Green defies FDA vaccine rules

Emergency order allows pharmacists to administer COVID-19 vaccine to people without underlying conditions, opposing federal decisions.

MB
Michael Brestovansky

September 24, 20252 min read

Gov. Josh Green delivered the State of the State address before lawmakers and leaders on Jan. 21.
Gov. Josh Green delivered the State of the State address before lawmakers and other leaders on Jan. 21. (Office of the Governor)

Gov. Josh Green used emergency powers Tuesday to ensure continued access to the COVID-19 vaccine.

In response to an initiative by the U.S. Food and Drug Administration to limit the use of a COVID-19 vaccine developed by pharmaceutical company Moderna, Inc., Green issued an emergency proclamation Tuesday to allow pharmacists to continue to administer the vaccine to people as young as three years old.

In August, the FDA authorized the use of a new Moderna vaccine, Spikevax, for people between the ages of 6 and 65 who have at least one underlying condition that increases their vulnerability to COVID. Spikevax would also be available for anyone over the age of 65, regardless of whether they have any underlying conditions.

Those age limits are more restrictive than those set in a 2020 authorization for a previous Moderna vaccine, which allowed the shot to be administered to people as young as six months old. The FDA terminated that authorization at the same time as approving Spikevax and its more limited age range.

But Green claimed in his proclamation that the FDA “has not provided any evidence” justifying the greater restrictions on the vaccine, and that there’s no science yet to support that Spikevax is riskier for healthy people with no underlying conditions than those with.

Meanwhile, last week, the Advisory Committee on Immunization Practices voted to only recommend COVID-19 vaccines to people six months old or older subject to shared decision making between patients and healthcare providers. This, Green’s proclamation argues, “has caused confusion and hesitancy amongst healthcare providers,” who are left unclear as to how to satisfy vaccination administration requirements.

On the other hand, the West Coast Health Alliance — a coalition of states including California, Hawai‘i, Oregon and Washington that formed in September to make its own public health recommendations separate from the U.S. Centers for Disease Control and Prevention — has issued its own COVID-19 vaccine recommendations, which include vaccinating all people between the ages of 2 and 64 who seek protection against the virus.

Green’s proclamation allows Hawai‘i pharmacists to continue to provide COVID-19 vaccinations to anyone older than 3 years old without a doctor’s prescription.

“Cutting off access for healthy children and adults would put Hawai‘i families at risk,” Green said in a statement. “As a physician, father and Governor, I have to stand up for science and evidence-based protection for our local families, and we will always act to make sure care remains accessible to everyone who needs it.”

The proclamation takes effect immediately and will remain in effect until Nov. 22 unless it is terminated early. Based on other emergency proclamations, Green could issue subsequent proclamations every 60 days to effectively extend it indefinitely.

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Authors

MB

Michael Brestovansky

Government & Politics Reporter

Michael Brestovansky is a Government and Politics reporter for Aloha State Daily covering crime, courts, government and politics.