PHOENIX — Attorney General Mark Brnovich is opening a new front in his legal battle with the Biden administration over mandates for some people to get vaccinated, raising questions about whether they have been properly tested for safety.
In fact, he contends that what Arizonans are being offered has not even gotten final approval despite publicity to the contrary.
The latest version of a lawsuit filed in federal court says that the process used by the Food and Drug Administration for full approval of the COVID vaccine “has been significantly accelerated.”
In legal filings, the attorney general cites the Centers for Disease Prevention and Control which says that vaccine licensing “is a lengthy process that can take 10 years or longer.”
“It also involves three phases of clinical trials with humans before they can be licensed,” Brnovich quotes the CDC, with the Phase 3 trials on a large group of human subjects typically lasting several years. That time compares recipients with those who have not been inoculated and allows for discovery of potential side effects.
In the case of the Pfizer vaccine, however, he said the Phase 3 trials were conducted of those who had been enrolled from July 27, 2020 and followed through up through mid-March of this year.
“The FDA thus required less than eight months of Phase 3 trial data, rather than the period of several years normally used to observe side effects and adverse effects,” Brnovich told U.S. District Court Judge Michael Liburdi.
But the situation, according to Brnovich, is even worse.
He claims that what the FDA gave final approval to was Pfizer’s Comirnaty version of the COVID-19 vaccine. Only thing is, Brnovich says, that's not the one being distributed here.
“The only Pfizer COVID-19 vaccine actually available in the United States is the prior Pfizer BionNTech COVID 19 version,” he said. And that, Brnovich said is “only available pursuant to an emergency use authorization,” just like the Moderna and Johnson & Johnson vaccines.
That distinction is important.
It starts with what Brnovich said is the fact that drugs authorized under an emergency use authorization are approved by the FDA through a procedure “that is less rigorous than the full approval process.”
More to the point, the attorney general said federal law spells out that recipients of vaccines available only under emergency use authorizations have the right “to accept or refuse administration” of those drugs. And that, he said, protects all the people that the Biden administration contends have to get vaccinated.
How accurate is that claim is in dispute.
In an Oct. 20 letter from the FDA to Pfizer, the federal agency says that the Comirnaty vaccine”is the same formulation as the Pfizer BioNTech vaccine.”
Brnovich press aide Katie Conner does not dispute that the formula is the same. But she argues there is something different in the way Comirnaty is manufactured that adds something.
And all that, Conner said, is important -- and backs up Brnovich's claim that what the president wants to order some Arizonans to take is not a fully approved drug “and is governed by different laws.”
Conner said her boss is not claiming the vaccines are unsafe. But she suggested that perhaps Arizona consumers weren't getting all the information they need.
“Vaccines must be a choice and Americans deserve all information and transparency from public officials and pharmaceutical companies to make the best decision for themselves and their families,” Conner said.
As to whether Brnovich himself has been inoculated, Conner said it would be “inappropriate” for her to answer that question.
All this is part of Brnovich’s attempt to get Liburdi to issue an order blocking the Biden administration from enforcing its policies requiring certain people to be vaccinated. Liburdi has scheduled a hearing for Nov. 10.
Hanging in the balance are three specific actions the Biden administration is taking.
First are the proposed new regulations by the Occupational Safety and Health Administration to require vaccines of all employees of companies with more than 100 workers. That rule, yet to be formally enacted, has a work-around, allowing instead for testing at least weekly.
Brnovich had previously sued over the last provision. But he never actually pursued that claim given that the rules do not exist.
The new version keeps that claim and adds two more.
One is the requirement that all federal employees be vaccinated or face loss of their jobs. The only exceptions are for those who qualify for medical or religious exemptions.
Brnovich himself has no legal standing in that fight. But to get around that, he has associated with a private attorney who has a client who is a federal employee who does not want to get vaccinated and says he fears he will lose his job.
The other is a closely related provision imposing the same mandates on anyone who works for a company or entity that has contracts with the federal governments. That can include the three state universities, all of which get federal dollars.
Brnovich said the state is harmed because the mandate will cause “large-scale resignations of unvaccinated employees of federal contractors.”
But Brnovich, who is running for U.S. Senate largely on criticism of the Biden administration's border enforcement policies, is hanging much of his legal claim not on whether the federal government has the power to impose such mandates but instead on the fact that it is not requiring vaccines of people as they cross into the country illegally or are allowed to remain. That, he contends “constitutes discrimination on the basis of national origin and alienage in violation of the Equal Protection Clause.”
“Defendants failure to articulate any justification for their differential, favorable treatment of unauthorized aliens demonstrates discriminatory intent,” Brnovich is arguing. And he said that statements by the president, like his “patience is wearing thin” with Americans who choose not to get vaccinated “further indicate discriminatory intent.”
“At the same time, driven by President Biden's campaign promises of lax immigration enforcement and loose border security, defendants have created a crisis at the southern border leading to an unprecedented wave of unlawful immigration into the U.S.” Brnovich said.
He cited figures from a Fox News report that 18% of migrant families who recently crossed the border tested positive for COVID. But Brnovich said the administration is is allowing these people to refuse vaccination, "thus protecting aliens' freedom and bodily autonomy more than for American citizens.”
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