourselves and help keep our schools open and safe for learning.”
“Many of our elementary schools stand ready to begin hosting clinics once a vaccine is approved for younger children,” DOE spokesperson Nanea Kalani told The Maui News on Monday. “Soon after a vaccine was approved for adolescents 12 and older, the department began standing up school-based vaccination clinics in early May to make access as easy and convenient as possible for students and their families.”
Kalani said that this aligns with a core essential strategy set by the state Department of Health, which encourages vaccinations for all eligible employees and students.
As of last week, all individuals 12 years old and up are already required to show proof of full vaccination status or provide a negative COVID-19 test result when visiting state facilities, including public schools.
In partnership with the Health Department and health service providers, DOE has held more than 150 school-based clinics statewide.
DOE schools and facilities reported 325 cases in the first week back to in-person classes in August, just as delta variant-fueled cases were beginning to crest statewide. While high school students are eligible for the vaccine, thousands of other elementary-aged kids are not, and the constant cycle of exposure and quarantine at all levels has prompted educators across the state to call for safer conditions and more support for staff.
Looking ahead, Lihikai Principal Barbara Oura Tavares said that administrators are prepared to adapt when necessary.
“The unpredictable nature of a pandemic requires us to be responsible and responsive so that we can pivot to any change or disruption,”
Tavares said in a statement. “We do our best by being prepared yet adaptive; by being collaborative in our planning, decision-making and actions; and by having clear, open communication. In the end, it is about ensuring that everyone who is a member of our school community is safe, healthy and cared for.”
Though it could be months until the Pfizer vaccine is approved for young children, some principals are worried that this may set off even more pushback among families and parents.
“Unfortunately, I continue to see the division between those who choose to be vaccinated and those who choose not to be and they are all digging in deeper,” said Melita Charan, head of school at Roots School Maui. “I know that everyone is tired and feels pushed to their edge, but my hope is that parents will do their best to model respectful and kind communication regardless of which side they stand for.”
The small private school in Haiku serves children in preschool through 6th grade and said it has not yielded any student COVID-19 cases since the pandemic started.
“We do believe that part of the reason for this is because we have worked so hard on our multiple mitigation strategies — masks, staying home when sick and being outdoors as much as possible,” Charan said Tuesday. “Although our new health policies may be seen as inconvenient, everyone understands that in order for us to continue to offer in-person classes, we have to put the health of our community first.”
Still, she feels that having an FDA-approved vaccine available for keiki under 12 years old could help reduce the number of pediatric cases.
“Vaccinations are the number one way to prevent hospitalization and death. Fortunately, we are not seeing too many keiki in the hospital and simultaneously, it is our responsibility to think about the ‘we’ and not just the ‘I’,” she added. “My hope is that we will all do everything we can to prevent the spread and possible loss of more kupuna and those individuals that are immune compromised.”
During the vaccine trial for younger individiuals, the antibody responses in the 2,268 participants given 10-microgram doses were comparable to those recorded in a previous Pfizer-BioNTech study in people 16 to 25 years of age immunized with 30-microgram doses.
The lower dosage of the vaccine was selected for “safety, tolerability and immunogenicity,” or the tendency to trigger an immune response, in keiki 5 to 11.
“Over the past nine months, hundreds of millions of people ages 12 and older from around the world have received our COVID-19 vaccine,” Bourla said in a news release Monday.
“We are eager to extend the protection afforded by the vaccine to this younger population, subject to regulatory authorization, especially as we track the spread of the delta variant and the substantial threat it poses to children.”
The trial had a 95 percent success rate, demonstrating a “strong immune response in this cohort of children one month after the second dose,” according to the news release. The data collected is the first from a pivotal trial of any COVID-19 vaccine in children under 12 years of age.
Side effects were comparable to those observed in participants 16 to 25 years of age.
“These trial results provide a strong foundation for seeking authorization of our vaccine for children 5 to 11 years old, and we plan to submit them to the FDA and other regulators with urgency,” Bourla said.
Pfizer and BioNTech plan to share the data with the FDA, European Medicines Agency and other regulators “as soon as possible.”
For the U.S., the companies are required to gather safety and efficacy data to file for full FDA approval for this age group before this vaccine can be rolled out, which could be at the end of this year.
Reports from trials for children from 2 to 5 years of age and children 6 months to 2 years of age are expected near the end of the year.
According to the Center for Disease Control and Prevention, there have been 266 deaths among children under the age of 17 with confirmed or presumed COVID-19 so far this year. About 434 in this same age group died from the flu last year.
If and when the next age group is approved for vaccinations, the topic remains controversial for many Maui families.
One parent of two young children, who requested anonymity, said “my opinion is it would be a lot safer” knowing that a vaccine is available for 5- to 11-year-olds while attending school together.
“I also know of families that are not willing to get vaccinated for themselves or their kids, if and when available,” the parent said.
With a shot potentially on the horizon for younger populations, Hannah Housman of Wailuku said that “parents should have the final say over what goes into their child’s body,” especially when it’s “new technology.”
As a mom to twin boys, ages 6, and two girls, ages 9 and 11, she noted that “my concern regarding vaccinating my children is that this is a new type of vaccine,” adding that her girls are worried about possible restrictions on their gymnastics program.
As mandated vaccinations or negative COVID-19 tests are expanding in schools and business, Housman is concerned that these routine checks for vaccine status or test results are creating isolation between peers.
“They are losing bits of their childhood as they are routinely informed of each other’s vaccine status and test results,” she said. “This is not healthy for our keiki. The stress this is putting on families of school age children is unbearable. We have to consider the social and mental health of our children as we move forward.”
Chris Blyth of Wailuku said that he is pro-vaccine, but when it comes to his 6-year-old son, who is caught up on childhood immunizations for attending public school, he would not agree to giving him a newly available COVID-19 vaccine.
“To be clear, COVID is indeed a dangerous virus for people in certain demographics. It can cause serious, potentially fatal, pulmonary, renal and cardiovascular impairment, especially among those who are elderly, infirm, obese or afflicted with other comorbidities,” Blyth said Tuesday night. “But the threat posed to kids by COVID is not an emergency sufficient to warrant the use of an experimental vaccine which we don’t know the medium and long-term efforts and efficiency of.”
With parents in their 70s, he had encouraged them to get vaccinated as soon as possible, but the statistical chance of death for kids in this age group is nearly 0 percent, he said, citing the CDC.
“We thank God for vaccines in general and believe that they have saved hundreds of thousands of lives over the years,” Blyth said.
* Dakota Grossman can be reached at firstname.lastname@example.org.