PHOENIX — In his legal dispute with the Biden administration over mandates, Attorney General Mark Brnovich is now raising questions about whether COVID-19 vaccines were properly tested for safety.
Brnovich, who is running in a crowded Republican primary for U.S. Senate, contends the COVID vaccines Arizonans are being offered have not gotten final approval, despite Food and Drug Administration statements to the contrary about the Pfizer vaccine.
The latest version of his lawsuit filed in federal court says the process used by the FDA for full approval “has been significantly accelerated.’’
He cites the Centers for Disease Prevention and Control’s statement 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 says, quoting the CDS, adding that the Phase 3 trials on a large group of human subjects typically last several years. That time is used to compare vaccine recipients with others who have not been inoculated and to allow discovery of potential side effects.
In the case of the Pfizer vaccine, however, he said the Phase 3 trials were conducted from July 27, 2020 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.
Brnovich claims that what the FDA gave final approval to was Pfizer’s Comirnaty version of the vaccine. But he said that’s not the one being distributed here.
“The only Pfizer COVID-19 vaccine actually available in the United States is the prior Pfizer BioNTech COVID 19 version,’’ he said. And that is “only available pursuant to an emergency use authorization,’’ as with the Moderna and Johnson & Johnson vaccines, he said.
Brnovich said 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. He said that legally protects all people the Biden administration contends must get vaccinated.
The accuracy of his claim about the current Pfizer vaccine is in dispute.
In an Oct. 20 letter from the FDA to Pfizer, the federal agency said 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.
Conner said Brnovich is not claiming the vaccines are unsafe. But she said, “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.”
As to whether Brnovich himself has been inoculated, Conner said it would be “inappropriate’’ for her to answer that question.
The CDC says more than 414 million doses of COVID-19 vaccine have been given in the U.S. through Oct., and that the vaccines are safe and effective.”The vaccines met the Food and Drug Administration’s rigorous scientific standards for safety, effectiveness, and manufacturing quality needed to support approval or authorization of a vaccine,” the agency says on its website.
Brnovich is trying to get the federal judge 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.
Another is the requirement that all federal employees be vaccinated or face loss of their jobs, with the only exceptions being for those who quality for medical or religious exemptions.
Brnovich has no legal standing in that fight. To get around that, he has associated with a private attorney with a client who is a federal employee who does not want to get vaccinated and says he fears he will lose his job.
The third is a closely related provision imposing the same mandates on anyone who works for a company or entity that has contracts with the federal government. That can include Arizona’s 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 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. Instead, he is saying the administration is not requiring vaccines of people as they cross into the country illegally or are allowed to remain. He contends that “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. He said that statements by Biden that his “patience is wearing thin’’ with Americans who choose not to get vaccinated “further indicate discriminatory intent.’’
Brnovich cited figures from a Fox News report that 18% of migrant families who recently crossed the border tested positive for COVID.
