Hawaii waits for approval of children’s shots from FDA

The state Department of Health is ready to roll out highly anticipated COVID-19 vaccinations for keiki ages 5 to 11 as soon as it gets the green light from federal authorities.

The department said the U.S. Food and Drug Administration must approve the use of the Pfizer-­BioNTech vaccine for this age group, and the Centers for Disease Control and Prevention must issue recommendations for its clinical use before administration can begin. But it is ready.

“DOH has been working with public- and private-sector partners to prepare for the likely authorization of COVID-19 vaccines for children 5-11 to ensure equitable distribution across the state,” said Health Director Dr. Elizabeth Char in a news release. “While Pfizer reports its vaccine provides robust protection for children 5-11, we await a review of the scientific evidence by federal regulators.”

DOH said it plans to offer the vaccines at a wide range of sites — from schools to pop-up clinics, community health centers, hospitals, pharmacies and a limited number of pediatricians’ offices. Also poised for a rollout is a comprehensive outreach campaign encouraging parents and guardians to support vaccinations for this group, as their consent will be required.

As of Thursday 70.6% of Hawaii’s population of more than 1.4 million had completed vaccinations, while 79.1% initiated them. DOH on Wednesday marked a milestone of more than 1 million people having completed vaccinations.

Hawaii has an estimated 119,473 children ages 5 to 11, or roughly 8.4% of the state’s population, according to DOH.

Dr. Melinda Ashton, Hawaii Pacific Health executive vice president and chief quality officer, said the pending approval is exciting, particularly for many parents who are anxious to get their kids vaccinated.

Ashton, also a pediatrician, expects patterns to be similar to the rollout of COVID-19 vaccines for adults, with an initial surge among those who have eagerly been waiting, followed by slower waves and then efforts to reach those who remain hesitant or still have questions.

“There are going to be opportunities to get your kids shots as soon as we get approval and the vaccine doses have arrived in Hawaii,” said Ashton. “If you have questions, now is a good time to talk to your pediatrician. Now would be a good time to start.”

The vaccines will be available to pediatricians, who must register with the state to administer them. So far, fewer than two dozen have expressed interest, according to DOH, which may be due to logistics. They would need to have an observation area to monitor vaccine recipients after their shots, and might not have the setup needed at their offices to accommodate several patients.

The Pfizer dose being considered for children ages 5 to 11 is one-third of the adult dose and administered with a smaller needle. It would require an initial shot followed by a second one three weeks later.

Although, children who contract the coronavirus do not tend to get as ill as seniors, they are still at risk of falling ill and developing long-term symptoms, said Ashton.

“I think parents are wondering, ‘Do I need to do this vaccination for my child?’ The value of doing it is, first of all, children do get COVID and some get long COVID,” she said. “Also, when they get infected they can pass this virus on to those with highest risk. Vaccination, although it’s not perfect in preventing infection, certainly should help to reduce the spread among the community.”

As of Oct. 14 nearly 6.2 million children tested positive for COVID-19 since the pandemic began, according to the American Academy of Pediatrics and Children’s Hospital Association.

In Hawaii, Ashton said, the state has fortunately recorded very few COVID-19 cases with serious illnesses in keiki, but there have been cases among those as young as infants.

Unvaccinated mothers can pass the virus to their baby, or older siblings to a younger child, so vaccinations help protect the family.

A third maternal death due to COVID-19 was recently confirmed by the Hawaii Maternal Review Committee. A pregnant woman died from the coronavirus after giving birth to her baby, which survived. Hawaii doctors are also urging pregnant and recently pregnant women to get vaccinated because they are at increased risk for severe illness from COVID-19.

Lena Haapala of Honolulu plans to get her 10-year-old daughter vaccinated as soon as possible, particularly since the school year is well underway.

She said getting notices of coronavirus cases during the first semester at school has proved nerve-wracking. And out of an abundance of caution, both she and her daughter got tested when a positive turned up in her daughter’s class. Fortunately, both tested negative, but even mild potential symptoms like a headache can make Haapala nervous.

“As soon as they allow it, we’re going to do it,” she said. “I’d feel she’s even more protected, plus wearing a mask and making sure they stay in their bubbles.”

The state Department of Education said it has hosted more than 150 school-based clinics statewide in partnership with DOH and health service providers, and continues to do so for eligible students and interested families and employees.

“In anticipation of a vaccine being approved for younger children, we are working closely with the Department of Health to identify elementary and middle schools in prioritized communities and match those schools with health service providers to host additional clinics,” said DOE in a statement.

Some 83,000 students in the 5-11 age group enrolled in public schools at the start of this school year.

The federal approval is still weeks away, as an FDA advisory committee is scheduled to meet Tuesday to discuss authorization of the vaccine, and a CDC advisory committee is scheduled to meet Nov. 2 to discuss clinical recommendations.

The number of daily coronavirus cases in Hawaii, meanwhile, continues to decline, following a steady downward trend that began in September.

On Thursday, DOH reported 156 new infections statewide, bringing the state’s total since the start of the pandemic to 82,886 cases. The seven-day average of daily cases was at 117, a 43% drop from two weeks earlier. The average positivity rate was at 1.7%.

The DOH expects the federal government to distribute the first waves of vaccine directly to states and has pre-ordered 41,700 doses — the full allotment for Hawaii — which would cover about 35% of children in the 5-to-11 age bracket.

Upon authorization, DOH said sites offering keiki vaccinations will be listed at HawaiiCOVID19.com/ vaccine.