‘Dangerous Games’: States Defy Federal Agencies, Create Their Own COVID Vaccine Rules

U.S. | Science & Health | Rights & Freedoms

3 hours ago

Originally posted by: Children's Health Defense

States across the U.S. are announcing plans to break with the new vaccine recommendations issued by federal health agencies and set their own policies on COVID-19 vaccinations.

Four Western states — California, Oregon, Washington and Hawaii — announced last week the formation of the West Coast Health Alliance, a public health partnership intended to issue its own immunization guidelines.

Washington went a step further, issuing a standing order last week that makes it “easier for Washington residents to get vaccinated” by allowing pharmacists and physicians in the state to administer COVID-19 vaccines to people ages 6 months and older, including pregnant women.

Several other states also moved to counter the U.S. Food and Drug Administration’s (FDA) announcement last month to end its broad authorization of COVID-19 vaccines, restricting the shots to people at higher risk for severe illness.

Last week, Massachusetts became the first state to mandate that insurers cover the COVID-19 vaccines.

In New York, the governor declared a “statewide disaster emergency” and an executive order to preserve access to the COVID-19 vaccine — a possible prelude to the formation of a public health alliance by eight northeastern states.

This week, Minnesota Gov. Tim Walz signed an executive order giving healthcare providers in the state the ability to “use their medical judgment” to recommend and administer vaccines.

On Wednesday, New Jersey’s Department of Health issued an executive directive authorizing anyone 6 months of age and older to receive a COVID-19 shot.

Last week, Pennsylvania’s State Board of Pharmacy voted to bypass federal guidelines by allowing pharmacists to continue administering COVID-19 vaccines. Colorado, Nevada and New Mexico have enacted similar guidelines.

‘These are dangerous games’

The governors of California, Oregon and Washington targeted the Centers for Disease Control and Prevention (CDC) in their joint statement announcing the alliance.

They said the CDC “has become a political tool that increasingly peddles ideology instead of science,” which “will lead to severe health consequences.”

Last week, MSNBC said the alliance is a “functional necessity.” An editorial in The Seattle Times said the creation of the alliance is “the right move.”

Andrew Nixon, a spokesperson for the U.S. Department of Health and Human Services (HHS), challenged the previous health policies in those states. In remarks quoted by The Hill, Nixon accused health officials of pushing “unscientific school lockdowns, toddler mask mandates and draconian vaccine passports during the COVID era.”

Such policies “completely eroded the American people’s trust in public health agencies,” Nixon said. “HHS will ensure policy is based on rigorous evidence and Gold Standard Science, not the failed politics of the pandemic.”

Last week at a press conference hosted by Florida Gov. Ron DeSantis, Florida Surgeon General Joseph Ladapo announced his state will eliminate all vaccine mandates, including for children to attend school.

Karl Jablonowski, Ph.D., senior research scientist at Children’s Health Defense (CHD), said vaccine policy is splitting the U.S. along partisan lines:

“We are, sadly, coming to the consensus of two public health states — split ideologically by ‘red states’ and ‘blue states.’ How we best practice public health is yet one more issue and tool to divide the public, and one more thing to flip-flop as administrations change.”

Research scientist and author James Lyons-Weiler, Ph.D., said the western and northeastern states “are executing an end-run around newly restrictive federal eligibility,” but in doing so, they are putting the public in danger.

“It’s important not to downplay the political gains in their base from distancing themselves from the Trump administration. But politics should not determine healthcare and public health policy. These are dangerous games,” he said.

Pediatrician Dr. Michelle Perro agreed. “Public health is not best served by fragmented, state-by-state policies, especially when it comes to something as complex and high-stakes as vaccinations,” she said.

Other experts suggested that state-level moves to issue their own vaccine recommendations may lead to unforeseen legal questions and expose those states to liability for vaccine injuries among those who follow those states’ guidance.

“These state-level efforts to override the current CDC vaccine recommendations appear to be poorly thought out, and are likely fraught with unintended consequences, both medical and political,” said internal medicine physician Dr. Clayton J. Baker.

States issuing recommendations aligned with Big Pharma-linked organizations

In their announcement last week, the governors of California, Oregon and Washington said the West Coast Health Alliance was a response to the “dismantling” of the CDC by the Trump administration. They said the alliance would issue its own vaccination guidelines “informed by respected national medical organizations.”

“We need to stand for the values of who we are and be able to point people to what we feel are science-based approaches,” said Washington state Secretary of Health Dennis Worsham, in remarks quoted by The Seattle Times.

Washington also issued a “COVID-19 vaccine standing order,” authorizing providers to “administer the most updated versions” of the COVID-19 vaccines to anyone 6 months of age or older, without a prescription.

Worsham said the shots would be administered “off-label,” referring to the use of an approved treatment for an unapproved health condition, age group, dosage or route of administration.

Worsham said that in the coming days, the alliance will issue guidance aligned with the recommendations of medical organizations, including the American Academy of Pediatrics (AAP) and the American College of Obstetricians and Gynecologists.

Last month, the AAP published an “evidence-based immunization schedule” which defies CDC guidance by recommending COVID-19 vaccination for all children between 6 and 23 months of age “to help protect against serious illness.”

The AAP also recommends a single dose of the COVID-19 vaccine for all children and adolescents 2-18 years old who are in a high-risk group, and for children in the same age group whose parent or guardian requests the shot.

The AAP, which represents 67,000 pediatricians, receives substantial funding from the federal government and from Big Pharma — including vaccine manufacturers.

In July, the group sued U.S. Health Secretary Robert F. Kennedy Jr. and other public health officials and agencies over changes to COVID-19 vaccine recommendations for children and pregnant women.

“These states are calling their approach ‘science-based,’” but their actions “reflect trade association positions, not science,” Lyons-Weiler said.

He said the states are enacting policies without waiting for the CDC Advisory Committee on Immunization Practices to vote next week on COVID-19 vaccine recommendations.

NPR reported that the alliance will also draw on recommendations from the Vaccine Integrity Project, launched in April and led by several former federal public health officials. The project, which aims to “shore up U.S. vaccination policy,” is funded by iAlumbra, a nonprofit founded by Walmart heiress Christy Walton.

Jablonowski said the AAP and the Vaccine Integrity Project are beholden to Big Pharma and are marked by conflicts of interest. He said:

“Dissenting states are aligning with guidelines authored by the AAP, which has Merck, Sanofi, Moderna and Pfizer in its President’s Circle of donors. The Vaccine Integrity Project … is supported by Christy Walton — heiress to Walmart and the profits from its pharmacy.

“For just a few $10,000 or $100,000 donations to buy the voices behind AAP or the Vaccine Integrity Project, Big Pharma stands to reap millions in profits. It is a return-on-donation so profitable, it would be a dereliction to shareholders if they didn’t intervene.”

According to Oregon Public Broadcasting, the states comprising the West Coast Health Alliance may enter into “bulk vaccine purchasing agreements” to secure enough doses of the COVID-19 vaccines for their populations.

In 2020, California, Oregon, Washington and Nevada formed the “Western States Pact” to coordinate COVID-19 pandemic restrictions, Oregon Public Broadcasting reported. Those states “were three of the final states to lift their mask mandates.”

New York declares ‘statewide disaster emergency’ to promote COVID shots

Last week, Massachusetts began requiring insurers to pay for vaccines recommended by the state as part of Gov. Maura Healey’s “immediate measures” to protect the availability of COVID-19 and other vaccines amid changing CDC guidelines.

Also last week, New York Gov. Kathy Hochul issued an executive order declaring a “statewide disaster emergency” due to “federal actions related to vaccine access.” The order authorizes pharmacists in the state to provide COVID-19 shots to anyone who wants one through Oct. 5, after which the order can be renewed.

Hochul indicated that the state legislature will seek to pass legislation next year making the regulations permanent.

“Extreme times call for extreme measures,” Hochul said when signing the order. “And this is the power I have to use in the interim until we are able to have the legislature get back in January and pass legislation that mandates this.”

New York’s press release announcing the executive order also states that it will issue a standing order authorizing pharmacists to “continue to provide timely and convenient access” to the COVID-19 vaccines.

Earlier this week, The Disinformation Chronicle published a copy of the guidance New York State’s Department of Health sent to providers, authorizing them to promote “off-label” administration of COVID-19 vaccines to adults and children.

The guidance states that COVID-19 vaccines are recommended for all adults and for all children between 6 and 23 months of age, and for children ages 2-18 who are in a high-risk group or whose parents request the shot — recommendations that match the AAP’s guidelines.

States may face legal liability for injuries from vaccines they recommend

Legal and medical experts told The Defender that states’ moves to enact their own vaccination regulations may expose them to legal liability for anyone injured by vaccines they received as a result of those states’ recommendations.

“States have long police powers in public health and have issued vaccine standing orders for influenza and routine immunizations,” Lyons-Weiler said. “What’s novel is the scale and coordination … and the explicit intent to counter federal eligibility constraints in real time.”

Attorney Greg Glaser said these states are following a “political agenda,” including through the “unprecedented” recommendation of off-label vaccine administration.

“The blue state recommendations that providers administer the shots off-label will generate liability because when injuries inevitably occur, the victims can likely sue for medical negligence,” Glaser said.

He said some judges may try to block such lawsuits using the Public Readiness and Emergency Preparedness Act (PREP Act).

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The PREP Act provides a liability shield to manufacturers of products issued under “emergency use authorization” in response to a public health emergency, including COVID-19 vaccines — and to those administering those products.

“Executive orders and standing orders are challengeable under state administrative law,” Lyons-Weiler said. “If states explicitly authorize off-label administration outside federal labeling and beyond any applicable PREP umbrella, exposure risk increases.”

Michael Kane, founder of Teachers for Choice and CHD’s director of advocacy, said New York and Massachusetts implicitly acknowledged these liability issues in the instructions they provided to their physicians, which incorporate “a ton of new, unprecedented protocols” for the administration of the COVID-19 vaccines.

Kane said:

“In New York, the provider must discuss myocarditis, pericarditis and other adverse reactions to the COVID-19 shot before administering it. They also must document the conversation and have the recipient of the shot sign that they were given this information beforehand.”

Glaser said another federal law, the Employment Retirement Income Security Act of 1974, “generally preempts state mandates for state-funded employer [insurance] plans.” He said this may lead to lawsuits in some states.

While many states are focusing on COVID-19 vaccine access, that focus may evolve. Kane said:

“We will likely see similar reactions if there are changes to other recommended shots on the CDC vaccine schedule. These syndicates are in a defensive posture to react to whatever comes out of Washington in defense of Big Pharma.”

Perro said the new state policies may also affect the federal health funding they receive. She said:

“When states make independent decisions about mandates, insurance coverage or standing orders for pharmacists to administer shots … they are doing so with federal money, but without federal accountability. That disconnect raises both ethical and practical concerns.”

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