We reported on Tuesday that Gov. Josh Green has issued an emergency order defying new guidance from the U.S. Food and Drug Administration regarding administering Moderna’s new Spikevax vaccine for Covid-19.
In brief, the FDA recently revoked its emergency authorization of an older Moderna Covid vaccine and set new age limits on administering the new Spikevax mRNA product: it is now “approved for use in individuals who are 65 years of age and older, or 6 months through 64 years of age with at least one underlying condition that puts them at high risk for severe outcomes from Covid-19.”
That quote comes from the FDA’s Aug. 27 revocation letter. You can read the letter, and the memo justifying the action, archived at the FDA’s website here.
Green’s emergency “Proclamation Relating to Pharmacist-Provided Vaccine Serves” asserts that the FDA “has not provided any evidence that the Covid-19 vaccine poses any more risk of harm” to people in the excluded ages. Therefore, Green is taking up the recommendations of the West Coast Health Alliance, which is a hui of Democrat administrations in California, Hawai‘i, Oregon and Washington formed this month, to defy federal health agencies of the Trump administration. Under his proclamation, Hawai‘i pharmacists are allowed to disregard the FDA guidelines and administer the Covid vaccine to children as young as age 3, whether they have an underlying medical condition or not.
There’s a lot to unpack here. Our first call was the state Attorney General’s office to ask for an explanation of Green’s authority to defy federal rule-making.
The AG punted. No explanation given.
Instead, the AG referred us to the state Department of Health. The DOH, as we reported yesterday, loves the proclamation. State Epidemiologist Sarah Kemble, in an interview with ASD, repeated the governor’s assertion that FDA provided no evidence for the change and insisted there’s “a big body of evidence” that Covid vaccinations have more benefits than the risks.
I’ve read the governor’s proclamation in full, and the FDA’s Aug. 27 letter and memorandum. Maybe Green and Kemble have not, because their arguments are talking right past the FDA’s argument.
What the FDA said is that the vaccines had been authorized in response to an emergency … and the emergency is over. Therefore, the vaccine is, rather than unsafe in any unusual fashion, simply unnecessary for categories of people, but still very much recommended for other categories with higher risk factors for Covid. And contrary to Green’s claim the FDA provided no evidence, the FDA memo does cite publications backing its assertions, see the memo at the link above.
If there’s a document that makes claims without evidence, it is actually Green’s own proclamation.
That’s hardly the only problem with the poses, arguments and attitudes on display in the proclamation. Here are some that stand out for me, maybe others stand out for you. The document is available here. Let’s go through some of them …
“WHEREAS, on January 30, 2020, the World Health Organization declared COVID-19 a public health emergency of international concern,” the proclamation begins.
Yes. That was five years ago. As the FDA states in its new guidance, the emergency is over. I can see where Green and others would love to keep it going, it’s been very good for his career and the power of bureaucrats in general, but the emergency is over. The Hawai‘i state Supreme Court put an end to former Gov. Ige’s state of Covid emergency as of March 26, 2022.
“WHEREAS, COVID-19 is a highly infectious disease that has caused over 2,000 deaths in Hawai’i and continues to cause hospitalization of Hawai‘i residents …”
The state is indeed still tracking “Covid-19 Hospitalization Metrics,” and as of now, the 7-day average for “hospitalized ICU Covid-19 patients” is four. The 7-day average of new admissions with Covid-19 is also four.
Some things are missing from that data, however. For example, are these ICU patients in ICUs because of Covid, or for other reasons but also tested positive for Covid? Authorities consistently played fast and loose with that distinction to justify their Covid policies.
Also missing is any sense of scale or context. What proportion of hospital care is going to Covid patients that would require any emergency proclamations?
According to a state DOH report on hospital utilization for 2022, the most recent full year available, Hawai‘i’s hospitals saw:
- 67,061 admissions to medical/surgical beds
- 8,452 admissions to critical care beds
- 13,730 admissions to obstetrics beds
- 8,167 admissions to pediatric beds
- 554 admissions to neonatal ICU beds
- 4,223 admissions to psychiatric beds
That’s 102,187 hospital admissions in a year. Assuming 2024 turns out much the same, how many admissions could have a Covid dimension?
The state Covid-19 Hospitalization Metrics site doesn’t give a running total, it provides 7-day averages. The highest 7-day average so far this year was a peak of 65 hospitalized Covid patients during Aug. 27 to Sep. 2. Let’s err on the side of caution and say, in the worst-case scenario, if every week of 2025 were at that average, we’d see 3,380 Covid admissions (65 times 52). But we won’t get anywhere near that number as no other week has been so high and many weeks have averages as low as 8 or 12.
But assuming potentially 3,380 Covid admissions, that works out to about, at most, 3% of all admissions we might see this year, and most likely the total will be lower. And, again, we’re talking about data that is not clearly distinguishing which patients were admitted for some other health problem but who also tested positive for Covid.
None of this math is in Green’s proclamation, nor these links to his own agency’s data. The proclamation proceeds from an intention for us all to stay, emotionally, in 2020 forever.
“WHEREAS, the COVID-19 pandemic strained the state’s health care system and negatively impacted the state’s economy …”
That was then. Where is the strain now? And excuse me, Doctor Governor, but the pandemic didn’t negatively impact the state’s economy alone, the decision of policymakers around the world to initiate lockdowns did most of that. I’ve yet to see local politicians even attempt to account for the costs of their lockdowns, economically, or in health and education impacts in Hawai‘i.
I’ll skip ahead to the action this proclamation really takes, which is to suspend state laws regarding vaccinations, laws which require that vaccines here will be administered “in accordance with the recommendations of the Advisory Committee on Immunization Practices of the United States Department of Health and Human Services.”
This is what Green and the other governors of the West Coast Health Alliance are actually doing: suspending the state laws that bind them to federal rules. Whether or not they can legally do so is exactly what Green’s Attorney General declined to answer. The Supremacy Clause of the U.S. Constitution says that federal law preempts state law, but here we have states defying administrative rules. Someone will have to draw a line from the rule-making aspect of these agencies to the authority invested in them by Congress.
If I were a pharmacist, I’d be on the phone with my lawyer and my malpractice insurance agent to ask, “Am I really safe going along with this? What kind of protection does this proclamation really give me?”
Bottom line: Green has presented no compelling evidence for why pharmacists in 2025 should keep administering a vaccine to people who don’t need it, for a pandemic that is long since over, in an emergency that isn’t emergent. This isn’t science-based, it's tribal. Trump said one thing, so these governors have to say the opposite.
As for the actions they’ve taken, there’s something tragically funny about Democrat governors forming a regional alliance — a kind of confederacy, if you will — to defy a Republic administration.
What’s next, secession?
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A. Kam Napier is editor in chief of Aloha State Daily. His opinions in Pipikaula Corner are his own and not reflective of the ASD team.
A. Kam Napier can be reached at kam@alohastatedaily.com.
