The Hawaiʻi Department of Health endorsed Gov. Josh Green’s emergency proclamation maintaining access to COVID-19 vaccines.
Green issued the proclamation Tuesday, Sept. 23, in response to new rules by the U.S. Food and Drug Administration limiting who can be given COVID-19 vaccinations.
While the FDA rules limit a new vaccine by pharmaceutical company Moderna to only people between the ages of 6 and 65 with underlying conditions that make them more susceptible to the coronavirus, Green’s proclamation challenges those rules, allowing pharmacists to continue to administer vaccines to people as young as 3 years old with no restrictions.
“The FDA rules makes it much muddier to tell who is actually eligible,” said state epidemiologist Sarah Kemble, who told ASD that there are a wide range of “underlying conditions” that increase the risk of extreme reactions to COVID-19.
For example, Kemble said, habitual smokers could be considered to be at higher risk from COVID, as could people who are overweight, or diabetic. Whether any of those conditions would make a person eligible for the vaccine under the new FDA rules is unclear, because those new rules are vague and unspecific, she said.
Furthermore, Kemble said the new Moderna vaccine — called Spikevax — is an updated version of the previous shot developed in 2024, with modifications to target more recent strains of the coronavirus. That previous shot was authorized for use by anyone as young as 6 months old.
Meanwhile, there is another Moderna-developed vaccine, called mNEXSPIKE, with even greater restrictions, only available for people between 12 and 65 at high risk for severe COVID-19 impacts.
“I can definitely say the FDA’s rule changes don’t refer to any new evidence to justify the changes,” Kemble said, adding that there remains “a big body of evidence” that the benefits of COVID vaccination outweigh the risks.
Kemble questioned FDA’s justification for limiting access to the vaccine — in an August memorandum, the FDA argued that COVID-related hospitalization rates are significantly reduced compared to 2020.
“It’s not even clear that hospitalization has come down a ton,” Kemble said.
According to state DOH data, hospitalizations of people with COVID spiked statewide over the summer, peaking in the last week of August with an average of 8 new COVID hospital admissions per day. This was the highest hospitalization rate since August 2024.
At the same time, Kemble pushed back against recommendations by the Advisory Committee on Immunization Practices, which voted last week to only recommend vaccines to people based on shared discussions between patients and health care providers.
“It’s a great thought to talk with your primary health care provider about it,” Kemble said. “But, especially in Hawai‘i, many people don’t have primary care providers.”
Kemble said the proclamation has been made through “a careful review of the legal landscape” by the state Attorney General. Although ASD reached out to the AG’s office to inquire about Green’s authority to defy FDA rules, the AG’s office declined to comment on the matter.
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